Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery
Phase 3
Recruiting
- Conditions
- Postoperative Urinary Retention (POUR)
- Interventions
- Drug: Placebo
- Registration Number
- NCT06843538
- Lead Sponsor
- TriHealth Inc.
- Brief Summary
The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 166
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Arm Tamsulosin - Control Arm Placebo -
- Primary Outcome Measures
Name Time Method Voiding trial on postoperative day 0 Day of surgery Whether or not patients pass or fail their postoperative voiding trial
- Secondary Outcome Measures
Name Time Method Secondary postoperative urinary retention 2 weeks following surgery Patients who develop urinary retention after discharge
Postoperative urinary tract infection 30 days after surgery Patients who develop a urinary tract infection after surgery
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of tamsulosin's alpha-1A adrenergic receptor antagonism reduce POUR in urogynecology patients?
How does peri-operative tamsulosin in NCT06843538 compare to standard-of-care alpha-blockers for POUR prevention in outpatient urogynecology surgery?
Which urodynamic biomarkers predict response to peri-operative tamsulosin in NCT06843538 for POUR prevention after outpatient urogynecology procedures?
What are the peri-operative adverse events of tamsulosin in NCT06843538 and how are they managed in urogynecology surgery patients?
Are there combination therapies with tamsulosin and anticholinergics that improve postoperative voiding outcomes in urogynecology patients?
Trial Locations
- Locations (1)
TriHealth
🇺🇸Cincinnati, Ohio, United States