E-OPTIMAL: The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
Study Details
Study Description
Brief Summary
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.
We propose to test the following null hypotheses:
-
There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery.
-
The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS) and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence (SUI).
The OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. A further goal of E-OPTIMAL is to investigate a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and SUI, by randomizing subjects to two different recruitment methods.
The primary aims of this extension study are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and stress urinary incontinence:
-
time to surgical failure;
-
the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group;
-
the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms (urinary, bowel, and prolapse), adjusted for PMT treatment group.
An additional primary aim (aim 4) is to determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention in E-OPTIMAL. We will utilize a conceptual framework that assesses three concepts (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level). This conceptual framework was developed following a review of the scant available literature on the topic, as well as during discussions with investigators who are experienced in recruiting and retaining participants in pelvic floor disorders studies.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Enrollment video arm Arm of subjects that will be shown a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process. |
Behavioral: Enrollment video
Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
|
No Intervention: No video intervention arm This group of subjects will not view a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process. |
|
Experimental: ULS Uterosacral Ligament Suspension was one of the randomized surgical treatments in the OPTIMAL study |
Procedure: ULS
uterosacral ligament suspension to suspend the vaginal apex
|
Experimental: SSLF Sacrospinous Ligament Fixation was one of the randomized surgical treatments in the OPTIMAL study. |
Procedure: SSLF
sacrospinous ligament fixation to suspend the vaginal apex
|
Experimental: PMT Perioperative Behavioral Therapy/Pelvic Muscle Training was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study. |
Behavioral: PMT
perioperative behavioral therapy / pelvic muscle training with formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery
|
Other: Usual Care No Perioperative Behavioral Therapy/Pelvic Muscle Training (i.e., usual care) was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study. |
Other: Usual Care
usual care both before and after prolapse surgery with respect to pelvic muscle training
|
Outcome Measures
Primary Outcome Measures
- Surgical Failure [6 months and 1, 2, 3, 4, and 5 years]
Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
- Recruitment Into E-OPTIMAL [At 24 Months post OPTIMAL Treatment]
Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.
- Retention in E-OPTIMAL [3, 4, and 5 Years Post OPTIMAL Treatment]
Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).
Secondary Outcome Measures
- Anatomic Failure [6 months and 1, 2, 3, 4, and 5 years]
Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
- Bothersome Bulge Symptoms [6 months and 1, 2, 3, 4, and 5 years]
Bothersome bulge symptoms were reported by the participant in response to the questions, 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' on the Pelvic Floor Disorders Inventory. An answer of "Yes" to either question indicates a failure while an answer to "No" for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
- Retreatment for Pelvic Organ Prolapse [6 months and 1, 2, 3, 4, and 5 years]
Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Other Outcome Measures
- Number of Participants With Granulation Tissue [2, 3, 4, and 5 years]
Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log.
- Number of Participants With Suture Exposure [2, 3, 4, and 5 years]
Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log.
- Number of Participants With Midurethral Sling Erosion or Exposure [2, 3, 4, and 5 years]
Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log.
- Number of Participants With Pelvic Organ Prolapse Surgery [2, 3, 4, and 5 years]
Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log.
- PGI-I [6 months, and 1, 2, 3, 4, and 5 years]
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up)
- Change From Baseline CRAIQ Score [6 months, and 1, 2, 3, 4, and 5 years]
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
- Change From Baseline POPIQ Score [6 months, and 1, 2, 3, 4, and 5 years]
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
- Change From Baseline UIQ Score [6 months, and 1, 2, 3, 4, and 5 years]
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
- Change From Baseline CRADI Score [6 months, and 1, 2, 3, 4, and 5 years]
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
- Change From Baseline POPDI Score [6 months, and 1, 2, 3, 4, and 5 years]
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
- Change From Baseline UDI Score [6 months, and 1, 2, 3, 4, and 5 years]
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
- Change From Baseline Hunskaar Score [6 months, and 1, 2, 3, 4, and 5 years]
The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score).
- Change From Baseline SF-36 Physical Health Score [6 months, and 1, 2, 3, 4, and 5 years]
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score).
- Change From Baseline SF-36 Mental Health Score [6 months, and 1, 2, 3, 4, and 5 years]
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score).
- Change From Baseline Brink Score [6 months, and 2, 3, 4, and 5 years]
The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year [0.5, 2, 3, 4, 5] Score - Baseline Score).
- POP-Q Point Ba [6 months, and 1, 2, 3, 4, and 5 years]
POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). The range for point Ba is -3 to total vaginal length (TVL). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum).
- POP-Q Point Bp [6 months, and 1, 2, 3, 4, and 5 years]
POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
- POP-Q Point C [6 months, and 1 2, 3, 4, and 5 years]
POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Completion of the Year 2 OPTIMAL in-person visit
Exclusion Criteria:
-
Inability to provide informed consent.
-
Subjects who are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL. Note: Subjects unable to return for annual visits are not excluded as they can participate in the telephone interview. However, every attempt will be made to encourage in-person participation.
Criteria for termination of participation:
(Due to evidence or likelihood that the subject can no longer consent for herself)
-
Subjects 75 years and older that fail the telephone mini-mental status examination. If the participant gets 5 or more of the 10 items "incorrect" the interviewer says "thank you very much for your time, that completes the interview for today." In other words, the interviewer in no way implies to the participant that they did not "pass" a test to continue. The interviewer contacts the appropriate site coordinator immediately after the interview to let them know of the outcome.
-
Subjects younger than 75 who appear to have cognitive deficits during the quality of life telephone interview will be administered the mini-mental status examination; those who fail will be excluded from further participation. (Proxy respondents will not be used.) Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
-
Subjects who become long-term residents of a skilled nursing facility.
-
Withdrawal of consent. Verbal assent will be obtained prior to each telephone interview and each in-person visit.
Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama | Birmingham | Alabama | United States | 35249 |
2 | University of California, San Diego Medical Center | La Jolla | California | United States | 92037 |
3 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
4 | Duke University | Durham | North Carolina | United States | 27710 |
5 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
6 | University of Texas Southwestern | Dallas | Texas | United States | 75390 |
7 | University of Utah | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- NICHD Pelvic Floor Disorders Network
Investigators
- Principal Investigator: Matthew D. Barber, MD, The Cleveland Clinic
- Principal Investigator: Eric Jelovsek, MD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 16P01S
Study Results
Participant Flow
Recruitment Details | The goal of the video/no video intervention was to gauge differences in recruitment for and retention in E-OPTIMAL, thus the video/no video randomization occurred before E-OPTIMAL consent. |
---|---|
Pre-assignment Detail | Treatment groups are from the original OPTIMAL trial. Participants in the E-OPTIMAL trial were recruited from OPTIMAL participants that completed the Year 2 OPTIMAL visit. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Period Title: Overall Study | ||||
STARTED | 95 | 91 | 91 | 97 |
Completed OPTIMAL Year 2 Visit | 81 | 80 | 79 | 87 |
Randomized to Video | 32 | 43 | 38 | 40 |
Randomized to No Video | 45 | 30 | 34 | 42 |
Consented to Participate E-OPTIMAL | 72 | 66 | 69 | 78 |
Completed E-OPTIMAL Year 3 Visit | 70 | 66 | 66 | 77 |
Completed E-OPTIMAL Year 4 Visit | 67 | 61 | 63 | 68 |
Completed E-OPTIMAL Year 5 Visit | 62 | 56 | 62 | 64 |
COMPLETED | 90 | 87 | 87 | 92 |
NOT COMPLETED | 5 | 4 | 4 | 5 |
Baseline Characteristics
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | Total |
---|---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Total of all reporting groups |
Overall Participants | 72 | 66 | 69 | 78 | 285 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
55.4
(10.8)
|
58.6
(10.6)
|
58.7
(10.5)
|
56.3
(11.2)
|
57.2
(10.8)
|
Sex/Gender, Customized (Count of Participants) | |||||
Female |
72
100%
|
66
100%
|
69
100%
|
78
100%
|
285
100%
|
Race/Ethnicity, Customized (Count of Participants) | |||||
American Indian or Alaska Native |
1
1.4%
|
1
1.5%
|
0
0%
|
0
0%
|
2
0.7%
|
Asian |
0
0%
|
2
3%
|
0
0%
|
0
0%
|
2
0.7%
|
Black or African American |
7
9.7%
|
3
4.5%
|
7
10.1%
|
4
5.1%
|
21
7.4%
|
Other |
5
6.9%
|
5
7.6%
|
4
5.8%
|
8
10.3%
|
22
7.7%
|
White |
59
81.9%
|
55
83.3%
|
58
84.1%
|
66
84.6%
|
238
83.5%
|
Race/Ethnicity, Customized (Count of Participants) | |||||
Hispanic/Latina |
15
20.8%
|
10
15.2%
|
13
18.8%
|
18
23.1%
|
56
19.6%
|
Not Hispanic/Latina |
57
79.2%
|
56
84.8%
|
56
81.2%
|
60
76.9%
|
229
80.4%
|
Insurance: Private/HMO (Count of Participants) | |||||
No |
70
97.2%
|
65
98.5%
|
68
98.6%
|
76
97.4%
|
279
97.9%
|
Yes |
2
2.8%
|
1
1.5%
|
1
1.4%
|
2
2.6%
|
6
2.1%
|
Insurance: Medicare or Medicaid (Count of Participants) | |||||
No |
55
76.4%
|
46
69.7%
|
47
68.1%
|
56
71.8%
|
204
71.6%
|
Yes |
17
23.6%
|
20
30.3%
|
22
31.9%
|
22
28.2%
|
81
28.4%
|
Insurance: Self-pay (Count of Participants) | |||||
No |
70
97.2%
|
65
98.5%
|
68
98.6%
|
76
97.4%
|
279
97.9%
|
Yes |
2
2.8%
|
1
1.5%
|
1
1.4%
|
2
2.6%
|
6
2.1%
|
Insurance: Other (Count of Participants) | |||||
No |
57
79.2%
|
55
83.3%
|
59
85.5%
|
60
76.9%
|
231
81.1%
|
Yes |
15
20.8%
|
11
16.7%
|
10
14.5%
|
18
23.1%
|
54
18.9%
|
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kg/m^2] |
30.2
(6.5)
|
28.2
(5.3)
|
28.8
(4.9)
|
28.3
(5.2)
|
28.9
(5.5)
|
Current Smoker (Count of Participants) | |||||
No |
64
88.9%
|
61
92.4%
|
64
92.8%
|
73
93.6%
|
262
91.9%
|
Yes |
8
11.1%
|
5
7.6%
|
5
7.2%
|
5
6.4%
|
23
8.1%
|
Diabetes (Count of Participants) | |||||
Unknown |
4
5.6%
|
2
3%
|
0
0%
|
1
1.3%
|
7
2.5%
|
No |
59
81.9%
|
59
89.4%
|
58
84.1%
|
72
92.3%
|
248
87%
|
Yes |
9
12.5%
|
5
7.6%
|
11
15.9%
|
5
6.4%
|
30
10.5%
|
Connective tissue disease (Count of Participants) | |||||
Unknown |
1
1.4%
|
1
1.5%
|
0
0%
|
3
3.8%
|
5
1.8%
|
No |
70
97.2%
|
65
98.5%
|
68
98.6%
|
72
92.3%
|
275
96.5%
|
Yes |
1
1.4%
|
0
0%
|
1
1.4%
|
3
3.8%
|
5
1.8%
|
Number of Vaginal Deliveries (Deliveries) [Median (Full Range) ] | |||||
Median (Full Range) [Deliveries] |
3
|
2
|
3
|
3
|
3
|
Number of Cesarean Deliveries (Deliveries) [Median (Full Range) ] | |||||
Median (Full Range) [Deliveries] |
0
|
0
|
0
|
0
|
0
|
Estrogen Use: Oral or patch (Count of Participants) | |||||
No |
63
87.5%
|
56
84.8%
|
60
87%
|
70
89.7%
|
249
87.4%
|
Yes |
9
12.5%
|
10
15.2%
|
9
13%
|
8
10.3%
|
36
12.6%
|
Estrogen Use: Vaginal cream or tablets (Count of Participants) | |||||
No |
59
81.9%
|
50
75.8%
|
49
71%
|
60
76.9%
|
218
76.5%
|
Yes |
13
18.1%
|
16
24.2%
|
20
29%
|
18
23.1%
|
67
23.5%
|
Menstrual Status (Count of Participants) | |||||
Not sure |
5
6.9%
|
4
6.1%
|
3
4.3%
|
3
3.8%
|
15
5.3%
|
Postmenopausal |
42
58.3%
|
48
72.7%
|
49
71%
|
49
62.8%
|
188
66%
|
premenopausal |
25
34.7%
|
14
21.2%
|
17
24.6%
|
26
33.3%
|
82
28.8%
|
Hysterectomy (Count of Participants) | |||||
No |
58
80.6%
|
42
63.6%
|
52
75.4%
|
59
75.6%
|
211
74%
|
Yes |
14
19.4%
|
24
36.4%
|
17
24.6%
|
19
24.4%
|
74
26%
|
Prior SUI Surgery (Count of Participants) | |||||
No |
71
98.6%
|
62
93.9%
|
67
97.1%
|
75
96.2%
|
275
96.5%
|
Yes |
1
1.4%
|
4
6.1%
|
2
2.9%
|
3
3.8%
|
10
3.5%
|
Prior POP Surgery (Count of Participants) | |||||
No |
68
94.4%
|
58
87.9%
|
67
97.1%
|
74
94.9%
|
267
93.7%
|
Yes |
4
5.6%
|
8
12.1%
|
2
2.9%
|
4
5.1%
|
18
6.3%
|
Pelvic Organ Prolapse-Q stage (Count of Participants) | |||||
2 |
27
37.5%
|
23
34.8%
|
26
37.7%
|
31
39.7%
|
107
37.5%
|
3 |
43
59.7%
|
37
56.1%
|
41
59.4%
|
45
57.7%
|
166
58.2%
|
4 |
2
2.8%
|
6
9.1%
|
2
2.9%
|
2
2.6%
|
12
4.2%
|
Outcome Measures
Title | Surgical Failure |
---|---|
Description | Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
Time Frame | 6 months and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 90 | 87 | 87 | 92 |
Failure |
17
23.6%
|
22
33.3%
|
20
29%
|
14
17.9%
|
Non-failure |
73
101.4%
|
65
98.5%
|
66
95.7%
|
77
98.7%
|
Failure |
28
38.9%
|
35
53%
|
30
43.5%
|
29
37.2%
|
Non-failure |
58
80.6%
|
51
77.3%
|
56
81.2%
|
62
79.5%
|
Failure |
31
43.1%
|
45
68.2%
|
39
56.5%
|
37
47.4%
|
Non-failure |
51
70.8%
|
39
59.1%
|
44
63.8%
|
52
66.7%
|
Failure |
37
51.4%
|
52
78.8%
|
46
66.7%
|
41
52.6%
|
Non-failure |
39
54.2%
|
26
39.4%
|
31
44.9%
|
40
51.3%
|
Failure |
41
56.9%
|
55
83.3%
|
49
71%
|
43
55.1%
|
Non-failure |
30
41.7%
|
22
33.3%
|
26
37.7%
|
32
41%
|
Failure |
47
65.3%
|
57
86.4%
|
49
71%
|
45
57.7%
|
Non-failure |
22
30.6%
|
20
30.3%
|
26
37.7%
|
25
32.1%
|
Title | Recruitment Into E-OPTIMAL |
---|---|
Description | Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL. |
Time Frame | At 24 Months post OPTIMAL Treatment |
Outcome Measure Data
Analysis Population Description |
---|
The objective of the Outcome Measure was to compare retention rates for the "Enrollment video arm" and "No video arm", and the OPTIMAL treatment received was not relevant to this analysis |
Arm/Group Title | Enrollment Video Arm | No Video Intervention Arm |
---|---|---|
Arm/Group Description | Arm of subjects that will be shown a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process. Enrollment video: Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process | This group of subjects will not view a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process. |
Measure Participants | 153 | 151 |
Consented to E-OPTIMAL |
142
197.2%
|
143
216.7%
|
Did not Consent to E-OPTIMAL |
11
15.3%
|
8
12.1%
|
Title | Retention in E-OPTIMAL |
---|---|
Description | Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study). |
Time Frame | 3, 4, and 5 Years Post OPTIMAL Treatment |
Outcome Measure Data
Analysis Population Description |
---|
The objective of the Outcome Measure was to compare retention rates after consent into E-OPTIMAL for the "Enrollment video arm" and "No video arm", and the OPTIMAL treatment received was not relevant to this analysis |
Arm/Group Title | Enrollment Video Arm | No Video Intervention Arm |
---|---|---|
Arm/Group Description | Arm of subjects that will be shown a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process. Enrollment video: Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process | This group of subjects will not view a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process. |
Measure Participants | 142 | 143 |
Retained |
139
193.1%
|
135
204.5%
|
Not Retained |
3
4.2%
|
8
12.1%
|
Retained |
131
181.9%
|
124
187.9%
|
Not Retained |
11
15.3%
|
19
28.8%
|
Retained |
124
172.2%
|
120
181.8%
|
Not Retained |
18
25%
|
23
34.8%
|
Title | Anatomic Failure |
---|---|
Description | Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
Time Frame | 6 months and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 90 | 86 | 86 | 92 |
Failure |
10
13.9%
|
12
18.2%
|
13
18.8%
|
11
14.1%
|
Non-failure |
80
111.1%
|
74
112.1%
|
72
104.3%
|
80
102.6%
|
Failure |
18
25%
|
23
34.8%
|
19
27.5%
|
25
32.1%
|
Non-failure |
67
93.1%
|
61
92.4%
|
65
94.2%
|
66
84.6%
|
Failure |
23
31.9%
|
31
47%
|
25
36.2%
|
29
37.2%
|
Non-failure |
59
81.9%
|
50
75.8%
|
55
79.7%
|
58
74.4%
|
Failure |
29
40.3%
|
37
56.1%
|
31
44.9%
|
31
39.7%
|
Non-failure |
46
63.9%
|
33
50%
|
40
58%
|
47
60.3%
|
Failure |
33
45.8%
|
40
60.6%
|
32
46.4%
|
33
42.3%
|
Non-failure |
36
50%
|
29
43.9%
|
36
52.2%
|
38
48.7%
|
Failure |
38
52.8%
|
42
63.6%
|
33
47.8%
|
35
44.9%
|
Non-failure |
28
38.9%
|
26
39.4%
|
34
49.3%
|
31
39.7%
|
Title | Bothersome Bulge Symptoms |
---|---|
Description | Bothersome bulge symptoms were reported by the participant in response to the questions, 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' on the Pelvic Floor Disorders Inventory. An answer of "Yes" to either question indicates a failure while an answer to "No" for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
Time Frame | 6 months and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 90 | 88 | 87 | 94 |
Failure |
10
13.9%
|
12
18.2%
|
8
11.6%
|
5
6.4%
|
Non-failure |
80
111.1%
|
73
110.6%
|
76
110.1%
|
88
112.8%
|
Failure |
21
29.2%
|
19
28.8%
|
15
21.7%
|
9
11.5%
|
Non-failure |
68
94.4%
|
64
97%
|
67
97.1%
|
81
103.8%
|
Failure |
24
33.3%
|
27
40.9%
|
21
30.4%
|
17
21.8%
|
Non-failure |
61
84.7%
|
56
84.8%
|
58
84.1%
|
69
88.5%
|
Failure |
27
37.5%
|
29
43.9%
|
28
40.6%
|
20
25.6%
|
Non-failure |
47
65.3%
|
45
68.2%
|
43
62.3%
|
55
70.5%
|
Failure |
27
37.5%
|
32
48.5%
|
31
44.9%
|
22
28.2%
|
Non-failure |
45
62.5%
|
40
60.6%
|
39
56.5%
|
46
59%
|
Failure |
30
41.7%
|
34
51.5%
|
33
47.8%
|
23
29.5%
|
Non-failure |
36
50%
|
34
51.5%
|
35
50.7%
|
42
53.8%
|
Title | Retreatment for Pelvic Organ Prolapse |
---|---|
Description | Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
Time Frame | 6 months and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 93 | 86 | 86 | 93 |
Retreated |
1
1.4%
|
0
0%
|
1
1.4%
|
0
0%
|
Not retreated |
90
125%
|
86
130.3%
|
82
118.8%
|
92
117.9%
|
Retreated |
2
2.8%
|
3
4.5%
|
2
2.9%
|
2
2.6%
|
Not retreated |
83
115.3%
|
82
124.2%
|
79
114.5%
|
87
111.5%
|
Retreated |
5
6.9%
|
3
4.5%
|
6
8.7%
|
2
2.6%
|
Not retreated |
76
105.6%
|
77
116.7%
|
73
105.8%
|
85
109%
|
Retreated |
7
9.7%
|
3
4.5%
|
10
14.5%
|
2
2.6%
|
Not retreated |
61
84.7%
|
59
89.4%
|
55
79.7%
|
68
87.2%
|
Retreated |
7
9.7%
|
4
6.1%
|
10
14.5%
|
5
6.4%
|
Not retreated |
52
72.2%
|
51
77.3%
|
52
75.4%
|
52
66.7%
|
Retreated |
8
11.1%
|
4
6.1%
|
10
14.5%
|
6
7.7%
|
Not retreated |
52
72.2%
|
50
75.8%
|
51
73.9%
|
53
67.9%
|
Title | Number of Participants With Granulation Tissue |
---|---|
Description | Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log. |
Time Frame | 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
No |
58
80.6%
|
60
90.9%
|
52
75.4%
|
63
80.8%
|
Yes |
14
19.4%
|
6
9.1%
|
17
24.6%
|
15
19.2%
|
No |
54
75%
|
54
81.8%
|
48
69.6%
|
56
71.8%
|
Yes |
14
19.4%
|
6
9.1%
|
17
24.6%
|
15
19.2%
|
No |
49
68.1%
|
49
74.2%
|
43
62.3%
|
50
64.1%
|
Yes |
14
19.4%
|
6
9.1%
|
18
26.1%
|
16
20.5%
|
No |
43
59.7%
|
48
72.7%
|
41
59.4%
|
45
57.7%
|
Yes |
15
20.8%
|
6
9.1%
|
19
27.5%
|
16
20.5%
|
Title | Number of Participants With Suture Exposure |
---|---|
Description | Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log. |
Time Frame | 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
No |
57
79.2%
|
55
83.3%
|
60
87%
|
60
76.9%
|
Yes |
15
20.8%
|
11
16.7%
|
9
13%
|
18
23.1%
|
No |
53
73.6%
|
50
75.8%
|
57
82.6%
|
52
66.7%
|
Yes |
16
22.2%
|
11
16.7%
|
9
13%
|
19
24.4%
|
No |
49
68.1%
|
44
66.7%
|
51
73.9%
|
46
59%
|
Yes |
17
23.6%
|
12
18.2%
|
10
14.5%
|
20
25.6%
|
No |
42
58.3%
|
42
63.6%
|
49
71%
|
40
51.3%
|
Yes |
17
23.6%
|
12
18.2%
|
11
15.9%
|
20
25.6%
|
Title | Number of Participants With Midurethral Sling Erosion or Exposure |
---|---|
Description | Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log. |
Time Frame | 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
No |
70
97.2%
|
66
100%
|
68
98.6%
|
78
100%
|
Yes |
1
1.4%
|
0
0%
|
1
1.4%
|
0
0%
|
No |
65
90.3%
|
59
89.4%
|
63
91.3%
|
70
89.7%
|
Yes |
2
2.8%
|
1
1.5%
|
1
1.4%
|
0
0%
|
No |
60
83.3%
|
53
80.3%
|
58
84.1%
|
63
80.8%
|
Yes |
3
4.2%
|
1
1.5%
|
1
1.4%
|
0
0%
|
No |
53
73.6%
|
51
77.3%
|
54
78.3%
|
57
73.1%
|
Yes |
3
4.2%
|
1
1.5%
|
2
2.9%
|
0
0%
|
Title | Number of Participants With Pelvic Organ Prolapse Surgery |
---|---|
Description | Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log. |
Time Frame | 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
No |
72
100%
|
64
97%
|
67
97.1%
|
76
97.4%
|
Yes |
0
0%
|
2
3%
|
2
2.9%
|
2
2.6%
|
No |
64
88.9%
|
59
89.4%
|
58
84.1%
|
68
87.2%
|
Yes |
1
1.4%
|
2
3%
|
5
7.2%
|
2
2.6%
|
No |
55
76.4%
|
51
77.3%
|
55
79.7%
|
53
67.9%
|
Yes |
1
1.4%
|
3
4.5%
|
5
7.2%
|
4
5.1%
|
No |
55
76.4%
|
50
75.8%
|
54
78.3%
|
54
69.2%
|
Yes |
2
2.8%
|
3
4.5%
|
5
7.2%
|
5
6.4%
|
Title | PGI-I |
---|---|
Description | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up) |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
A little better |
12
16.7%
|
11
16.7%
|
10
14.5%
|
12
15.4%
|
A little worse |
5
6.9%
|
2
3%
|
5
7.2%
|
5
6.4%
|
Much better |
23
31.9%
|
22
33.3%
|
17
24.6%
|
20
25.6%
|
Much worse |
1
1.4%
|
1
1.5%
|
1
1.4%
|
1
1.3%
|
No change |
2
2.8%
|
1
1.5%
|
2
2.9%
|
3
3.8%
|
Very much better |
26
36.1%
|
26
39.4%
|
29
42%
|
31
39.7%
|
Very much worse |
0
0%
|
1
1.5%
|
1
1.4%
|
2
2.6%
|
A little better |
13
18.1%
|
10
15.2%
|
6
8.7%
|
6
7.7%
|
A little worse |
4
5.6%
|
1
1.5%
|
2
2.9%
|
6
7.7%
|
Much better |
22
30.6%
|
24
36.4%
|
18
26.1%
|
28
35.9%
|
Much worse |
0
0%
|
0
0%
|
1
1.4%
|
0
0%
|
No change |
4
5.6%
|
2
3%
|
5
7.2%
|
4
5.1%
|
Very much better |
26
36.1%
|
25
37.9%
|
30
43.5%
|
27
34.6%
|
Very much worse |
1
1.4%
|
0
0%
|
2
2.9%
|
1
1.3%
|
A little better |
14
19.4%
|
14
21.2%
|
9
13%
|
13
16.7%
|
A little worse |
3
4.2%
|
5
7.6%
|
6
8.7%
|
3
3.8%
|
Much better |
20
27.8%
|
20
30.3%
|
20
29%
|
25
32.1%
|
Much worse |
3
4.2%
|
0
0%
|
0
0%
|
1
1.3%
|
No change |
4
5.6%
|
1
1.5%
|
3
4.3%
|
4
5.1%
|
Very much better |
21
29.2%
|
21
31.8%
|
25
36.2%
|
23
29.5%
|
Very much worse |
1
1.4%
|
0
0%
|
2
2.9%
|
1
1.3%
|
A little better |
5
6.9%
|
19
28.8%
|
10
14.5%
|
13
16.7%
|
A little worse |
7
9.7%
|
3
4.5%
|
5
7.2%
|
6
7.7%
|
Much better |
18
25%
|
24
36.4%
|
17
24.6%
|
23
29.5%
|
Much worse |
6
8.3%
|
2
3%
|
0
0%
|
3
3.8%
|
No change |
5
6.9%
|
2
3%
|
4
5.8%
|
1
1.3%
|
Very much better |
23
31.9%
|
10
15.2%
|
21
30.4%
|
21
26.9%
|
Very much worse |
0
0%
|
0
0%
|
3
4.3%
|
1
1.3%
|
A little better |
9
12.5%
|
14
21.2%
|
7
10.1%
|
16
20.5%
|
A little worse |
4
5.6%
|
6
9.1%
|
1
1.4%
|
2
2.6%
|
Much better |
21
29.2%
|
19
28.8%
|
14
20.3%
|
19
24.4%
|
Much worse |
4
5.6%
|
1
1.5%
|
4
5.8%
|
1
1.3%
|
No change |
3
4.2%
|
2
3%
|
4
5.8%
|
2
2.6%
|
Very much better |
13
18.1%
|
12
18.2%
|
19
27.5%
|
19
24.4%
|
Very much worse |
2
2.8%
|
0
0%
|
3
4.3%
|
1
1.3%
|
A little better |
13
18.1%
|
16
24.2%
|
13
18.8%
|
11
14.1%
|
A little worse |
2
2.8%
|
4
6.1%
|
4
5.8%
|
5
6.4%
|
Much better |
17
23.6%
|
19
28.8%
|
12
17.4%
|
21
26.9%
|
Much worse |
4
5.6%
|
0
0%
|
6
8.7%
|
2
2.6%
|
No change |
4
5.6%
|
5
7.6%
|
3
4.3%
|
3
3.8%
|
Very much better |
12
16.7%
|
11
16.7%
|
18
26.1%
|
15
19.2%
|
Very much worse |
2
2.8%
|
0
0%
|
1
1.4%
|
2
2.6%
|
Title | Change From Baseline CRAIQ Score |
---|---|
Description | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 66 | 60 | 62 | 74 |
0.5 years |
-71.3
|
-45.5
|
-35
|
-66.8
|
1 years |
-73.3
|
-43.4
|
-37.6
|
-60.5
|
2 years |
-47.5
|
-25.1
|
-19.2
|
-38.9
|
3 years |
-54.6
|
-20.9
|
-12.9
|
-36.1
|
4 years |
-40
|
-16.6
|
-8.5
|
-39.1
|
5 years |
-35.7
|
-14.8
|
7.4
|
-22.7
|
Title | Change From Baseline POPIQ Score |
---|---|
Description | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 66 | 60 | 62 | 74 |
0.5 years |
-95
|
-61.3
|
-55.2
|
-98.6
|
1 years |
-100.2
|
-68.8
|
-58.9
|
-95.9
|
2 years |
-68.9
|
-56.6
|
-42.8
|
-79.3
|
3 years |
-82.6
|
-48.7
|
-29.3
|
-76.9
|
4 years |
-84.5
|
-42.3
|
-32.9
|
-73
|
5 years |
-72.1
|
-50.3
|
-16.8
|
-71.9
|
Title | Change From Baseline UIQ Score |
---|---|
Description | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 66 | 60 | 62 | 74 |
0.5 years |
-107.7
|
-85.4
|
-77.3
|
-116.4
|
1 years |
-116.3
|
-92
|
-84.3
|
-121.8
|
2 years |
-90.3
|
-80.4
|
-67.7
|
-99.1
|
3 years |
-94.3
|
-69.1
|
-59
|
-92.3
|
4 years |
-89.5
|
-68.3
|
-59.2
|
-90.3
|
5 years |
-75.9
|
-72.1
|
-47.8
|
-84.8
|
Title | Change From Baseline CRADI Score |
---|---|
Description | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 70 | 64 | 64 | 74 |
0.5 years |
-72.3
|
-71.8
|
-69.6
|
-56.3
|
1 years |
-64.1
|
-67.5
|
-77.7
|
-63.3
|
2 years |
-46.2
|
-49.1
|
-62
|
-50.4
|
3 years |
-45.3
|
-53.1
|
-48.7
|
-44.7
|
4 years |
-35.1
|
-54.1
|
-44.8
|
-48.8
|
5 years |
-37.4
|
-43.1
|
-39.1
|
-39.8
|
Title | Change From Baseline POPDI Score |
---|---|
Description | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 70 | 64 | 64 | 74 |
0.5 years |
-95.1
|
-90.2
|
-92.3
|
-72.6
|
1 years |
-90.6
|
-96
|
-91.9
|
-81.1
|
2 years |
-76
|
-79.1
|
-76.9
|
-65.9
|
3 years |
-69.5
|
-77.7
|
-66.9
|
-61.7
|
4 years |
-70.7
|
-78.3
|
-65.1
|
-62.8
|
5 years |
-64.8
|
-75.8
|
-63.7
|
-61.1
|
Title | Change From Baseline UDI Score |
---|---|
Description | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 70 | 64 | 64 | 74 |
0.5 years |
-105.7
|
-96
|
-95
|
-88.9
|
1 years |
-102.9
|
-95.9
|
-94
|
-96.8
|
2 years |
-90.8
|
-89.1
|
-81.2
|
-81.3
|
3 years |
-84.9
|
-75
|
-70.5
|
-72
|
4 years |
-81.7
|
-76.2
|
-70.8
|
-75.3
|
5 years |
-73.9
|
-77.9
|
-69
|
-74.4
|
Title | Change From Baseline Hunskaar Score |
---|---|
Description | The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 69 | 64 | 64 | 74 |
0.5 years |
-3.6
|
-2.9
|
-3.2
|
-3.5
|
1 years |
-3.6
|
-3.3
|
-3.4
|
-3.2
|
2 years |
-3
|
-3.2
|
-2.8
|
-2.7
|
3 years |
-2.5
|
-2.6
|
-2.5
|
-2.8
|
4 years |
-2.5
|
-2.5
|
-2.4
|
-2.6
|
5 years |
-1.6
|
-2.6
|
-2
|
-2.4
|
Title | Change From Baseline SF-36 Physical Health Score |
---|---|
Description | The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 62 | 67 | 76 |
0.5 years |
7.1
|
4.3
|
5.6
|
7.7
|
1 years |
8
|
5.6
|
6.6
|
6.8
|
2 years |
7.6
|
5.2
|
4.9
|
6.1
|
3 years |
4.3
|
1.1
|
3.5
|
3.1
|
4 years |
4.8
|
0.3
|
2.9
|
2.9
|
5 years |
3.2
|
0.9
|
2.5
|
2.7
|
Title | Change From Baseline SF-36 Mental Health Score |
---|---|
Description | The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 62 | 67 | 76 |
0.5 years |
2.5
|
3.1
|
2.6
|
1.3
|
1 years |
4.1
|
3.4
|
0.6
|
2.7
|
2 years |
0.8
|
2
|
3.1
|
1.6
|
3 years |
3
|
2.4
|
1.6
|
2.3
|
4 years |
1.4
|
1.7
|
0.5
|
1.2
|
5 years |
3.1
|
1.8
|
0.8
|
1.2
|
Title | Change From Baseline Brink Score |
---|---|
Description | The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year [0.5, 2, 3, 4, 5] Score - Baseline Score). |
Time Frame | 6 months, and 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 68 | 64 | 68 | 76 |
0.5 years |
0.2
|
0
|
0.6
|
0.4
|
2 years |
-0.1
|
0.1
|
0.4
|
0
|
3 years |
0
|
-0.3
|
0.3
|
-0.5
|
4 years |
0.1
|
-0.5
|
0.2
|
-0.5
|
5 years |
0.2
|
-0.6
|
0.4
|
-0.3
|
Title | POP-Q Point Ba |
---|---|
Description | POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). The range for point Ba is -3 to total vaginal length (TVL). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
0.5 years |
-1.2
|
-1.2
|
-1.4
|
-1.3
|
1 years |
-0.9
|
-1.2
|
-1
|
-1.2
|
2 years |
-0.9
|
-0.8
|
-1.1
|
-1.1
|
3 years |
-1.1
|
-0.7
|
-0.8
|
-1.1
|
4 years |
-0.8
|
-0.9
|
-0.8
|
-1.1
|
5 years |
-0.8
|
-1
|
-0.7
|
-0.9
|
Title | POP-Q Point Bp |
---|---|
Description | POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse. |
Time Frame | 6 months, and 1, 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
0.5 years |
-2.3
|
-2.5
|
-2.2
|
-2.2
|
1 years |
-2.2
|
-2.4
|
-2.2
|
-2.2
|
2 years |
-2
|
-2.3
|
-2.2
|
-2
|
3 years |
-2.3
|
-2.4
|
-2.1
|
-2.2
|
4 years |
-2.2
|
-2.3
|
-2.2
|
-2
|
5 years |
-2.2
|
-2.3
|
-1.9
|
-1.9
|
Title | POP-Q Point C |
---|---|
Description | POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse. |
Time Frame | 6 months, and 1 2, 3, 4, and 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized. |
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL |
---|---|---|---|---|
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
Measure Participants | 72 | 66 | 69 | 78 |
0.5 years |
-7.2
|
-7.3
|
-6.5
|
-7
|
1 years |
-7
|
-6.5
|
-6.6
|
-6.8
|
2 years |
-6.8
|
-6.6
|
-6.5
|
-6.8
|
3 years |
-6.9
|
-6.4
|
-6.3
|
-6.3
|
4 years |
-6.3
|
-6.2
|
-6.4
|
-6.6
|
5 years |
-6.5
|
-6.4
|
-5.8
|
-6.6
|
Adverse Events
Time Frame | 2 years through 5 years. | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Only specific adverse events were recorded during the extended follow-up of the OPTIMAL trial (E-OPTIMAL). Video/No video randomization arms were only assessed with regard to retention/recruitment rates and were not expected to impact outcomes or adverse events. Adverse Events were only collected with respect to the OPTIMAL treatment received. | |||||||
Arm/Group Title | SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | ||||
Arm/Group Description | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | ||||
All Cause Mortality |
||||||||
SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/72 (1.4%) | 0/66 (0%) | 2/69 (2.9%) | 1/78 (1.3%) | ||||
Serious Adverse Events |
||||||||
SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/72 (0%) | 0/66 (0%) | 0/69 (0%) | 0/78 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
SSLF+BPMT | SSLF+USUAL | ULS+BPMT | ULS+USUAL | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 29/72 (40.3%) | 17/66 (25.8%) | 27/69 (39.1%) | 34/78 (43.6%) | ||||
Injury, poisoning and procedural complications | ||||||||
Suture exposure | 17/72 (23.6%) | 12/66 (18.2%) | 11/69 (15.9%) | 20/78 (25.6%) | ||||
Midurethral sling erosion and exposure | 3/72 (4.2%) | 1/66 (1.5%) | 2/69 (2.9%) | 0/78 (0%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Granulation tissue | 15/72 (20.8%) | 6/66 (9.1%) | 19/69 (27.5%) | 16/78 (20.5%) | ||||
Surgical and medical procedures | ||||||||
Pelvic organ prolapse surgery | 2/72 (2.8%) | 3/66 (4.5%) | 5/69 (7.2%) | 5/78 (6.4%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Marie Gantz |
---|---|
Organization | RTI International |
Phone | 919-597-5110 |
mgantz@rti.org |
- 16P01S