Urodynamic Study and Stress Incontinence

Phase 2

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: sling surgery

• Registration Number: NCT03300973
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-01-15
• Status Verified: 2017-09
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-28
• Last Update Submitted: 2017-09-28
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Study First Posted: 2017-10-04
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• stress urinary incontinence

Exclusion Criteria

• mixed incontinence
• recurrent cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery only group	sling surgery	60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study
urodynamics study group	sling surgery	65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery

Primary Outcome Measures

Name	Time	Method
cure of stress incontinence	1 week after surgery	by clinical assessment

Secondary Outcome Measures

Name	Time	Method
cure of stress incontinence	3 months after surgery	by clinical assessment

Trial Locations

Locations (1)

Kasr El Ainiy Hospital; 🇪🇬 Cairo, Egypt