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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT04597372
Phase
PHASE2
Status
Recruiting
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Conditions

  • Urinary Retention Postoperative

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 3, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
West Penn HospitalPittsburghPennsylvania15224
AHN Clinical Trials Contact
[email protected]
(412)-330-6151
Lindsay Turner, MD (PRINCIPAL_INVESTIGATOR)

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By research site
West Penn Hospital· Pittsburgh, PA

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