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

Primary Purpose

Stress Incontinence, Female

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
laser therapy
Sponsored by
University Women's Hospital Tübingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Incontinence, Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department for Women's Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

laser therapy

Arm Description

Erbium-laser therapy will be applied

Outcomes

Primary Outcome Measures

Quality of life
Quality of life will be access via ICIQ-SF questionaire

Secondary Outcome Measures

Full Information

First Posted
August 28, 2017
Last Updated
March 5, 2019
Sponsor
University Women's Hospital Tübingen
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1. Study Identification

Unique Protocol Identification Number
NCT03267719
Brief Title
Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence
Acronym
laser
Official Title
Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Women's Hospital Tübingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Incontinence, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laser therapy
Arm Type
Experimental
Arm Description
Erbium-laser therapy will be applied
Intervention Type
Device
Intervention Name(s)
laser therapy
Intervention Description
Transvaginal erbium-laser treatment
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of life will be access via ICIQ-SF questionaire
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christl Reisenauer, Prof. Dr.
Organizational Affiliation
University Women's Hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Women's Health
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence

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