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Completed

NCT Number: NCT03267719

Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser Therapy

Device

Transvaginal erbium-laser treatment

Primary outcomes

  1. Quality of life

    Time frame: 6 month

    Quality of life will be access via ICIQ-SF questionaire

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: laser

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2017
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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