## Protocol Section
### Identification Module
**NCT ID:** NCT06421428

**Acronym:** LEI

**Brief Title:** Lived Experienced Incontinence Lived Experienced Incontinence - LEI

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

#### Organization Study ID Info
**ID:** LEI
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2025-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Università Vita-Salute San Raffaele

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS San Raffaele

#### Responsible Party

**Investigator Affiliation:** IRCCS San Raffaele

**Investigator Full Name:** Sara Trapani

**Investigator Title:** Principal Investigator, Midwife (RM), PhD student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Urinary Incontinence

- Experience, Life

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: LEI Interview

- Other: LEI Survey

**Label:** Women's single sample

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Women's single sample

**Description:** 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.

**Name:** LEI Interview

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Women's single sample

**Description:** 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.

**Name:** LEI Survey

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** LEI (Lived Experience Incontinence) Interview

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** 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.

**Measure:** LEI (Lived Experience Incontinence) survey

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** 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)

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** trapani.sara@hsr.it

**Name:** Sara Trapani

**Phone:** 3389879403

**Role:** CONTACT

**Contact 2:**

**Email:** villa.giulia@hsr.it

**Name:** Giulia Villa

**Phone:** 0291751779

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milan

**Contacts:**

***Contact 1:***

- **Email:** trapani.sara@hsr.it

- **Name:** Sara Trapani

- **Phone:** 3389879403

- **Role:** CONTACT

***Contact 2:***

- **Email:** villa.giulia@hsr.it

- **Name:** Giulia Villa

- **Phone:** 0291751779

- **Role:** CONTACT

***Contact 3:***

- **Name:** Massimo Candiani

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Stefano Salvatore

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Duilio F. Manara

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 6:***

- **Name:** Stefania Rinaldi

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 7:***

- **Name:** Ilaria Baini

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 8:***

- **Name:** Giulia Villa

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 9:***

- **Name:** Sara Trapani

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** IRCCS Ospedale San Raffaele

**Zip:** 20132

#### Overall Officials

**Official 1:**

**Affiliation:** Director of Center for Nursing Research and Innovation (CeNRI)

**Name:** Duilio F. Manara

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Director of U.O. Obstetrics and Gynecology

**Name:** Massimo Candiani

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** U.O. Obstetrics and Gynecology

**Name:** Stefano Salvatore

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** U.O. Obstetrics and Gynecology

**Name:** Stefania Rinaldi

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** U.O. Obstetrics and Gynecology

**Name:** Ilaria Baini

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** Center for Nursing Research and Innovation (CeNRI)

**Name:** Giulia Villa

**Role:** STUDY_CHAIR

**Official 7:**

**Affiliation:** U.O. Obstetrics and Gynecology

**Name:** Sara Trapani

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014555

- Term: Urination Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000059411

- Term: Lower Urinary Tract Symptoms

- ID: D000020924

- Term: Urological Manifestations

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019960

- Term: Elimination Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M17299

- Name: Urinary Incontinence

- Relevance: HIGH

- As Found: Urinary Incontinence

- ID: M7936

- Name: Enuresis

- Relevance: HIGH

- As Found: Urinary Incontinence

- ID: M27171

- Name: Nocturnal Enuresis

- Relevance: LOW

- As Found: Unknown

- ID: M17305

- Name: Urination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29464

- Name: Lower Urinary Tract Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21832

- Name: Elimination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014549

- Term: Urinary Incontinence

- ID: D000004775

- Term: Enuresis

### Misc Info Module

- Version Holder: 2024-05-31
