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Italian Validation of the Pelvic Floor Distress Inventory (PFDI-20) Questionnaire

NCT05472129 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-07-25

No results posted yet for this study

Summary

Quality of life (QoL) assessment is a milestone of clinical practice in gynecology. In particular, the use of validated QoL questionnaires is of the utmost importance for pelvic floor disorders, due to their functional nature and high prevalence. Pelvic floor dysfunctions such as lower urinary tract, bowel and sexual dysfunctions often coexisting with pelvic organ prolapse affect a substantial proportion of women and can often cause bothersome symptoms and have a negative effect on psychological and social well-being. Assessment of QoL in women with pelvic floor dysfunctions is essential for making a diagnosis and designating an adequate treatment. Therefore, it is necessary to evaluate women's subjective perception. A valid way to measure the patients' perspectives is through self-administered questionnaires that can address the presence and severity of symptoms, and their impact in daily activities and QoL. Symptom severity and QoL can be assessed by two specific questionnaires, the Pelvic Floor Distress Inventory (PFDI-20) and the Prolapse Quality of Life (P- QOL).

Conditions

  • Disorder of Muscle of Pelvic Region and Thigh (Diagnosis)

Interventions

OTHER

self-administered questionnaires

The validation process of a linguistic translation must maintain conceptual and technical equivalence between the source and the target language.The questionnaire was submitted to women during a gynecological medical interview and they were asked to evaluate their perceived degree of difficulty in understanding each question item. After that, the final Italian version of the questionnaire was obtained

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-03-01
Completion
2022-04-30

Countries

  • Italy

Study Locations

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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 NCT05472129 on ClinicalTrials.gov