Pelvic Organ ProlapseNCT00372190
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
A study testing Tensionfree vaginal mesh kit (Prolift) and classic vaginal prolapse surgery (fascia plication) in people with Pelvic Organ Prolapse, run by Radboud University Medical Center at 13 sites in Netherlands.
Trial summary
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications. 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?
- Tensionfree vaginal mesh kit (Prolift) and classic vaginal prolapse surgery (fascia plication)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 13 sitesNetherlands
- Study dates
- Aug 2006to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
- patient has agreed to undergo implantation of TVM (prolift) or fascial plication
- patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
- patient is willing to complete quality of life questionnaires at 6 and 12 months
Who cannot join
- patient is or wants to become pregnant
- patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
- patient has current urinary tract or vaginal infections
- patient has a blood coagulation disorder
- patient has a compromised immune system or any other condition that would compromise healing
- patient has renal insufficiency and/or upper urinary tract obstruction
Show all 10Show fewer
- patient is unwilling or unable to return for evaluation
- patient has had previous irradiation
- patient has any malignancy
- patient has large ovarian cysts of large myoma
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites
Gelre ziekenhuizen
Apeldoorn
Slysis Zorggroep, location Rijnstate
Arnhem
Reinier de Graaf Gasthuis
Delft
Medisch Spectrum Twente
Enschede
Groene Hart Ziekenhuis
Gouda
St. Antonius Ziekenhuis
Nieuwegein
UMC St Radboud
Nijmegen
Ikazia
Rotterdam
Refaja
Stadskanaal
St. Elisabeth hospital
Tilburg
Twee Steden Ziekenhuis
Tilburg
Zaans Medisch Centrum
Zaandam
Isala klinieken
Zwolle
About this study
Official title: A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.
This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.
Read the detailed description
Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.
An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Tensionfree vaginal mesh kit (Prolift), classic vaginal prolapse surgery (fascia plication)
- Keywords
- Pelvic organ prolapse, recurrence, mesh, complications, treatment
- Medical subject headings
- Pelvic Organ Prolapse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tensionfree vaginal mesh kit (Prolift)Device
Also called Prolift mesh
Insertion of a tension free vaginal mesh using a Prolift mesh kit
classic vaginal prolapse surgery (fascia plication)Procedure or surgery
Also called Conventional
classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
| Study group | Role | What they receive |
|---|---|---|
| Mesh surgery | Experimental | Trocar guided tension free vaginal mesh insertion by Prolift mesh kit Receives: Device: Tensionfree vaginal mesh kit (Prolift) |
| Conventional vaginal surgery | Active comparator | Classical vaginal prolapse surgery (fascia plication) Receives: Procedure: classic vaginal prolapse surgery (fascia plication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher
Measured: 12 months
Secondary outcomes (3)
Mesh Exposure at 12 Months
cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)
Measured: 12 months
"Patient Global Impression of Improvement" (PGI-I) at 12 Months
Number of participants with much to very much improvement compared to baseline
Measured: at 12 months
Bulge Symptoms
Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months.
Scores range from 0 (least/no bother) to 100 (maximum bother)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2009
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 194 participants (actual)
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, Drs., Principal investigator, UMC St Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372190
- Sponsor's protocol ID
- P0609
- Status last verified
- Apr 2017
- First submitted
- 5 Sep 2006
- Last updated
- 3 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):242-250. doi: 10.1097/AOG.0b013e318203e6a5.
PubMed 21252735Milani AL, Damoiseaux A, IntHout J, Kluivers KB, Withagen MIJ. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial. Int Urogynecol J. 2018 Jun;29(6):847-858. doi: 10.1007/s00192-017-3512-3. Epub 2017 Nov 22.
PubMed 29167974Withagen MI, Milani AL, de Leeuw JW, Vierhout ME. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial. BJOG. 2012 Feb;119(3):354-60. doi: 10.1111/j.1471-0528.2011.03231.x.
PubMed 22239416
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse
- ClinicalTrials.gov ID
- NCT00372190
- Acronym / sponsor ID
- P0609
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, recurrence, mesh, complications, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Posted 3 Jul 2017
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 a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.
This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.
Detailed description
Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.
An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh surgery | Experimental | Device: Tensionfree vaginal mesh kit (Prolift)Trocar guided tension free vaginal mesh insertion by Prolift mesh kit |
| Conventional vaginal surgery | Active comparator | Procedure: classic vaginal prolapse surgery (fascia plication)Classical vaginal prolapse surgery (fascia plication) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
- patient has agreed to undergo implantation of TVM (prolift) or fascial plication
- patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
- patient is willing to complete quality of life questionnaires at 6 and 12 months
Key exclusion criteria (10 listed)
- patient is or wants to become pregnant
- patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
- patient has current urinary tract or vaginal infections
- patient has a blood coagulation disorder
- patient has a compromised immune system or any other condition that would compromise healing
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 |
|---|---|---|
| Tensionfree vaginal mesh kit (Prolift)Also: Prolift meshInsertion of a tension free vaginal mesh using a Prolift mesh kit | Device | Mesh surgery |
| classic vaginal prolapse surgery (fascia plication)Also: Conventionalclassic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse | Procedure or surgery | Conventional vaginal surgery |
Primary outcome
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months
Time frame: 12 months
Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher
3 secondary outcomes
Mesh Exposure at 12 Months
Time frame: 12 months
"Patient Global Impression of Improvement" (PGI-I) at 12 Months
Time frame: at 12 months
Bulge Symptoms
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21252735Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):242-250. doi: 10.1097/AOG.0b013e318203e6a5.
- Derived from this study: PubMed 29167974Milani AL, Damoiseaux A, IntHout J, Kluivers KB, Withagen MIJ. Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial. Int Urogynecol J. 2018 Jun;29(6):847-858. doi: 10.1007/s00192-017-3512-3. Epub 2017 Nov 22.
- Derived from this study: PubMed 22239416Withagen MI, Milani AL, de Leeuw JW, Vierhout ME. Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial. BJOG. 2012 Feb;119(3):354-60. doi: 10.1111/j.1471-0528.2011.03231.x.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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, Drs. principal investigator
UMC St Radboud
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tensionfree vaginal mesh kit (Prolift) and classic vaginal prolapse surgery (fascia plication) in people with Pelvic Organ Prolapse, run by Radboud University Medical Center at 13 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 10 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: finished, as of the sponsor's last update on 3 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 3 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00372190, which also lists 3 linked publications.
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 3 Jul 2017.