Mild to moderate stress urinary incontinence
Conditions
Interventions
Trial Group:Treatment with Er:YAG Laser System
Sponsors
Tongji Hospital, Tongji Medical College Hust
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Women aged 18 years or older; 2. Clinically diagnosed with mild or moderate simple stress urinary incontinence (leakage volume of 1g <= 1 hour urine pad test < 50g), who have received at least one form of conservative treatment (such as lifestyle modification, pelvic floor muscle training, drug therapy, etc.) and whose urinary incontinence symptoms have not improved significantly; 3. Agree to participate in this clinical trial and voluntarily sign the informed consent form, and are willing to cooperate in completing the follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have undergone vaginal surgery or urinary incontinence surgery; 2. Those with stress urinary incontinence, urge urinary incontinence, or mixed urinary incontinence; 3. Those without a sexual history; 4. Those with vesicovaginal fistula, history of bladder tumor, or those who have received radiotherapy in the treatment area; 5. Those with a history of photosensitive disorders; 6. Those with untreated urinary tract infections or active systemic infections; 7. Those with untreated vaginitis or unhealed damage to the vaginal cavity, vaginal opening, or vestibule; 8. Those with unexplained vaginal bleeding or cervical lesions (such as erosion, etc.); 9. Those diagnosed with endometriosis; 10. Those with pelvic organ prolapse classified as grade >= II (according to the Baden-Walker classification method); 11. Those with fecal incontinence; 12. Those with malignant diseases (such as malignant tumors, etc.) or epilepsy; 13. Those who have had chronic bronchitis, emphysema, asthma, or chronic constipation causing increased abdominal pressure in the past; 14. Pregnant or lactating women; 15. Those who are participating in other interventional drug or medical device clinical trials and have not reached the primary endpoint; 16. Researchers who consider other reasons as unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate 3 months after completion of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of urine leakage in 1h urine pad test 3 month and 6 months after the completion of treatment to the baseline;Changes in Urinary Incontinence Quality of Life Questionnaire (I-QOL) score 3 month, 6 months ,12 months and 24 months after the completion of treatment to the baseline;Changes in Urinary Incontinence Questionnaire Short Form (ICI-Q-SF) score 3 month, 6 months ,12 months and 24 months after the completion of treatment to the baseline; | — |
Countries
China
Contacts
Public ContactWang Shaogang
Tongji Hospital, Tongji Medical College Hust
Outcome results
None listed