Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

Phase 2

Recruiting

• Conditions: Urinary Retention Postoperative
• Interventions: Drug: Placebo; Drug: Tamsulosin

• Registration Number: NCT04597372
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief Summary

The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.

Detailed Description

The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo.

Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Study Start: 2021-11-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• 18 years or older
• willing and able to provide informed consent
• postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
• Ability to speak and read English
• Tolerate pill ingestion

Exclusion Criteria

• allergy/intolerance to Tamsulosin or sulfa drugs
• preoperative history of urinary retention as defined by preoperative post void residual of >150mL
• current use of alpha antagonist medication for hypertension
• severe dementia
• end stage renal or liver disease
• history of severe heart failure or major cardiovascular event in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.
Tamsulosin	Tamsulosin	10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Primary Outcome Measures

Name	Time	Method
To determine the impact of Tamsulosin on duration of urinary retention	Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course	The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.

Secondary Outcome Measures

Name	Time	Method
To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).	Date of failed the retrograde voiding trial and up to 6 weeks.	The electronic medical record (EMR) will be reviewed to determine if subjects were treated for a urinary tract infection (UTI). UTIs will be diagnosed by a urine culture confirming bacteriuria of at least 10 \^5 CFU/mL. UTIs treated presumptively and without culture will also be included as positive cultures.
To quantify the effect of Tamsulosin on patient quality of life.	Prior to discharge and again at 2 weeks follow up	Patients will be asked to complete the Euroqol-5D (EQ-5D) questionnaire to assess quality of life. The EQ-5D is scored with a 5-digit code of index values which reflect how good or bad a health state is (Level 1 indicates no problem where is Level 5 indicates extreme problems).

Trial Locations

Locations (1)

West Penn Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States