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

Not Applicable

Recruiting

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: Fractional carbon dioxide laser sham treatment; Procedure: Fractional carbon dioxide laser treatment

• Registration Number: NCT05629481
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-04-20
• Status Verified: 2022-11
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	Fractional carbon dioxide laser sham treatment	Participants in the sham group underwent three sham treatment sessions with 4-6 weeks intervals.
CO2 laser group	Fractional carbon dioxide laser treatment	Participants in the CO2 laser group underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) treatment sessions with 4-6 weeks intervals.

Primary Outcome Measures

Name	Time	Method
treatment efficacy	through study completion, an average of 6 months	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.

Secondary Outcome Measures

Name	Time	Method
King's Health Questionnaire (KHQ) score decreases more than 50% baseline	through study completion, an average of 6 months	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.
Incontinence-specific Quality of Life (I-QOL) score increases more than 50% baseline	through study completion, an average of 6 months	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.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China