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Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

Primary Purpose

Urinary Retention Postoperative

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years or older
  • willing and able to provide informed consent
  • postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
  • Ability to speak and read English
  • Tolerate pill ingestion

Exclusion Criteria:

  • allergy/intolerance to Tamsulosin or sulfa drugs
  • preoperative history of urinary retention as defined by preoperative post void residual of >150mL
  • current use of alpha antagonist medication for hypertension
  • severe dementia
  • end stage renal or liver disease
  • history of severe heart failure or major cardiovascular event in the last 6 months

Sites / Locations

  • West Penn HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tamsulosin

Placebo

Arm Description

10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Outcomes

Primary Outcome Measures

To determine the impact of Tamsulosin on duration of urinary retention
The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.

Secondary Outcome Measures

To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).
The electronic medical record (EMR) will be reviewed to determine if subjects were treated for a urinary tract infection (UTI). UTIs will be diagnosed by a urine culture confirming bacteriuria of at least 10 ^5 CFU/mL. UTIs treated presumptively and without culture will also be included as positive cultures.
To quantify the effect of Tamsulosin on patient quality of life.
Patients will be asked to complete the Euroqol-5D (EQ-5D) questionnaire to assess quality of life. The EQ-5D is scored with a 5-digit code of index values which reflect how good or bad a health state is (Level 1 indicates no problem where is Level 5 indicates extreme problems).

Full Information

First Posted
October 5, 2020
Last Updated
November 4, 2022
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04597372
Brief Title
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
Official Title
The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators
Johns Hopkins University

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.
Detailed Description
The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo. Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin
Arm Type
Experimental
Arm Description
10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.
Primary Outcome Measure Information:
Title
To determine the impact of Tamsulosin on duration of urinary retention
Description
The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.
Time Frame
Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course
Secondary Outcome Measure Information:
Title
To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).
Description
The electronic medical record (EMR) will be reviewed to determine if subjects were treated for a urinary tract infection (UTI). UTIs will be diagnosed by a urine culture confirming bacteriuria of at least 10 ^5 CFU/mL. UTIs treated presumptively and without culture will also be included as positive cultures.
Time Frame
Date of failed the retrograde voiding trial and up to 6 weeks.
Title
To quantify the effect of Tamsulosin on patient quality of life.
Description
Patients will be asked to complete the Euroqol-5D (EQ-5D) questionnaire to assess quality of life. The EQ-5D is scored with a 5-digit code of index values which reflect how good or bad a health state is (Level 1 indicates no problem where is Level 5 indicates extreme problems).
Time Frame
Prior to discharge and again at 2 weeks follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older willing and able to provide informed consent postoperative urinary retention as defined by a failed RGVT prior to hospital discharge Ability to speak and read English Tolerate pill ingestion Exclusion Criteria: allergy/intolerance to Tamsulosin or sulfa drugs preoperative history of urinary retention as defined by preoperative post void residual of >150mL current use of alpha antagonist medication for hypertension severe dementia end stage renal or liver disease history of severe heart failure or major cardiovascular event in the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlyn Copp-Millward
Phone
412-578-4368
Email
Caitlyn.Copp-millward@AHN.ORG
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Kramer
Phone
412.578.4216
Email
caroline.kramer3@ahn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Turner, MD
Organizational Affiliation
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlyn Copp-Millward
Phone
412-578-4368
Email
Caitlyn.Copp-millward@AHN.ORG
First Name & Middle Initial & Last Name & Degree
Caroline Kramer
Phone
412.578.4216
Email
carline.kramer3@ahn.org
First Name & Middle Initial & Last Name & Degree
Lindsay Turner, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published; patient identifiers will not be used in the research publications.
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Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

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