Evaluation and Comparison of Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen in Treatment of Stress Urinary Incontinence in Female (KEMS-CRO)

Evaluation and Comparison of Short-term Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen

The aim of this prospective, randomized controlled study is to evaluate and compare efficacy between the most available conservative treatment (magnetic stimulation and Kegel exercise) for stress urinary incontinence in Croatia. We will assess quality-of-life, patient global improvement, and vaginal pressure measured with perineometer in three different time points: at the enrollment, after 8 weeks of treatment and 3 months after the both treatments are done.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Peritron perineometer

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10 000
    • Recruiting
    • Clinical Hospital Centre Zagreb, Croatia
    • Contact: Mislav Mikuš, MD; Phone Number: + 385 1 460 4646; Email: m.mikus19@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• urodinamically confirmed stress urinary incontinence, at least one vaginal delivery in gynecological history.

Exclusion Criteria:

• urinary tract malignancies, vulvovaginitis, current uroinfection, previous pelvic surgeries, neurologic and psychiatric diseases, previous conservative treatment of stress urinary incontinence in less than 6 months, Stage III and IV of genital prolapse, latex allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Kegel exercise; Using high-intensity Kegel exercise regimen for 8 weeks (5 times a week; 3 times a day involved; 3 sets of 10-12 contractions)	Device: Peritron perineometer; Perineometry will be used to assess quality of each observed treatment modality.
Active Comparator: Magnetic stimulation; Using 16 extracorporeal magnetic innervation treatments during 8 weeks (2 times a week).	Device: Peritron perineometer; Perineometry will be used to assess quality of each observed treatment modality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment	We assume that after 8 weeks of treatment, in magnetic stimulation arm of study, we will observe more treatment ''responders'' - with at least 4-point reduction in overall ICIQ-SF score	8 weeks from the start of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Greater proportion of increased perineometry value in magnetic stimulation arm group	We assume that after 8 weeks of treatment, in magnetic stimulation arm of study, we will observe more treatment ''responders'' - at least more than 30% of increase in overall vaginal pressure, measured by a Peritron perineometer	8 weeks
Greater proportion of better patient global improvement in magnetic stimulation arm group	We assume that after 3 months of treatment finish, in magnetic stimulation arm of study, we will observe more women who are satisfied with the treatment, compared to Kegel exercise arm - using Patient Global Improvement Score (PGI-I)	3 months from treatment finish

Collaborators and Investigators

• Sponsor: University of Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2020
• Primary Completion (Anticipated): January 2, 2021
• Study Completion (Anticipated): January 10, 2021

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: UniZG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: From February 2021.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No