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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03267719
Other study ID # Uro-Laser
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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