Pelvic Organ ProlapseU-GYN-QOLNCT01134588
Assessment of Quality of Life in Disorders of the Pelvic Floor
A study testing Paper questionnaire and Touch screen questionnaire in people with Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Paper questionnaire and Touch screen questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient has pelvic organ prolapse
- the patient requires a surgical intervention within the next 4 to 8 weeks
- the patient understands and reads french
- the patient is affiliated with a social security system
- the patient has given consent
Who cannot join
- the patient refuses to participate
- the patient is under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Paper questionnaire, Touch screen questionnaire
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper questionnaireOther
Touch screen questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Reference group | Active comparator | This group will fill out paper questionnaires. Receives: Other: Paper questionnaire |
| Experimental group | Experimental | This group will fill out touch-screen questionnaires. Receives: Other: Touch screen questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence / absence of a completely filled out questionnaire
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Letouzey, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134588
- Sponsor's protocol ID
- LOCAL/2009/VL-01
- Acronym
- U-GYN-QOL
- Status last verified
- Mar 2015
- First submitted
- 1 Jun 2010
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Disorders of the Pelvic Floor
- ClinicalTrials.gov ID
- NCT01134588
- Acronym / sponsor ID
- U-GYN-QOL / LOCAL/2009/VL-01
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference group | Active comparator | Other: Paper questionnaireThis group will fill out paper questionnaires. |
| Experimental group | Experimental | Other: Touch screen questionnaireThis group will fill out touch-screen questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the patient has pelvic organ prolapse
- the patient requires a surgical intervention within the next 4 to 8 weeks
- the patient understands and reads french
- the patient is affiliated with a social security system
- the patient has given consent
Key exclusion criteria (2 listed)
- the patient refuses to participate
- the patient is under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paper questionnaire | Other | Reference group |
| Touch screen questionnaire | Other | Experimental group |
Primary outcome
Presence / absence of a completely filled out questionnaire
Time frame: 6 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Letouzey, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper questionnaire and Touch screen questionnaire in people with Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence / absence of a completely filled out questionnaire (time frame: 6 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.