NCT05472129|Completed
Loading search results
Sponsor study identifier
observational
200
1 country
1
Study Start
October 1, 2021
Actual (reported)Primary Completion
March 1, 2022
Actual (reported)Study Completion
April 30, 2022
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2021
Actual (reported)March 1, 2022
Actual (reported)April 30, 2022
Actual (reported)July 21, 2022
Actual (reported)July 25, 2022
Actual (reported)Primary endpoint
the evaluation of the validity, internal consistency, and test-retest reliability.
14 days
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".
Controls were identified as women answering "Not applicable - I do not have symptoms" or "not at all", otherwise patients were defined as cases.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University of Milano Bicocca
Monza, MB, 20900, Italy
200 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2022
First Posted
July 25, 2022
Study Start
October 1, 2021
Actual (reported)A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life
Contact the study team to confirm eligibility.
Primary Completion
March 1, 2022
Actual (reported)Study Completion
April 30, 2022
Actual (reported)Last Updated
July 25, 2022
Record last verified: 2022-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: