Efficacy of Electroacupuncture (EA) for Women With Pure Stress Urinary Incontinence (SUI)

NCT02445573 | Completed Results

• 1 other identifier: 2012BAI24B01-021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA) for women with pure stress urinary incontinence (SUI).

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; electroacupuncture; efficacy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of Urine Leakage Measured by 1-hour Pad Test

  Baseline and week 6

Secondary Outcomes (3)

• Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)

  Baseline, weeks 1-6, weeks 15-18 and weeks 27-30

• Change From Baseline of the Total ICIQ-SF Scores

  Baseline, and weeks 6, 18 and 30

• Patient Self-evaluation of Therapeutic Effect

  weeks 6, 18 and 30

Other Outcomes (1)

• Adverse Events

  weeks 1-30

Study Arms (2)

EA group

ACTIVE COMPARATOR

Other: EA

Sham EA group

PLACEBO COMPARATOR

Other: sham EA

Interventions

EA OTHER

When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.

EA group

sham EA OTHER

When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.

Sham EA group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible women were 40 to 75 years of age, and met the clinical diagnosis recommendations of SUI by the International Consultation on Urological Diseases:
• involuntary urine leakage on effort, exertion, sneezing or coughing which stopped when the stress ends;
• visible involuntary leakage from the urethra synchronous with increased abdominal pressure, or a pad weight gain \>1 g in 1-hour pad test;
• without symptoms of urinary frequency and urgency.

You may not qualify if:

• Women were excluded from the study if they met any of the following criteria: \*other type of urinary incontinence (UI) (urge, mixed, or overflow UI, etc);
• symptomatic urinary tract infection;
• ever received UI or pelvic surgery;
• a severity of pelvic organ prolapse ≥ degree 2;
• residual urinary volume \>30 ml;
• maximum flow rate ≤ 20 ml/s;
• limited in walking, stairs climbing and running;
• receiving specialized treatment for SUI, or taking medicine affecting bladder function;
• serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, injury of cauda equina, or myeleterosis;
• being pregnant or breastfeeding;
• with cardiac pacemaker, metal allergy or severe needle phobia;
• unlike to give written formed consent.

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• Xu H, Liu B, Wu J, Du R, Liu X, Yu J, Liu Z. A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence. PLoS One. 2016 Mar 9;11(3):e0150821. doi: 10.1371/journal.pone.0150821. eCollection 2016.

  PMID: 26960195 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

Results Point of Contact

• Title: Dr. Huanfang Xu
• Organization: Guang'anmen hospital of China Academy of Chinese Medical Sciences

huanfang_xu@126.com

+86 10 8800 1124

Study Officials

• Zhishun Liu, doctor

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: doctor

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 15, 2015
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 15, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-05

Locations

CN (1)