Electroacupuncture Treatment for Urinary Incontinence (UI) in Women (ELECAPUN)

Analysis of the Effectiveness of Electroacupuncture Treatment for Urinary Incontinence in Women: A Controlled and Randomized Clinical Trial

The investigators have developed an investigation comparing electroacupuncture with pelvic floor exercises in female urinary incontinence (UI). It is a randomized clinical trial with 71 women with UI and two arms: 37 women received electroacupuncture with pelvic floor exercises and another arm with 34 women who only received pelvic floor exercises. The investigators evaluated the effectiveness using the International consultation on incontinence questionaire-urinary incontinence short form (ICQ-UI SF) Spanish version. The investigators also evaluated the safety of electroacupuncture in our sample.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Pelvic Floor Muscle Weakness; Electroacupuncture; Women
• Intervention / Treatment: Device: electroacupuncture group

Detailed Description

The International Continence Society defines urinary incontinence (UI) as the objectively demonstrable involuntary loss of urine. It affects women of any age. UI significantly impairs patients quality of life, limits their autonomy and reduces their self-esteem. The impairment of health-related quality of life due to UI can be even greater than that caused by some chronic diseases such as diabetes or high blood pressure.

It is common for this type of disorder to be significantly associated with depressive symptoms and feelings of anxiety, which end up affecting the physical, psychological, social, cultural and sexual levels.

UI is classified into: Stress or Effort UI (the most frequent), urge UI and mixed UI. In stress UI, involuntary urine leakage is associated with physical exertion that causes an increase in abdominal pressure; it occurs as a result of a failure in the urethral resistance mechanisms. In urge UI, the involuntary loss of urine is preceded by a compelling desire to urinate; it is due to an increase in urinary bladder contractility. In mixed UI, involuntary urine loss is associated with stress and urge incontinence.

The prevalence of UI varies according to the type of study, the definition and assessment of UI and the characteristics of the population studied (mainly age and sex, with the frequency increasing with age and in women). Worldwide, figures ranging from 5% to 72% have been published; in Spain, the available data range from 15% to 42%, the average prevalence being estimated at 40.6%. The therapeutic approach to UI can be pharmacological (anticholinergics, alpha-blockers and topical estrogens are the most commonly used agents), urological surgery, external devices (such as pessary and urethral occluder), pelvic floor exercises and stimulation by electroacupuncture.

The International Consultation on Urological Diseases recommended pelvic floor muscle training as A level evidence treating simple mild and moderate stress urinary incontinence, which curative rate varies 30% to 60%, although it is a lifelong treatment. Conservative interventions such as pelvic floor muscle training are more likely to be used than drugs or surgery while a woman is pregnant or in the postnatal period.

Pelvic floor exercises for the treatment of urinary incontinence was popularized by Arnold Kegel (1948). It has been recommended in the treatment of stress and mixed urinary incontinence, but has increasingly become part of the treatment of urge UI. It is based on two functions of the pelvic floor muscles: support of the pelvic organs, and a contribution to the urethral sphincter closure mechanism.

From the interpretation of traditional Chinese medicine, the problem of urinary incontinence may be due to a deficiency of energy or "Qi". The pelvic floor, bladder and anal sphincter need significant energy to function properly. This is why it is thought that acupuncture may be a beneficial treatment, as it may increase energy along the urinary tract. UI can be included in two syndromes depending on the signs and symptoms presented by the patient.

Our investigators work compares the effectiveness of electroacupuncture on the point R7 together with pelvic floor exercises versus pelvic floor exercises alone.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain
    • Jose Antonio Lomeña

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women presenting moderate-severe UI according to the ICIQ-SF questionnaire.
• Any type of urinary incontinence
• Assigned to the Torre del Mar (Malaga) health center..
• The participants gave their voluntary consent to participate in the study.

Exclusion Criteria:

• After pelvic floor operation or operation for urinary incontinence.

• Pregnancy or lactation.

  • Diagnosed neurological disease that may affect the pelvic floor.
• Grade II major genital prolapse.
• Inability to understand the messages and commands required to carry out the study procedure or answer the questionnaire.
• Women whose stay in the city is shorter than the duration of the research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: kegel´s exercise (pelvic floor exercise); A midwife/nurse works with the women according to the following protocol: 1.-identify anal sphincter, and try to raise it from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting; 2.- identify elevator ani muscle and try to raise vagina from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting, bent forward, elbows on knees; 3.- contract elevator ani muscle with a position of sitting, lying, and standing; 4.- contract anal sphincter with a position of sitting, lying, and standing. The sessions are conducted by the same midwife/nurse to women in both groups/arms to be performed by the women at home. .	Device: electroacupuncture group; compare the effectiveness of electroacupuncture on point B7 plus pelvic floor exercises versus pelvic floor exercises alone in women with urinary incontinence (UI) .; Other Names: pelvic floor exercise
Experimental: Electroacupuncture group; Acupuncture point called bilateral R7 receive acupuncture with 0.25*40 mm needle with a perpendicular puncture 1.5 cun. The electrical stimulator is applied to bilateral R7, with dilatation wave 50 Hz and direct electric current of 1 milliamperes.. Each session lasts 30 minutes per day. Participants are treated 1 time per week for 12 weeks, total 12 sessions for each patient. Equipment: Electroacupuncture device.; device made in China	Device: electroacupuncture group; compare the effectiveness of electroacupuncture on point B7 plus pelvic floor exercises versus pelvic floor exercises alone in women with urinary incontinence (UI) .; Other Names: pelvic floor exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change at 3 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.	The investigators used the ICIQ-SF questionnaire at 3 months. The investigators aimed to find a variation in the mean of the questionnaire of two or more points over the initial ICIQ-SF 0 questionnaire. The ICIQ (International Consultation on Incontinence Questionnaire) is a self-administered questionnaire that identifies individuals with urinary incontinence and the impact on quality of life. Any score greater than zero is considered a diagnosis of UI. Scores are from zero to 24 points. Zero points would indicate no urinary incontinence and 24 points is the highest possible score and corresponds to the highest severity of urinary incontinence.	Change in ICIQ-SF score for each participant at 3 months
Change at 6 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version. International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.	The investigators used the ICIQ-SF questionnaire at 6 months. The investigators aimed to find a variation in the mean of the questionnaire of two or more points over the initial ICIQ-SF 0 questionnaire. The ICIQ (International Consultation on Incontinence Questionnaire) is a self-administered questionnaire that identifies individuals with urinary incontinence and the impact on quality of life. Any score greater than zero is considered a diagnosis of UI. Scores are from zero to 24 points. Zero points would indicate no urinary incontinence and 24 points is the highest possible score and corresponds to the highest severity of urinary incontinence.	change in ICIQ-SF score for each participant at 6 months.
Change at 12 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.	The investigators used the ICIQ-SF questionnaire at 12 months. The investigators aimed to find a variation in the mean of the questionnaire of two or more points over the initial ICIQ-SF 0 questionnaire. The ICIQ (International Consultation on Incontinence Questionnaire) is a self-administered questionnaire that identifies individuals with urinary incontinence and the impact on quality of life. Any score greater than zero is considered a diagnosis of UI. Scores are from zero to 24 points. Zero points would indicate no urinary incontinence and 24 points is the highest possible score and corresponds to the highest severity of urinary incontinence.	Change in ICIQ-SF score for each participant at 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
appearance of adverse effects with electroacupuncture	The appearance of adverse effects with electroacupuncture such as pain, infection, paresthesia, hematoma or any other contingency derived from the technique applied will be recorded.	Side effects reported for each participant through study completion, an average of 1 year. Number of Participants with pain at puncture site or hematoma or infection at puncture site during 12 months.

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Investigators: Principal Investigator: Silvia Moga Lozano, doctor, Andaluz Health Service

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Urination Disorders; Neuromuscular Manifestations; Elimination Disorders; Urinary Incontinence; Muscle Weakness; Enuresis
• Other Study ID Numbers: Electroacupuncture and UI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No