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

University of Zagreb100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

100

Conditions

Stress Urinary Incontinence

Interventions

Peritron perineometer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 8 weeks from the start of the treatment

Secondary Outcomes

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

Time frame: 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)

Time frame: 3 months from treatment finish