- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03267719
Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence (laser)
March 5, 2019 updated by: University Women's Hospital Tübingen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tübingen, Germany, 72076
- Department for Women's Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: laser therapy
Erbium-laser therapy will be applied
|
Transvaginal erbium-laser treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 6 month
|
Quality of life will be access via ICIQ-SF questionaire
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christl Reisenauer, Prof. Dr., University Women's Hospital Tübingen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 31, 2017
Primary Completion (ACTUAL)
March 1, 2018
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
August 28, 2017
First Submitted That Met QC Criteria
August 28, 2017
First Posted (ACTUAL)
August 30, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 6, 2019
Last Update Submitted That Met QC Criteria
March 5, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uro-Laser
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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