female overactive bladder.
Conditions
Interventions
Control group:Sham-electroacupuncture and Solifenacin succinate
Experimental group:Electroacupuncture and Solifenacin succinate
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for OAB; (2) Aged 18 to 75 years female; (3) Disease duration = 3 months; (4) OABSS score between 3 and 11; (5) No abnormalities in routine urine tests; (6) No mental or intellectual disorders able to understand the items in the various scales and complete the assessments; (7) Agrees to participate in this study and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe heart liver kidney or other major diseases; or patients with severe liver and kidney dysfunction; (2) Patients with pelvic organ prolapse = grade II history of urological or pelvic floor surgery; (3) Patients whose OAB symptoms are caused by other diseases (e.g. due to cerebrovascular accidents spinal cord injuries etc. or with a maximum urinary flow rate 100 ml etc.); (4) Patients with urological diseases (e.g. urolithiasis urogenital tuberculosis etc.) malignant tumors or neurological diseases; (5) Pregnant or lactating women patients with blood diseases diabetes or psychiatric disorders; (6) Patients who have used medications that may affect bladder function within 1 month prior to enrollment or have received behavioral treatments for OAB within 3 months prior to enrollment; (7) Patients with a pacemaker implanted; (8) Patients with ulcers pustules skin infections etc. at the acupuncture sites or those allergic to metals or with severe trypanophobia; (9) Patients who have previously undergone electroacupuncture treatment; (10) Researchers who have participated in other clinical medical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the average 24-hour urinary frequency at week 4 compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the average 24-hour urinary frequency;Patient subjective efficacy assessment;Average 24-hour urinary incontinence episodes;Generalized Anxiety Disorder Scale (GAD-7);Overactive Bladder Symptom Score (OABSS);Overactive Bladder Questionnaire (OAB-q) score;Average 24-hour urgency episodes;King Health Questionnaire (KHQ); | — |
Countries
China
Contacts
Public ContactChen Yuelai
Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China
Outcome results
None listed