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

NCT06421428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-08-20

No results posted yet for this study

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

Conditions

Interventions

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 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.

OTHER

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.

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    collaborator OTHER
  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Duilio F. Manara · Director of Center for Nursing Research and Innovation (CeNRI)

  • Massimo Candiani · Director of U.O. Obstetrics and Gynecology

  • Stefano Salvatore · U.O. Obstetrics and Gynecology

  • Stefania Rinaldi · U.O. Obstetrics and Gynecology

  • Ilaria Baini · U.O. Obstetrics and Gynecology

  • Giulia Villa · Center for Nursing Research and Innovation (CeNRI)

  • Sara Trapani · U.O. Obstetrics and Gynecology

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-02-01
Completion
2025-02-01

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421428 on ClinicalTrials.gov