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Laser Therapy for Treatment of Urogenital Symptoms in Women

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ClinicalTrials.gov Identifier: NCT03681678
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Kenneth M Peters, MD, William Beaumont Hospitals

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

Condition or disease Intervention/treatment
Genitourinary System; Disorder, Female Burning Vagina Dyspareunia Irritation; Vagina Menopause Related Conditions Urinary Incontinence Urinary Bladder, Overactive Urinary Tract Infections Stress Urinary Incontinence Device: fCO2 Laser Therapy Group

Detailed Description:

Fractional carbon dioxide (fCO2) laser treatment of the vaginal tissue has been proposed as a treatment for various genitourinary symptoms, including vaginal itching, burning, dryness, dyspareunia (difficult or painful sexual intercourse), dysuria (painful or difficult urination), nocturia (waking at night to urinate), incontinence (the involuntary loss of urine), urine frequency, urine urgency, and urinary tract infection (UTI).

Case report and case series data suggest that laser treatment of the vaginal tissues is well tolerated by patients and does not pose serious risks to the patient. Several case series demonstrate improvements in vulvovaginal and urinary symptoms, and in sexual function. However, these studies are from a select few centers, are small, and are also biased in that the laser treatment is only available to patients who are able to pay for it. Additionally, most studies report only on vulvovaginal symptoms, despite increasing use of laser for urinary symptoms. Several recent editorials have called for larger studies with longer follow-up and high quality outcome measures. This study has been designed to address these needs.

This is a prospective observational study of women undergoing vaginal treatment with the fCO2 laser for a wide range of patients with vulvovaginal, sexual and/or urologic complaints. The effects of fCO2 therapy will be evaluated by various physical assessments and patient questionnaires.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Fractional Carbon Dioxide Laser Therapy of the Vagina for Treatment of Urogenital Symptoms in Women
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021

Group/Cohort Intervention/treatment
fCO2 Laser Therapy Group
Women treated with the fCO2 laser
Device: fCO2 Laser Therapy Group
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.




Primary Outcome Measures :
  1. Change in Patient Global Impression of Improvement (PGI-I) score at 16 weeks (4 weeks post-initial treatment). [ Time Frame: 16 weeks ( 4 weeks post-initial treatment). ]
    The primary outcome will be the average change in patients' PGI-I scores from baseline to 16 weeks post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome.


Secondary Outcome Measures :
  1. Change in Patient Global Impression of Improvement (PGI-I) score [ Time Frame: 6 months and 36 months post-initial treatment ]
    The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome.

  2. Change in vaginal pH and overall vaginal health on physical exam as measured by the Vaginal Health Inventory Score (VHIS). [ Time Frame: 6 months and 36 months post-initial treatment ]
    The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. A VHIS score less than 15 is indicative of vaginal atrophy.

  3. Change in urinary symptoms as measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID). [ Time Frame: 6 months and 36 months post-initial treatment ]
    Patients will complete the QUID, which consists of 6 questions. Responses to the questions indicate the frequency of urinary incontinence. Scores are: 0 (none of the time), 1 (rarely), 2 (once in awhile), 3 (often), 4 (most of the time), or 5 (all of the time). Responses to items 1, 2, and 3 are summed for the Stress Urinary Incontinence Score. Responses to items 4, 5, and 6 are summed for the Urge Incontinence Score.

  4. Change in overactive bladder (OAB) symptoms as measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF). [ Time Frame: 6 months and 36 months post-initial treatment ]
    The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal.

  5. Change in voiding diaries. [ Time Frame: 6 months and 36 months post-initial treatment ]
    A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency and incontinence episodes.

  6. Change in sexual function, including dyspareunia symptoms, as measured by the Female Sexual Function Inventory (FSFI). [ Time Frame: 6 months and 36 months post-initial treatment ]
    The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction.

  7. Change in frequency of UTI occurrences, as measured by a positive urine culture test. [ Time Frame: 6 months and 36 months post-initial treatment ]
    A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency).

  8. Change in mental health status as measured by the Generalized Anxiety Disorder Questionnaire (GAD-7). [ Time Frame: 6 months and 36 months post-initial treatment ]
    The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total, each answer is scored on a scale from 0 = not at all to 3 = nearly every day. Scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended.

  9. Change in mental health status as measured by the Patient Health Questionnaire (PHQ-8). [ Time Frame: 6 months and 36 months post-initial treatment ]
    The PHQ-8 is an eight item questionnaire that is a valid diagnostic and severity measure for depressive disorders. Each question is scored from 0 = not at all to 3 = nearly every day. A score of 10 or greater is considered major depression and a score of 20 or more as severe major depression.

  10. Change in life and sexual impact of vulvovaginal skin symptoms. [ Time Frame: 6 months and 36 months post-initial treatment ]
    The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. Total I-QOL is a combined score of all items. All 22 items are summed to calculate a total I-QOL score, ranging from 22 to 110, with a high score indicating a better quality of life. The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items). Scores are summed based on the same 5-point scale. 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. A high score indicates a better quality of life.

  11. Change in the presence of lactobacillus, assessed by vaginal swab. [ Time Frame: 6 months and 36 months post-initial treatment ]
    Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Female
  2. 18 years of age or greater and 90 years of age or less
  3. One or more of the following indications for fCO2 laser treatment:

    1. Genitourinary symptoms of menopause, including after natural, medical- induced or surgical menopause
    2. Vaginal dryness, burning, itching or dyspareunia not related to menopause
    3. Stress urinary incontinence
    4. Recurrent urinary tract infections (UTIs), defined as 4 or more in a year
    5. Overactive bladder
  4. Must sign the informed consent
  5. Must be willing to comply with the study protocol

Exclusion Criteria:

  1. Contraindications to fCO2 laser treatment, such as:

    1. Currently implanted synthetic pelvic mesh, sling or tape
    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. Undiagnosed vaginal or cervical lesions
  2. Patients who have received vaginal fCO2 laser treatment within the past 12 months
  3. Patients treated with vaginal estrogen within the past 3 months
  4. Patients with undiagnosed vaginal bleeding
  5. Active vulvar or vaginal infection, including herpes, candidiasis, etc.
  6. Current urinary tract infection (UTI), confirmed by positive urine culture and patient-reported symptoms
  7. Pelvic or vaginal surgery with the past 9 months
  8. Pelvic organ prolapse beyond the introitus
  9. 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
  10. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681678


Contacts
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Contact: Evelyn Shea, RN 248-551-3551 Evelyn.Shea@Beaumont.org
Contact: Jennifer Bowlus, RN 248-551-3517 Jennifer.Bowlus@Beaumont.org

Locations
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United States, Michigan
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Evelyn Shea, RN    248-551-3551    Evelyn.Shea@Beaumont.org   
Contact: Jennifer Bowlus, RN    248-551-3517    Jennifer.Bowlus@Beaumont.org   
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals

Additional Information:

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Responsible Party: Kenneth M Peters, MD, Chief Urology, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03681678     History of Changes
Other Study ID Numbers: 2018-142
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Kenneth M Peters, MD, William Beaumont Hospitals:
Laser Therapy

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Tract Infections
Urinary Incontinence, Stress
Dyspareunia
Urinary Bladder, Overactive
Vaginitis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Infection
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Urinary Bladder Diseases
Vaginal Diseases