Clinical trial NCT03671694: Laser Vaginal Treatment for SUI
Official title: Laser Vaginal Treatment for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: laser treatment
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief 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?

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1. Female patient, aged 18 years or older at the time of enrollment,
2. 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).
3. The patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it.
4. objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc
5. Bladder capacity ≥200cc
6. Post void residual ≤100cc with Stage I or lower pelvic organ prolapse

Exclusion Criteria:

1. Patient is pregnant, lactating, or plans to become pregnant during the course of the Study; or Patient is \<12 months post partum
2. Patient has other predominant type of UI (eg Urgency UI, overflow UI, fistula)
3. Patient has a vaginal condition that does not allow proper vaginal placement of the laser probe in its protective speculum
4. Current chemo/ radiotherapy; history of pelvic radiation
5. Systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury)
6. Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms
7. History of synthetic sling
8. Pelvic surgery \< 3 months
9. Current evaluation or treatment for chronic pelvic pain
10. Patient has pelvic organ/ vaginal prolapse extending to or out of the vaginal opening
11. Participation in another treatment intervention that might interfere with the results of this trial
12. 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).
13. Patient has ambulatory 24 hour pad test, where the increased pad weight is \< 3 grams.
14. Patient is non-ambulatory (ambulatory with assistive devices allowed)

Primary outcomes:
measure: SUI cure
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Adverse effects
timeFrame: 6,12 24 months post treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, University of Toronto
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Patricia Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: