Back to resultsClinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
the IncontiLaseTM procedure
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence
Exclusion Criteria:
- < 20 years old female
Sites / Locations
- Department of Obstetrics & Gynecology, National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stress urinary incontinence
Arm Description
Women with stress urinary incontinence
Outcomes
Primary Outcome Measures
The change of pad weight from baseline
The change of pad weight from baseline after IncontiLaseTM procedure
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02130375
First Posted
April 28, 2014
Last Updated
January 27, 2016
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02130375
Brief Title
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
Official Title
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stress urinary incontinence
Arm Type
Experimental
Arm Description
Women with stress urinary incontinence
Intervention Type
Procedure
Intervention Name(s)
the IncontiLaseTM procedure
Intervention Description
Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence
Primary Outcome Measure Information:
Title
The change of pad weight from baseline
Description
The change of pad weight from baseline after IncontiLaseTM procedure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The change of maximum urethral closure procedure from baseline
Description
The change of maximum urethral closure procedure from baseline after the IncontiLaseTM procedure by urodynamic studies
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
The change of female sexual functional score from baseline after treatment
Description
The change of female sexual functional score from baseline after treatment
Time Frame
3 months
Title
The change of periurethral blood flow from baseline
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence
Exclusion Criteria:
< 20 years old female
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, MD, PhD
Organizational Affiliation
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics & Gynecology, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
We'll reach out to this number within 24 hrs