Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.

NCT02861391 | Completed

• 1 other identifier: 0205-16-RMB
• Study Type: interventional
• Target: 125
• 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 stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Conditions

Exposure Laser

Outcome Measures

Primary Outcomes (1)

• Pad weight test.

  Pad weight results in grams.

  15 months from recruitment.

Secondary Outcomes (5)

• Urinary distress index 6 questionnaire.

  15 months from recruitment.

• Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.

  15 months from recruitment.

• International Consultation of Incontinence questionnaire.

  15 months from recruitment.

• Cough test

  15 months from recruitment.

• Visual analogue scale.

  15 months from recruitment.

Study Arms (2)

CO2 AcuPulse Laser treatment

EXPERIMENTAL

Subjects with USI as diagnosed by cough test intended to receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Device: CO2 AcuPulse Laser

Sham laser treatment

SHAM COMPARATOR

Subjects with USI as diagnosed by cough test intended to receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Device: Sham Laser

Interventions

CO2 AcuPulse Laser DEVICE

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

CO2 AcuPulse Laser treatment

Sham Laser DEVICE

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

Sham laser treatment

Eligibility Criteria

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

You may qualify if:

• Negative urine culture.
• Positive cough test.
• Normal Papanicolaou (PAP) test from the past 3 years.

You may not qualify if:

• signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence.
• Overactive bladder.
• Previous bulking injections.
• Previous transvaginal mesh implant.
• Previous surgery for stress urinary incontinence.
• Presence of pelvic organ prolapse.
• Presence of an active or recurring genital infection or urinary tract infection.
• Previous laser-based or other energy-based treatments for gynecological indications.
• Vaginal bleeding of unknown reason.
• Pregnancy.
• Current pelvic floor physiotherapy.
• Current treatment with local or systemic hormone replacement therapy.

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Roy Lauterbach

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 10, 2016
• Study Start: October 4, 2019
• Primary Completion: November 1, 2021
• Study Completion: January 30, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)