Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Efficacy Study

NCT02452879 | Unknown DMC

• 1 other identifier: Z121107001012148
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean frequency of micturitions per 24 hours

  Mean daily micturition frequency = Sum of 3-day micturition frequency in a week/3 . The investigator gets the frequency of mictuitions by micturition diary.Mean daily micturition frequency will be calculated based on the micturition diary at week 0(baseline), 2, 4, 6, 8, 20, 32.

  4, 8 weeks in treatment, 12th and 24th weeks of follow-up

Secondary Outcomes (1)

• The response rate of improvement in symptoms

  8 weeks in treatment, The average response rate of improvement in global response during 8 weeks in treatment. The response rate in first 4 weeks in treatment, 12 and 24 weeks of follow-up will also be evaluated

Other Outcomes (4)

• Patient-Rated Global Assessments of treatment Benefit, Satisfaction, and Willingness to Continue (The BSW)

  Week 4th , 8th in treatment , 12nd and 24th of follow-up

• The mean number of daily urgency micturition, nocturia, leakage of urine, the mean degree of daily urgency micturition

  4 weeks, 8 weeks in treatment, 12nd and 24th weeks of follow-up.

• Daily mean incidence of urgency micturition (%), daily mean incidence of leakage of urine(%)

  Week 0(baseline), 4, 8, 12 and 24 of follow-up

Study Arms (3)

Electroacupuncture group

EXPERIMENTAL

Needle on bilateral BL33 acupoint 50-60mm with a 60°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3). Needle with 75mm long needle. An electric stimulator is put on. SDZ-V electric stimulator (produced by Suzhou Medical Instrument Co.Ltd). continuous wave(CW), 10Hz. Stop turning up the current intensity when patients could not stand. 3 times a week. Once every other day. The treatment period lasts eight weeks. totally 24 times.30min/time.

Device: Electroacupuncture

Placebo group

PLACEBO COMPARATOR

with the patient in the prone position. The acupoint routine disinfection of skin, and then the fixed pad is adhered on the acupoint. The 1.5 inches blunt tip needle pierce through the fixed pad, then it reaches the surface of the skin, uniform lifting thrusting and twirling all 3 times but do not pierce the skin. Then connect the electric acupuncture apparatus with special power supply wire electrode (special power line as the middle wire cut, looks as normal; that electroacupuncture instrument display connected to the state, but the actual without electricity), in the bilateral Zhongliao points, Hui Yang points on the needle handle; the period of treatment and the other manipulation of the placebo group are same as the deep needling acupoint group.

Device: Sham Electroacupuncture

Solifenacin Succinate group

ACTIVE COMPARATOR

Solifenacin Succinate Tablets (made by the Anse Tailai Pharmaceutical (China) R \& D limited company) 5mg, 1 tablets each time, 1 times / day, oral administration of 30min before meal, even for 8 weeks.

Drug: Solifenacin Succinate

Interventions

Electroacupuncture DEVICE

For the deep needling acupoint group, needle on bilateral BL33 50-60mm with a 60°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3). Needle with 75mm long needle. An electric stimulator is put on. SDZ-V Hua Tuo Brand electric stimulator (produced by Suzhou Medical Instrument Co.Ltd). continuous wave(CW), 10Hz. Stop turning up the current intensity when patients could not stand. 3 times a week. Once every other day The treatment period lasts eight weeks. totally 24 times.30min/time.

Electroacupuncture group

Sham Electroacupuncture DEVICE

with the patient in the prone position. The acupoint routine disinfection of skin, and then the fixed pad is adhered on the acupoint. The 1.5 inches blunt tip needle pierce through the fixed pad, then it reaches the surface of the skin, uniform lifting thrusting and twirling all 3 times but do not pierce the skin. Then connect the electric acupuncture apparatus with special power supply wire electrode (special power line as the middle wire cut, looks as normal; that electroacupuncture instrument display connected to the state, but the actual without electricity), in the bilateral Zhongliao points, Hui Yang points on the needle handle; the period of treatment and the other manipulation of the placebo group are same as the deep needling acupoint group.

Placebo group

Solifenacin Succinate DRUG

made by the Anse Tailai Pharmaceutical (China) R \& D limited company) 5mg / tablet

Solifenacin Succinate group

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of overactive bladder.
• Frequent micturition.（average urinary frequency of ≥8 voids per day）
• No relevant drug use within 2 weeks and no acupuncture treatment within 1 month before the study; not in other clinical trials.
• Self-reported bladder symptoms ≥3 months
• Capable of giving informed consent .
• Capable and willing to follow all study-related procedures

You may not qualify if:

• Frequent micturition and urinary urgency are secondary to other diseases.
• Clinical diagnosis of simple stress urinary incontinence.
• Patients with urinary track infection and vagenal infection.
• Patients with implantable pelvic stimulator.
• Current use of electric therapy on pelvic area/back/legs.
• Current use of clostridium botulinum therapy on vesical or pelvic muscles.
• participation in any clinical inverstigation involving or impacting gynecological/urinary/renal function.
• Suffering from severe cardiac/hepatic/renal injury or cognitive disorder/aphasia/ dysphrenia/malnutrition, or in poor perform status and unable to cooperate.
• Patients in gestation and in lactation period.
• Patients in coagulation disorders or taking anticoagulation drugs.
• People with cardiac pacemaker or metal allergy.
• Patients having got eletroacupunture therapy or solifenacin in 4 weeks before the study.
• Patients are afraid of needles.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Capital Medical University: collaborator
• Beijing Hospital: collaborator

Study Sites (1)

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

Beijing, Beijing Municipality, 10053, China

RECRUITING

Related Publications (1)

• 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

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Electroacupuncture; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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)

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

• Jia Baohui, Master

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

  STUDY CHAIR

Central Study Contacts

Jia Baohui, Master

CONTACT

13520090050; myrroossee@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Physician

Study Record Dates

• First Submitted: May 2, 2015
• First Posted: May 25, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

CN (1)