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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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a Prospective Single-center, Participant-blinded, Randomized Controlled Clinical Trial of Fractional Carbon Dioxide Laser Treatment for Female Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Fractional carbon dioxide laser treatment
* Procedure: Fractional carbon dioxide laser sham treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 laser group<br>Participants in the CO2 laser group underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) treatment sessions with 4-6 weeks intervals. | Procedure: Fractional carbon dioxide laser treatment<br>* 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.<br>|
| Sham Comparator: Sham group<br>Participants in the sham group underwent three sham treatment sessions with 4-6 weeks intervals. | Procedure: Fractional carbon dioxide laser sham treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment efficacy | 1-hour pad test, used to assess improvement in the amount of urine leakage. That pad weight increases >2g is considered positive. The improvement criteria was considered as 1-h pad test weight decreasing > 50% baseline. | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| King's Health Questionnaire (KHQ) score decreases more than 50% baseline | King's Health Questionnaire (KHQ) contains 3 parts consisting of 21 items. The subscales in Part 1 and Part 2 scored from 0 to 100. The urinary symptoms scale in Part 3 is scored from 0 to 30. Every subscale and urinary symptoms scale calculate the score respectively and lower scores indicate better quality of life. | through study completion, an average of 6 months | 
| Incontinence-specific Quality of Life (I-QOL) score increases more than 50% baseline | Incontinence-specific Quality of Life (I-QOL) contains three subscales including avoidance or limiting behaviors (8 items), psychological impacts (9 items), and social embarrassment (5 items). Overall assessment and three subscales of I-QOL scored from 0 to 100, and higher scores indicate better quality of life. | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment