PROVOID: What is the Effect of Prolapse Surgery on Voiding?

• Sponsor: Universiteit Antwerpen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04429360
• Collaborator: (none)
• Enrollment: 453
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 12.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse; Stress Urinary Incontinence; Overactive Bladder; Voiding Disorders; Urge Incontinence	Procedure: pelvic reconstructive surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 453 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: What is the Effect of Prolapse Surgery on Voiding?
• Actual Study Start Date: Jun 8, 2020
• Anticipated Primary Completion Date: Jun 8, 2022
• Anticipated Study Completion Date: Jun 8, 2023

Outcome Measures

Primary Outcome Measures

1. Change in lower urinary tract symptoms pre- postoperatively [1 year follow-up]

   Voiding diary

2. Change in lower urinary tract symptoms pre- postoperatively [1 year follow-up]

   Questionnaire: PFDI-20

Secondary Outcome Measures

1. Change in clinical outcome measures [1 year follow-up]

   POP-Q

2. Change in clinical outcome measures [1 year follow-up]

   Transperineal ultrasound (TPUS)

3. Change in voiding [1 year follow-up]

   home-uroflowmetry

4. Change in QoL [1 year follow-up]

   Questionnaire: PFIQ-7

5. Change in QoL [1 year follow-up]

   Questionnaire: PISQ-12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Antwerp	Edegem	Antwerp	Belgium	2650

Sponsors and Collaborators

• Universiteit Antwerpen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof Yves Jacquemyn, Head of Department Gynecology, UZA, Universiteit Antwerpen
• ClinicalTrials.gov Identifier: NCT04429360
• Other Study ID Numbers: EDGE000835
• First Posted: Jun 12, 2020
• Last Update Posted: Jun 12, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof Yves Jacquemyn, Head of Department Gynecology, UZA, Universiteit Antwerpen: Pelvic Organ Prolapse; Surgery; 3D/4D imaging; urinary incontinence; voiding dysfunction; patient reported outcome
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Jun 12, 2020