NCT04429360

Brief Summary

The aim of our study is to examine the effect of prolapse surgery on voiding. Our study is the very first one to combine several innovative low-invasive and low-cost methods to analyse the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

April 30, 2020

Last Update Submit

June 9, 2020

Conditions

Pelvic Organ ProlapseStress Urinary IncontinenceOveractive BladderVoiding DisordersUrge Incontinence

Keywords

Pelvic Organ ProlapseSurgery3D/4D imagingurinary incontinencevoiding dysfunctionpatient reported outcome

Outcome Measures

Primary Outcomes (2)

  • Change in lower urinary tract symptoms pre- postoperatively

    Voiding diary

    1 year follow-up

  • Change in lower urinary tract symptoms pre- postoperatively

    Questionnaire: PFDI-20

    1 year follow-up

Secondary Outcomes (5)

  • Change in clinical outcome measures

    1 year follow-up

  • Change in clinical outcome measures

    1 year follow-up

  • Change in voiding

    1 year follow-up

  • Change in QoL

    1 year follow-up

  • Change in QoL

    1 year follow-up

Interventions

pelvic reconstructive surgeryPROCEDURE

Pelvic reconstructive surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women attending a gynecological unit with symptoms of pelvic organ prolapse and who will undergo pelvic floor surgery as management of their symptoms.

You may qualify if:

  • age ≥18 years
  • Dutch, French or English- speaking women
  • symptoms of pelvic organ prolapse
  • preoperatively pelvic floor surgery.

You may not qualify if:

  • \- history of neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary Incontinence, StressUrinary Bladder, OveractiveUrinary Incontinence, UrgeUrinary Incontinence

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsUrinary Bladder Diseases

Central Study Contacts

Sascha Vereeck, Dr.

CONTACT

003238215945saschavereeck@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department Gynecology, UZA

Study Record Dates

First Submitted

April 30, 2020

First Posted

June 12, 2020

Study Start

June 8, 2020

Primary Completion

June 8, 2022

Study Completion

June 8, 2023

Last Updated

June 12, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)