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Completed

NCT Number: NCT02130375

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

The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • < 20 years old female

Treatment and study plan

the IncontiLaseTM procedure

Procedure

Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence

Primary outcomes

  1. The change of pad weight from baseline

    Time frame: 3 months

    The change of pad weight from baseline after IncontiLaseTM procedure

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 5, 2014
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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