Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tamsulosin, Placebo.
- Who it may be relevant to
- Registry conditions: Postoperative Urinary Retention (POUR). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial
Overview
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).
Interventions
- Drug Tamsulosin
This intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively. - Drug Placebo
This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.
Primary outcome measures
- Voiding trial on postoperative day 0 [Time frame: Day of surgery]
Secondary outcome measures (2)
- Secondary postoperative urinary retention [Time frame: 2 weeks following surgery]
- Postoperative urinary tract infection [Time frame: 30 days after surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- TriHealth — Cincinnati
Identifiers
NCT: NCT06843538 · 24-108