Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: sham laser; Device: carbon dioxide laser

• Registration Number: NCT05097456
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Detailed Description

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronic files.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-28
• Primary Completion: 2021-11-15
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• Negative urine analysis.
• Normal Pap smear test from the recent 3 years.
• No previous gynecological laser treatments.
• Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria

• Active genital infection.
• Subject presenting abnormal Pap result from the last three years.
• Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year).
• Transvaginal mesh implant.
• Serious systemic disease or any chronic condition that could interfere with study compliance.
• Any vaginal bleeding of unknown reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham treatment	sham laser	sham treatment
Laser treatment	carbon dioxide laser	carbon dioxide treatment

Primary Outcome Measures

Name	Time	Method
Pad weight test	From treatment up to 12 months post treatment	Change in pad weight

Secondary Outcome Measures

Name	Time	Method
Urinary distress index questionnaire	From treatment up to 12 months post treatment	Change in urinary distress index questionnaire scores
Cough test	From treatment up to 12 months post treatment	Positive cough test
International consultation on incontinence questionnaire-urinary incontinence	From treatment up to 12 months post treatment	Change in international consultation on incontinence questionnaire-urinary incontinence scores
Pelvic organ prolapse/urinary incontinence sexual questionnaire	From treatment up to 12 months post treatment	Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel