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Completed

NCT Number: NCT03524339

Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Stress Urinary Incontinence Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospitals, Cleveland, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be 18 years or older as well as willing and able to provide informed consent
  • Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
  • Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.

Exclusion criteria

  • Patient unable or unwilling to provide informed consent
  • Severe allergy to sulfa drugs
  • Known allergy to tamsulosin or another alpha antagonist medication
  • History of urinary retention
  • Planned bladder catheterization greater than 24 hours after surgery
  • Current use of alpha antagonist medication for hypertension
  • End stage renal or liver disease

Treatment and study plan

Placebo oral capsule

Drug

Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.

Tamsulosin

Drug

Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.

Primary outcomes

  1. Postoperative Urinary Retention

    Time frame: Within 72 hours of surgery

    Failed voiding trial upon removal of catheter

Secondary outcomes

  1. International Prostate Symptom Score

    Time frame: Within 1 week of surgery

    Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst)

  2. Postoperative Urinary Tract Infection

    Time frame: Within 6 weeks after surgery

    Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.

  3. Sent Home With Catheterization

    Time frame: within 6 weeks of surgery

    Urinary retention that required homegoing catheterization

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 14, 2018
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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