Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-09
Brief Title:
Lived Experienced Incontinence Lived Experienced Incontinence - LEI
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Urinary Incontinence Lived Experience of Adult Women A Phenomenological Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEI
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 womens 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
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 womens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None