Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Urinary Incontinence

Treatments: Drug: solifenacin; Procedure: acupuncture; Procedure: PFMT

Study type: Interventional

Funder types: Other

Identifiers

NCT02047032

2012BAI24B01-MUI

Details and patient eligibility

About

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).

Full description

Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A gynecologist or urologist will make the diagnosis. Central randomization will be performed by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing.

Sample size: Sample size is based on the primary outcome. According to literature, the investigators predict that MUI patient's average 72-h incontinence episode frequency of the week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin. The number of the acupuncture group is 57%. For the assessment of noninferiority, 250 participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%).

Quality control: A 3-level monitoring system (monitors responsible for one center, monitors responsible for all centers and monitors responsible for the whole trial) will be established to check the performance of the trial in time. Outcome assessment, completion of case report forms and data management will be under strict supervision.

Data management: The Remote Dara Capture (RDC) system will be used for data entering. Both paper and electronic case report form will be reserved. A data verification plan is made.

Enrollment: 500 patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

acupuncture

Experimental group

Description:

BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).

Treatment:

Procedure: acupuncture

Solifenacin plus PFMT

Active Comparator group

Description:

Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.

Treatment:

Procedure: PFMT

Drug: solifenacin