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

A

Allegheny Health Network (AHN)

Status and phase

Enrolling
Phase 2

Conditions

Urinary Retention Postoperative

Treatments

Drug: Placebo
Drug: Tamsulosin

Study type

Interventional

Funder types

Other

Identifiers

NCT04597372
IRB00264995

Details and patient eligibility

About

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.

Full description

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.

Enrollment

154 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

154 participants in 2 patient groups, including a placebo group

Tamsulosin
Experimental group
Description:
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.
Treatment:
Drug: Tamsulosin
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Lindsay Turner; AHN Clinical Trials Contact

Data sourced from clinicaltrials.gov

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