ElectroacupunctureELECAPUNNCT04842695
Electroacupuncture Treatment for Urinary Incontinence (UI) in Women
A study testing electroacupuncture group in people with Electroacupuncture and Urinary Incontinence, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Electroacupuncture, Urinary Incontinence, Women
- What is being tested?
- electroacupuncture group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2020to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- electroacupuncture group
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture groupDevice
Also called pelvic floor exercise
compare the effectiveness of electroacupuncture on point B7 plus pelvic floor exercises versus pelvic floor exercises alone in women with urinary incontinence (UI) .
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: 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 Receives: Device: electroacupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change in ICIQ-SF score for each participant at 12 months.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start7 Jan 2020
- Primary completion5 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroacupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Moga Lozano, doctor, Principal investigator, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842695
- Sponsor's protocol ID
- Electroacupuncture and UI
- Acronym
- ELECAPUN
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of Electroacupuncture Treatment for Urinary Incontinence in Women: A Controlled and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04842695
- Acronym / sponsor ID
- ELECAPUN / Electroacupuncture and UI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| kegel´s exercise (pelvic floor exercise) | Active comparator | Device: electroacupuncture groupA 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. . |
| Electroacupuncture group | Experimental | Device: electroacupuncture groupAcupuncture 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 |
Who may qualify
- Ages
- 36 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- After pelvic floor operation or operation for urinary incontinence.
- Pregnancy or lactation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupuncture groupAlso: pelvic floor exercisecompare the effectiveness of electroacupuncture on point B7 plus pelvic floor exercises versus pelvic floor exercises alone in women with urinary incontinence (UI) . | Device | Electroacupuncture group, kegel´s exercise (pelvic floor exercise) |
Primary outcome
Change at 3 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.
Time frame: Change in ICIQ-SF score for each participant at 3 months
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 at 6 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version. International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.
Time frame: change in ICIQ-SF score for each participant at 6 months.
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 at 12 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version.
Time frame: Change in ICIQ-SF score for each participant at 12 months.
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.
1 secondary outcome
appearance of adverse effects with electroacupuncture
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Moga Lozano, doctor principal investigator
Andaluz Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture group in people with Electroacupuncture and Urinary Incontinence, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change at 3 months in the International Consultation on Incontinence Questionnaire (ICIQ-SF) spanish version. (time frame: Change in ICIQ-SF score for each participant at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.