Laser Therapy for Treatment of Urogenital Symptoms in Women

NCT03681678 | Completed Results FDA Device

• 1 other identifier: 2018-142
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.

Conditions

Genitourinary System; Disorder, Female; Burning Vagina; Dyspareunia; Irritation; Vagina; Menopause Related Conditions; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Tract Infections; Stress Urinary Incontinence

Keywords

Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment

  PGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better", 2 is "Much Better, 3 is "A Little Bit Better", 4 is "No Change", 5 is "A Little Worse", 6 is "Much Worse", and 7 is "Very Much Worse". A score from 1 to 3 would indicate improvement.

  4 weeks post-initial treatment

Secondary Outcomes (11)

• Change in Patient Global Impression of Improvement (PGI-I) Score

  6 months and 36 months post-initial treatment

• Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS).

  6 months and 36 months post-initial treatment

• Change in Urinary Symptoms as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID).

  6 months and 36 months post-initial treatment

• Change in Overactive Bladder (OAB) Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF).

  6 months and 36 months post-initial treatment

• Change in Voiding Diaries.

  6 months and 36 months post-initial treatment

Study Arms (1)

fCO2 Laser Therapy Group

Women treated with the fCO2 laser

Device: fCO2 Laser Therapy Group

Interventions

fCO2 Laser Therapy Group DEVICE

Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.

fCO2 Laser Therapy Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women meeting all of the inclusion criteria and non of the exclusion criteria may be enrolled in the study.

You may qualify if:

• Female
• years of age or greater and 90 years of age or less
• One or more of the following indications for fCO2 laser treatment:
• Genitourinary symptoms of menopause, including after natural, medical- induced or surgical menopause
• Vaginal dryness, burning, itching or dyspareunia not related to menopause
• Stress urinary incontinence
• Recurrent urinary tract infections (UTIs), defined as 4 or more in a year
• Overactive bladder
• Must sign the informed consent
• Must be willing to comply with the study protocol

You may not qualify if:

• Contraindications to fCO2 laser treatment, such as:
• Currently implanted synthetic pelvic mesh, sling or tape
• Current or previous genital cancers
• Radiation to the vaginal or colo-rectal tissue
• Currently pregnant or less than 3 months following pregnancy
• Undiagnosed vaginal or cervical lesions
• Patients who have received vaginal fCO2 laser treatment within the past 12 months
• Patients treated with vaginal estrogen within the past 3 months
• Patients with undiagnosed vaginal bleeding
• Active vulvar or vaginal infection, including herpes, candidiasis, etc.
• Current urinary tract infection (UTI), confirmed by positive urine culture and patient-reported symptoms
• Pelvic or vaginal surgery with 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 the 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 6 months or less prior to the date of the screening visit

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Dyspareunia; Vaginitis; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Tract Infections; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vaginal Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Infections

Results Point of Contact

• Title: Jennifer Giordano
• Organization: William Beaumont Hospital

jennifer.giordano@corewellhealth.org

248-551-3517

Study Officials

• Kenneth Peters, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Urology

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: September 24, 2018
• Study Start: October 8, 2018
• Primary Completion: December 15, 2022
• Study Completion: June 10, 2025
• Last Updated: December 23, 2025
• Results First Posted: October 16, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)