Laser Vaginal Treatment for Stress Urinary Incontinence

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    182
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 27 October 2022
cough
incontinence
prolapse
leakage of urine
Accepts healthy volunteers

Summary

RCT designed to answer the question:

Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?

Description

This is a double blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm followed by an open label trial at 6 months for any sham treatment arm participants who do not meet treatment success.

The primary goal is to compare the subjective success rates for the resolution of UI for the vaginal laser treatment at 6 months. Secondary aims include an assessment of complications, resolution of SUI symptoms (objective and subjective measures), patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 182 patients. At the 6-month post treatment evaluation, the treatment allocation will be unmasked. The trial will be of approximately 3 years in duration (1 year to recruit and 2 years for follow up).

Details
Condition Stress Urinary Incontinence
Treatment Erbium-YAG laser vaginal treatment
Clinical Study IdentifierNCT03671694
SponsorSunnybrook Health Sciences Centre
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patient, aged 18 years or older at the time of enrollment
primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation; for a duration of at least 3 months (patient can be rescreened after this time interval has passed)
The patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it
objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc
Bladder capacity ≥200cc
Post void residual ≤100cc with Stage I or lower pelvic organ prolapse

Exclusion Criteria

Patient is pregnant, lactating, or plans to become pregnant during the course of the Study; or Patient is <12 months post partum
Patient has other predominant type of UI (eg Urgency UI, overflow UI, fistula)
Patient has a vaginal condition that does not allow proper vaginal placement of the laser probe in its protective speculum
Current chemo/ radiotherapy; history of pelvic radiation
Systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury)
Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms
History of synthetic sling
Pelvic surgery < 3 months
Current evaluation or treatment for chronic pelvic pain
Patient has pelvic organ/ vaginal prolapse extending to or out of the vaginal opening
Participation in another treatment intervention that might interfere with the results of this trial
Patient has a medical condition or disorder that may limit life expectancy or that may cause non-compliance with the protocol (e.g. unable to perform self-evaluations and/or accurately report medical history, urinary symptoms, and/or data)
Patient has ambulatory 24 hour pad test, where the increased pad weight is < 3 grams
Patient is non-ambulatory (ambulatory with assistive devices allowed)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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