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NCT Number: NCT01784172

Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

About this study

Stress urinary incontinence (SUI) is a common disease of female. The inconvenience caused by SUI affects the patients' quality of life and health seriously. To date, there has not specific therapy on SUI. Former research showed acupuncture may work for SUI. This multi-center randomized controlled clinical trial of acupuncture for simple female stress urinary incontinence is designed to confirm the efficacy and safety of EA. This project is conducted by Chinese researchers, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for simple female stress urinary incontinence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnosis of Simple female stress urinary incontinence
  • 40-75 years old
  • Volunteered to join this research and signed the informed consent

Exclusion criteria

  • urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence, etc
  • After operation for urinary incontinence or pelvic floor operation
  • Edeoptosis≥Degree 2
  • Symptomatic urinary tract infection
  • RUV>30ml
  • Qmax<20ml/s
  • Constrained movement of walking, stairs climbing, running
  • Patients with continuous treatment for stress urinary incontinence or medicine for bladder function
  • With serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, MSA, Injury of cauda equine, myeleterosis.
  • During pregnancy or lactation period
  • With cardiac pacemaker, Metal allergy or severe needle phobia

Treatment and study plan

electroacupuncture group

Device

Procedure: electro-acupuncture;Points: Bilateral Zhongliao (BL33) Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50～60mm to outward and upward by 75mm filiform needle. Twirl, lift and thrust for 3 times, until local sour and heavy feeling coming.The electric stimulator is applied to bilateral BL33 and BL35, with continuous wave,50 Hz and electric current 1- 5mA.Every session lasts for 30 min per day.The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.

Other names: SDA-V electroacupuncture apparatus(Huatuo,made in China)

sham electroacupuncture group

Device

Procedure: sham electroacupuncture;Points: Bilateral sham Zhongliao (BL33) sham Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Both sham BL33 and BL35 are given non-penetrating needling with blunt needle. Twirl, lift and thrust for 3 times. The sham electric stimulator is applied to bilateral sham BL33 and sham BL35. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.

Other names: Sham SDZ-V electroacupuncture apparatus(Huatuo,China)

Primary outcomes

  1. value difference of 1h pad test, compared with the baseline

    Time frame: the 6 weeks

    quantity of fluid loss will be measured by 1h pad test, comparing the value of 6 weeks with the baseline(0 week), the primary outcome is the value difference.

Secondary outcomes

  1. average frequency difference of urinary incontinence in 72h

    Time frame: the 6 weeks, the15-18 weeks, 27-30 weeks

    • The average frequency difference of urinary incontinence in 72h of the 6 weeks is the average frequency difference of urinary incontinence in 72h of 2nd, 4th, 6th weeks based on the '72h voiding diary'; 2. The average frequency difference of urinary incontinence in 72h of the15-18 weeks is the average frequency difference of urinary incontinence in 72h of 15-18 weeks based on the '72h voiding diary'; 3. The average frequency difference of urinary incontinence in 72h of the 27-30 weeks is the average frequency difference of urinary incontinence in 72h of 27-30 weeks based on the '72h voiding diary'.

  2. ICIQ-SF

    Time frame: the 6, 18, 30 week

    International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) is a brief instrument used to assess the impact of UI in patients'lives

  3. Patient subjective effectiveness evaluation

    Time frame: the 6, 18, 30 week

    3 point scoring: no help=0; Small help=1; Medium help=2; Great help=3

  4. Weekly usage of pad

    Time frame: the 6 weeks, 7-18weeks, 19-30 weeks

    The value of 6 weeks is the average weekly usage of pads during 1-6 week; The value of 7-18weeks is the average weekly usage of pads during 7-18 weeks; The value of 19-30 weeks is the average weekly usage of pads during 19-30 weeks.

  5. Usage of specialty therapy for Simple female stress urinary incontinence

    Time frame: the 6 weeks, 7-18weeks, 19-30 weeks

    Compare the difference of uase of specialty therapy for Simple female stress urinary incontinence between the 2 groups during the 1-6 weeks, 7-18 weeks and 19-30 weeks.

  6. subgroup analysis: Relevency between 1h pad test, frequency of urinary incontinence in 72h and extent of urinary incontinence

    Time frame: the 6, 18, 30 week

    the 6th week: analyse the relevancy between 1h pad test and extent of urinary incontinence; the 18th and 30th weeks: analyse the relevancy between frequency of urinary incontinence in 72h and extent of urinary incontinence.

  7. Incidence of adverse events

    Time frame: the 1-6 weeks

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

Registry information

Official study title

The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2013
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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