Lived Experienced Incontinence Lived Experienced Incontinence - LEI

Urinary Incontinence Clinical Trial

— LEI  

Official title:

Urinary Incontinence: Lived Experience of Adult Women. A Phenomenological Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421428
• Other study ID #: LEI
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2024
• Source: IRCCS San Raffaele
• Contact: Sara Trapani
• Phone: 3389879403
• Email: trapani.sara[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Experience, Life
• Urinary Incontinence

Intervention

Other:
• LEI Interview
In accordance with the IPA (Interpretative phenomenological analysis) methodology, a semi-structured interview outline will be defined, aimed at understanding the lived experiences of women ("lived experience") during their coexistence with urinary incontinence and during the treatment process. The screwdriver questions were formulated starting from the reference literature and will be discussed in a focus group composed of a uro-gynecologist, two midwives, a nurse, an expert in qualitative methodology. The final screwdriver questions resulting from the focus group will be tested on a small group of women.
• LEI Survey
Some sociodemographic data identified from the reference literature will be collected in paper form immediately at the end of each interview, for the description of the sample. The data will concern: age, nationality, marital status, level of education, number of children, menopause, social relationships, level of information, period of onset of symptoms, type of symptomatology, frequency of episodes of urinary incontinence, quantity of urinary leakage, uro-gynecological pathological history.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LEI (Lived Experience Incontinence) Interview	To explore, in a Northern Italian context, the experience of women aged = 18 years affected by Urinary Incontinence (UI) through a semi-structured interview (open questions).; Specifically, the topics addressed in the interview will be: Emotions and daily life of women with UI (i.e. subjective meaning of UI, lifestyle changes, women's mood); Behavioral strategies implemented to deal with the problem (i.e. choice to give up leisure activities, society's attention to the problem, tools and sources of information); Perceptions regarding UI treatment plan (i.e. health expectations and desires, decision-making process that led to undertaking the treatment)	Baseline
Secondary	LEI (Lived Experience Incontinence) survey	To collect some sociodemographic data regarding women affected by UI: age, nationality, marital status, level of education, number of children, menopause, social relationships, level of information, period of onset of symptoms, type of symptomatology, frequency of episodes of urinary incontinence, quantity of urinary leakage, uro-gynecological pathological history.	Baseline