Pelvic Organ ProlapseNCT02383199
Polypropylene Mesh in Prolapse Surgery
An observational study of Pelvic Organ Prolapse, run by Turku University Hospital.
Trial summary
The purpose of this study was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. The complications and the effect of the learning curve of the surgeons to the outcome is also reported. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2014
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 195 first patients with pelvic organ prolapse operated on a in Turku University Hospital using polypropylene mesh
195 first patients with pelvic organ prolapse operated on using polypropylene mesh
About this study
Official title: Polypropylene Mesh in Prolapse Surgery; Long-term Outcome and Complications.
The purpose of this study was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. The complications and the effect of the learning curve of the surgeons to the outcome is also reported.
- Conditions
- Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective outcome with validated questionnaires
Validated questionnaires
Measured: 7 years
Secondary outcomes (2)
Objective outcome: anatomic outcome with Pelvic Organ Prolapse Quantification (POP-Q) system
Measured: 7 years
Number of patients with adverse events and reoperations.
POP-Q
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionNov 2014
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pia Heinonen, MD, Principal investigator, Turku university hospital, Department of gynecology and obsteterics, Turku, Finland':'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383199
- Sponsor's protocol ID
- 134/2013
- Status last verified
- Mar 2015
- First submitted
- 2 Feb 2015
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypropylene Mesh in Prolapse Surgery; Long-term Outcome and Complications.
- ClinicalTrials.gov ID
- NCT02383199
- Acronym / sponsor ID
- 134/2013
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Mar 2015 (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 was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. The complications and the effect of the learning curve of the surgeons to the outcome is also reported.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 195 first patients with pelvic organ prolapse operated on a in Turku University Hospital using polypropylene mesh
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective outcome with validated questionnaires
Time frame: 7 years
Validated questionnaires
2 secondary outcomes
Objective outcome: anatomic outcome with Pelvic Organ Prolapse Quantification (POP-Q) system
Time frame: 7 years
Number of patients with adverse events and reoperations.
Time frame: 7 years
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 27 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.
Pia Heinonen, MD principal investigator
Turku university hospital, Department of gynecology and obsteterics, Turku, Finland':'
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Turku University Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Subjective outcome with validated questionnaires (time frame: 7 years). 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 27 Mar 2015.