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

NCT05629481 | Unknown

• 1 other identifier: QL-URO-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• King's Health Questionnaire (KHQ) score decreases more than 50% baseline

  through study completion, an average of 6 months

• Incontinence-specific Quality of Life (I-QOL) score increases more than 50% baseline

  through study completion, an average of 6 months

Study Arms (2)

CO2 laser group

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

Participants in the sham group underwent three sham treatment sessions with 4-6 weeks intervals.

Procedure: Fractional carbon dioxide laser sham treatment

Interventions

Fractional carbon dioxide laser treatment PROCEDURE

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.

CO2 laser group

Fractional carbon dioxide laser sham treatment PROCEDURE

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.

Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-70 years
• Clinical diagnosis of stress urinary incontinence (SUI)

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 31778906 BACKGROUND

• 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.

  PMID: 35662546 RESULT

• 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.

  PMID: 6683978 RESULT

• 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.

  PMID: 32896930 RESULT

• 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.

  PMID: 8918174 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhonghua Xu, MD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yueqing Tang, MD

CONTACT

+8618560083899; sdurology@163.com

Zhonghua Xu, MD

CONTACT

+8618560086000; xuzhonghua1963@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 29, 2022
• Study Start: April 20, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: March 6, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)