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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02130375
First received: April 28, 2014
Last updated: May 12, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The change of female sexual functional score from baseline after treatment

  • The change of periurethral blood flow from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   20 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130375

Contacts
Contact: Ho-Hsiung Lin, MD, PhD 886-2-23123456 ext 71557 hhlin@ntuh.gov.tw

Locations
Taiwan
Department of Obstetrics & Gynecology, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ho-Hsiung Lin, MD, PhD    886-2-23123456 ext 71557    hhlin@ntuh.gov.tw   
Principal Investigator: Ho-Hsiung Lin, MD, PhD         
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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02130375     History of Changes
Other Study ID Numbers: 201402021RINB
Study First Received: April 28, 2014
Last Updated: May 12, 2014
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on August 28, 2014