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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02130375
First Posted: May 5, 2014
Last Update Posted: January 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

Condition Intervention Phase
Stress Urinary Incontinence Procedure: the IncontiLaseTM procedure Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The change of pad weight from baseline [ Time Frame: 3 months ]
    The change of pad weight from baseline after IncontiLaseTM procedure


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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

  • The change of periurethral blood flow from baseline [ Time Frame: 3 months ]

Enrollment: 35
Study Start Date: May 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • < 20 years old female
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130375


Locations
Taiwan
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ho-Hsiung Lin, MD, PhD Department of Obstetrics & Gynecology, National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02130375     History of Changes
Other Study ID Numbers: 201402021RINB
First Submitted: April 28, 2014
First Posted: May 5, 2014
Last Update Posted: January 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders