mild to moderate stress urinary incontinence
Conditions
Interventions
Intervention Group:Treatment with Er:YAG Laser System
Control Group:The control group was treated with a sham treatment using the same Er:YAG laser system with the same parameter settings, except that a metal shield was added to the handpiece's light ent
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18=age=70 years old; 2. Patients with clinical diagnosis of stress urinary incontinence; 3. 1g=1h urine pad test with urine leakage <50g; 4. Those who agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone vaginal surgery or urinary incontinence surgery; 2. Patients with urge incontinence or filling incontinence or mixed incontinence; 3. Patients without sexual life history; 4. Patients with vesicovaginal fistula, bladder tumor or who have received radiation therapy; 5. Patients with a history of photosensitivity diseases; 6. Patients with uncured urinary tract infection or active systemic infection; 7. Patients with uncured vaginitis; 8. Patients with unhealed injuries to the vaginal cavity, vaginal opening or vestibule; 9. Patients with unexplained vaginal bleeding or cervical lesions (such as erosion, etc.); 10. Patients diagnosed with endometriosis; 11. Patients with pelvic organ prolapse grade = grade II (according to Baden-Walker POP-Q grading method); 12. Patients with fecal incontinence; 13. Patients with previous chronic bronchitis/emphysema/asthma/chronic constipation caused by increased abdominal pressure; 14. Severe liver and kidney dysfunction (ALT or creatinine value > 1.5 times the upper limit of normal); 15. Patients who did not terminate other treatments for stress urinary incontinence (including Kegel exercise, functional electrical stimulation, etc.) during the trial; 16. Those who suffer from diseases that make treatment and evaluation difficult (such as sepsis, bacteremia, toxemia, severe metabolic diseases, cancer metastasis, malignant diseases, mental diseases, unrecovered viral infections, etc.); 17. Pregnant and lactating women, or those who have childbearing plans during the trial; 18. Patients with poor compliance, unwilling or unable to complete treatment and follow-up; 19. Patients who have participated in clinical trials of other drugs or medical devices within the past 3 months; 20. Patients who are considered by the investigator to be unsuitable to participate in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate 3 months after completion of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate 1 month after completion of treatment;Changes of urine leakage in 1h urine pad test before the first treatment and 1 month and 3 months after the completion of treatment;The frequency of urinary incontinence before the first treatment and after the completion of treatment (1 month, 3 months) for 3 consecutive days;Changes in Urinary Incontinence Quality of Life Questionnaire (I-QOL) score before the first treatment and after completion of treatment (1 month, 3 months, 6 months);Changes in Urinary Incontinence Questionnaire Short Form (ICI-Q-SF) score before the first treatment and after completion of treatment (1 month, 3 months, 6 months);Subject's VAS pain score at each treatment and 1 month after treatment completion;The use of Er:YAG laser system and the occurrence of equipment defects; | — |
Countries
China
Contacts
Public ContactZhang Yaoguang
Beijing Hospital
Outcome results
None listed