Clinical trial NCT02047032: Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
Official title: Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: electroacupuncture
urinary incontinence
PFMT
Solifenacin
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
timeFrame: baseline, weeks 1-12
Secondary outcomes:
measure: Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
timeFrame: baseline, weeks 13-24, week 25-36
measure: Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
timeFrame: Weeks 1-12, 13-24, 25-36
measure: Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
timeFrame: Baseline, weeks 1-12, 13-24, 25-36
measure: Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
timeFrame: baseline, weeks 12, 24 and 36
measure: Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
timeFrame: Baseline, weeks 1-12, 13-24, 25-36
measure: the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
timeFrame: Weeks 4 and 12
measure: Patient's Treatment Satisfaction Degree
timeFrame: Weeks 12, 36
measure: Patient Global Impression Improvement
timeFrame: Weeks 12, 36
measure: Electroacupuncture Acceptance Assessment
timeFrame: Weeks 2, 6 and 12
measure: The Number of Participants Using Urine Pads
timeFrame: Weeks 1-12, 13-24, 25-36
measure: Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
timeFrame: Weeks 1-12, 13-24, 25-36
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
name: Zhishun Liu, doctor
role: STUDY_DIRECTOR
References:
citation: Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.
citation: Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9.
citation: Liu B, Liu Y, Qin Z, Zhou K, Xu H, He L, Li N, Su T, Sun J, Yue Z, Zang Z, Zhang W, Zhao J, Zhou Z, Liu L, Wu D, Wu J, Zhou J, Pang R, Wang Y, Liu J, Yu J, Liu Z. Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial. Mayo Clin Proc. 2019 Jan;94(1):54-65. doi: 10.1016/j.mayocp.2018.07.021.
citation: Liu B, Wang Y, Xu H, Chen Y, Wu J, Mo Q, Liu Z. Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol. BMC Complement Altern Med. 2014 Aug 15;14:301. doi: 10.1186/1472-6882-14-301.