Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence

Stress Incontinence, Female Clinical Trial

— laser  

Official title:

Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267719
• Other study ID #: Uro-Laser
• Status: Completed
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: March 2019
• Source: University Women's Hospital Tübingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Description:

The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Light or moderate stress incontinence

• mixed urine incontinence with predominance of the stress component

• written informed consent

Exclusion Criteria:

• Pregnancy

• patients treated radiotherapy in the small basin

• connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome)

• patient with or after malignant disease of the uterus, ovaries, vagina and vulva

• former surgery due to stress incontinence (except for the patients who had a TVT insert with removal of the TVT)

• Descensus genitalis> POPQ Stage 1

• former surgery due to a genital lowering with vaginal netting

Related Conditions & MeSH terms

• Stress Incontinence, Female
• Urinary Incontinence, Stress

Intervention

Device:
• laser therapy
Transvaginal erbium-laser treatment

Locations

Country	Name	City	State
Germany	Department for Women's Health	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Women's Hospital Tübingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life will be access via ICIQ-SF questionaire	6 month