Trial Outcomes & Findings for Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence (NCT NCT01194999)

Results Overview

Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

132 participants

Primary outcome timeframe

Baseline to final follow-up.

Results posted on

2012-09-20

Participant Flow

Recruitment occurred over the course of one year (October 2010 - October 2011). Patients requiring pubovaginal sling procedures for stress incontinence were invited to participate if they possessed limited comorbidities.

No significant pres-assignment measures were taken.

Participant milestones

Participant milestones
Measure	Pubovaginal Sling Procedure Patients undergoing pubovaginal slings for stress urinary incontinence.
Overall Study STARTED	132
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Pubovaginal Sling Procedure Patients undergoing pubovaginal slings for stress urinary incontinence.
Overall Study Lost to Follow-up	17

Baseline Characteristics

Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pubovaginal Sling Procedure n=132 Participants Patients undergoing pubovaginal slings for stress urinary incontinence.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	118 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age Continuous	51.35 years STANDARD_DEVIATION 11.28 • n=5 Participants
Sex: Female, Male Female	132 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	132 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to final follow-up.

Population: All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy.

Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.

Outcome measures

Outcome measures
Measure	Pubovaginal Sling Procedure n=88 Participants Patients undergoing pubovaginal slings for stress urinary incontinence.
Change in OAB Symptoms Post Pubovaginal Sling Operation Patients with improved OAB	63 participants
Change in OAB Symptoms Post Pubovaginal Sling Operation Patients with stable OAB	21 participants
Change in OAB Symptoms Post Pubovaginal Sling Operation Patients with worsening OAB	4 participants

Adverse Events

Pubovaginal Sling Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph A Zadra, MD CM FRCSC

Barrie Urology Associates - The Male/Female Health and Research Centre

Phone: 705-727-0551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place