The Effect of Tamsulosin on Postoperative Urinary Retention

NCT04682366 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00070462
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

Postoperative care; Urinary tract infection; Female pelvic reconstructive surgery; Enhanced recovery after surgery; Tamsulosin; Flomax

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative (Day 0) Urinary Retention

  Urinary retention can be defined as \>150cc residual volume during an active voiding trial

  Up to 6 weeks postoperatively

Secondary Outcomes (5)

• Urinary Tract Infection Rate

  Week 6

• Incidence of Delayed Urinary Retention

  Week 6

• Number Emergency Department (ED) Visits

  Up to 30 days postoperatively

• Total Number of Days of Bladder Catheterization

  Week 6

• Patient Level of Satisfaction With Voiding Function

  Day 0 and 1 week postoperatively

Study Arms (2)

Tamsulosin

EXPERIMENTAL

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.

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Tamsulosin DRUG

Oral drug: 10 days of 0.4 mg of oral Tamsulosin

Tamsulosin

Placebo DRUG

Oral drug: 10 days of identical-appearing placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Urinary Retention; Urinary Tract Infections

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Majid Mirzazadeh
• Organization: Wake Forest

mmirzaza@wakehealth.edu

336-716-4131

Study Officials

• Majid Mirzazadeh, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: October 19, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)