Laser Vaginal Treatment for SUI

NCT ID: NCT03671694

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2025-11-30

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).

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

laser treatment

Erbium-YAG laser treatment to the vagina

Group Type: ACTIVE_COMPARATOR

Erbium-YAG laser vaginal treatment

Intervention Type: PROCEDURE

Erbium-YAG laser vaginal treatment

sham treatment

sham treatment with laser placebo

Group Type: PLACEBO_COMPARATOR

Erbium-YAG laser vaginal treatment

Intervention Type: PROCEDURE

Erbium-YAG laser vaginal treatment

Interventions

Erbium-YAG laser vaginal treatment

Erbium-YAG laser vaginal treatment

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre, University of Toronto

Toronto, Ontario, Canada

Countries

Canada

References

Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

Reference Type: DERIVED

PMID: 40709601 (View on PubMed)

Other Identifiers

Sunnybrook_womens

Identifier Type: -

Identifier Source: org_study_id