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Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

Primary Purpose

Urinary Retention

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tamsulosin 0.4Mg Capsule

Placebo oral tablet

About this trial

This is an interventional prevention trial for Urinary Retention focused on measuring Female Pelvic Floor Disorders, Postoperative Urinary Retention, Tamsulosin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.

ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings

Exclusion Criteria:

i. Diagnosis of urinary retention preoperatively (post void residual >150ml)

ii. Malignancy

iii. History of neurological disease

iv. History of spinal cord injuries

v. Allergy to Tamsulosin

vi. Perioperative complications requiring prolonged postoperative bladder drainage

vii. Incontinence procedures other than mid-urethral slings

Sites / Locations

Cleveland Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Preoperative Tamsulosin

Preoperative Placebo

Arm Description

The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.

The control group will receive one oral dose of placebo pill prior to surgery.

Outcomes

Primary Outcome Measures

Tamsulosin Effect

Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.

Secondary Outcome Measures

Postoperative Narcotic Use

Amount of postoperative narcotic use will be tracked to assess if increased narcotic use has an effect on postoperative voiding trial (The amount of narctoic use will be measured in milligrams)

Effect of Tamsulosin on postoperative blood pressure

A side effect of Tamsulosin in hypotension, therefore, postoperative blood pressure will be evaluated to see if Tamsulosin had a significant impact on blood pressure

Full Information

NCT ID

NCT04232683

First Posted

January 8, 2020

Last Updated

May 24, 2023

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04232683

Brief Title

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

Official Title

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 18, 2019 (Actual)

Primary Completion Date

February 11, 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Cleveland Clinic

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

5. Study Description

Brief Summary

Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.

Detailed Description

This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.

6. Conditions and Keywords

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

Urinary Retention

Keywords

Female Pelvic Floor Disorders, Postoperative Urinary Retention, Tamsulosin

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preoperative Tamsulosin

Arm Type

Experimental

Arm Description

The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.

Arm Title

Preoperative Placebo

Arm Type

Placebo Comparator

Arm Description

The control group will receive one oral dose of placebo pill prior to surgery.

Intervention Type

Drug

Intervention Name(s)

Tamsulosin 0.4Mg Capsule

Intervention Description

Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Other Intervention Name(s)

Preoperative Placebo

Intervention Description

Placebo pill given preoperatively

Primary Outcome Measure Information:

Title

Tamsulosin Effect

Description

Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.

Time Frame

Up to 4 hours after surgery while patient is in post-anesthesia care unit.

Secondary Outcome Measure Information:

Title

Postoperative Narcotic Use

Description

Amount of postoperative narcotic use will be tracked to assess if increased narcotic use has an effect on postoperative voiding trial (The amount of narctoic use will be measured in milligrams)

Time Frame

Up to 4 hours after surgery while patient is in post-anesthesia care unit.

Title

Effect of Tamsulosin on postoperative blood pressure

Description

A side effect of Tamsulosin in hypotension, therefore, postoperative blood pressure will be evaluated to see if Tamsulosin had a significant impact on blood pressure

Time Frame

Up to 4 hours after surgery while patient is in post-anesthesia care unit

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure. ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings Exclusion Criteria: i. Diagnosis of urinary retention preoperatively (post void residual >150ml) ii. Malignancy iii. History of neurological disease iv. History of spinal cord injuries v. Allergy to Tamsulosin vi. Perioperative complications requiring prolonged postoperative bladder drainage vii. Incontinence procedures other than mid-urethral slings

Facility Information:

Facility Name

Cleveland Clinic Florida

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

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