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

NCT05097456 | Completed

• 1 other identifier: 0292-20-RMB
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Pad weight test

  Change in pad weight

  From treatment up to 12 months post treatment

Secondary Outcomes (4)

• Cough test

  From treatment up to 12 months post treatment

• Urinary distress index questionnaire

  From treatment up to 12 months post treatment

• International consultation on incontinence questionnaire-urinary incontinence

  From treatment up to 12 months post treatment

• Pelvic organ prolapse/urinary incontinence sexual questionnaire

  From treatment up to 12 months post treatment

Study Arms (2)

Laser treatment

ACTIVE COMPARATOR

carbon dioxide treatment

Device: carbon dioxide laser

Sham treatment

SHAM COMPARATOR

sham treatment

Device: sham laser

Interventions

carbon dioxide laser DEVICE

carbon dioxide laser

Laser treatment

sham laser DEVICE

sham laser

Sham treatment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Roy Lauterbach, MD

  Rambam healthcare campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 28, 2021
• Study Start: March 1, 2020
• Primary Completion: November 15, 2021
• Study Completion: December 31, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)