Clinical trial NCT05629481: A Study of Fractional Carbon Dioxide Laser Treatment for Female Stress Urinary Incontinence
Official title: a Prospective Single-center, Participant-blinded, Randomized Controlled Clinical Trial of Fractional Carbon Dioxide Laser Treatment for Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: treatment
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: treatment efficacy
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: King's Health Questionnaire (KHQ) score decreases more than 50% baseline
timeFrame: through study completion, an average of 6 months
measure: Incontinence-specific Quality of Life (I-QOL) score increases more than 50% baseline
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Zhonghua Xu, MD
role: STUDY_CHAIR
References:
citation: Palacios S, Ramirez M. Efficacy of the use of fractional CO2RE intima laser treatment in stress and mixed urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 2020 Jan;244:95-100. doi: 10.1016/j.ejogrb.2019.10.048. Epub 2019 Nov 12.
citation: Alexander JW, Karjalainen P, Ow LL, Kulkarni M, Lee JK, Karjalainen T, Leitch A, Ryan G, Rosamilia A. CO2 surgical laser for treatment of stress urinary incontinence in women: a randomized controlled trial. Am J Obstet Gynecol. 2022 Sep;227(3):473.e1-473.e12. doi: 10.1016/j.ajog.2022.05.054. Epub 2022 May 31.
citation: Amiragova MG, Arakhangel'skaia MI. [Role of the midbrain reticular formation in hormonal supply to the body in conditions of chronic emotional stress]. Biull Eksp Biol Med. 1983 Aug;96(8):16-21. Russian.
citation: Franic D, Fistonic I, Franic-Ivanisevic M, Perdija Z, Krizmaric M. Pixel CO2 Laser for the Treatment of Stress Urinary Incontinence: A Prospective Observational Multicenter Study. Lasers Surg Med. 2021 Apr;53(4):514-520. doi: 10.1002/lsm.23319. Epub 2020 Sep 8.
citation: O'Toole AW, O'Toole R, Webster SW, Lucal B. Nurses' diagnostic work on possible physical child abuse. Public Health Nurs. 1996 Oct;13(5):337-44. doi: 10.1111/j.1525-1446.1996.tb00259.x.