Postoperative Urinary Retention (POUR)
Conditions
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).
Interventions
DRUGTamsulosin
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.
DRUGPlacebo
This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voiding trial on postoperative day 0 | Day of surgery | Whether or not patients pass or fail their postoperative voiding trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactGisele C Moran, MD, MPH
Outcome results
None listed