Pelvic Organ ProlapseLOLIPOPNCT04110821
Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse and Quality of Life, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This is an observational study that gives baseline and follow-up information, that does not directly influence the allocation of patients to various treatment Options (conservative and surgical therapy of Pelvic Organ Prolapse) but the knowledge gained of the data will help to develop treatment strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Organ Prolapse, Quality of Life, Incontinence
- How many people
- 134 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2019to Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study all patients with POP being treated at the study site are subject to inclusion. This concerns patients with different symptoms of POP such as urine or fecal incontinence, chronic obstipation, dysfunction of the bowel evacuation, micturition disorder, chronic pelvic pain, complaints associated to pelvic floor descent and pelvic organ prolapse. They also may have combinations of these symptoms.
Who may be able to join
- Pelvic Organ Prolapse (POP)
Who cannot join
- < 18 years
- Patients unable to understand an informed consent
- Patients unwilling to participate
- emergency operations
- pregnancy
- Overactive Bladder without descensus
- Stool incontinence without POP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel/Dep. of Visceral Surgery (Clarunis)
Basel
Daniel Steinemann, PD Dr. MD, +41 61 777 75 27, daniel.steinemann@clarunis.ch
Daniel Steinemann, PD Dr. MD
About this study
Official title: Quality of Life After Conservative and Surgical Treatment of Pelvic Organ
This is an observational study that gives baseline and follow-up information, that does not directly influence the allocation of patients to various treatment Options (conservative and surgical therapy of Pelvic Organ Prolapse) but the knowledge gained of the data will help to develop treatment strategies.
- Conditions
- Pelvic Organ Prolapse, Quality of Life, Incontinence
- Medical subject headings
- Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom change assessed by German Pelvic Floor Questionnaire (GPFQ)
Change in the symptom scores assessed by the German Pelvic Floor Questionnaire (GPFQ) by at least 1.0 points 6 months post-therapy.
The GPFQ does contain the domains bladder function, bowel function, prolapse and sexual symptoms. In each domain a total of 10 points may be reached. The maximum symptom score for the entire questionnaire are 40 points. The minimal symptom score is 0 points. The minimal important difference (MID) for patients with Pelvic Organ Prolapse (POP) is 1.0 points. A decrease of the symptom score by at least 1 point reflects a meaningful improvement.
Measured: before therapy and up to 5 years post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Sep 2019
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
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 University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Steinemann, PD Dr. med., Principal investigator, University Hospital Basel, Clarunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110821
- Sponsor's protocol ID
- 2019-01190
- Other IDs
- 2019
- Acronym
- LOLIPOP
- Status last verified
- Jul 2024
- First submitted
- 27 Sep 2019
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Conservative and Surgical Treatment of Pelvic Organ
- ClinicalTrials.gov ID
- NCT04110821
- Acronym / sponsor ID
- LOLIPOP / 2019-01190
- Conditions
- Pelvic Organ Prolapse, Quality of Life, Incontinence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Oct 2019 (actual)
- 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.
This is an observational study that gives baseline and follow-up information, that does not directly influence the allocation of patients to various treatment Options (conservative and surgical therapy of Pelvic Organ Prolapse) but the knowledge gained of the data will help to develop treatment strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study all patients with POP being treated at the study site are subject to inclusion. This concerns patients with different symptoms of POP such as urine or fecal incontinence, chronic obstipation, dysfunction of the bowel evacuation, micturition disorder, chronic pelvic pain, complaints associated to pelvic floor descent and pelvic organ prolapse. They also may have combinations of these symptoms.
Key inclusion criteria (1 listed)
- Pelvic Organ Prolapse (POP)
Key exclusion criteria (7 listed)
- < 18 years
- Patients unable to understand an informed consent
- Patients unwilling to participate
- emergency operations
- pregnancy
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
symptom change assessed by German Pelvic Floor Questionnaire (GPFQ)
Time frame: before therapy and up to 5 years post-therapy
Change in the symptom scores assessed by the German Pelvic Floor Questionnaire (GPFQ) by at least 1.0 points 6 months post-therapy. The GPFQ does contain the domains bladder function, bowel function, prolapse and sexual symptoms. In each domain a total of 10 points may be reached. The maximum symptom score for the entire questionnaire are 40 points. The minimal symptom score is 0 points. The minimal important difference (MID) for patients with Pelvic Organ Prolapse (POP) is 1.0 points. A decrease of the symptom score by at least 1 point reflects a meaningful improvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
Daniel Steinemann, PD Dr. med. principal investigator
University Hospital Basel, Clarunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Quality of Life, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jul 2024. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel C Steinemann, PD Dr. med. (+41 61 777 75 27, daniel.steinemann@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom change assessed by German Pelvic Floor Questionnaire (GPFQ) (time frame: before therapy and up to 5 years post-therapy). 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 30 Jul 2024.