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

Not Applicable

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Peritron perineometer

• Registration Number: NCT04307680
• Lead Sponsor: University of Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Status Verified: 2020-08
• Study Start: 2020-08-02
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-25
• Primary Completion: 2021-01-02
• Study Completion: 2021-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic stimulation	Peritron perineometer	Using 16 extracorporeal magnetic innervation treatments during 8 weeks (2 times a week).
Kegel exercise	Peritron perineometer	Using high-intensity Kegel exercise regimen for 8 weeks (5 times a week; 3 times a day involved; 3 sets of 10-12 contractions)

Primary Outcome Measures

Name	Time	Method
Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment	8 weeks from the start of the 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

Name	Time	Method
Greater proportion of better patient global improvement in magnetic stimulation arm group	3 months from treatment finish	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)
Greater proportion of increased perineometry value in magnetic stimulation arm group	8 weeks	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

Trial Locations

Locations (1)

Clinical Hospital Centre Zagreb, Croatia; 🇭🇷 Zagreb, Croatia