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

NCT06421428 | Completed

• 1 other identifier: LEI
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Incontinence; Experience, Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• LEI (Lived Experience Incontinence) survey

  Baseline

Study Arms (1)

Women's single sample

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.

Other: LEI Interview; Other: LEI Survey

Interventions

LEI Interview OTHER

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.

Women's single sample

LEI Survey OTHER

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.

Women's single sample

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female sex
• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Università Vita-Salute San Raffaele: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milan, 20132, Italy

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Duilio F. Manara

  Director of Center for Nursing Research and Innovation (CeNRI)

  STUDY CHAIR

• Massimo Candiani

  Director of U.O. Obstetrics and Gynecology

  STUDY CHAIR

• Stefano Salvatore

  U.O. Obstetrics and Gynecology

  STUDY CHAIR

• Stefania Rinaldi

  U.O. Obstetrics and Gynecology

  STUDY CHAIR

• Ilaria Baini

  U.O. Obstetrics and Gynecology

  STUDY CHAIR

• Giulia Villa

  Center for Nursing Research and Innovation (CeNRI)

  STUDY CHAIR

• Sara Trapani

  U.O. Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Midwife (RM), PhD student

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 20, 2024
• Study Start: November 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)