The Effect of Tamsulosin on Postoperative Urinary Retention

  • STATUS
    Recruiting
  • End date
    May 18, 2024
  • participants needed
    88
  • sponsor
    Wake Forest University Health Sciences
Updated on 18 May 2022

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.

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.

Details
Condition Urinary Retention
Treatment Placebo, Tamsulosin
Clinical Study IdentifierNCT04682366
SponsorWake Forest University Health Sciences
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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