Clinical trial NCT04842695: Electroacupuncture Treatment for Urinary Incontinence (UI) in Women
Official title: Analysis of the Effectiveness of Electroacupuncture Treatment for Urinary Incontinence in Women: A Controlled and Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electroacupuncture
Urinary Incontinence
Women
Pelvic Floor Muscle Weakness
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 71
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical study in which participants are assigned to 2 groups.Group K receive kegel´s exercise and the group A receive kegel´s exercise plus electroacupuncture in a point called R7.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change at 3 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.
timeFrame: Change in ICIQ-SF score for each participant at 3 months
measure: Change at 6 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version. International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.
timeFrame: change in ICIQ-SF score for each participant at 6 months.
measure: Change at 12 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.
timeFrame: Change in ICIQ-SF score for each participant at 12 months.
Secondary outcomes:
measure: appearance of adverse effects with electroacupuncture
timeFrame: 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.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Jose Antonio Lomeña
Study officials:
affiliation: Andaluz Health Service
name: Silvia Moga Lozano, doctor
role: PRINCIPAL_INVESTIGATOR
References: