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

NCT04253067 | Withdrawn FDA Device

• 1 other identifier: 2020-LaserSUI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Keywords

Laser Therapy

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of fCO2 laser therapy in women with mild to moderate SUI symptoms compared to sham by evaluating the responder rate.

  A patient is called a responder if there is a greater than or equal to 50% reduction from baseline in the number of subject-reported SUI episodes over 3 days on a voiding diary.

  4 weeks after completing all treatments

Secondary Outcomes (11)

• To compare fCO2 laser therapy vs. sham in relation to the change in the total number of voids per day as measured by the 3-day voiding diary.

  8 weeks after the primary endpoint

• To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impression of SUI severity.

  8 weeks after the primary endpoint

• To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impression of SUI improvement.

  8 weeks after the primary endpoint

• To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported urogenital distress.

  8 weeks after the primary endpoint

• To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Impact Questionnaire (IIQ-7).

  8 weeks after the primary endpoint

Study Arms (2)

Active fCO2 laser treatment

ACTIVE COMPARATOR

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.

Device: Active fCO2 laser treatment

Sham fCO2 laser treatment

SHAM COMPARATOR

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.

Device: Sham fCO2 laser treatment

Interventions

Active fCO2 laser treatment 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.

Active fCO2 laser treatment

Sham fCO2 laser treatment 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.

Sham fCO2 laser treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age ≥18 years and ≤75 of age
• Mild to moderate SUI defined by Stamey Grade 1 and 2
• Positive bladder stress test at screening
• Negative urinary tract infection (UTI) at the time of study enrollment. If a patient does have a UTI, they may be rescreened after treatment
• No additional SUI therapy in the past 2 months such as pelvic floor physical therapy, medications, or participation in another SUI study
• No prior history of midurethral sling or fascial sling for SUI
• No prior history of urethral bulking procedure for SUI
• No prior history of autologous muscle derived stem cell injection in the urethra
• Must sign the informed consent form
• Must be willing to comply with the study protocol

You may not qualify if:

• Contraindications to fCO2 laser treatment, such as:
• previous pelvic mesh surgery
• current or previous genital cancers,
• radiation to the vaginal or colo-rectal tissue,
• currently pregnant or less than 3 months following pregnancy
• active infections (candidiasis, herpes genitalis, etc.)
• vaginal or cervical lesions noted on initial exam
• Patients with undiagnosed vaginal bleeding not related to menses
• Active vulvar or vaginal infection, including herpes
• Current UTI, confirmed by positive urine culture and patient-reported UTI symptoms
• Recurrent UTI defined as 3 UTIs in the past 6 months or 4 UTIs in the past 1 year
• Pelvic or vaginal surgery within the past 9 months
• Pelvic organ prolapse beyond the introitus
• 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.
• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

• 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.

  PMID: 40709601 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Peters

  Beaumont Hospital-Royal Oak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single-blind, participant and biostatistician will be blinded to treatment group. Subjects will be randomized 1:1 to active fCO2 laser treatment group or sham treatment group. Randomization will be performed using a table of random numbers. Randomization envelopes will be provided by the biostatistician and will be securely stored in a locked cabinet. The research coordinator(s) will be responsible for maintaining the confidentiality and security of the randomization envelopes. An enrollment and randomization log will be stored securely. The biostatistician will prepare more envelopes, if necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: Subjects will be randomized 1:1 to active fCO2 laser therapy or sham. Study will be performed in a single-blind manner. (Participant and biostatistician)

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)