Pelvic Organ ProlapseZPPNCT05885711
Self-management Pessary Project
An observational study of Pelvic Organ Prolapse, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse. The primary question it aims to answer is: how many patients succeed learning self-management if offered a standardized training? Secondary outcomes are: how many patients are willing… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- self-management
- How many people
- 288 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jan 2023to 1 Mar 2025
- How long will I take part?
- 12 Months
- 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
- Adult, Older adult
Study population: New patients that get fitted a pessary in second line (hospital)
Who may be able to join
- fitted a ring, sieve of knob pessary
- above 18 years old
- able to understand patient information
Who cannot join
- fitted a new pessary to replace an old one (continuing former pessary therapy)
- fitted a new pessary after they experienced adverse effects of a former pessary
Trial locations and contacts
1 site in 1 country.
Research Nurses contact
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medisch Centrum
Heerlen
M Weemhoff, MD, PhD, zpp@zuyderland.nl
About this study
Official title: Dutch Title: Zelfmanagement Pessarium Project
The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse.
The primary question it aims to answer is:
Read more
- how many patients succeed learning self-management if offered a standardized training?
Secondary outcomes are:
- how many patients are willing to learn self-management?
- what patient factors contribute to successfully learning self-management and willingness to self-manage?
- how satisfied are patients with pessary therapy and self-management?
- the occurrence of side-effects
- continuation and quitting of pessary therapy and self-management
- cross-over to surgery
- number of visits to doctor because of pessary therapy
- healthcare costs
Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary).
Researchers will compare the self-managing patient to the non-self-managing patients.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- self-management
- Keywords
- pelvic organ prolapse, pessary, self-management
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-managementOther
self-managing a pessary: removing, cleaning and inserting
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that succeed in learning self-management of the pessary
Patients were offered self-management training, after explanation they were asked to remove and insert their pessary twice. Succes was defined as removing and inserting the pessary completely independent the second time.
Measured: immediately after self-management training, it is determined whether patients can remove and insert their pessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start9 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (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
- 288 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Weemhoff, Principal investigator, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885711
- Sponsor's protocol ID
- Z2022098
- Acronym
- ZPP
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutch Title: Zelfmanagement Pessarium Project
- ClinicalTrials.gov ID
- NCT05885711
- Acronym / sponsor ID
- ZPP / Z2022098
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, pessary, self-management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 2 Jun 2023 (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 goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse.
The primary question it aims to answer is:
- how many patients succeed learning self-management if offered a standardized training?
Secondary outcomes are:
- how many patients are willing to learn self-management?
- what patient factors contribute to successfully learning self-management and willingness to self-manage?
- how satisfied are patients with pessary therapy and self-management?
- the occurrence of side-effects
- continuation and quitting of pessary therapy and self-management
- cross-over to surgery
- number of visits to doctor because of pessary therapy
- healthcare costs
Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary).
Researchers will compare the self-managing patient to the non-self-managing patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- New patients that get fitted a pessary in second line (hospital)
Key inclusion criteria (3 listed)
- fitted a ring, sieve of knob pessary
- above 18 years old
- able to understand patient information
Key exclusion criteria (2 listed)
- fitted a new pessary to replace an old one (continuing former pessary therapy)
- fitted a new pessary after they experienced adverse effects of a former pessary
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 |
|---|---|---|
| self-managementself-managing a pessary: removing, cleaning and inserting | Other | – |
Primary outcome
Number of patients that succeed in learning self-management of the pessary
Time frame: immediately after self-management training, it is determined whether patients can remove and insert their pessary
Patients were offered self-management training, after explanation they were asked to remove and insert their pessary twice. Succes was defined as removing and inserting the pessary completely independent the second time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Research Nurses contact
M Weemhoff principal investigator
Zuyderland Medisch Centrum
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, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 3 inclusion and 2 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 2 Jun 2023. 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 Netherlands. 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 M Weemhoff, MD, PhD (088 4596146, zpp@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that succeed in learning self-management of the pessary (time frame: immediately after self-management training, it is determined whether patients can remove and insert their pessary). 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 2 Jun 2023.