Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

Phase 2

Completed

• Conditions: Urinary Retention; Lower Urinary Tract Symptoms; Stress Urinary Incontinence; Pelvic Organ Prolapse
• Interventions: Drug: Placebo oral capsule; Drug: Tamsulosin

• Registration Number: NCT03524339
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-14
• Study Start: 2018-08-01
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-09
• Status Verified: 2021-10
• Results First Submitted: 2021-10-08
• Results First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Results First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

• Patients must be 18 years or older as well as willing and able to provide informed consent
• Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
• Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.

Exclusion Criteria

• Patient unable or unwilling to provide informed consent
• Severe allergy to sulfa drugs
• Known allergy to tamsulosin or another alpha antagonist medication
• History of urinary retention
• Planned bladder catheterization greater than 24 hours after surgery
• Current use of alpha antagonist medication for hypertension
• End stage renal or liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule	-
Tamsulosin	Tamsulosin	-

Primary Outcome Measures

Name	Time	Method
Postoperative Urinary Retention	Within 72 hours of surgery	Failed voiding trial upon removal of catheter

Secondary Outcome Measures

Name	Time	Method
Sent Home With Catheterization	within 6 weeks of surgery	Urinary retention that required homegoing catheterization
Postoperative Urinary Tract Infection	Within 6 weeks after surgery	Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.
International Prostate Symptom Score	Within 1 week of surgery	Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst)

Trial Locations

Locations (2)

University Hospitals; 🇺🇸 Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States