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

October 8, 2021 updated by: Graham Chapman, University Hospitals Cleveland Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2
  • Phase 3

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
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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
Placebo Comparator: Placebo
Drug: Placebo oral capsule
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
Experimental: Tamsulosin
Drug: Tamsulosin
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Urinary Retention
Time Frame: Within 72 hours of surgery
Failed voiding trial upon removal of catheter
Within 72 hours of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score
Time Frame: 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)
Within 1 week of surgery
Postoperative Urinary Tract Infection
Time Frame: Within 6 weeks after surgery
Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.
Within 6 weeks after surgery
Sent Home With Catheterization
Time Frame: within 6 weeks of surgery
Urinary retention that required homegoing catheterization
within 6 weeks of surgery

Collaborators and Investigators

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

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Graham Chapman, University Hospitals Case Western Reserve University

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)

August 1, 2018

Primary Completion (Actual)

June 9, 2020

Study Completion (Actual)

June 9, 2020

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tamsulosin for POUR

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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