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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

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

NCT ID

NCT04597372

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

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

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

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

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

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

Caitlyn.Copp-millward@AHN.ORG

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Kramer

Phone

412.578.4216

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

Caitlyn.Copp-millward@AHN.ORG

First Name & Middle Initial & Last Name & Degree

Caroline Kramer

Phone

412.578.4216

carline.kramer3@ahn.org

First Name & Middle Initial & Last Name & Degree

Lindsay Turner, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Results will be published; patient identifiers will not be used in the research publications.

Citations:

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Citation

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

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