A Single-Blind, Randomized Study to Compare fCO2 Laser Therapy Versus Sham for Treatment of SUI in Women

NCT ID: NCT04253067

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2020-10-31

Brief Summary

This is a prospective randomized sham-controlled study of patients undergoing vaginal treatment with a fractional carbon dioxide (fCO2) laser for stress urinary incontinence (SUI) symptoms. Eligible participants will be randomized (like a flip of a coin) to receive active or sham fCO2 laser treatments. Three treatments with the fCO2 laser or sham to the vagina will be performed, approximately four weeks apart.

Detailed Description

Stress urinary incontinence (SUI) is a common problem that affects 35-40% of women worldwide. SUI occurs when a woman experiences involuntary leakage of urine with physical activities such as exercise, coughing and sneezing that increases intra-abdominal pressure. Vaginal laser therapy offers a potential novel treatment for SUI, however there is limited scientific evidence to show benefits to treatment. A sham controlled study will further add to the literature and evidence to support or oppose the use of the fCO2 laser for SUI.

The purpose of this study is to compare active therapy to sham treatment to determine if a true benefit to treatment exists. Eligible participants will be randomized 1:1, to receive active or sham fCO2 laser treatments. Three treatments, active or sham, to the vagina will be performed approximately four weeks apart. The primary efficacy endpoint is four weeks after completing all treatments. Treatment durability and safety will be assessed eight weeks after the primary endpoint.

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Keywords

Laser Therapy

Study Design

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

Study Groups

Active fCO2 laser treatment

Laser probe will be inserted into the vagina. The laser treatment is delivered at 6 points to the vaginal wall. Delivery begins at the most proximal and the wand is retracted by 1 cm and another row of laser treatment is delivered. The number of levels is determined by vaginal length.

Group Type: ACTIVE_COMPARATOR

Active fCO2 laser treatment

Intervention Type: DEVICE

The laser probe is inserted into the vagina. Laser treatment is delivered at 6 points at each level of the vaginal wall (12, 2, 4, 6, and 10 o'clock positions). Delivery begins at the most proximal and the probe is retracted by 1 cm and another row of laser treatments are delivered. The number of levels is determined by the patient's vaginal length.

Sham fCO2 laser treatment

Laser probe will be inserted into the vagina. To prevent the delivery of laser energy, the laser will remain in standby mode during the visit. Keeping the laser in standby mode prevents laser exposure. The treatment will appear to be the same as the active treatment. The machine maintains a low humming noise while in standby mode.

Group Type: SHAM_COMPARATOR

Sham fCO2 laser treatment

Intervention Type: DEVICE

The laser probe is inserted into the vagina. The laser will remain in standby mode during the treatment preventing laser exposure. The treatment will appear to be the same as the active treatment with the probe starting at the most proximal and following the same 6 points of treatment delivery. The probe is retracted in the same manner and another row of treatment is simulated. The machine maintains a low humming noise while in standby mode. No active laser treatment is delivered.

Interventions

Active fCO2 laser treatment

The laser probe is inserted into the vagina. Laser treatment is delivered at 6 points at each level of the vaginal wall (12, 2, 4, 6, and 10 o'clock positions). Delivery begins at the most proximal and the probe is retracted by 1 cm and another row of laser treatments are delivered. The number of levels is determined by the patient's vaginal length.

Intervention Type: DEVICE

Sham fCO2 laser treatment

The laser probe is inserted into the vagina. The laser will remain in standby mode during the treatment preventing laser exposure. The treatment will appear to be the same as the active treatment with the probe starting at the most proximal and following the same 6 points of treatment delivery. The probe is retracted in the same manner and another row of treatment is simulated. The machine maintains a low humming noise while in standby mode. No active laser treatment is delivered.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Female

2. Age ≥18 years and ≤75 of age

3. Mild to moderate SUI defined by Stamey Grade 1 and 2

4. Positive bladder stress test at screening

5. Negative urinary tract infection (UTI) at the time of study enrollment. If a patient does have a UTI, they may be rescreened after treatment

6. No additional SUI therapy in the past 2 months such as pelvic floor physical therapy, medications, or participation in another SUI study

7. No prior history of midurethral sling or fascial sling for SUI

8. No prior history of urethral bulking procedure for SUI

9. No prior history of autologous muscle derived stem cell injection in the urethra

10. Must sign the informed consent form

11. Must be willing to comply with the study protocol

Exclusion Criteria

1. Contraindications to fCO2 laser treatment, such as:

1. previous pelvic mesh surgery

2. current or previous genital cancers,

3. radiation to the vaginal or colo-rectal tissue,

4. currently pregnant or less than 3 months following pregnancy

5. active infections (candidiasis, herpes genitalis, etc.)

6. vaginal or cervical lesions noted on initial exam

2. Patients with undiagnosed vaginal bleeding not related to menses

3. Active vulvar or vaginal infection, including herpes

4. Current UTI, confirmed by positive urine culture and patient-reported UTI symptoms

5. Recurrent UTI defined as 3 UTIs in the past 6 months or 4 UTIs in the past 1 year

6. Pelvic or vaginal surgery within the past 9 months

7. Pelvic organ prolapse beyond the introitus

8. Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase patient's risk, may affect the conduct of the study, etc.) for the treatment and/or study.

9. Participation in an investigational trial that used a study treatment, medication and/or biologic within 30 days or less prior to the date of the screening visit.

Deferral

Patients may be deferred and rescreened at a later date under the following conditions:

• Patients with active vulvar or vaginal infections may be rescreened after treatment
• Patients with an active UTI may be rescreened after treatment
• Patients with undiagnosed vaginal bleeding may be rescreened after complete work-up, treatment and resolution of vaginal bleeding
• Patients pregnant within the past 3 months
• Patients with recent vaginal or uterine surgery within the 9 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Kenneth M Peters, MD

Director and Chair of the Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Peters

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital-Royal Oak

Locations

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Countries

United States

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

2020-LaserSUI

Identifier Type: -

Identifier Source: org_study_id