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

Stress Urinary Incontinence Clinical Trial

— KEMS-CRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307680
• Other study ID #: UniZG
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2020
• Est. completion date: January 10, 2021

Study information

• Verified date: August 2020
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 10, 2021
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Peritron perineometer
Perineometry will be used to assess quality of each observed treatment modality.

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre Zagreb, Croatia	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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