NCT06421428

Lived Experienced Incontinence Lived Experienced Incontinence - LEI

Urinary Incontinence: Lived Experience of Adult Women. A Phenomenological Study
IRCCS San Raffaele·ClinicalTrials.gov·otherNot yet recruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
LEI Interview
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
IRCCS San Raffaele
Location
Milan, Italy
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2024
End date
Oct 01, 2025
Enrollment
20 participants
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 ≥ 18 years
 affected by Urinary Incontinence (UI) Study Population: Women ≥ 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
Other specified urinary incontinenceFaecal incontinenceUnspecified urinary incontinenceStress incontinenceBladder disorder, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06421428
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.