Electroacupuncture Treatment for Urinary Incontinence (UI) in Women

NCT04842695 | Completed

• 1 other identifier: Electroacupuncture and UI
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Electroacupuncture; Urinary Incontinence; Women; Pelvic Floor Muscle Weakness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• appearance of adverse effects with electroacupuncture

  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.

Study Arms (2)

kegel´s exercise (pelvic floor exercise)

ACTIVE COMPARATOR

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

Electroacupuncture group

EXPERIMENTAL

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

Interventions

electroacupuncture group DEVICE

compare the effectiveness of electroacupuncture on point B7 plus pelvic floor exercises versus pelvic floor exercises alone in women with urinary incontinence (UI) .

Also known as: pelvic floor exercise

Electroacupuncture group; kegel´s exercise (pelvic floor exercise)

Eligibility Criteria

• Age: 36 Years - 69 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Jose Antonio Lomeña

Málaga, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Silvia Moga Lozano, doctor

  Andaluz Health Service

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: April 13, 2021
• Study Start: January 7, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 10, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-02

Locations

ES (1)