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Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery

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ClinicalTrials.gov Identifier: NCT03524339
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Graham Chapman, University Hospitals Cleveland Medical Center

Brief Summary:
This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.

Condition or disease Intervention/treatment Phase
Urinary Retention Lower Urinary Tract Symptoms Stress Urinary Incontinence Pelvic Organ Prolapse Drug: Placebo oral capsule Drug: Tamsulosin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo oral capsule
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.

Experimental: Tamsulosin Drug: Tamsulosin
Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.




Primary Outcome Measures :
  1. Postoperative urinary retention [ Time Frame: Within 72 hours of surgery ]
    Failed voiding trial upon removal of catheter


Secondary Outcome Measures :
  1. International Prostate Symptom Score [ Time Frame: Within 1 week of surgery ]
    Total and subscale scores reported. Total score range 0-35, with 0 being less symptomatic and 35 being more symptomatic. Total score is sum of individual questions. Seven subgroups address incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia. Each subgroup is scored 0-5 with 5 being most symptomatic. The last question is independent, rates quality of life from 0 (best) to 6 (worst)

  2. Postoperative Urinary Tract Infection [ Time Frame: Within 6 weeks after surgery ]
    Treated for urinary tract infection with antibiotics or urinalysis or urine culture suggests infection.

  3. Delayed urinary retention [ Time Frame: Within 6 weeks of surgery ]
    Urinary retention requiring catheterization after passing the initial voiding trial

  4. Sent home with catheterization [ Time Frame: within 6 weeks of surgery ]
    Urinary retention that required homegoing catheterization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must be 18 years or older as well as willing and able to provide informed consent
  • Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
  • Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.

Exclusion Criteria:

  • Patient unable or unwilling to provide informed consent
  • Severe allergy to sulfa drugs
  • Known allergy to tamsulosin or another alpha antagonist medication
  • History of urinary retention
  • Planned bladder catheterization greater than 24 hours after surgery
  • Current use of alpha antagonist medication for hypertension
  • End stage renal or liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524339


Contacts
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Contact: Graham Chapman, MD 4409155543 graham.chapman@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Graham Chapman, MD    440-915-5543    graham.chapman@uhhospitals.org   
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Graham C Chapman, MD    440-915-5543    graham.chapman@uhhospitals.org   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Graham Chapman University Hospitals Case Western Reserve University

Publications:

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Responsible Party: Graham Chapman, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03524339     History of Changes
Other Study ID Numbers: Tamsulosin for POUR
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Incontinence
Enuresis
Prolapse
Urinary Incontinence, Stress
Pelvic Organ Prolapse
Urinary Retention
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents