- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110821
Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse (LOLIPOP)
Quality of Life After Conservative and Surgical Treatment of Pelvic Organ
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Daniel C Steinemann, PD Dr. med.
- Phone Number: +41 61 777 75 27
- Email: daniel.steinemann@clarunis.ch
Study Contact Backup
- Name: Sebastian Christen
- Phone Number: +41 61 777 75 53
- Email: sebastian.christen@clarunis.ch
Study Locations
-
-
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Basel, Switzerland
- Recruiting
- University Hospital Basel/Dep. of Visceral Surgery (Clarunis)
-
Contact:
- Daniel Steinemann, PD Dr. MD
- Phone Number: +41 61 777 75 27
- Email: daniel.steinemann@clarunis.ch
-
Principal Investigator:
- Daniel Steinemann, PD Dr. MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pelvic Organ Prolapse (POP)
Exclusion Criteria:
- < 18 years
- Patients unable to understand an informed consent
- Patients unwilling to participate
- emergency operations
- pregnancy
- Overactive Bladder without descensus
- Stool incontinence without POP
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
before therapy and up to 5 years post-therapy
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Steinemann, PD Dr. med., University Hospital Basel, Clarunis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01190
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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