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Clinical Trials/NCT06421428
NCT06421428
Completed
Not Applicable

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

IRCCS San Raffaele1 site in 1 country15 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
IRCCS San Raffaele
Enrollment
15
Locations
1
Primary Endpoint
LEI (Lived Experience Incontinence) Interview
Status
Completed
Last Updated
8 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
February 1, 2025
Last Updated
8 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Trapani

Principal Investigator, Midwife (RM), PhD student

IRCCS San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old
  • Urinary Incontinence
  • Informed consent signed
  • Comprehension of written and spoken Italian language
  • Female patients of the pelvic floor rehabilitation outclinic at San Raffaele Hospital

Exclusion Criteria

  • Young age (\< 18 years)
  • Puerperium (up to 40 days post-partum)

Outcomes

Primary Outcomes

LEI (Lived Experience Incontinence) Interview

Time Frame: Baseline

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)

Secondary Outcomes

  • LEI (Lived Experience Incontinence) survey(Baseline)

Study Sites (1)

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