Effect of Tamsulosin on urinary retention after pelvic surgery
The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study
This study is testing if Tamsulosin can help women who have urinary retention after pelvic surgery get better faster than those who receive a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04597372 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) in women following pelvic reconstructive surgery. It is a double-blind, randomized, placebo-controlled trial where participants will receive either Tamsulosin or a placebo after being diagnosed with POUR. The primary outcome will be the duration of catheterization, measured in days, and secondary outcomes include the incidence of urinary tract infections and quality of life assessments using the Euroqol-5D (EQ-5D) scale. The study will involve women aged 18 and older who consent to participate and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who experience postoperative urinary retention after pelvic reconstructive surgery.
Not a fit: Patients with a history of urinary retention prior to surgery or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of urinary retention post-surgery, enhancing recovery and quality of life for patients.
How similar studies have performed: Other studies have shown promising results with Tamsulosin in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- West Penn Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay Turner, MD — Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Study coordinator: Lindsay Turner
- Email: lindsay.turner@AHN.ORG
- Phone: (412)-330-4567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.