Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse (LOLIPOP)

November 1, 2022 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Basel, Switzerland
        • Recruiting
        • University Hospital Basel/Dep. of Visceral Surgery (Clarunis)
        • Contact:
        • Principal Investigator:
          • Daniel Steinemann, PD Dr. MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Steinemann, PD Dr. med., University Hospital Basel, Clarunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2019

Primary Completion (Anticipated)

September 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-01190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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