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

Quality of Life Clinical Trial

— LOLIPOP  

Official title:

Quality of Life After Conservative and Surgical Treatment of Pelvic Organ

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110821
• Other study ID #: 2019-01190
• Status: Recruiting
• Start date: September 15, 2019
• Est. completion date: December 2027

Study information

• Verified date: November 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Daniel C Steinemann, PD Dr. med.
• Phone: +41 61 777 75 27
• Email: daniel.steinemann[@]clarunis.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: December 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Incontinence
• Pelvic Organ Prolapse
• Prolapse
• Quality of Life

Locations

Country	Name	City	State
Switzerland	University Hospital Basel/Dep. of Visceral Surgery (Clarunis)	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before therapy and up to 5 years post-therapy