Evaluation of Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Vaginal Elasticity.

NCT02847897 | Completed

• 1 other identifier: 0217-16-RMB
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with vaginal prolapse. Eligible subjects will receive 3 treatment sessions, 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Conditions

Exposure Laser

Outcome Measures

Primary Outcomes (1)

• The change in vaginal prolapse symptoms as measured by VHI score at 3 months follow-up visit compared to baseline.

  8 months.

Secondary Outcomes (9)

• • Prolapse symptoms improvement as evaluated by the investigator using VHI score at 1 and 6 months follow up visits compared to baseline

  8 months.

• • Prolapse symptoms improvement as evaluated by the subject using Visual Analogue Scale (VAS) at 1, 3 and 6 months follow up visits compared to baseline

  8 months.

• • Improvement in sexual function as evaluated by the subject Female Sexual Function Index (FSFI) at 1, 3 and 6 months follow up visits compared to baseline

  8 months.

• • Improvement in urinary incontinence as evaluated by subject Incontinence Quality of Life Questionnaire (I-QOL) at 1, 3 and 6 months follow up visits compared to baseline.

  8 months.

• • Improvement in prolapse grade at 1, 3 and 6 months follow up visits compared to baseline

  8 months.

Study Arms (1)

CO2 AcuPulse Laser treatment

EXPERIMENTAL

Subjects with vulvovaginal atrophy intended to receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Device: CO2 AcuPulse Laser

Interventions

CO2 AcuPulse Laser DEVICE

Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

CO2 AcuPulse Laser treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy post-menopausal women as defined by one of the following: A. ≥ 40 years old, last spontaneous menstrual bleeding occurred at least ≥ 12 months prior to screening B. ≥ 45 years old, does not remember the date of last spontaneous menstrual bleeding and provides lab results showing that the follicle-stimulating hormone (FSH) level is \> 40 IU/L C. Underwent a hysterectomy without oophorectomy and provides lab results showing that serum FSH levels \> 40IU/L D. Underwent bilateral oophorectomy at least 12 weeks prior to screening
• Presence of one or more of the prolapse related symptoms (e.g. dryness, itching, burning, dysuria or dyspareunia)
• At least 10 subjects of the sample will have symptoms of urinary stress incontinence (Stamey classification Grade =1)
• Negative urine analysis
• Normal Papanicolaou (PAP) test from the recent year
• Sexually active (having sex at least once a month) or wishing to maintain an active sexual life
• Able and willing to comply with the treatment/follow-up schedule and requirements

You may not qualify if:

• Vaginal Health Index Score (VHIS) \< 5
• Active genital infection
• Subject presenting abnormal PAP result from the last three years with any of the following findings according to the Bethesda System (2001) classification:
• A. Atypical Squamous Cells of Undetermined Significance (ASCUS with positive human papilloma virus (HPV) High Risk Positive B. Atypical Squamous Cells-cannot exclude high grade squamous intraepithelial lesion C. Atypical Glandular Cells (Endocervical, Endometrial not otherwise specified) D. Low Grade squamous intraepithelial lesion (LSIL) E. High Grade squamous intraepithelial lesion (HSIL) F. Carcinoma
• Systemic steroids use within the last 3 months
• Systemic hormonal replacement therapies within the last 3 months
• Local hormonal replacement therapies within last month
• Vaginal lubricants within 7 days prior to enrollment
• Recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year)
• Pelvic organ prolapse (POP) \>II according to the pelvic organ prolapse quantification system
• Transvaginal mesh implant
• Serious systemic disease or any chronic condition that could interfere with study compliance
• Taken part in a clinical trial within 30 days prior to screening.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Study Officials

• Lior Lowenstein, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Roy Lauterbach

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)