Recruiting
Phase 2

Tamsulosin

Sponsor:

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

Code:

NCT04597372

Conditions

Urinary Retention Postoperative

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tamsulosin

Placebo

Study Details

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.

Conditions

Urinary Retention Postoperative

Study ID

NCT04597372

Start date

Nov 3, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

154 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

Tamsulosin

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

Placebo

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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Lindsay Turner

(412)-330-4567lindsay.turner@AHN.ORG

AHN Clinical Trials Contact

(412)-330-4567clinicaltrials@ahn.org

Locations

West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

AHN Clinical Trials Contact

(412)-330-6151clinicaltrials@ahn.org

Principal Investigator:

Lindsay Turner, MD

More Information

Sponsor

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

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2026-03-20.