Stress Urinary Incontinence Clinical Trial
Official title:
Differences in the Effectiveness of Electromagnetic Stimulation Therapy and Kegel Exercises Based on Compliance, Subjective - Objective Symptoms and Pelvic Floor Muscle Strength in Postpartum Stress Urinary Incontinence
Verified date | August 2021 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Electromagnetic stimulation is a new modality and alternative in women with urinary incontinence (UI). However, there was not much evidence that compares the use of electromagnetic stimulation to Kegel Exercises in post-partum stress urinary incontinence (SUI). We evaluate the compliance rate, effectiveness (UDI-6 and 1-hour pad test), and pelvic muscle strength of electromagnetic stimulation on stress urinary incontinence compared with Kegel pelvic floor muscle exercises in post-partum women as conservative therapy. This study was a single-blind randomized trial in postpartum women diagnosed with stress urinary incontinence who came to YPK Mandiri Hospital. We recruited 40 Patients and were randomized into two groups, the electromagnetic stimulation (n=20) and Kegel exercises (n=20). The electromagnetic stimulation procedure was done three times a week for five weeks, and the Kegel exercises group will be instructed to do the exercises every day for eight weeks. Our primary objective is to measure compliance, symptom reduction (using the UDI-6 questionnaire and the 1-hour pad test), and pelvic floor muscle strength.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - postpartum women aged 20 years or over with a diagnosis of stress urinary incontinence three months postpartum - signed an informed consent form - a urine leakage when coughing with bladder volume 200 to 250 ml - able to perform a pad test 1-hour Exclusion Criteria: - uncontrolled diabetes mellitus - grade 3 and 4 pelvic organ prolapse - mixed incontinence in the patient - chronic degenerative disease/trauma that affected muscle and nerve function - previous history of pelvic surgery - pacemaker |
Country | Name | City | State |
---|---|---|---|
Indonesia | RS YPK Mandiri | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Cacciari LP, Dumoulin C, Hay-Smith EJ. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a cochrane systematic review abridged republication. Braz J Phys Ther. 2019 Mar - Apr;23(2):93-107. doi: 10.1016/j.bjpt.2019.01.002. Epub 2019 Jan 22. — View Citation
Fujishiro T, Enomoto H, Ugawa Y, Takahashi S, Ueno S, Kitamura T. Magnetic stimulation of the sacral roots for the treatment of stress incontinence: an investigational study and placebo controlled trial. J Urol. 2000 Oct;164(4):1277-9. — View Citation
Lim R, Lee SW, Tan PY, Liong ML, Yuen KH. Efficacy of electromagnetic therapy for urinary incontinence: A systematic review. Neurourol Urodyn. 2015 Nov;34(8):713-22. doi: 10.1002/nau.22672. Epub 2014 Sep 22. Review. — View Citation
Peng L, Zeng X, Shen H, Luo DY. Magnetic stimulation for female patients with stress urinary incontinence, a meta-analysis of studies with short-term follow-up. Medicine (Baltimore). 2019 May;98(19):e15572. doi: 10.1097/MD.0000000000015572. — View Citation
Stewart F, Berghmans B, Bø K, Glazener CM. Electrical stimulation with non-implanted devices for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Dec 22;12:CD012390. doi: 10.1002/14651858.CD012390.pub2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compliance | Patients are compliant when they attend or done 80% of the intended regimens of therapy. | five weeks for Electomagnet stimulation, eight weeks for Kegel Exercises | |
Primary | UDI-6 Questionnaire | Symptoms reduction | five weeks for Electomagnet stimulation, eight weeks for Kegel Exercises | |
Primary | Symptoms reduction | 1-hour pad test | five weeks for Electomagnet stimulation, eight weeks for Kegel Exercises | |
Primary | Pelvic floor muscle strength | Measured by Peritron | five weeks for Electomagnet stimulation, eight weeks for Kegel Exercises |
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