Pelvic Organ ProlapseVROUW2NCT02231099
Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery
A study testing Prolift + M and conventional vaginal prolapse surgery in people with Pelvic Organ Prolapse and Cystocele, run by Radboud University Medical Center at 5 sites in Netherlands.
Trial summary
Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Cystocele, Rectocele
- What is being tested?
- Prolift + M and conventional vaginal prolapse surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 5 sitesNetherlands
- Study dates
- Jan 2011to Sep 2015
- Phase
- Interventional
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a anterior and/or posterior prolapse POP-Q stage II or more. Subjects with a middle compartment prolapse may only be included if there is a co-existing anterior or posterior defect which needs surgical correction.
- Subject has agreed to undergo implantation of Prolift+MTM or fascial plication
- Subject is willing to return for follow-up evaluation and QoL questionnaires completion at 6weeks, 6 months, 12 months and 24 months follow-ups.
Who cannot join
- Pregnancy
- Age < 45 years
- Subject has had a previous surgery for pelvic organ prolapse. A previous mid-urethral sling procedure is not an exclusion criterion.
- Have current urinary tract or vaginal infections
- Have blood coagulation disorders
- Have a compromised immune system or any other conditions that would compromise healing
Show all 9Show fewer
- Are unwilling or unable to return for evaluation
- Previous irradiation
- Presence of any malignancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Gelre ziekenhuizen Apeldoorn
Apeldoorn
Reinier de Graaf Group
Delft, 2625 AD
UMC St Radboud
Nijmegen, 6500 HB
Zaans Medisch Centre
Zaandam, 1500 EE
Isala clinics
Zwolle, 8025 AB
About this study
Official title: A Prospective and Comparative Study of the (Cost)Effectiveness Preformance of Tension Free Vaginal Mesh Plus Monocryl (Prolift+M) Versus Conventional Vaginal Prolaps Surgery in Primary Pelvic Organ Prolapse
Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate.
In this study the investigators compare the effectiveness of the Tension free Vaginal mesh + Monocryl with standard vaginal prolapse surgery without mesh.
Read the detailed description
Rationale: Pelvic organ prolapse is highly prevalent in the female population. The incidence of pelvic organ prolapse increases with age, so the longer life expectancy of women may cause pelvic organ prolapse to become an even more major health issue. The recurrence rate of pelvic organ prolapse after surgical treatment is high. The recurrence rate of the anterior vaginal wall prolapse after an anterior colporrhaphy is 30%-45%. The posterior vaginal wall prolapse recurrence rate after a posterior colporrhaphy is 12-25%. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate (2-11%).
Objective: To compare the clinical and cost effectiveness of the Tension free Vaginal Mesh + Monocryl (Prolift+M) with the standard vaginal prolapse surgery (i.e. fascial placation). A secondary objective is to track the post-operative and long-term complications of both procedures. A third objective is to evaluate recovery after surgery.
Study design: a prospective, multicentre, randomized, non-blinded study between Tension free Vaginal Mesh + Monocryl (Prolift+MTM) and standard vaginal prolapse surgery (i.e. fascial placation).
Study population: women with a primary pelvic organ prolapse of the anterior and/or posterior compartment POP stage II or more, in the age of 45 years or older.
Intervention (if applicable): Prolapse surgery with tension free vaginal mesh + Monocryl (Prolift + M) versus conventional vaginal prolapse surgery.
Main study parameters/endpoints: The main outcome is the percentage of patients with objective anatomical success (POP stage < 2) after 24 months. As secondary outcome the subjective improvement in quality of life will be measured by generic (EQ-5D,PGI-I) and disease-specific (UDI, DDI, IIQ and PFDI20) quality of life instrument. Sexual functioning will be measured by generic (FSFI) and disease specific (PISQ12) questionnaires. Complications will be monitored with special notice for pain (Mc Gill pain questionnaire) Recovery will be measured with the Recovery index 10. The economical endpoint is short term (2 year) incremental cost-effectiveness in terms of costs per additional year free of prolapse and costs per QALY gained.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden associated with participation: complete a disease specific Quality of life questionnaire 4 times, complete a recovery index questionnaire 3 times. Visit the hospital 4 times after the surgery (this is 2 times more often than patients not participating in the study). Since subjects are selected from subjects already agreeing to complete a surgical procedure, the additional risks of participation in this study are low. These risks include tissue erosion (vaginal, rectal or bladder), vaginal pain/dyspareunia.
- Conditions
- Pelvic Organ Prolapse, Cystocele, Rectocele, Uterine Prolapse
- Being tested
- Prolift + M, conventional vaginal prolapse surgery
- Keywords
- recurrent pelvic organ prolapse, mesh
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele, Rectocele, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolift + MProcedure or surgery
prolapse surgery with mesh
conventional vaginal prolapse surgeryProcedure or surgery
Also called anterior colporrhaphy, posterior colporrhaphy
conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy
| Study group | Role | What they receive |
|---|---|---|
| prolift + m | Experimental | surgery with mesh (prolift+M) Receives: Procedure: Prolift + M |
| conventional vaginal prolapse surgery | Active comparator | conventional vaginal prolapse surgery; anterior colporrhaphy or posterior colporrhaphy or spinal ligament fixation Receives: Procedure: conventional vaginal prolapse surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective anatomic success (POPQ stage <2)
clinical investigation including POPQ
Measured: 24 months
Secondary outcomes (5)
subjective improvement in quality of life
Questionnaires; Euroqol5D, PGI-I, UDI, DDI and PFDI20
Measured: 24 months
sexual function/dysfunction
PISQ-12, BESAQ
Measured: 24 months
complications
clinical investigation
Measured: 24 months
recovery
Recovery Index 10
Measured: 6 weeks
cost-effectiveness
Costs of the strategies Tension free Vaginal mesh+Monocryl as well as standard vaginal prolapse surgery will be estimated using direct medical costs based on the actual costs of the surgery, personnel, material costs and costs for surgery due to recurrence or complications.
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 posted4 Sep 2014 (estimated)
- Study startJan 2011
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariella Withagen, Radboud University Medical Center
- Investigators
- Mariella IJ Withagen, MD, PhD, Principal investigator, Radboud Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231099
- Sponsor's protocol ID
- VROUW2
- Acronym
- VROUW2
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2012
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Comparative Study of the (Cost)Effectiveness Preformance of Tension Free Vaginal Mesh Plus Monocryl (Prolift+M) Versus Conventional Vaginal Prolaps Surgery in Primary Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT02231099
- Acronym / sponsor ID
- VROUW2 / VROUW2
- Conditions
- Pelvic Organ Prolapse, Cystocele, Rectocele, Uterine Prolapse
- Keywords
- recurrent pelvic organ prolapse, mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 4 Sep 2014 (estimated)
- 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.
Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate.
In this study the investigators compare the effectiveness of the Tension free Vaginal mesh + Monocryl with standard vaginal prolapse surgery without mesh.
Detailed description
Rationale: Pelvic organ prolapse is highly prevalent in the female population. The incidence of pelvic organ prolapse increases with age, so the longer life expectancy of women may cause pelvic organ prolapse to become an even more major health issue. The recurrence rate of pelvic organ prolapse after surgical treatment is high. The recurrence rate of the anterior vaginal wall prolapse after an anterior colporrhaphy is 30%-45%. The posterior vaginal wall prolapse recurrence rate after a posterior colporrhaphy is 12-25%. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate (2-11%).
Objective: To compare the clinical and cost effectiveness of the Tension free Vaginal Mesh + Monocryl (Prolift+M) with the standard vaginal prolapse surgery (i.e. fascial placation). A secondary objective is to track the post-operative and long-term complications of both procedures. A third objective is to evaluate recovery after surgery.
Study design: a prospective, multicentre, randomized, non-blinded study between Tension free Vaginal Mesh + Monocryl (Prolift+MTM) and standard vaginal prolapse surgery (i.e. fascial placation).
Study population: women with a primary pelvic organ prolapse of the anterior and/or posterior compartment POP stage II or more, in the age of 45 years or older.
Intervention (if applicable): Prolapse surgery with tension free vaginal mesh + Monocryl (Prolift + M) versus conventional vaginal prolapse surgery.
Main study parameters/endpoints: The main outcome is the percentage of patients with objective anatomical success (POP stage < 2) after 24 months. As secondary outcome the subjective improvement in quality of life will be measured by generic (EQ-5D,PGI-I) and disease-specific (UDI, DDI, IIQ and PFDI20) quality of life instrument. Sexual functioning will be measured by generic (FSFI) and disease specific (PISQ12) questionnaires. Complications will be monitored with special notice for pain (Mc Gill pain questionnaire) Recovery will be measured with the Recovery index 10. The economical endpoint is short term (2 year) incremental cost-effectiveness in terms of costs per additional year free of prolapse and costs per QALY gained.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden associated with participation: complete a disease specific Quality of life questionnaire 4 times, complete a recovery index questionnaire 3 times. Visit the hospital 4 times after the surgery (this is 2 times more often than patients not participating in the study). Since subjects are selected from subjects already agreeing to complete a surgical procedure, the additional risks of participation in this study are low. These risks include tissue erosion (vaginal, rectal or bladder), vaginal pain/dyspareunia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolift + m | Experimental | Procedure: Prolift + Msurgery with mesh (prolift+M) |
| conventional vaginal prolapse surgery | Active comparator | Procedure: conventional vaginal prolapse surgeryconventional vaginal prolapse surgery; anterior colporrhaphy or posterior colporrhaphy or spinal ligament fixation |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has a anterior and/or posterior prolapse POP-Q stage II or more. Subjects with a middle compartment prolapse may only be included if there is a co-existing anterior or posterior defect which needs surgical correction.
- Subject has agreed to undergo implantation of Prolift+MTM or fascial plication
- Subject is willing to return for follow-up evaluation and QoL questionnaires completion at 6weeks, 6 months, 12 months and 24 months follow-ups.
Key exclusion criteria (9 listed)
- Pregnancy
- Age < 45 years
- Subject has had a previous surgery for pelvic organ prolapse. A previous mid-urethral sling procedure is not an exclusion criterion.
- Have current urinary tract or vaginal infections
- Have blood coagulation disorders
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 |
|---|---|---|
| Prolift + Mprolapse surgery with mesh | Procedure or surgery | prolift + m |
| conventional vaginal prolapse surgeryAlso: anterior colporrhaphy, posterior colporrhaphyconventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy | Procedure or surgery | conventional vaginal prolapse surgery |
Primary outcome
objective anatomic success (POPQ stage <2)
Time frame: 24 months
clinical investigation including POPQ
5 secondary outcomes
subjective improvement in quality of life
Time frame: 24 months
sexual function/dysfunction
Time frame: 24 months
complications
Time frame: 24 months
recovery
Time frame: 6 weeks
cost-effectiveness
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
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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.
Mariella IJ Withagen, MD, PhD principal investigator
Radboud Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolift + M and conventional vaginal prolapse surgery in people with Pelvic Organ Prolapse and Cystocele, run by Radboud University Medical Center at 5 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 3 inclusion and 9 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 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
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?
objective anatomic success (POPQ stage <2) (time frame: 24 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 6 Feb 2015.