Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Treatments: Cholinergic Antagonists; Solifenacin Succinate

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