Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

NCT02047032 | Completed Results

• 1 other identifier: 2012BAI24B01-MUI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Incontinence

Keywords

electroacupuncture; urinary incontinence; PFMT; Solifenacin

Outcome Measures

Primary Outcomes (1)

• Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12

  The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)

  baseline, weeks 1-12

Secondary Outcomes (11)

• Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36

  baseline, weeks 13-24, week 25-36

• Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency

  Weeks 1-12, 13-24, 25-36

• Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes

  Baseline, weeks 1-12, 13-24, 25-36

• Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score

  baseline, weeks 12, 24 and 36

• Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36

  Baseline, weeks 1-12, 13-24, 25-36

Study Arms (2)

acupuncture

EXPERIMENTAL

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).

Procedure: acupuncture

Solifenacin plus PFMT

ACTIVE COMPARATOR

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.

Drug: solifenacin; Procedure: PFMT

Interventions

acupuncture PROCEDURE

For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.

Also known as: electroacupuncture

acupuncture

solifenacin DRUG

Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )

Also known as: competitive cholinergic receptor antagonist

Solifenacin plus PFMT

PFMT PROCEDURE

Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).

Also known as: pelvic floor muscle training

Solifenacin plus PFMT

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Beijing, 100053, China

Location

Related Publications (4)

• 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.

  PMID: 36148895 DERIVED

• 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.

  PMID: 31919102 DERIVED

• 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.

  PMID: 30611454 DERIVED

• 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.

  PMID: 25128002 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Acupuncture Therapy; Electroacupuncture; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The noninferiority margin to PFMT-solifenacin in MUI women was hard to define. PFMT were led by trained research assistants instead of professional therapists, which may dilute the effect of the control group.

Results Point of Contact

• Title: Zhishun Liu
• Organization: Gunang'anmen Hospital

liuzhishun@aliyun.com

86 88002331

Study Officials

• Zhishun Liu, doctor

  Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Acupuncture Department of Guangan'men Hospital

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 28, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)