Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence

Phase 4

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: the IncontiLaseTM procedure

• Registration Number: NCT02130375
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

Detailed Description

To get the objective urodynamic and sonographic effects of IncontiLaseTM procedure on women with stress urinary incontinence; and its impact on urinary symptoms and female sexual function.

Study Timeline

• Study First Submitted: 2014-04-28
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence

Exclusion Criteria

• < 20 years old female

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stress urinary incontinence	the IncontiLaseTM procedure	Women with stress urinary incontinence

Primary Outcome Measures

Name	Time	Method
The change of pad weight from baseline	3 months	The change of pad weight from baseline after IncontiLaseTM procedure

Secondary Outcome Measures

Name	Time	Method
The change of maximum urethral closure procedure from baseline	3 months	The change of maximum urethral closure procedure from baseline after the IncontiLaseTM procedure by urodynamic studies

Trial Locations

Locations (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan