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Urodynamic Study and Stress Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
sling surgery
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring urodynamic study, stress urinary incontinence

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • stress urinary incontinence

Exclusion Criteria:

  • mixed incontinence
  • recurrent cases

Sites / Locations

  • Kasr El Ainiy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

urodynamics study group

surgery only group

Arm Description

65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery

60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study

Outcomes

Primary Outcome Measures

cure of stress incontinence
by clinical assessment

Secondary Outcome Measures

cure of stress incontinence
by clinical assessment
cure of stress incontinence
by clinical assessment

Full Information

First Posted
September 21, 2017
Last Updated
September 28, 2017
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03300973
Brief Title
Urodynamic Study and Stress Incontinence
Official Title
Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
urodynamic study, stress urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
urodynamics study group
Arm Type
Active Comparator
Arm Description
65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery
Arm Title
surgery only group
Arm Type
Active Comparator
Arm Description
60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study
Intervention Type
Procedure
Intervention Name(s)
sling surgery
Intervention Description
transoburator vaginal tape ,inside out procedure under spinal anathesia
Primary Outcome Measure Information:
Title
cure of stress incontinence
Description
by clinical assessment
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
cure of stress incontinence
Description
by clinical assessment
Time Frame
one month after surgery
Title
cure of stress incontinence
Description
by clinical assessment
Time Frame
3 months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stress urinary incontinence Exclusion Criteria: mixed incontinence recurrent cases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M Hassan, lecturer
Phone
01003733671
Email
saramohamed7880@yahoo.com
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sarah M Hassan, Lecturer
Phone
01003733671
Email
saramohamed7880@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Urodynamic Study and Stress Incontinence

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