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NCT04429360 Clinical Trial

What is the Effect of Prolapse Surgery on Voiding?

Overactive Bladder Clinical Trial

— PROVOID  

Official title:
What is the Effect of Prolapse Surgery on Voiding?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04429360
Other study ID # EDGE000835
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 8, 2020
Est. completion date June 8, 2023

Study information
Verified date June 2020
Source Universiteit Antwerpen
Contact Sascha Vereeck, Dr.
Phone 003238215945
Email saschavereeck@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 453
Est. completion date June 8, 2023
Est. primary completion date June 8, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• pelvic reconstructive surgery
Pelvic reconstructive surgery

Locations
Country Name City State
Belgium University Hospital of Antwerp Edegem Antwerp

Sponsors (1)
Lead Sponsor Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in lower urinary tract symptoms pre- postoperatively Voiding diary 1 year follow-up
Primary Change in lower urinary tract symptoms pre- postoperatively Questionnaire: PFDI-20 1 year follow-up
Secondary Change in clinical outcome measures POP-Q 1 year follow-up
Secondary Change in clinical outcome measures Transperineal ultrasound (TPUS) 1 year follow-up
Secondary Change in voiding home-uroflowmetry 1 year follow-up
Secondary Change in QoL Questionnaire: PFIQ-7 1 year follow-up
Secondary Change in QoL Questionnaire: PISQ-12 1 year follow-up
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