Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02680145
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arm: 1
• Actual Duration (Months): 45.7
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally, we will assess the impact that preoperative pessary use has on patient self-reported preparedness for surgery.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Vault Prolapse; Pelvic Organ Prolapse; Uterine Prolapse; Pelvic Floor Prolapse	Device: Preoperative Pessary Use	N/A

Detailed Description

It is anticipated that this trial will define the clinical utility of routine preoperative pessary placement, and by shaping patient expectations and increasing preparedness for surgery, we anticipate improving satisfaction and quality of life.

At the initial office visit baseline symptoms are evaluation with validated questionnaire.

The patients' will undergo pessary fitting at least 7 days (but no more than 28 days) prior to scheduled surgical prolapse repair.

Symptomatic change from baseline will be assessed with validated questionnaire preoperatively.

The pessary will be removed at the time of surgery, and the patient will undergo surgical correction of their pelvic organ prolapse (including all restorative surgical procedures, abdominal and transvaginal). A concomitant anti-incontinence procedure will be performed at the discretion of the treating physician in consultation with the patient.

The patients' symptomatic outcome from surgery will then be reassessed by validated questionnaire at 6 weeks and 3 months postoperatively.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
• Actual Study Start Date: Mar 11, 2016
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Preoperative Pessary Use All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse	Device: Preoperative Pessary Use; Pessary use for 1-4 weeks prior to surgical prolapse repair

Outcome Measures

Primary Outcome Measures

1. Patient Global Impression of Improvement (PGI-I) Score [3 months postoperatively]

   Number of participants considered treatment success assessed using the 7-point Likert scale of the Patient Global Impression of Improvement (PGI-I) of 1= very much better and 7=very much worse. Patient's will be considered treatment success if they answer "much better" or "very much better" on the PGI-I scale.

2. Prolapse Symptom Severity [Baseline, 3 month post surgery]

   Mean value of score on self-reported Pelvic Organ Prolapse Distress Inentory-6 (POPDI-6) questionnaire. Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.

3. Bother of Bladder/Vaginal/Bowel Symptoms [Baseline, 3 month post surgery]

   Mean value of score on self-reported Floor Impact Questionnaire-7 (PFIQ-7). Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.

4. Overactive Bladder Symptom Score (OABSS) [Baseline, 3 month post surgery]

   Mean value of score on self-reported Overactive Bladder Symptom Score (OABSS) questionnaire. Minimum scale score = 0; maximum scale score = 15 and a higher score indicates worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Older than 18 years of age

• With symptomatic pelvic organ prolapse

• Electing for surgical repair of pelvic organ prolapse (transvaginal or transabdominal) at least 7 days after office consultation

• Understand and have signed written informed consent for preoperative pessary placement.

Exclusion Criteria:

• Previous use of a pessary for pelvic organ prolapse

• Patients undergoing obliterative prolapse surgery (i.e. Colpocleisis),

• Are scheduled for surgery for pelvic organ prolapse less than 7 days after office consultation or greater than 4 weeks after office consultation

• Have an isolated rectocele

• Have allergies to both latex and silicone

• Have an active pelvic infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: John A Occhino, MD, MS, Mayo Clinic
• Study Chair: Brian Linder, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 22, 2016

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: John A. Occhino, Assistant Professor of Obstetrics-Gynecology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02680145
• Other Study ID Numbers: 15-006186
• First Posted: Feb 11, 2016
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by John A. Occhino, Assistant Professor of Obstetrics-Gynecology, Mayo Clinic: Pessary; Prolapse; Cystocele
• Additional relevant MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Arm/Group Title	Preoperative Pessary Use
Arm/Group Description	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair
Period Title: Overall Study
STARTED	58
COMPLETED	47
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Preoperative Pessary Use
Arm/Group Description	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair
Overall Participants	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.7 (10.7)
Sex: Female, Male (Count of Participants)
Female	58 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	56 96.6%
More than one race	0 0%
Unknown or Not Reported	2 3.4%
Region of Enrollment (participants) [Number]
United States	58 100%

Outcome Measures

1. Primary Outcome

Title	Patient Global Impression of Improvement (PGI-I) Score
Description	Number of participants considered treatment success assessed using the 7-point Likert scale of the Patient Global Impression of Improvement (PGI-I) of 1= very much better and 7=very much worse. Patient's will be considered treatment success if they answer "much better" or "very much better" on the PGI-I scale.
Time Frame	3 months postoperatively

Outcome Measure Data

Analysis Population Description

40 participants completed the PGI-I form 3 months after surgery for data analysis.

Arm/Group Title	Preoperative Pessary Use
Arm/Group Description	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair
Measure Participants	40
Count of Participants [Participants]	39 67.2%

2. Primary Outcome

Title	Prolapse Symptom Severity
Description	Mean value of score on self-reported Pelvic Organ Prolapse Distress Inentory-6 (POPDI-6) questionnaire. Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.
Time Frame	Baseline, 3 month post surgery

Outcome Measure Data

Analysis Population Description

Data was available for analysis on 36 participants which completed questionnaire at both time points.

Arm/Group Title	Preoperative Pessary Use
Arm/Group Description	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair
Measure Participants	36
Baseline score	48.6 (24.7)
Follow-up score	7.3 (14.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative Pessary Use
	Comments	Baseline score vs Follow-up score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Bother of Bladder/Vaginal/Bowel Symptoms
Description	Mean value of score on self-reported Floor Impact Questionnaire-7 (PFIQ-7). Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.
Time Frame	Baseline, 3 month post surgery

Outcome Measure Data

Analysis Population Description

Data was available for analysis on 40 participants which completed questionnaire at both time points.

Arm/Group Title	Preoperative Pessary Use
Arm/Group Description	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair
Measure Participants	40
Baseline score	72.1 (69.2)
Follow-up score	18.8 (49.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative Pessary Use
	Comments	Baseline score vs Follow-up score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Primary Outcome

Title	Overactive Bladder Symptom Score (OABSS)
Description	Mean value of score on self-reported Overactive Bladder Symptom Score (OABSS) questionnaire. Minimum scale score = 0; maximum scale score = 15 and a higher score indicates worse outcome.
Time Frame	Baseline, 3 month post surgery

Outcome Measure Data

Analysis Population Description

Data was available for analysis on 32 participants which completed questionnaire at both time points.

Arm/Group Title	Preoperative Pessary Use
Arm/Group Description	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair
Measure Participants	32
Baseline score	12.0 (3.9)
Follow-up score	9.6 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative Pessary Use
	Comments	Baseline score vs Follow-up score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Arm/Group Title	Preoperative Pessary Use
Arm/Group Description	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair
All Cause Mortality
	Preoperative Pessary Use
	Affected / at Risk (%)	# Events
Total	0/58 (0%)
Serious Adverse Events
	Preoperative Pessary Use
	Affected / at Risk (%)	# Events
Total	0/58 (0%)
Other (Not Including Serious) Adverse Events
	Preoperative Pessary Use
	Affected / at Risk (%)	# Events
Total	13/58 (22.4%)
Gastrointestinal disorders
Nausea	1/58 (1.7%)	1
Dyspepsia	1/58 (1.7%)	1
Exacerbated chronic constipation	1/58 (1.7%)	1
General disorders
Allergic Reaction on abdomen at surgical site	1/58 (1.7%)	1
Hepatobiliary disorders
Hyponatremia post operative	1/58 (1.7%)	1
Infections and infestations
Vaginal infection	1/58 (1.7%)	1
Metabolism and nutrition disorders
Hyperkalemia post operative	1/58 (1.7%)	1
Musculoskeletal and connective tissue disorders
Pelvic Pain	1/58 (1.7%)	1
Pelvic floor myalgia	1/58 (1.7%)	1
Nervous system disorders
Dizziness	1/58 (1.7%)	1
Renal and urinary disorders
Urinary Incontinence	4/58 (6.9%)	4
Incidental cystotomy repair (1 cm)	1/58 (1.7%)	1
Urinary Tract Infection	1/58 (1.7%)	1
Reproductive system and breast disorders
Vaginal dryness with itching	1/58 (1.7%)	1
Vaginal Pain	1/58 (1.7%)	1
Vaginal Bleeding Post operative	1/58 (1.7%)	1
Ureteral vaginal fistula	1/58 (1.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.