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

Laser Thermotherapy, Stress Urinary Incontinence Clinical Trial

Official title:

Far Eastern Memorial Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03693690
• Other study ID #: 107089-F
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Far Eastern Memorial Hospital
• Contact: Sheng-Mou Hsiao, MD
• Phone: +89667000
• Email: smhsiao2[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Laser Thermotherapy, Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	New Taipei	Banqiao

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global response assessment		2 years
Secondary	Duration of sustained efficacy	Duration of global response assessment = 2 at each visit	2 years