E-OPTIMAL: The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

Sponsor
NICHD Pelvic Floor Disorders Network (Other)
Overall Status
Completed
CT.gov ID
NCT01166373
Collaborator
(none)
285
7
6
75
40.7
0.5

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:
  1. 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.

  2. 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
  • Behavioral: Enrollment video
  • Procedure: SSLF
  • Procedure: ULS
  • Behavioral: PMT
  • Other: Usual Care
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:

  1. time to surgical failure;

  2. the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group;

  3. 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

Study Type:
Interventional
Actual Enrollment :
285 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

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

  1. 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.)

  2. 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.

  3. 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

  1. 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.)

  2. 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.)

  3. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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.

  18. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Completion of the Year 2 OPTIMAL in-person visit
Exclusion Criteria:
  1. Inability to provide informed consent.

  2. 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)

  1. 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.

  2. 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.

  3. Subjects who become long-term residents of a skilled nursing facility.

  4. 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.
Responsible Party:
NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier:
NCT01166373
Other Study ID Numbers:
  • 16P01S
First Posted:
Jul 21, 2010
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by NICHD Pelvic Floor Disorders Network
Additional relevant MeSH terms:

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

1. Primary Outcome
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%
2. Primary Outcome
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%
3. Primary Outcome
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%
4. Secondary Outcome
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%
5. Secondary Outcome
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%
6. Secondary Outcome
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%
7. Other Pre-specified Outcome
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%
8. Other Pre-specified Outcome
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%
9. Other Pre-specified Outcome
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%
10. Other Pre-specified Outcome
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%
11. Other Pre-specified Outcome
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%
12. Other Pre-specified Outcome
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
13. Other Pre-specified Outcome
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
14. Other Pre-specified Outcome
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
15. Other Pre-specified Outcome
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
16. Other Pre-specified Outcome
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
17. Other Pre-specified Outcome
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
18. Other Pre-specified Outcome
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
19. Other Pre-specified Outcome
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
20. Other Pre-specified Outcome
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
21. Other Pre-specified Outcome
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
22. Other Pre-specified Outcome
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
23. Other Pre-specified Outcome
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
24. Other Pre-specified Outcome
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

[Not Specified]

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
Email mgantz@rti.org
Responsible Party:
NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier:
NCT01166373
Other Study ID Numbers:
  • 16P01S
First Posted:
Jul 21, 2010
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020