Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence (laser)

July 19, 2024 updated by: University Hospital Tuebingen
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

  • Germany
      • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laser therapy
Erbium-laser therapy will be applied
Device: laser therapy
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.

Sponsor

University Hospital Tuebingen

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)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

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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