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

NCT ID: NCT04232683

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Preoperative Tamsulosin

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

Group Type EXPERIMENTAL

Tamsulosin 0.4Mg Capsule

Intervention Type DRUG

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

Preoperative Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo pill given preoperatively

Interventions

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Tamsulosin 0.4Mg Capsule

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

Intervention Type DRUG

Placebo oral tablet

Placebo pill given preoperatively

Intervention Type DRUG

Other Intervention Names

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Preoperative Placebo

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Eric Hurtado

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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FLA 19-073

Identifier Type: -

Identifier Source: org_study_id

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