Clinical trial NCT04597372: Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Urinary Retention Postoperative
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2020-10-22
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the impact of Tamsulosin on duration of urinary retention
timeFrame: Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course
Secondary outcomes:
measure: To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).
timeFrame: Date of failed the retrograde voiding trial and up to 6 weeks.
measure: To quantify the effect of Tamsulosin on patient quality of life.
timeFrame: Prior to discharge and again at 2 weeks follow up
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Lindsay Turner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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