Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence

NCT03787654 | Unknown

• 1 other identifier: 2018-163-KY
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to determine the effect of electroacupuncture in female patients with urgency-predominant mixed urinary incontinence. A three-arm non-inferior randomized controlled trial (RCT) using electroacupuncture, sham electroacupuncture and solifenacin with a total sample of 282 is proposed. The hypothesis is that the improvement (difference in number of urgency urinary incontinence episodes between baseline and 12-week evaluation) in the electroacupuncture group would be 50% or less of the difference in the improvement between the Solifenacin and the sham electroacupuncture groups.

Conditions

Mixed Urinary Incontinence; Urgency-predominant Mixed Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.

  3-day voiding diary is a reliable objective method to quantify the incontinence episode frequency and are a sensitive measurement to monitor the treatment response. In voiding diary, voiding episodes, urgency episodes, incontinence episodes, the volume drunk and the pads consumed are all recorded.

  week 12

Secondary Outcomes (14)

• Change of urgency urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.

  week 4, week 8, week 24, week 36

• Change of urinary incontinence episodes in average 24 hours from baseline based on 3-day voiding diary.

  week 4, week 8, week 12, week 24, week 36

• Proportion of subjects with at least 50% reduce of urgency urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary.

  week 4, week 8, week 12, week 24, week 36

• Proportion of subjects with complete resolution of urgency urinary incontinence episodes in average 24 hours based on 3-day voiding diary.

  week 4, week 8, week 12, week 24, week 36

• Proportion of subjects with at least 50% reduce of urinary incontinence episodes in average 24 hours compared with baseline based on 3-day voiding diary.

  week 4, week 8, week 12, week 24, week 36

Other Outcomes (3)

• Proportion of subjects bearing expectancy towards acupuncture AND proportion of subjects bearing expectancy towards drugs.

  baseline

• Proportion of subjects successfully blinded

  week 12

• Incidence of adverse events

  week 0-36

Study Arms (3)

electroacupuncture group

EXPERIMENTAL

Acupoints of bilateral Zhongliao (BL33), Huiyang (BL35) and Sanyinjiao (SP6) are stimulated by Huatuo Brand disposable needles and SDZ-V electronic apparatus.

Device: electroacupuncture

sham electroacupuncture group

SHAM COMPARATOR

Sham acupoints 1 cun(≈15mm) horizontally outwardly lateral to BL33 and BL35, and 0.5 cun(≈10mm) horizontally behind SP6 are stimulated superficially with a small electricity current by needles of 0.30×40mm size and SDZ-V electronic apparatus.

Device: sham electroacupuncture

Solifenacin group

ACTIVE COMPARATOR

subjects will orally take Solifenacin 5-10mg per day.

Drug: Solifenacin

Interventions

electroacupuncture DEVICE

BL33 and BL35 are inserted by needles of 0.30×75mm size till a depth of 60\~70mm. SP6 is inserted by needle of 0.30×40mm size till a depth of 25-30mm. After manipulation and deqi sensation generation, the electrodes will be attached to the acupoints transversely with 20Hz continuous wave and an electricity current of 2mA-6.5mA at BL33 and BL35, and 1-3.5mA at SP6. The current is adjusted from zero to the degree where patients can tolerate. Subjects receive 3 sessions per week（every other day ideally) for 12 weeks, 36 sessions in total.

Also known as: EA group

electroacupuncture group

sham electroacupuncture DEVICE

In sham electroacupuncture group, sham acupoints 1 cun(≈15mm） horizontally outwardly lateral to BL33 and BL35, and 0.5 cun (≈10mm) horizontally behind SP6 are stimulated by needles of 0.30×40mm size. The needles are inserted to a depth of 2-3mm to stand still, without any manipulation and sensation of deqi. The electrodes will also be attached to needles with an electricity current of 0.1-0.3mA. The sessions will be the same as the electroacupuncture group.

Also known as: SEA group

sham electroacupuncture group

Solifenacin DRUG

Subjects take solifenacin 5-10mg per day for a succession of 36 weeks. The dose change is decided by doctors under a comprehensive consideration of side effects and Patient Global Symptom Control (PGSC), which is applied to evaluate the effectiveness of Solifenacin at the 4th, 8th, 12th and 24th week.The medicine can be discontinued at any time if the adverse effect is rather severe.

Also known as: Drug group

Solifenacin group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients diagnosed with mixed urinary incontinence in accordance with EAU guideline by history intaking and physical examination\[8\];
• Age between 18 and 80 years old;
• Urgency index greater than stress index by MESA questionnaire\[12\];
• At least 4 episodes of urgency urinary incontinence in 72-hour voiding diary;
• With MUI for at least 3 months, and more than 50% of the total incontinence episodes is urgency one in 72-hour voiding diary;
• Positive cough test;
• A voluntarily-signed written informed content.

You may not qualify if:

• Having pure stress urinary incontinence, pure urgency urinary incontinence, overflow urinary incontinence or neurogenic bladder;
• Uncontrolled urinary tract infection;
• Tumor in urinary system or pelvic organs;
• Pelvic organ prolapse≥degreeⅡ;
• Residual urine volume≥100ml;
• Maximum flow rate\<15ml/s;
• Treated incontinence by acupuncture or positive medications, such as antimuscarinic drug within the past 1 month;
• Underwent surgery of anti-incontinence or in pelvic area, metrectomy included;
• Complication of uncontrolled diabetes and severe hypertension;
• Complicated diseases in nerves system that could hamper hypourethral function, such as Multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, cauda equina nerve injury and multiple system atrophy;
• Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
• Installed a cardiac pacemaker;
• Allergic to solifenacin or with contraindications to antimuscarinic drug, like urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis, angle-closure glaucoma;
• Allergic to metal or intolerant to the stimulation of electroacupuncture;
• Already with child or plan to conceive in the future 1 year, or within 1 year after delivery.

Sponsors & Collaborators

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

Study Sites (1)

Guang An Men Hospital

Beijing, 100053, China

RECRUITING

Related Publications (1)

• Sun Y, Liu Y, Su T, Sun J, Wu Y, Liu Z. Electroacupuncture versus solifenacin for women with urgency-predominant mixed urinary incontinence: a protocol for a three-armed non-inferiority randomized controlled trial. BMC Complement Med Ther. 2020 Jan 23;20(1):18. doi: 10.1186/s12906-019-2784-1.

  PMID: 32020889 DERIVED

MeSH Terms

Interventions

Electroacupuncture; Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; 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

Study Officials

• Zhishun Liu, PhD

  Guanganmen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhishun Liu, PhD

CONTACT

86-10-88002331; zhishunjournal@163.com

Yuanjie Sun, Master

CONTACT

86-010-18810337542; puzhisun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants in electroacupuncture and sham electroacupuncture groups are blinded, and solifenacin group is open.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 22, 2018
• First Posted: December 26, 2018
• Study Start: March 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-02

Locations

CN (1)