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

Sponsor
The Cleveland Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04232683
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
29.4
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tamsulosin 0.4Mg Capsule
  • Drug: Placebo oral tablet
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders
Actual Study Start Date :
Dec 18, 2019
Actual Primary Completion Date :
Feb 11, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preoperative Tamsulosin

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

Drug: Tamsulosin 0.4Mg Capsule
Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
Placebo Comparator: Preoperative Placebo

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

Drug: Placebo oral tablet
Placebo pill given preoperatively
Other Names:
  • Preoperative Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tamsulosin Effect [Up to 4 hours after surgery while patient is in post-anesthesia care unit.]

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

    Secondary Outcome Measures

    1. Postoperative Narcotic Use [Up to 4 hours after surgery while patient is in post-anesthesia care unit.]

      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)

    2. Effect of Tamsulosin on postoperative blood pressure [Up to 4 hours after surgery while patient is in post-anesthesia care unit]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

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

    Exclusion Criteria:

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

    2. Malignancy

    3. History of neurological disease

    4. History of spinal cord injuries

    5. Allergy to Tamsulosin

    6. Perioperative complications requiring prolonged postoperative bladder drainage

    7. Incontinence procedures other than mid-urethral slings

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Florida Weston Florida United States 33331

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric Hurtado, Principal Investigator, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT04232683
    Other Study ID Numbers:
    • FLA 19-073
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Eric Hurtado, Principal Investigator, The Cleveland Clinic
    Female Pelvic Floor Disorders
    Postoperative Urinary Retention
    Tamsulosin
    Additional relevant MeSH terms:
    Urinary Retention
    Pelvic Floor Disorders
    Tamsulosin

    Study Results

    No Results Posted as of Jun 9, 2022