What is the Effect of Prolapse Surgery on Voiding?

• Conditions: Urge Incontinence; Voiding Disorders; Stress Urinary Incontinence; Overactive Bladder; Pelvic Organ Prolapse

• Registration Number: NCT04429360
• Lead Sponsor: Universiteit Antwerpen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-30
• Status Verified: 2020-06
• Study Start: 2020-06-08
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12
• Primary Completion: 2022-06-08
• Study Completion: 2023-06-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 453

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in lower urinary tract symptoms pre- postoperatively	1 year follow-up	Questionnaire: PFDI-20

Secondary Outcome Measures

Name	Time	Method
Change in clinical outcome measures	1 year follow-up	Transperineal ultrasound (TPUS)
Change in voiding	1 year follow-up	home-uroflowmetry
Change in QoL	1 year follow-up	Questionnaire: PISQ-12

Trial Locations

Locations (1)

University Hospital of Antwerp; 🇧🇪 Edegem, Antwerp, Belgium