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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629481
• Other study ID #: QL-URO-002
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: November 2022
• Source: Qilu Hospital of Shandong University
• Contact: Yueqing Tang, MD
• Phone: +8618560083899
• Email: sdurology[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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