Urinary Incontinence Clinical Trial
— ELECAPUNOfficial 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.
Status | Completed |
Enrollment | 71 |
Est. completion date | February 10, 2021 |
Est. primary completion date | February 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 36 Years to 69 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Jose Antonio Lomeña | Málaga |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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. | |
Primary | 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 | 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. |
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