Impact of Tamsulosin on Urinary Retention After Urogynecology Surgery
Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial
This study tests if giving tamsulosin before pelvic surgery can help patients avoid needing a catheter after their operation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | TriHealth Inc. Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06843538 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering tamsulosin before urogynecology surgeries can reduce the likelihood of patients needing a Foley catheter upon discharge. It focuses on patients undergoing pelvic organ prolapse repair or incontinence surgery. Participants will be randomly assigned to receive either tamsulosin or a placebo to assess the medication's effectiveness in preventing postoperative urinary retention.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for pelvic organ prolapse repair or incontinence surgery.
Not a fit: Patients with a history of urinary retention requiring catheterization or those undergoing non-urogynecological surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer patients requiring catheterization after surgery, improving recovery and comfort.
How similar studies have performed: Other studies have explored the use of alpha blockers in similar contexts, showing promising results, but this specific approach is being evaluated in a novel setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Patients undergoing any pelvic organ prolapse repair or incontinence surgery Exclusion Criteria: * Any surgery involving a non-urogynecologist * Patients already on an alpha blocker * Baseline hypotension * History of syncope * Postural orthostatic tachycardia syndrome (POTS) * Non-English speaker or interpreter unavailable for Spanish-speaking patient * Impaired cognition impeding proper consenting * Any other medical contraindication for tamsulosin use * History of urinary retention requiring continuous or intermittent catheterization * Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis * Pregnancy
Where this trial is running
Cincinnati, Ohio
- TriHealth — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Gisele C Moran, MD, MPH
- Email: gisele_moran@trihealth.com
- Phone: 513-862-1123
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.