Skip to main content
OpenTrials
Completed

NCT Number: NCT02724891

Web-based Validation Pelvic Floor Questionnaires

Patient-reported outcomes are commonly used in healthcare. Examples include validated symptom-based questionnaires and health diaries. In the field of Female Pelvic Medicine and Reconstructive Surgery there are many questionnaires and diaries that have been validated for a paper-based administration. As technology is incorporated into delivery of medical care and research, investigators need to consider how to collect data electronically while ensuring that this new format is equivalent to the paper questionnaires they rely on. In this study, the investigators aim to validate a series of validated questionnaires and symptom diaries administered via the web and smartphone for a more streamlined care for the patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Floor Dysfunction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

Health questionnaires and health diaries are two forms of patient-reported outcomes (PRO) commonly used in healthcare. Health questionnaires are often used as intake logs, discerning and recording the symptoms and severity of a problem at the time of presentation. Health diaries, in contrast, are ongoing logs which allow for mindful attention to symptoms and monitoring of response to therapy. Unfortunately, both types of PRO forms are often under-utilized or uninterpretable because they are collected on paper. Within urogynecology, PRO scales such as the Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Bristol Stool Chart, Bladder Diaries and others are used ubiquitously. Their impact, however, is diminished by poor compliance and recall bias. The move towards electronic PRO measures would be endorsed by patients (who can track and interact with their data), physicians (who can track progress and study group outcomes) and by regulators (who want to ensure accurate and reproducible data collection). Electronic PRO tools, particularly on the patient's own device, would allow for increased rate of reporting through mobile availability, time stamping of data to prevent recall bias and reduction in data entry mistakes and costs.

Study Procedures After informed consent is obtained, demographic data will be collected. Subjects will be administered the questionnaires either in paper or web-based or smartphone form based on a random number block scheme. At least two weeks later but prior to treatment they will complete the other form of the questionnaire. This can occur at their next office visit or can be completed at home. Subjects will be emailed and/or called by research staff to remind them to complete the second set of questionnaires.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women at least 18 years of age presenting with pelvic floor dysfunction

Exclusion criteria

  • Unable to repeat questionnaires or return to the office in 2 weeks
  • No access to computer/web or smartphone
  • Pregnancy (as gestational age will advance during 2 week time interval and symptoms may change)

Treatment and study plan

paper form

Other

questionnaires in paper form

web/smartphone form

Other

questionnaires in web/smartphone

Primary outcomes

  1. Test-retest reliability of PFDI-20 in the electronic format

    Time frame: minimum 2 week interval until subject receives treatment for the condition or up to one year

    Subjects will complete the paper and either web-based or smartphone versions of the PFDI-20 with at least a 2 week interval between administration of the 2 versions.

  2. Test-retest reliability of PFIQ-7 in the electronic format

    Time frame: minimum 2 week interval until subject receives treatment for the condition or up to one year

    Subjects will complete the paper and either web-based or smartphone versions of the PFIQ-7 with at least a 2 week interval between administration of the 2 versions.

  3. Test-retest reliability of PISQ-12 in the electronic format

    Time frame: minimum 2 week interval until subject receives treatment for the condition or up to one year

    Subjects will complete the paper and either web-based or smartphone versions of the PISQ-12 with at least a 2 week interval between administration of the 2 versions.

  4. Test-retest reliability of BSS in the electronic format

    Time frame: minimum 2 week interval until subject receives treatment for the condition or up to one year

    Subjects will complete the paper and either web-based or smartphone versions of the BSS with at least a 2 week interval between administration of the 2 versions.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • The Methodist Hospital Research Institute
  • University of Arkansas
  • University of Calgary
  • University of Wisconsin, Madison

Registry information

Official study title

Validation of Electronic (Web-based and Smartphone) Administration of Measures of Pelvic Floor Dysfunction

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2016
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.