The Effect of Tamsulosin on Postoperative Urinary Retention

January 29, 2024 updated by: Wake Forest University Health Sciences

Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial

This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned.

Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo.

Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage II or greater pelvic organ prolapse in > 1 vaginal compartment
  • Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
  • Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
  • Willing to remain compliant with Investigation Product (IP)

Exclusion Criteria:

  • Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
  • Patients whose surgical plan would necessitate a voiding trial on postop day >0
  • Less than 21 years of age
  • Unable to understand English
  • Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty
  • Patient with known allergy to Tamsulosin or sulfa drugs
  • Patients with upcoming cataract surgery
  • Patient with orthostatic hypotension
  • History of postvoid residual (PVR>150) prior to surgery with prolapse reduction
  • Patients with hypertension on alpha-blockers
  • Single compartment prolapse repair (anterior or posterior repair only)
  • Use of mesh for prolapse repair
  • High tone pelvic floor dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamsulosin
Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.
Drug: Tamsulosin
Oral drug: 10 days of 0.4 mg of oral Tamsulosin
Placebo Comparator: Placebo
Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.
Drug: Placebo
Oral drug: 10 days of identical-appearing placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Postoperative (Day 0) Urinary Retention
Time Frame: Up to 6 weeks postoperatively
Urinary retention can be defined as >150cc residual volume during an active voiding trial
Up to 6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Tract Infection Rate
Time Frame: Week 6
Urinary tract infection rate
Week 6
Incidence of Delayed Urinary Retention
Time Frame: Week 6
Delayed urinary retention will be defined as post-void residual > 150 cc
Week 6
Number Emergency Department (ED) Visits
Time Frame: Up to 30 days postoperatively
Up to 30 days postoperatively
Total Number of Days of Bladder Catheterization
Time Frame: Week 6
Week 6
Patient Level of Satisfaction With Voiding Function
Time Frame: Day 0 and 1 week postoperatively
Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)
Day 0 and 1 week postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Majid Mirzazadeh, MD, Wake Forest Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2021

Primary Completion (Actual)

November 10, 2022

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00070462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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