Stress Urinary Incontinence
Conditions
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.
Interventions
DEVICEPeritron perineometer
Perineometry will be used to assess quality of each observed treatment modality.
Sponsors
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Greater proportion of reduced ICIQ-SF score in magnetic stimulation arm group after 8 weeks of treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Greater proportion of increased perineometry value in magnetic stimulation arm group | 8 weeks | 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 |
| Greater proportion of better patient global improvement in magnetic stimulation arm group | 3 months from treatment finish | 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) |
Countries
Croatia
Outcome results
None listed