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Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse

Quality of Life After Conservative and Surgical Treatment of Pelvic Organ

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04110821
Acronym
LOLIPOP
Enrollment
134
Registered
2019-10-01
Start date
2019-09-15
Completion date
2028-12-31
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence, Pelvic Organ Prolapse, Quality of Life

Brief 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.

Interventions

None listed

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
symptom change assessed by German Pelvic Floor Questionnaire (GPFQ)before therapy and up to 5 years post-therapyChange 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.

Countries

Switzerland

Contacts

Primary ContactDaniel C Steinemann, PD Dr. med.
daniel.steinemann@clarunis.ch+41 61 777 75 27
Backup ContactSebastian Christen
sebastian.christen@clarunis.ch+41 61 777 75 53

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026