What this study is
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.
What's being tested
- Tamsulosin
Intervention · DRUG
Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
- Placebo
Intervention · 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
- 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
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Conditions
- Urinary Retention Postoperative
- Enrolling
- 154 people
- Starts
- 2021-11-03
- Est. completion
- 2026-12
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWest Penn Hospital
Pittsburgh, Pennsylvania, United States
- AHN Clinical Trials Contact · Contact(412)-330-6151clinicaltrials@ahn.org
- Lindsay Turner, MD · Principal investigator
Recruiting
Study team
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID IRB00264995
Principal investigator
Lindsay Turner, MD
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.