What is the Effect of Prolapse Surgery on Voiding? | NCT04429360

Studies
What is the Effect of Prolapse Surgery on Voiding?

NCT04429360

Sponsor

Universiteit Antwerpen

Status

Unknown status

Last Update Posted

Jun 12, 2020Actual

Enrollment

453Estimated

Phase

Not provided

Conditions

Pelvic Organ Prolapse
Stress Urinary Incontinence
Overactive Bladder
Voiding Disorders
Urge Incontinence

Interventions

pelvic reconstructive surgery

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2020Actual

Primary Completion Date

Jun 8, 2022Estimated

Completion Date

Jun 8, 2023Estimated

First Submitted Date

Apr 30, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2020

Last Update Posted Date

Jun 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Yves Jacquemyn, Head of Department Gynecology, UZA, Universiteit AntwerpenPrincipal Investigator

Lead Sponsor

Universiteit AntwerpenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

453Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pelvic reconstructive surgery	Procedure	Pelvic reconstructive surgery

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sascha Vereeck, Dr.	Contact	003238215945		saschavereeck@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Antwerp	Recruiting	Edegem	Antwerp	2650	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse
D014550	Urinary Incontinence, Stress
D053201	Urinary Bladder, Overactive
D053202	Urinary Incontinence, Urge
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D014555	Urination Disorders

Browse Leaves

Not provided

Browse Branches

Not provided