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

NCT04110821 | Recruiting

• 1 other identifier: 2019-01190
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Quality of Life; Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Pelvic Organ Prolapse (POP)

You may not qualify if:

• \< 18 years
• Patients unable to understand an informed consent
• Patients unwilling to participate
• emergency operations
• pregnancy
• Overactive Bladder without descensus
• Stool incontinence without POP

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

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

Basel, Switzerland

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Steinemann, PD Dr. med.

  University Hospital Basel, Clarunis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Steinemann, PD Dr. med.

CONTACT

+41 61 777 75 27; daniel.steinemann@clarunis.ch

Sebastian Christen

CONTACT

+41 61 777 75 53; sebastian.christen@clarunis.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: September 15, 2019
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CH (1)