A Study of Fractional Carbon Dioxide Laser Treatment for Female Stress Urinary Incontinence
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CO2 laser group All participants included underwent three vaginal fractional CO2 laser (AcuPulse, Lumenis, Yokneam Illit, Israel) treatment sessions with 4-6 weeks intervals. |
Procedure: Fractional carbon dioxide laser treatment
All participants included 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 all 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.
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Outcome Measures
Primary Outcome Measures
- 1-h pad test weight decreases more than 50% baseline [through study completion, an average of 12 months]
1-hour pad test, used to assess improvement in the amount of urine leakage. That pad weight increases >2g is considered positive. The cure criteria of SUI was considered as 1-h pad test weight increasing </= 2g and the improvement criteria was considered as 1-h pad test weight decreasing > 50% baseline
- ICIQ-SF score decreases less than 5 points [through study completion, an average of 12 months]
International Consultation of Incontinence Questionnaire-Short Form (ICIQ-SF), used to assess improvement of the symptoms of urine leakage. The score scale is from 1 to 21, and higher scores means more severe urinary incontinence symptoms.
Secondary Outcome Measures
- King's Health Questionnaire (KHQ) score decreases more than 50% baseline [through study completion, an average of 12 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 12 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged 18-70 years
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Clinical diagnosis of stress urinary incontinence (SUI)
Exclusion Criteria:
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pregnancy
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pelvic organs prolapse no more than grade II
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gynecologic and urinary tract infections
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previous surgical intervention for stress urinary incontinence (SUI)
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Urgency urinary incontinence (UUI) or Mixed urinary incontinence (MUI)
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serious chronic disease or other reasons that compromised safety and interfered with study compliance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital of Shandong University | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
Investigators
- Study Chair: Zhonghua Xu, MD, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
- QL-URO-002