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

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04597372

Collaborator

Johns Hopkins University (Other)

154

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Postoperative	Drug: Tamsulosin Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 3, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamsulosin 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.	Drug: Tamsulosin Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
Placebo Comparator: Placebo 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.	Drug: Placebo 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.

Arm

Intervention/Treatment

Experimental: Tamsulosin

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.

Drug: Tamsulosin

Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.

Placebo Comparator: Placebo

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.

Drug: Placebo

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.

Outcome Measures

Primary Outcome Measures

To determine the impact of Tamsulosin on duration of urinary retention [Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course]
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). [Date of failed the retrograde voiding trial and up to 6 weeks.]
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. [Prior to discharge and again at 2 weeks follow up]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Penn Hospital	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Johns Hopkins University

Investigators

Principal Investigator: Lindsay Turner, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Lindsay Turner, Director of Urogynecology, Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

ClinicalTrials.gov Identifier:

NCT04597372

Other Study ID Numbers:

IRB00264995

First Posted:

Oct 22, 2020

Last Update Posted:

Dec 9, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Additional relevant MeSH terms:

Urinary Retention

Tamsulosin

Study Results

No Results Posted as of Dec 9, 2021