Trial Outcomes & Findings for Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use (NCT NCT02680145)

Last Updated: 2020-08-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

58 participants

Primary outcome timeframe

3 months postoperatively

Results posted on

2020-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Preoperative Pessary Use 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 Study STARTED	58
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preoperative Pessary Use n=58 Participants 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
Age, Continuous	60.7 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months postoperatively

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

Outcome measures

Outcome measures
Measure	Preoperative Pessary Use n=40 Participants 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
Patient Global Impression of Improvement (PGI-I) Score	39 Participants

PRIMARY outcome

Timeframe: Baseline, 3 month post surgery

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

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.

Outcome measures

Outcome measures
Measure	Preoperative Pessary Use n=36 Participants 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
Prolapse Symptom Severity Baseline score	48.6 score on a scale Standard Deviation 24.7
Prolapse Symptom Severity Follow-up score	7.3 score on a scale Standard Deviation 14.2

PRIMARY outcome

Timeframe: Baseline, 3 month post surgery

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

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.

Outcome measures

Outcome measures
Measure	Preoperative Pessary Use n=40 Participants 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
Bother of Bladder/Vaginal/Bowel Symptoms Baseline score	72.1 score on a scale Standard Deviation 69.2
Bother of Bladder/Vaginal/Bowel Symptoms Follow-up score	18.8 score on a scale Standard Deviation 49.3

PRIMARY outcome

Timeframe: Baseline, 3 month post surgery

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

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.

Outcome measures

Outcome measures
Measure	Preoperative Pessary Use n=32 Participants 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
Overactive Bladder Symptom Score (OABSS) Baseline score	12.0 score on a scale Standard Deviation 3.9
Overactive Bladder Symptom Score (OABSS) Follow-up score	9.6 score on a scale Standard Deviation 2.7

Adverse Events

Preoperative Pessary Use

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Preoperative Pessary Use n=58 participants at risk 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
Renal and urinary disorders Urinary Incontinence	6.9% 4/58 • Number of events 4 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Musculoskeletal and connective tissue disorders Pelvic Pain	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Reproductive system and breast disorders Vaginal dryness with itching	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
General disorders Allergic Reaction on abdomen at surgical site	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Nervous system disorders Dizziness	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Gastrointestinal disorders Nausea	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Reproductive system and breast disorders Vaginal Pain	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Reproductive system and breast disorders Vaginal Bleeding Post operative	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Metabolism and nutrition disorders Hyperkalemia post operative	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Hepatobiliary disorders Hyponatremia post operative	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Musculoskeletal and connective tissue disorders Pelvic floor myalgia	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Gastrointestinal disorders Dyspepsia	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Gastrointestinal disorders Exacerbated chronic constipation	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Renal and urinary disorders Incidental cystotomy repair (1 cm)	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Infections and infestations Vaginal infection	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Reproductive system and breast disorders Ureteral vaginal fistula	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
Renal and urinary disorders Urinary Tract Infection	1.7% 1/58 • Number of events 1 • Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.

Additional Information

Dr. John A. Occhino

Mayo Clinic

Phone: (507) 538-5883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place