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Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04232683
Enrollment
100
Registered
2020-01-18
Start date
2019-12-18
Completion date
2025-10-11
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

Keywords

Female Pelvic Floor Disorders, Postoperative Urinary Retention, Tamsulosin

Brief summary

Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.

Detailed description

This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.

Interventions

DRUGTamsulosin 0.4Mg Capsule

Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased

DRUGPlacebo oral tablet

Placebo pill given preoperatively

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure. ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings

Exclusion criteria

i. Diagnosis of urinary retention preoperatively (post void residual \>150ml) ii. Malignancy iii. History of neurological disease iv. History of spinal cord injuries v. Allergy to Tamsulosin vi. Perioperative complications requiring prolonged postoperative bladder drainage vii. Incontinence procedures other than mid-urethral slings

Design outcomes

Primary

MeasureTime frameDescription
Tamsulosin EffectUp to 4 hours after surgery while patient is in post-anesthesia care unit.Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.

Secondary

MeasureTime frameDescription
Postoperative Narcotic UseUp to 4 hours after surgery while patient is in post-anesthesia care unit.Amount of postoperative narcotic use will be tracked to assess if increased narcotic use has an effect on postoperative voiding trial (The amount of narctoic use will be measured in milligrams)
Effect of Tamsulosin on postoperative blood pressureUp to 4 hours after surgery while patient is in post-anesthesia care unitA side effect of Tamsulosin in hypotension, therefore, postoperative blood pressure will be evaluated to see if Tamsulosin had a significant impact on blood pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026