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

Stress Urinary Incontinence Clinical Trial

Official title:

Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097456
• Other study ID #: 0292-20-RMB
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 31, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• carbon dioxide laser
carbon dioxide laser
• sham laser
sham laser

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pad weight test	Change in pad weight	From treatment up to 12 months post treatment
Secondary	Cough test	Positive cough test	From treatment up to 12 months post treatment
Secondary	Urinary distress index questionnaire	Change in urinary distress index questionnaire scores	From treatment up to 12 months post treatment
Secondary	International consultation on incontinence questionnaire-urinary incontinence	Change in international consultation on incontinence questionnaire-urinary incontinence scores	From treatment up to 12 months post treatment
Secondary	Pelvic organ prolapse/urinary incontinence sexual questionnaire	Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores	From treatment up to 12 months post treatment