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

University of Zagreb

Status: Unknown

Conditions: Stress Urinary Incontinence

Treatments: Device: Peritron perineometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04307680

UniZG

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Kegel exercise

Active Comparator group

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)

Treatment:

Device: Peritron perineometer

Magnetic stimulation

Active Comparator group

Description:

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

Treatment:

Device: Peritron perineometer