Factors Affecting Therapeutic Efficacy of Vaginal Laser Therapy for Female Stress Urinary Incontinence, and the Effect of Vaginal Laser Therapy on Overactive Bladder Syndrome and Sexual Function

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Sheng-Mou Hsiao，Far Eastern Memorial Hospital

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

September 5, 2018

Estimated Primary Completion Date

December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Global response assessment[ Time Frame: 2 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Duration of sustained efficacy[ Time Frame: 2 years ]
Duration of global response assessment ≥ 2 at each visit

Descriptive Information

Brief Title ^ICMJE

Factors Affecting Therapeutic Efficacy of Vaginal Laser Therapy for Female Stress Urinary Incontinence, and the Effect of Vaginal Laser Therapy on Overactive Bladder Syndrome and Sexual Function

Official Title ^ICMJE

Far Eastern Memorial Hospital

Brief Summary

The main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy.

Detailed Description

Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence. However, factor affecting treatment efficacy of vaginal laser therapy remains unknown. Thus the main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy. Besides, the durability of vaginal laser therapy will be assessed. The above knowledge should be helpful for clinical decision making.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Vaginal laser thermotherapy
Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence.

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2020

Estimated Primary Completion Date

December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - >20 years old female - had stress urinary incontinence symptoms - Sexual behavior - No urinary tract infection - At their own expense for vaginal laser therapy Exclusion Criteria: - Abnormal vaginal bleeding - Vaginal fistula

Sex/Gender

Sexes Eligible for Study:

Female

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Taiwan

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Sheng-Mou Hsiao，Far Eastern Memorial Hospital

Study Sponsor ^ICMJE

Far Eastern Memorial Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Far Eastern Memorial Hospital

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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