Back to resultsEvaluation and Comparison of Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen in Treatment of Stress Urinary Incontinence in Female (KEMS-CRO)
Primary Purpose
Stress Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Peritron perineometer
Sponsored by
About this trial
This is an interventional diagnostic trial for Stress Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- Clinical Hospital Centre Zagreb, CroatiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Kegel exercise
Magnetic stimulation
Arm Description
Using high-intensity Kegel exercise regimen for 8 weeks (5 times a week; 3 times a day involved; 3 sets of 10-12 contractions)
Using 16 extracorporeal magnetic innervation treatments during 8 weeks (2 times a week).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04307680
Brief Title
Evaluation and Comparison of Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen in Treatment of Stress Urinary Incontinence in Female
Acronym
KEMS-CRO
Official Title
Evaluation and Comparison of Short-term Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2020 (Actual)
Primary Completion Date
January 2, 2021 (Anticipated)
Study Completion Date
January 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kegel exercise
Arm Type
Active Comparator
Arm Description
Using high-intensity Kegel exercise regimen for 8 weeks (5 times a week; 3 times a day involved; 3 sets of 10-12 contractions)
Arm Title
Magnetic stimulation
Arm Type
Active Comparator
Arm Description
Using 16 extracorporeal magnetic innervation treatments during 8 weeks (2 times a week).
Intervention Type
Device
Intervention Name(s)
Peritron perineometer
Intervention Description
Perineometry will be used to assess quality of each observed treatment modality.
Primary Outcome Measure Information:
Title
Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment
Description
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
Time Frame
8 weeks from the start of the treatment
Secondary Outcome Measure Information:
Title
Greater proportion of increased perineometry value in magnetic stimulation arm group
Description
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
Time Frame
8 weeks
Title
Greater proportion of better patient global improvement in magnetic stimulation arm group
Description
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)
Time Frame
3 months from treatment finish
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Hospital Centre Zagreb, Croatia
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mislav Mikuš, MD
Phone
+ 385 1 460 4646
Email
m.mikus19@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
From February 2021.
Learn more about this trial
Evaluation and Comparison of Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen in Treatment of Stress Urinary Incontinence in Female
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