Stress Urinary Incontinence
Conditions
Keywords
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.
Interventions
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.
PROCEDUREFractional 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.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment efficacy | through study completion, an average of 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| King's Health Questionnaire (KHQ) score decreases more than 50% baseline | through study completion, an average of 6 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 6 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. |
Countries
China
Contacts
Primary ContactYueqing Tang, MD
Backup ContactZhonghua Xu, MD
Outcome results
None listed