Clinical trial NCT06421428: Lived Experienced Incontinence Lived Experienced Incontinence - LEI
Official title: Urinary Incontinence: Lived Experience of Adult Women. A Phenomenological Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urinary Incontinence
Experience, Life
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Università Vita-Salute San Raffaele
First posted: 2024-05-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population under investigation will be made up of women aged ≥ 18 years (excluding pregnant women and women who have given birth less than 40 days) suffering from urinary incontinence and who understand and speak in the Italian language. Will be enrolled on a voluntary basis 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, because they are also able to narrate their experience of re-education of the pelvic floor.

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Female sex
2. Age ≥ 18 years old
3. Urinary Incontinence
4. Informed consent signed
5. Comprehension of written and spoken Italian language
6. Female patients of the pelvic floor rehabilitation outclinic at San Raffaele Hospital

Exclusion Criteria:

1. Male sex
2. Young age (\< 18 years)
3. Pregnancy
4. Puerperium (up to 40 days post-partum)

Primary outcomes:
measure: LEI (Lived Experience Incontinence) Interview
timeFrame: Baseline
Secondary outcomes:
measure: LEI (Lived Experience Incontinence) survey
timeFrame: Baseline
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
affiliation: Director of Center for Nursing Research and Innovation (CeNRI)
name: Duilio F. Manara
role: STUDY_CHAIR
affiliation: Director of U.O. Obstetrics and Gynecology
name: Massimo Candiani
role: STUDY_CHAIR
affiliation: U.O. Obstetrics and Gynecology
name: Stefano Salvatore
role: STUDY_CHAIR
affiliation: U.O. Obstetrics and Gynecology
name: Stefania Rinaldi
role: STUDY_CHAIR
affiliation: U.O. Obstetrics and Gynecology
name: Ilaria Baini
role: STUDY_CHAIR
affiliation: Center for Nursing Research and Innovation (CeNRI)
name: Giulia Villa
role: STUDY_CHAIR
affiliation: U.O. Obstetrics and Gynecology
name: Sara Trapani
role: PRINCIPAL_INVESTIGATOR
References: