Pelvic Organ ProlapseSUPPORTNCT05713422
Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair
An observational study of Pelvic Organ Prolapse, run by Marjolein Spiering at 2 sites in Netherlands.
Trial summary
The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 305 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Apr 2023to Dec 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients indicated for vaginal pelvic organ prolapse surgery.
Who may be able to join
- Female patient >18 years of age
- Complaints of pelvic organ prolapse
- Indication for prolapse surgery (level I and/or level II repair)
- Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm
Who cannot join
- Unable to understand the Dutch language
- Pregnancy at baseline or intendancy to become pregnant during the study period
- Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)
- Unwilling and / or incapable of giving informed consent
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Spaarne Gasthuis
Haarlem
Bergman Clinics
Hilversum, 1213PA
About this study
Official title: Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair; a Comparative Cohort Trial (SUPPORT)
The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.
Read the detailed description
Preoperative measurements, performed at baseline:
- Patient characteristics (age, BMI, smoking, obstetric history)
- Physical examination including POP-Q score. The genital hiatus (gh) at rest (as part of the POP-Q) will be used to assess the wideness of the vaginal introitus.
- Pelvic Floor Distress Inventory (PFDI-20) questionnaire and Patient Global Impression of Severity (PGI-S)
- Pelvic Floor Ultrasound 2DStudy measurements;
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-ir), Dutch Perineal Support Questionnaire (DPSQ), General Quality of Life (EQ-5D-5L), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)
- Patient and surgeons considerations with respect to level III repair;
Postoperative measurements:
- Regular physical check-up will be at 4-8 weeks after procedure.
- Physical examination including POP-Q score
- Patient Global Impression of Improvement score (PGI-I)
- Pelvic Floor Ultrasound 2D
- iMCQ, iPCQ, EQ-5D-5L questionnaire
Extra follow up:
- Physical check-up 12 \& 24 months after surgery:
- Physical examination including POP-Q score
- Pelvic Floor Ultrasound 2D
- PFDI-20, PGI-I, DPSQ, PISQ-ir, iMCQ, iPCQ, EQ-5D-5L questionnaire
- Conditions
- Pelvic Organ Prolapse
- Keywords
- POP, prolapse, perineoplasty
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Operative procedure; standard treatment | Vaginal level I and/or level II repair will be performed as usual (eg anterior and/or posterior colporrhaphy, sacrospinous fixation etc.) without perineoplasty as decided by surgeon and patient. This procedure is considered as the control group. | |
| Operative procedure; standard treatment including level III repair | Vaginal level I and/or level II repair will be performed as usual, but now including perineoplasty (level III repair) as decided by surgeon and patient. The decision of a perineoplasty to vaginal level I and/or level II repair is based on a shared decision made by surgeon together with the patient. The considerations upon which this decision has been established in a consensus meeting of Dutch urogynecologists and will be collected by a questionnaire, This group is considered as the 'intervention' group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success
composite outcome defined as meeting the 3 following conditions: [1] "much improved" or "improved" in response to the patient global impression of improvement questionnaire, [2] no re-intervention performed in the same compartment within the first 12 months after index surgery, [3] no stage 2 or more POP in the operated compartment.
Measured: 12 months
Secondary outcomes (4)
Morbidity
complications and re-interventions due to complications, pain
Measured: 24 months
Effectiveness
disease specific and general quality of life
Measured: 24 months
Anatomical outcomes
Measured: 24 months
Societal costs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start23 Apr 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (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
- 305 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Marjolein Spiering
- Sponsor type
- University, hospital or other
- Collaborators
- Spaarne Gasthuis
- Responsible party
- Sponsor-investigator, Marjolein Spiering, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713422
- Sponsor's protocol ID
- NL82381.018.22
- Acronym
- SUPPORT
- Status last verified
- Aug 2024
- First submitted
- 27 Jan 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair; a Comparative Cohort Trial (SUPPORT)
- ClinicalTrials.gov ID
- NCT05713422
- Acronym / sponsor ID
- SUPPORT / NL82381.018.22
- Conditions
- Pelvic Organ Prolapse
- Keywords
- POP, prolapse, perineoplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Marjolein SpieringUniversity, hospital or other
- Collaborators
- Spaarne Gasthuis
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 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 study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.
Detailed description
Preoperative measurements, performed at baseline:
- Patient characteristics (age, BMI, smoking, obstetric history)
- Physical examination including POP-Q score. The genital hiatus (gh) at rest (as part of the POP-Q) will be used to assess the wideness of the vaginal introitus.
- Pelvic Floor Distress Inventory (PFDI-20) questionnaire and Patient Global Impression of Severity (PGI-S)
- Pelvic Floor Ultrasound 2DStudy measurements;
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-ir), Dutch Perineal Support Questionnaire (DPSQ), General Quality of Life (EQ-5D-5L), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)
- Patient and surgeons considerations with respect to level III repair;
Postoperative measurements:
- Regular physical check-up will be at 4-8 weeks after procedure.
- Physical examination including POP-Q score
- Patient Global Impression of Improvement score (PGI-I)
- Pelvic Floor Ultrasound 2D
- iMCQ, iPCQ, EQ-5D-5L questionnaire
Extra follow up:
- Physical check-up 12 \& 24 months after surgery:
- Physical examination including POP-Q score
- Pelvic Floor Ultrasound 2D
- PFDI-20, PGI-I, DPSQ, PISQ-ir, iMCQ, iPCQ, EQ-5D-5L questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative procedure; standard treatment | – | –Vaginal level I and/or level II repair will be performed as usual (eg anterior and/or posterior colporrhaphy, sacrospinous fixation etc.) without perineoplasty as decided by surgeon and patient. This procedure is considered as the control group. |
| Operative procedure; standard treatment including level III repair | – | –Vaginal level I and/or level II repair will be performed as usual, but now including perineoplasty (level III repair) as decided by surgeon and patient. The decision of a perineoplasty to vaginal level I and/or level II repair is based on a shared decision made by surgeon together with the patient. The considerations upon which this decision has been established in a consensus meeting of Dutch urogynecologists and will be collected by a questionnaire, This group is considered as the 'intervention' group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for vaginal pelvic organ prolapse surgery.
Key inclusion criteria (4 listed)
- Female patient >18 years of age
- Complaints of pelvic organ prolapse
- Indication for prolapse surgery (level I and/or level II repair)
- Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm
Key exclusion criteria (4 listed)
- Unable to understand the Dutch language
- Pregnancy at baseline or intendancy to become pregnant during the study period
- Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)
- Unwilling and / or incapable of giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical success
Time frame: 12 months
composite outcome defined as meeting the 3 following conditions: [1] "much improved" or "improved" in response to the patient global impression of improvement questionnaire, [2] no re-intervention performed in the same compartment within the first 12 months after index surgery, [3] no stage 2 or more POP in the operated compartment.
4 secondary outcomes
Morbidity
Time frame: 24 months
Effectiveness
Time frame: 24 months
Anatomical outcomes
Time frame: 24 months
Societal costs
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Marjolein Spiering at 2 sites 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success (time frame: 12 months). 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 5 Aug 2024.