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NCT02130375 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02130375
Other study ID # 201402021RINB
Secondary ID
Status Completed
Phase Phase 4
First received April 28, 2014
Last updated January 27, 2016
Start date May 2014
Est. completion date December 2015

Study information
Verified date January 2016
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 99 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• the IncontiLaseTM procedure
Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence

Locations
Country Name City State
Taiwan Department of Obstetrics & Gynecology, National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Other The change of female sexual functional score from baseline after treatment The change of female sexual functional score from baseline after treatment 3 months No
Other The change of periurethral blood flow from baseline 3 months No
Primary The change of pad weight from baseline The change of pad weight from baseline after IncontiLaseTM procedure 3 months No
Secondary The change of maximum urethral closure procedure from baseline The change of maximum urethral closure procedure from baseline after the IncontiLaseTM procedure by urodynamic studies 3 months No
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Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
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