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

NCT05472129 | Completed

• 1 other identifier: ITA PFDI-20
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

quality of life; pelvic floor disorders

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  the evaluation of the validity, internal consistency, and test-retest reliability.

  14 days

Study Arms (2)

Cases

Cases were defined, with respect to bowel, bladder or prolapse symptoms using the question: "How much do your symptoms bother you?" and the following choice of answers: "Not applicable - I do not have symptoms", "not at all", "a little", "quite a lot" and "very much".

Other: self-administered questionnaires

Control

Controls were identified as women answering "Not applicable - I do not have symptoms" or "not at all", otherwise patients were defined as cases.

Other: self-administered questionnaires

Interventions

self-administered questionnaires OTHER

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

Cases; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recruitment will occur from gynecologic outpatients in several university hospitals in Italy. Study participants will be patients referred to the urogynecological outpatient for pelvic floor disorders (genital prolapse and/or urinary incontinence). The end of the study will be determined when 200 patients (100 cases and 100 controls) will have been enrolled. Considering the outpatient activity of the departments we plan to enroll this number of patients within 6 month.

You may qualify if:

• Women ≥18 years old referred to urogynecological outpatient for genital prolapse or incontinence.
• Informed consent freely granted and acquired before the start of the study

You may not qualify if:

• Insufficient Italian language proficiency and psychiatric or neurological disorders

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

University of Milano Bicocca

Monza, MB, 20900, Italy

Location

MeSH Terms

Conditions

Disease; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: October 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 30, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)