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Completed

NCT Number: NCT04643353

Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.

This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).

Women with symptomatic stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm.

There are 3 visits (with a maximum of 6 visits) where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.

The primary objective is to evaluate the effects of VEL treatment for the subjective cure or improvement of SUI.

The secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The presence of mild (score 1-2) to moderate (3-6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorized by the four-level Sandvik severity index score (SIS). Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12).
  • Voluntary informed consent

Exclusion criteria

  • Any previous PFE-treatment in the last year for the same problem
  • Previous surgery for incontinence or prolapse
  • Severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD)
  • Prolapse grade III or more
  • Pregnancy
  • Vaginal bleeding, injuries or infection in the treated area

Treatment and study plan

Non-ablative vaginal Erbium YAG laser treatment

Device

Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting, which enables non-ablative, thermal-only operation. The parameters are selected based on extensive preclinical and clinical studies.

PFE

Other

PFE will be prescribed as it is already implemented in clinical practice (i.e. up to 2x 9 sessions with a pelvic floor physiotherapist of choice). Type of physiotherapy, number of completed sessions and duration of therapy will be recorded.

Primary outcomes

  1. Primary outcome is the subjective success rate (cure or improvement) of SUI

    Time frame: 4 months after randomisation

    The tool used is the UDI-6 questionnaire. Converted UDI-6 scores range between 0 and 300. The "minimum important difference" is defined as a (MID)=11. In that score, cure is defined as answering "No" (0) to the question "Do you experience urine leakage related to physical activity, coughing or sneezing?".

Secondary outcomes

  1. Assessment of overall urinary symptoms by means of the Urogenital Distress Inventory (UDI-6).

    Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

    The final UDI-6 score is calculated by adding all scores, and dividing the result to 6 to obtain a mean value which is in turn multiplied by 25 to obtain the scale score. The score varies from 0 to 100. The basic interpretation of the score is that the higher the score, the higher the disability . This questionnaire is available and validated in English , Dutch and French .

  2. Assessment of the objective success rate by means of the cough stress test (CST).

    Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

    A working group of the International Continence Society (ICS) has developed instructions on the performance, interpretation and reporting of the CST in a standardized manner: the ICS-Uniform Cough Stress Test (ICS-UCST).

    For the ICS-UCST it is recommended that the patient is in a supine/lithotomy position with 200-400 mL of fluid in the bladder, which can be non-invasively assessed with a bladder scan. She coughs forcefully 1-4 times and the examiner directly visualizes the urethral meatus for the presence of leakage. Leakage of fluid from the urethral meatus coincident with/ simultaneous to the cough(s) is considered a positive test. If the test is negative (i.e, no leakage detected), then accessory stress testing such as repeating the test in the upright position should be considered.

  3. Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI)

    Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

    5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better)

  4. Assessment of the degree of discomfort of the treatment procedure by the patient

    Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

    VAS-score (0-10cm, continuous scale)

  5. Assessment of the longevity of the effect of laser therapy

    Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

    measured by the need for, and the timing for repeating the same, or initiating an alternative therapy.

  6. Assessment of sexual function

    Time frame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment

    by means of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR). The PISQ-IR is a questionnaire with twenty questions. Q1 is a dividing question on being sexually active or not. Not sexually active (NSA) women are referred to Q2-Q6. Sexually active (SA) women are asked to fill out Q7-Q20. The questionnaire for NSA women consists of five questions or 12 items. A higher score refers to a higher impact of the PFD on sexual functioning. The questionnaire for SA women consists of 14 questions wherein women with a partner have to fill out all 14, being 22 items. Women without partner can skip questions 13 and 14, filling out 19 items. A lower score refers to a lower impact of the PFD on sexual functioning. This questionnaire is available and validated in English, Dutch and French .

  7. Assessment of treatment compliance in the PFE-group

    Time frame: At end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatmentAt every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24

    Therefore we will monitor how many of the participants attended the PFE treatment complete all sessions with their physical therapist.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: VELSUI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2020
Registry last updated
Sep 26, 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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