Pelvic Organ ProlapsePROVOIDNCT04429360
What is the Effect of Prolapse Surgery on Voiding?
An observational study of Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Universiteit Antwerpen at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder
- What is being tested?
- pelvic reconstructive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 453 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jun 2020to 8 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- age ≥18 years
- Dutch, French or English- speaking women
- symptoms of pelvic organ prolapse
- preoperatively pelvic floor surgery.
Who cannot join
- history of neurological disease
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Antwerp
Edegem, Antwerp, 2650
Sascha Vereeck, Dr., 003238215945, saschavereeck@hotmail.com
About this study
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.
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder, Voiding Disorders, Urge Incontinence
- Being tested
- pelvic reconstructive surgery
- Keywords
- Pelvic Organ Prolapse, Surgery, 3D/4D imaging, urinary incontinence, voiding dysfunction, patient reported outcome
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress, Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic reconstructive surgeryProcedure or surgery
Pelvic reconstructive surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower urinary tract symptoms pre- postoperatively
Voiding diary
Measured: 1 year follow-up
Change in lower urinary tract symptoms pre- postoperatively
Questionnaire: PFDI-20
Measured: 1 year follow-up
Secondary outcomes (5)
Change in clinical outcome measures
POP-Q
Measured: 1 year follow-up
Change in clinical outcome measures
Transperineal ultrasound (TPUS)
Measured: 1 year follow-up
Change in voiding
home-uroflowmetry
Measured: 1 year follow-up
Change in QoL
Questionnaire: PFIQ-7
Measured: 1 year follow-up
Change in QoL
Questionnaire: PISQ-12
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start8 Jun 2020
- Primary completion8 Jun 2022 (estimated)
- Study completion8 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 453 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Yves Jacquemyn, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429360
- Sponsor's protocol ID
- EDGE000835
- Acronym
- PROVOID
- Status last verified
- Jun 2020
- First submitted
- 30 Apr 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Prolapse Surgery on Voiding?
- ClinicalTrials.gov ID
- NCT04429360
- Acronym / sponsor ID
- PROVOID / EDGE000835
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder, Voiding Disorders, Urge Incontinence
- Keywords
- Pelvic Organ Prolapse, Surgery, 3D/4D imaging, urinary incontinence, voiding dysfunction, patient reported outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 453 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 8 Jun 2022 (estimated)
- Study completion
- 8 Jun 2023 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- age ≥18 years
- Dutch, French or English- speaking women
- symptoms of pelvic organ prolapse
- preoperatively pelvic floor surgery.
Key exclusion criteria (1 listed)
- history of neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic reconstructive surgeryPelvic reconstructive surgery | Procedure or surgery | – |
Primary outcome
Change in lower urinary tract symptoms pre- postoperatively
Time frame: 1 year follow-up
Voiding diary
Change in lower urinary tract symptoms pre- postoperatively
Time frame: 1 year follow-up
Questionnaire: PFDI-20
5 secondary outcomes
Change in clinical outcome measures
Time frame: 1 year follow-up
Change in clinical outcome measures
Time frame: 1 year follow-up
Change in voiding
Time frame: 1 year follow-up
Change in QoL
Time frame: 1 year follow-up
Change in QoL
Time frame: 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sascha Vereeck, Dr. (003238215945, saschavereeck@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower urinary tract symptoms pre- postoperatively (time frame: 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.