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Completed

NCT Number: NCT02418299

Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)

The purpose of this study was to evaluate the effect of a non-invasive Er:YAG thermal laser therapy in treating female stress and mixed urinary incontinence.

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Key information

About this study

Urinary incontinence (UI) is a common disorder that affects women of various ages and impacts all aspects of life. Therapeutic approaches range from conservative therapy, which is heavily dependent on patient compliance, to different, more invasive, surgical procedures.

The aim of the study was to evaluate the non-invasive erbium:yttrium-aluminum-garnet (Er:YAG) laser treatment (IncontiLase) as a potential treatment strategy for stress UI (SUI) and mixed UI (MUI). The treatment works by thermally affecting vaginal mucosa, with an emphasis on the anterior vaginal wall, resulting with partial denaturation of collagen fibres and stimulation if new collagen formation, all of which leads to firmer support for the urethra and the improvement of incontinence symptoms.

The investigators included 175 women with newly diagnosed SUI (66% of women) and MUI (34 %), respectively and performed on average 2.5±0.5 procedures in each woman separated by a two-month period, using Er:YAG laser. Patients were clinically examined and classified by incontinence types (SUI and MUI) and grades (mild, moderate, severe and very severe) using International Consultation on Incontinence Modular Questionnaire (ICIQ) and assessing Incontinence Severity Index (ISI): ISI before the therapy was 5.7±2.1 points. Treatment discomfort was measured at every session with visual analogue system pain scale, and adverse effects and patients' satisfaction were followed. Follow-ups were performed at two, six and twelve months after the treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinically confirmed UI
  • normal PAP smear (Papanicolaou cytology)
  • negative urine culture
  • integrity of the vaginal mucosa (without injuries or bleeding)

Exclusion criteria

  • pregnancy
  • intake of photosensitive drugs
  • vaginal injuries or vaginal bleeding
  • infection in the treated area
  • clinical diagnosis of pure urge urinary incontinence

Treatment and study plan

IncontiLase Er:YAG laser treatment

Device

Each patient will receive 2-3 sessions of Er:YAG laser treatment for stress and mixed urinary incontinence (IncontiLase)

Other names: IncontiLase

Primary outcomes

  1. Change in the Incontinence Severity Index (ISI) calculated from the ICIQ-UI short form questionnaire

    Time frame: at baseline and 2, 6 and 12 months after treatment

Secondary outcomes

  1. VAS index for the assessment of pain

    Time frame: at baat baseline and 2, 6 and 12 months after treatment

Sponsors and collaborators

Lead sponsor

Juna d.o.o.

Industry

Registry information

Official study title

Prospective, Single Centre Study of Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2015
Registry last updated
Apr 17, 2015

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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