incontinence
Conditions
Interventions
Group A:Er:YAG laser treatment
Group B:Biofeedback electrical stimulation
Sponsors
Pudong New Area Gongli Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 years or older; 2. Mild and moderate patients clinically diagnosed as simple stress urinary incontinence (1h pad test grading method); 3. Those who agree to participate in the clinical trial and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone pelvic surgery or urinary incontinence surgery; 2. Patients with urge incontinence or filling incontinence or true incontinence or severe stress incontinence; 3. Patients without sexual life history; 4. Bladder tumors or patients who have received radiation therapy; 5. Patients with untreated urinary tract infection or bladder infection; 6. Patients with vesico-vaginal fistula; 7. Patients with vaginal cavity, vaginal opening or vestibular injury; 8. Patients diagnosed with endometriosis; 9. Patients with pelvic organ prolapse grade >= II (according to POP-Q); 10. Patients with stool incontinence; 11. Patients with vaginal bleeding of unknown causes or cervical lesions (such as erosion); 12. Severe hepatic and renal dysfunction (ALT > normal upper limit 3 times; Creatinine > 225 umol/L); 13. The disease may cause difficulty in treatment and evaluation (e.g.sepsis, bacteremia, toxemia, severe metabolic disease, cancer metastasis, mental illness, etc.); 14. Having other conditions that could make the trial difficult or significantly shorten the patients' life expectancy(< 1 year), such as cancer, liver disease, cardiac insufficiency, or a life expectancy of less than 12 months; 15. Pregnant and lactating women, or those with family planning; 16. Patients with poor compliance, unwilling or unable to complete treatment and follow-up plans; 17. Patients who are participating in clinical trials of other drugs or medical devices; 18. Patients considered unsuitable for inclusion by other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effectiveness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of urinary incontinence;International consultation on incontinence questionnaire-short form;Incontinence Impact Questionnaire-7;Evaluation of the performance of Er: YAG laser therapy system;Visual analogue scale;Evaluation of patient satisfaction; | — |
Countries
China
Contacts
Public ContactJianwei Lyu
Pudong New Area Gongli Hospital
Outcome results
None listed