NCT03267719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 22, 2024

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

August 28, 2017

Last Update Submit

July 19, 2024

Conditions

Stress Incontinence, Female

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Quality of life will be access via ICIQ-SF questionaire

    6 month

Study Arms (1)

laser therapy

EXPERIMENTAL

Erbium-laser therapy will be applied

Device: laser therapy

Interventions

laser therapyDEVICE

Transvaginal erbium-laser treatment

laser therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Light or moderate stress incontinence
  • mixed urine incontinence with predominance of the stress component
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Women's Health

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Christl Reisenauer, Prof. Dr.

    University Women's Hospital Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

August 31, 2017

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

July 22, 2024

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)