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

NCT ID: NCT04307680

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-02

Study Completion Date

2021-01-10

Brief Summary

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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

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Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Peritron perineometer

Intervention Type DEVICE

Perineometry will be used to assess quality of each observed treatment modality.

Magnetic stimulation

Using 16 extracorporeal magnetic innervation treatments during 8 weeks (2 times a week).

Group Type ACTIVE_COMPARATOR

Peritron perineometer

Intervention Type DEVICE

Perineometry will be used to assess quality of each observed treatment modality.

Interventions

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Peritron perineometer

Perineometry will be used to assess quality of each observed treatment modality.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Mislav Mikuš

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Hospital Centre Zagreb, Croatia

Zagreb, , Croatia

Site Status RECRUITING

Countries

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Croatia

Facility Contacts

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Mislav Mikuš, MD

Role: primary

+ 385 1 460 4646

Other Identifiers

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UniZG

Identifier Type: -

Identifier Source: org_study_id

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