Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT02047032
Eligibility Criteria:
Inclusion Criteria:
* females meet the meet the diagnostic criteria of mixed urinary incontinence
* aged 35-75 years
* moderate and severe urinary incontinence with the urinary incontinence severity index between 3 and 9
* suffering from urinary incontinence at least for 3 months with the 72-h incontinence episode frequency≥2 in the baseline assessment
* voluntarily join the research and sign the informed consent
Exclusion Criteria:
* pure stress urinary incontinence, pure urgency urinary incontinence, overflow incontinence and neurogenic bladder
* medicine use for urinary incontinence or may affect the bladder function, or taking any non-drug therapy (such as electric stimulation, bladder training and pelvic floor muscle training) in the last month
* symptomatic urinary tract infection and non-functional urologic disease
* having ever undergone an operation for urinary incontinence or on the pelvic floor (including hysterectomy)
* pelvic organ prolapse degree ≥2
* residual urinary volume (RUV) \>30 mL
* maximum flow rate (Qmax) \<20 mL/s;
* be allergic to solifenacin or having contradictions for muscarine antagonist (such as urinary retention, gastric retention, myasthenia gravis, ulcerative colitis and angle closure glaucoma)
* diseases affect function of lower urinary tract, such as uncontrolled diabetes, multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal injury, cauda equina injury and multiple system atrophy.
* serious cardiovascular, pulmonary, cerebral, liver, kidney, hematopoietic system or psychiatric disease and cognitive impairment
* patients with severe renal dysfunction or moderate hepatic dysfunction who are using strong Cyp3a4 Inhibitor like ketoconazole
* unable or limited to walking, up and down stairs and running
* poor compliance with electroacupuncture, pelvic floor muscle training or drug
* pregnancy, lactation or within the 12 months after birth
* having a cardiac pacemaker, a metal allergy, or a severe needle phobia.
* volunteer of other trials
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02047032
Study Brief:
Protocol Section:
NCT02047032