Lived Experienced Incontinence Lived Experienced Incontinence - LEI - Trial NCT06421428
Access comprehensive clinical trial information for NCT06421428 through Pure Global AI's free database. This phase not specified trial is sponsored by IRCCS San Raffaele and is currently Not yet recruiting. The study focuses on Urinary Incontinence,Experience, Life. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
IRCCS San Raffaele
Timeline & Enrollment
N/A
Sep 01, 2024
Oct 01, 2025
Primary Outcome
LEI (Lived Experience Incontinence) Interview
Summary
Study Description: Scientific literature demonstrated the negative influence of Urinary
 Incontinence (UI) on the quality of life connected to the physical, psychological, and social
 health of women.
 
 However, a limited number of studies investigated in depth the emotional experience of women
 affected by this disorder, their behaviors, and their experiences in managing the problem.
 Health professionals need to understand these aspects to offer the best care, also taking
 into account women's cultural and territorial differences. Research conducted on the topic in
 the Italian context is lacking, therefore the present study aims to explore, in a Northern
 Italian context, the experience of adult women affected by UI.
 
 Study Design: Qualitative phenomenological study (observational, cross-sectional, monocenter)
 Objective: To explore, in a Northern Italian context, the experience of women aged โฅ 18 years
 affected by Urinary Incontinence (UI) Study Population: Women โฅ 18 years old, not pregnant
 nor having given birth for less than 40 days, suffering from urinary incontinence who access
 the Pelvic Floor Rehabilitation Outpatient Clinic of the San Raffaele Hospital in Milan.
 
 Sample Size: Women who have already had at least a couple of pelvic floor rehabilitation
 meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time
 frame foreseen by the study. These subjects represent a precious resource and are considered
 more informative for the researcher as they testify to the emotions and daily life that
 influence the symptoms of urinary incontinence, but they are also able to narrate their
 experience of re-education of the pelvic floor.
 
 It is assumed that approximately 20 women will be involved to reach data saturation.
 
 Statistical Design: The interviews will be analyzed with the hermeneutic-phenomenological IPA
 (Interpretative phenomenological analysis) method, which involves the identification of units
 of meaning, categories and themes in accordance with the language of the speakers. The
 analysis of qualitative data will be made possible thanks to the use of data management
 software (NViVO). The socio-demographic data collected will be presented with absolute and
 relative frequencies
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06421428
Non-Device Trial

