overactive bladder
Conditions
Interventions
control group:transcutaneous tibial nerve stimulation
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18-80 years gender not limited; (2) Meeting the diagnostic criteria for Overactive Bladder (OAB) according to the "2022 Version Chinese Diagnosis and Treatment Guidelines for Urological and Andrological Diseases"; (3) Disease course lasting more than 3 months; (4) Voluntarily participating in this clinical trial and signing the informed consent form; (5) After enrollment agreeing not to arbitrarily increase or decrease relevant medications affecting pelvic and lower urinary tract symptoms during the trial period; (6) Able to have good communication with the investigator and willing to comply with all requirements of the entire trial.
Exclusion criteria
Exclusion criteria: (1) Women who are pregnant or lactating; (2) Patients complicated with uncontrolled urinary tract infections urinary tract obstruction urological tumors interstitial cystitis or other diseases; (3) Patients with severe comorbidities significantly affecting health such as non-urinary malignant tumors; (4) Having received botulinum toxin treatment within the recent 12 months; (5) Those who have undergone sacral neuromodulation therapy; (6) Pelvic organ prolapse with POP-Q stage > II; (7) Participation in other clinical trials within 3 months prior to this trial; (8) Patients with psychiatric disorders unable to cooperate with physicians; (9) Judged by the investigator as unsuitable for this study or unable to comply with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-hour micturition frequency from baseline to week 8 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 24-hour micturition frequency from baseline to week 4 of treatment.;Change in 24-hour micturition frequency from week4 to week 8 of treatment.;urgency episodes;nocturia frequency;average urine volume;PPBC-S;AUA-SI-QOL ;OABSS;Proportion of subjects achieving a clinically meaningful improvement in OABSS score; | — |
Countries
China
Contacts
Public ContactQiongqiong Liu /Ran Pang
Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine
Outcome results
None listed