ClinicalTrials.Veeva

Menu

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

S

Shandong University

Status

Enrolling

Conditions

Stress Urinary Incontinence

Treatments

Procedure: Fractional carbon dioxide laser sham treatment
Procedure: Fractional carbon dioxide laser treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05629481
QL-URO-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Central trial contact

Zhonghua Xu, MD; Yueqing Tang, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems