Laser Therapy for Treatment of Urogenital Symptoms in Women

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    William Beaumont Hospitals
Updated on 31 March 2021
urinary tract infection
burning sensation
laser therapy
carbon dioxide
burning
dyspareunia
incontinence
overactive bladder
urinary tract infections
urinary incontinence
stress incontinence
recurrent urinary tract infection
recurrent urinary tract infections

Summary

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

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.

Details
Condition Urinary Incontinence, Dyspareunia, Vaginitis, Lichen Sclerosus et Atrophicus, Stress incontinence, Urinary tract infection, Overactive Bladder, Recurrent Urinary Tract Infection, Recurrent Urinary Tract Infections, Menopause Related Conditions, Genitourinary System; Disorder, Female, Burning Vagina, Genitourinary System; Disorder, Female, Genitourinary System; Disorder, Female, Urinary Tract Infections, Genitourinary System; Disorder, Female, Genitourinary System; Disorder, Female, Genitourinary System; Disorder, Female, Genitourinary System; Disorder, Female, Genitourinary System; Disorder, Female, urinary tract infection (uti), urinary infection, recurrent utis, stress urinary incontinence, Genitourinary System; Disorder, Female, Genitourinary System; Disorder, Female, Genitourinary System; Disorder, Female
Treatment fCO2 Laser Therapy Group
Clinical Study IdentifierNCT03681678
SponsorWilliam Beaumont Hospitals
Last Modified on31 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 90 yrs?
Are you female?
Do you have any of these conditions: Dyspareunia or Urinary tract infection or Overactive Bladder or Genitourinary System; Disorder, Female or Menopause Related Conditions or Burning Vagi...?
Do you have any of these conditions: Urinary Tract Infections or recurrent utis or Urinary tract infection or Lichen Sclerosus et Atrophicus or Overactive Bladder or Genitourinary System;...?
Do you have any of these conditions: Overactive Bladder or urinary tract infection (uti) or Urinary tract infection or Genitourinary System; Disorder, Female or Burning Vagina or Lichen S...?
Do you have any of these conditions: Urinary tract infection or Urinary Tract Infections or Menopause Related Conditions or urinary tract infection (uti) or recurrent utis or Overactive B...?
Female
18 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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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