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The Effect of Tamsulosin on Postoperative Urinary Retention

Primary Purpose

Urinary Retention

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring Postoperative care, Urinary tract infection, Female pelvic reconstructive surgery, Enhanced recovery after surgery, Tamsulosin, Flomax

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Wake Forest Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tamsulosin

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

The rate of postoperative urinary retention (POUR)
Urinary retention can be defined as >150cc residual volume during an active voiding trial

Secondary Outcome Measures

Urinary tract infection rate
Incidence of delayed urinary retention
Delayed urinary retention will be defined as post-void residual > 150 cc
Number Emergency Department (ED) visits
Total number of days of bladder catheterization
Patient level of satisfaction with voiding function
Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)

Full Information

First Posted
December 18, 2020
Last Updated
March 10, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04682366
Brief Title
The Effect of Tamsulosin on Postoperative Urinary Retention
Official Title
Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Challenges in enrollment led to decission for termination
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
Postoperative care, Urinary tract infection, Female pelvic reconstructive surgery, Enhanced recovery after surgery, Tamsulosin, Flomax

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
Oral drug: 10 days of 0.4 mg of oral Tamsulosin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral drug: 10 days of identical-appearing placebo
Primary Outcome Measure Information:
Title
The rate of postoperative urinary retention (POUR)
Description
Urinary retention can be defined as >150cc residual volume during an active voiding trial
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Urinary tract infection rate
Time Frame
Week 6
Title
Incidence of delayed urinary retention
Description
Delayed urinary retention will be defined as post-void residual > 150 cc
Time Frame
Week 6
Title
Number Emergency Department (ED) visits
Time Frame
Up to 30 days postoperatively
Title
Total number of days of bladder catheterization
Time Frame
Week 6
Title
Patient level of satisfaction with voiding function
Description
Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)
Time Frame
Day 0 and 1 week postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Mirzazadeh, MD
Organizational Affiliation
Wake Forest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Tamsulosin on Postoperative Urinary Retention

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