Treatment of urinary incontinence and improvement of quality of life Urological and Genital Diseases
Conditions
Interventions
This single-center, randomized, double-blind, placebo-controlled trial was conducted over a 6-week follow-up period at the Nutratech S.r.l. facilities (Rende, CS, Italy) between June and September 202
Sponsors
Ekuberg Pharma
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Caucasian women aged 45 to 70 years 2. A diagnosis of stress (S) and/or urge (U) urinary incontinence (UI) confirmed by a board-certified gynecologist based on clinical anamnesis and the answers to the Questionnaire for Urinary Incontinence Diagnosis (QUID). The cut-off value was set at = 4 for SUI and = 6 for UUI.
Exclusion criteria
Exclusion criteria: 1. A positive medical history of pathologies (acute, chronic, or progressive) or pharmacological treatments (i.e. alpha-adrenergic blockers/stimulants, anticholinergics, calcium channel blockers, psychoactive drugs, misoprostol, opioids, hormone replacement therapy, diuretics) that could potentially interfere with the test product 2. Simultaneous participation in other clinical trials 3. Participation in a similar trial without an adequate washout period 4. Food intolerance or food allergies (including allergies to ingredients of the test product) 5. Concomitant use of food supplements, topical products or procedures to treat UI 6. Prior use of UI-active products or procedures without an adequate washout period 7. History of drug, alcohol, or substance abuse 8. Nutrition and eating disorders (e.g. bulimia, psychogenic eating disorders, etc.) 9. Pregnancy or breastfeeding women 10. Absence of adequate contraceptive measures in women of childbearing age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in stress urinary incontinence (SUI) and urge urinary incontinence (UUI) symptoms measured using the Questionnaire for Urinary Incontinence Diagnosis (QUID) before and after 6 weeks (W6) of product use 2. The gynecologist's opinion of the product's efficacy measured using a verbal rating scale at the end of the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (QoL) measured using a QoL questionnaire consisting of 10 items focused on the participant's perception of the urinary incontinence discomforts in the last two weeks. Answers were on an 11-point numerical rating scale (NRS) from 0 (“not at all”) to 10 (“maximum discomfort”) before and after 6 weeks (W6) of product use | — |
Countries
Italy
Contacts
Public ContactDavide Carati
Outcome results
None listed