Active — Not RecruitingNot Applicable

Laser Vaginal Treatment for SUI

Canada144 participantsStarted 2018-09-19

Plain-language 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?

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

SUI cure

Timeframe: 6 months post treatment

NCT IDNCT03671694

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-24

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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