The Effect of Tamsulosin on Postoperative Urinary Retention

Wake Forest University (WFU)

Status and phase: Terminated; Phase 4

Conditions: Urinary Retention

Treatments: Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT04682366

IRB00070462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Tamsulosin

Experimental group

Description:

Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.

Treatment:

Drug: Tamsulosin

Placebo

Placebo Comparator group

Description:

Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.

Treatment:

Drug: Placebo