A Study of Fractional Carbon Dioxide Laser Treatment for Female Stress Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Urinary incontinence (UI) is a common disease that refers to involuntary loss of urine. The prevalence of female UI varies widely across different studies, mostly ranging from 25-40%. Stress urinary incontinence (SUI) is the most common type of UI. SUI is defined as involuntary loss of urine when abdominal pressure increases suddenly such as coughing or sneezing. SUI affects women's quality of life seriously, causing psychological problems such as anxiety and depression, even socialization difficulties. There are many treatment options for female SUI, including non-surgical and surgical interventions. Clinicians and patients need a highly effective and low-risk therapy urgently, thus energy-based therapies were born on demand. This study aims to demonstrate the efficacy and safety of the fractional CO2 laser in the treatment of female SUI, as well as its impact on women's quality of life.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Single-Blind, Randomized Study to Compare fCO2 Laser Therapy Versus Sham for Treatment of SUI in Women

NCT04253067

Stress Urinary Incontinence Urinary Incontinence

WITHDRAWN NA

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

NCT02861391

Exposure Laser

COMPLETED NA

A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.

NCT05570071

Urinary Incontinence, Stress

UNKNOWN NA

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

NCT05097456

Stress Urinary Incontinence

COMPLETED NA

Treatment for Female Stress Urinary Incontinence

NCT00270738

Female Urinary Incontinence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Urinary incontinence (UI) is a common disease that refers to involuntary loss of urine. The prevalence of female UI varies widely across different studies, mostly ranging from 25-40%. Stress urinary incontinence (SUI) is the most common type of UI. SUI is defined as involuntary loss of urine when abdominal pressure increases suddenly such as coughing or sneezing. SUI affects women's quality of life seriously, causing psychological problems such as anxiety and depression, even socialization difficulties.

There are many treatment options for female SUI, including non-surgical and surgical interventions. For example, pelvic floor muscle training (PFMT) is the primary non-surgical treatment method, requiring females to perform Kegel exercises consistently. PMFT has been shown to be effective for female SUI, but the efficacy is dependent on the quality of PMFT. Outpatient PFMT has a higher objective cure rate compared with home PFMT. Surgery is the most effective treatment option, and the most common procedure is the mid-urethral sling (MUS). Nevertheless, surgical risks such as persistent pain after surgery, bleeding, infection, and urinary dysfunction cannot be ignored. Many outpatients are unable to persist in performing high-quality PFMT and do not consent to surgical treatment. Clinicians and patients need a highly effective and low-risk therapy urgently, thus energy-based therapies were born on demand.The result of energy-based therapies including radiofrequency (RF), Erbium: YAG (Er: YAG) laser, and CO2 laser is controversial, which has been reported in several papers. This study aims to demonstrate the efficacy and safety of the fractional CO2 laser in the treatment of female SUI, as well as its impact on women's quality of life.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CO2 laser group

Participants in the CO2 laser group underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) treatment sessions with 4-6 weeks intervals.

Group Type EXPERIMENTAL

Fractional carbon dioxide laser treatment

Intervention Type PROCEDURE

Participants underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) treatment sessions with 4-6 weeks intervals. The same laser device parameters (10 mJ, 10% density, spot diameter of 12×12 mm2) were used in participants. A special laser probe was inserted into the patient's vagina after cleaning and disinfection. The laser procedure was performed at the 0, 2, 4, 6, 8, and 10 o'clock positions by rotating the laser probe from the proximal vagina to the distal, and additional procedures were performed at the 11 and 1 o'clock positions 5 mm above the introitus vaginae.

Sham group

Participants in the sham group underwent three sham treatment sessions with 4-6 weeks intervals.

Group Type SHAM_COMPARATOR

Fractional carbon dioxide laser sham treatment

Intervention Type PROCEDURE

Participants underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) sham treatment sessions with 4-6 weeks intervals. A special laser probe was inserted into the patient's vagina after cleaning and disinfection. The sham procedure was performed at the 0, 2, 4, 6, 8, and 10 o'clock positions by rotating the laser probe from the proximal vagina to the distal, and additional sham procedures were performed at the 11 and 1 o'clock positions 5 mm above the introitus vaginae.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fractional carbon dioxide laser treatment

Participants underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) treatment sessions with 4-6 weeks intervals. The same laser device parameters (10 mJ, 10% density, spot diameter of 12×12 mm2) were used in participants. A special laser probe was inserted into the patient's vagina after cleaning and disinfection. The laser procedure was performed at the 0, 2, 4, 6, 8, and 10 o'clock positions by rotating the laser probe from the proximal vagina to the distal, and additional procedures were performed at the 11 and 1 o'clock positions 5 mm above the introitus vaginae.

Intervention Type PROCEDURE

Fractional carbon dioxide laser sham treatment

Participants underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) sham treatment sessions with 4-6 weeks intervals. A special laser probe was inserted into the patient's vagina after cleaning and disinfection. The sham procedure was performed at the 0, 2, 4, 6, 8, and 10 o'clock positions by rotating the laser probe from the proximal vagina to the distal, and additional sham procedures were performed at the 11 and 1 o'clock positions 5 mm above the introitus vaginae.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged 18-70 years
* Clinical diagnosis of stress urinary incontinence (SUI)

Exclusion Criteria

* pregnancy
* pelvic organs prolapse no more than grade II
* gynecologic and urinary tract infections
* previous surgical intervention for stress urinary incontinence (SUI)
* Urgency urinary incontinence (UUI) or Mixed urinary incontinence (MUI)
* serious chronic disease or other reasons that compromised safety and interfered with study compliance

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes