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

NCT05021302 | Completed

• 1 other identifier: 20-05-0561
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence; Postpartum

Keywords

Kegel Exercises; Pelvic Floor Electrical Stimulation; Perineometer; Post-partum Stress Urinary Incontinence; Pelvic Floor

Outcome Measures

Primary Outcomes (4)

• 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

• UDI-6 Questionnaire

  Symptoms reduction

  five weeks for Electomagnet stimulation, eight weeks for Kegel Exercises

• Symptoms reduction

  1-hour pad test

  five weeks for Electomagnet stimulation, eight weeks for Kegel Exercises

• Pelvic floor muscle strength

  Measured by Peritron

  five weeks for Electomagnet stimulation, eight weeks for Kegel Exercises

Study Arms (2)

Kegel exercises group

PLACEBO COMPARATOR

20 women in this group

Behavioral: Kegel Exercises

Electromagnetic stimulation group

EXPERIMENTAL

20 women in this group

Procedure: NOVAMAG NT-60

Interventions

NOVAMAG NT-60 PROCEDURE

The Electromagnetic stimulation consists of 15 sessions with 20 minutes duration and three times a week. The total length of therapy is five weeks.

Electromagnetic stimulation group

Kegel Exercises BEHAVIORAL

Self-supporting pelvic floor muscle strengthening exercises performed at home by contracting and relaxing quickly (2 seconds of contraction and 4 seconds of rest), followed by a slow contraction (contraction for 5 seconds, and rest for 10 seconds with five times each) five sets per day. The average length of exercise for each session is 2 minutes, with total exercise per day is 50 times. Thus, the total length of exercise is 10 minutes. It was done every day for eight weeks.

Also known as: Pelvic floor muscle training

Kegel exercises group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RS YPK Mandiri

Jakarta Pusat, Jakarta Special Capital Region, 10350, Indonesia

Location

Related Publications (5)

• 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.

  PMID: 25251335 BACKGROUND

• 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.

  PMID: 10992380 BACKGROUND

• Stewart F, Berghmans B, Bo K, Glazener CM. Electrical stimulation with non-implanted devices for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Dec 22;12(12):CD012390. doi: 10.1002/14651858.CD012390.pub2.

  PMID: 29271482 BACKGROUND

• 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.

  PMID: 31083230 BACKGROUND

• 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.

  PMID: 30704907 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physicians that evaluated the perineometer, UDI-6, and 1-hour pad test will be blinded for the group allocation to reduce bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We recruited consecutively for 40 patients divided into two groups by simple randomization, with 20 participants in each group.

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 25, 2021
• Study Start: March 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)