Clinical trial NCT04682366: The Effect of Tamsulosin on Postoperative Urinary Retention
Official title: Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Retention
Keywords: Postoperative care
Urinary tract infection
Female pelvic reconstructive surgery
Enhanced recovery after surgery
Tamsulosin
Flomax
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 4
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.

Detailed description: The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned.

Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo.

Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.

Eligibility criteria: Inclusion Criteria:

* Stage II or greater pelvic organ prolapse in \> 1 vaginal compartment
* Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
* Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
* Willing to remain compliant with Investigation Product (IP)

Exclusion Criteria:

* Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
* Patients whose surgical plan would necessitate a voiding trial on postop day \>0
* Less than 21 years of age
* Unable to understand English
* Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty
* Patient with known allergy to Tamsulosin or sulfa drugs
* Patients with upcoming cataract surgery
* Patient with orthostatic hypotension
* History of postvoid residual (PVR\>150) prior to surgery with prolapse reduction
* Patients with hypertension on alpha-blockers
* Single compartment prolapse repair (anterior or posterior repair only)
* Use of mesh for prolapse repair
* High tone pelvic floor dysfunction

Primary outcomes:
measure: Number of Participants With Postoperative (Day 0) Urinary Retention
timeFrame: Up to 6 weeks postoperatively
Secondary outcomes:
measure: Urinary Tract Infection Rate
timeFrame: Week 6
measure: Incidence of Delayed Urinary Retention
timeFrame: Week 6
measure: Number Emergency Department (ED) Visits
timeFrame: Up to 30 days postoperatively
measure: Total Number of Days of Bladder Catheterization
timeFrame: Week 6
measure: Patient Level of Satisfaction With Voiding Function
timeFrame: Day 0 and 1 week postoperatively
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Majid Mirzazadeh, MD
role: PRINCIPAL_INVESTIGATOR
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