Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04597372

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urinary Retention Postoperative

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location status: Recruiting

Location contact

AHN Clinical Trials Contact

CONTACT

[email protected]

(412)-330-6151

Lindsay Turner, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.

Placebo

Drug

Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.

Primary outcomes

  1. To determine the impact of Tamsulosin on duration of urinary retention

    Time frame: 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 outcomes

  1. To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).

    Time frame: 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.

  2. To quantify the effect of Tamsulosin on patient quality of life.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

AHN Clinical Trials Contact

CONTACT

[email protected]

(412)-330-4567

Lindsay Turner

CONTACT

[email protected]

(412)-330-4567

Sponsors and collaborators

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2020
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.