Treatment of female stress and female stress predominant urinary incontinence Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women =18 years old and over 2. At least a 3-month history of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a predominant stress component 3. At least 7 incontinence episodes per week, as recorded in a 3-day bladder diary 4. The enrolled women should have a positive cough stress test (CST) and a grade 3 or 4 PFM contraction based on the PERFECT Assessment Scheme
Exclusion criteria
Exclusion criteria: 1. Daytime frequency (>8 micturitions per day) or nocturia (>1 voidings per night) 2. Neurogenic incontinence or systemic diseases such as diabetes mellitus, or chronic kidney disease 3. Previously received medications for incontinence or had undergone any type of continence surgery 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incontinence episodes measured using a 3-day bladder dairy at baseline and week 12 (end of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline and week 12 (end of the study): 1. Overall health status measured using the King's Health Questionnaire (KHQ) 2. Patient's impression of improvement measured using the Patient Global Impression of Improvement (PGI-I) scoring 3. Quality of life measured using the Quality of life (QoL) scoring 4. Sexual function measured using the Female Sexual Function Index (FSFI) scoring 5. The change in the strength of pelvic floor muscles measured using the PERFECT assessment scheme | — |
Countries
Greece