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Urodynamic Study and Stress Incontinence

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ClinicalTrials.gov Identifier: NCT03300973
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
sarah mohamed hassan, Kasr El Aini Hospital

Brief Summary:
A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: sling surgery Phase 2

Detailed Description:
group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.
Actual Study Start Date : January 15, 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: urodynamics study group
65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery
Procedure: sling surgery
transoburator vaginal tape ,inside out procedure under spinal anathesia

Active Comparator: surgery only group
60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study
Procedure: sling surgery
transoburator vaginal tape ,inside out procedure under spinal anathesia




Primary Outcome Measures :
  1. cure of stress incontinence [ Time Frame: 1 week after surgery ]
    by clinical assessment


Secondary Outcome Measures :
  1. cure of stress incontinence [ Time Frame: one month after surgery ]
    by clinical assessment

  2. cure of stress incontinence [ Time Frame: 3 months after surgery ]
    by clinical assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stress urinary incontinence

Exclusion Criteria:

  • mixed incontinence
  • recurrent cases

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): NCT03300973


Contacts
Contact: Sarah M Hassan, lecturer 01003733671 saramohamed7880@yahoo.com

Locations
Egypt
Kasr El Ainiy Hospital Recruiting
Cairo, Egypt, 11562
Contact: sarah M Hassan, Lecturer    01003733671    saramohamed7880@yahoo.com   
Sponsors and Collaborators
Kasr El Aini Hospital

Responsible Party: sarah mohamed hassan, lecturer of obstetrics and gynecology Cairo university, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03300973     History of Changes
Other Study ID Numbers: 11279
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by sarah mohamed hassan, Kasr El Aini Hospital:
urodynamic study
stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders