What is the Effect of Prolapse Surgery on Voiding? (PROVOID)

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Voiding Disorders; Pelvic Organ Prolapse; Stress Urinary Incontinence; Urge Incontinence
• Intervention / Treatment: Procedure: pelvic reconstructive surgery

• Study Type: Observational
• Enrollment (Anticipated): 453

Contacts and Locations

• Study Contact: Name: Sascha Vereeck, Dr.; Phone Number: 003238215945; Email: saschavereeck@hotmail.com

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • University Hospital of Antwerp
      • Contact: Sascha Vereeck, Dr.; Phone Number: 003238215945; Email: saschavereeck@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- history of neurological disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical outcome measures	POP-Q	1 year follow-up
Change in clinical outcome measures	Transperineal ultrasound (TPUS)	1 year follow-up
Change in voiding	home-uroflowmetry	1 year follow-up
Change in QoL	Questionnaire: PFIQ-7	1 year follow-up
Change in QoL	Questionnaire: PISQ-12	1 year follow-up

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Anticipated): June 8, 2022
• Study Completion (Anticipated): June 8, 2023

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Pelvic Organ Prolapse; urinary incontinence; patient reported outcome; voiding dysfunction; 3D/4D imaging
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Other Study ID Numbers: EDGE000835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No