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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-08-26

No results posted yet for this study

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

Interventions

PROCEDURE

NOVAMAG NT-60

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

BEHAVIORAL

Kegel Exercises

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05021302 on ClinicalTrials.gov