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Living With Urinary Incontinence: Women's Experiences in a Qualitative Phenomenological Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06421428
Acronym
LEI
Enrollment
15
Registered
2024-05-20
Start date
2024-11-01
Completion date
2025-02-01
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Experience, Life, Urinary Incontinence

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

Interventions

OTHERLEI 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 scientific literature and with reference to the Theoretical Domains Framework (TDF), created and validated by Michie et al. (2005) and later updated by Cane et al. (2012). The interview questions 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.

OTHERLEI 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.

Sponsors

Università Vita-Salute San Raffaele
CollaboratorOTHER
IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
LEI (Lived Experience Incontinence) InterviewBaselineTo 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)

Secondary

MeasureTime frameDescription
LEI (Lived Experience Incontinence) surveyBaselineTo 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026