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NCT Number: NCT04110821

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

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.

Recruiting

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Key information

Conditions

Pelvic Organ Prolapse Incontinence Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel/Dep. of Visceral Surgery (Clarunis)

Basel, Switzerland

Location status: Recruiting

Location contact

Daniel Steinemann, PD Dr. MD

CONTACT

[email protected]

+41 61 777 75 27

Daniel Steinemann, PD Dr. MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel C Steinemann, PD Dr. med.

CONTACT

[email protected]

+41 61 777 75 27

Sebastian Christen

CONTACT

[email protected]

+41 61 777 75 53

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Quality of Life After Conservative and Surgical Treatment of Pelvic Organ

Acronym: LOLIPOP

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2019
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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