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

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ClinicalTrials.gov Identifier: NCT02130375
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: the IncontiLaseTM procedure Phase 4

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  (Clinical Trial)
Actual Enrollment : 35 participants
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
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


Secondary Outcome Measures :
  1. 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:
  1. 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

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


Information from the National Library of Medicine

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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

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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02130375     History of Changes
Other Study ID Numbers: 201402021RINB
First Posted: May 5, 2014    Key Record Dates
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