Evaluation and Comparison of Short-term Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- University of Zagreb
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment
- Last Updated
- 5 years ago
Overview
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.
Investigators
Mislav Mikuš
Dr
University of Zagreb
Eligibility Criteria
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
Time Frame: 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 Outcomes
- Greater proportion of better patient global improvement in magnetic stimulation arm group(3 months from treatment finish)
- Greater proportion of increased perineometry value in magnetic stimulation arm group(8 weeks)