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

NCT04307680 | Unknown DMC

• 1 other identifier: UniZG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Greater proportion of increased perineometry value in magnetic stimulation arm group

  8 weeks

• Greater proportion of better patient global improvement in magnetic stimulation arm group

  3 months from treatment finish

Study Arms (2)

Kegel exercise

ACTIVE COMPARATOR

Using high-intensity Kegel exercise regimen for 8 weeks (5 times a week; 3 times a day involved; 3 sets of 10-12 contractions)

Device: Peritron perineometer

Magnetic stimulation

ACTIVE COMPARATOR

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

Device: Peritron perineometer

Interventions

Peritron perineometer DEVICE

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

Kegel exercise; Magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• urodinamically confirmed stress urinary incontinence, at least one vaginal delivery in gynecological history.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Clinical Hospital Centre Zagreb, Croatia

Zagreb, 10 000, Croatia

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: August 2, 2020
• Primary Completion: January 2, 2021
• Study Completion: January 10, 2021
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From February 2021.

Locations

CR (1)