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

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

Sponsors

Lead Sponsor: University Hospitals Cleveland Medical Center

Source University Hospitals Cleveland Medical Center
Brief Summary

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

Overall Status Completed
Start Date August 1, 2018
Completion Date June 9, 2020
Primary Completion Date June 9, 2020
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Postoperative urinary retention Within 72 hours of surgery
Secondary Outcome
Measure Time Frame
International Prostate Symptom Score Within 1 week of surgery
Postoperative Urinary Tract Infection Within 6 weeks after surgery
Delayed urinary retention Within 6 weeks of surgery
Sent home with catheterization within 6 weeks of surgery
Enrollment 132
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo oral capsule

Description: 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.

Arm Group Label: Placebo

Intervention Type: Drug

Intervention Name: Tamsulosin

Description: 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.

Arm Group Label: Tamsulosin

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Graham Chapman Principal Investigator University Hospitals Case Western Reserve University
Location
Facility:
University Hospitals Cleveland Medical Center | Cleveland, Ohio, 44106, United States
University Hospitals | Cleveland, Ohio, 44106, United States
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Hospitals Cleveland Medical Center

Investigator Full Name: Graham Chapman

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Label: Tamsulosin

Type: Experimental

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov