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NCT03300973 Clinical Trial

Urodynamic Study and Stress Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:
Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03300973
Other study ID # 11279
Secondary ID
Status Recruiting
Phase Phase 2
First received September 21, 2017
Last updated September 28, 2017
Start date January 15, 2016
Est. completion date October 2017

Study information
Verified date September 2017
Source Kasr El Aini Hospital
Contact Sarah M Hassan, lecturer
Phone 01003733671
Email saramohamed7880@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 125
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- stress urinary incontinence

Exclusion Criteria:

- mixed incontinence

- recurrent cases

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• sling surgery
transoburator vaginal tape ,inside out procedure under spinal anathesia

Locations
Country Name City State
Egypt Kasr El Ainiy Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary cure of stress incontinence by clinical assessment 1 week after surgery
Secondary cure of stress incontinence by clinical assessment one month after surgery
Secondary cure of stress incontinence by clinical assessment 3 months after surgery
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