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

January 27, 2016 updated by: National Taiwan University Hospital
The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Department of Obstetrics & Gynecology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • < 20 years old female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stress urinary incontinence
Women with stress urinary incontinence
Procedure: the IncontiLaseTM procedure
Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of pad weight from baseline
Time Frame: 3 months
The change of pad weight from baseline after IncontiLaseTM procedure
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of maximum urethral closure procedure from baseline
Time Frame: 3 months
The change of maximum urethral closure procedure from baseline after the IncontiLaseTM procedure by urodynamic studies
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of female sexual functional score from baseline after treatment
Time Frame: 3 months
The change of female sexual functional score from baseline after treatment
3 months
The change of periurethral blood flow from baseline
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 5, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201402021RINB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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