CystoceleNCT00833001
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
An observational study of Cystocele and Rectocele, run by Ethicon, Inc. at 8 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystocele, Rectocele, Enterocele
- What is being tested?
- GYNECARE PROLIFT+M* Pelvic Floor Repair System
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Apr 2008to Dec 2011
- 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 over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair.
Who may be able to join
- Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently.
- Age > or = 18 years.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.
Who cannot join
- Additional surgical intervention for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment).
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Previous hysterectomy within 6 months of scheduled surgery.
- Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
- Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
Show all 12Show fewer
- History of any pelvic radiation therapy.
- History of chemotherapy within 6 months of the planned procedure.
- Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
- Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
- Nursing or pregnant or intends future pregnancy.
- In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany5 sites
DRT Krankenhaus
Chemnitz, 09034
Martin Luther University
Halle, 06097
Kreiskrankenhaus
Hamelin, 31785
Universitatsklinik Tubingen
Tübingen, 72076
St. Marien-Hospital
Vechta, D-49377
About this study
Official title: A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
Read the detailed description
Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.
- Conditions
- Cystocele, Rectocele, Enterocele
- Being tested
- GYNECARE PROLIFT+M* Pelvic Floor Repair System
- Keywords
- Anterior vaginal prolapse (medial, lateral,apical cystocele), Posterior vaginal prolapse (rectocele and/or enterocele), Vault prolapse (enterocele, uterine/vaginal vault prolapse)
- Medical subject headings
- Cystocele, Rectocele, Hernia, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GYNECARE PROLIFT+M* Pelvic Floor Repair SystemDevice
Also called ULTRAPRO* mesh
Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber
| Study group | Role | What they receive |
|---|---|---|
| 1 | GYNECARE PROLIFT+M* Pelvic Floor Repair System Receives: Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification (POP-Q) score
Measured: 12 months post-procedure
Secondary outcomes (11)
Summary of treated compartment ICS POP-Q stage
Measured: 3, 12, 24 and 36 months
Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP
Measured: 12, 24 and 36 months
Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment
Measured: Procedure to 36 months
Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI
Measured: 3, 12, 24 and 36 months
Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ).
Measured: 3, 12, 24 and 36 months
Days to return to normal activities (walking, driving, work, household activities and sexual intercourse)
Measured: 1, 3, and 12 months
Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline
Measured: 12, 24 and 36 months
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
Measured: Baseline to 36 months
Adverse Events
Measured: Procedure to 36 months
Determination of any exposures/erosions including location
Measured: Procedure to 36 months
Summary of International Continence Society (ICS) Stages
Measured: 3, 24, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CystoceleStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Robinson, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833001
- Sponsor's protocol ID
- 300-07-006
- Status last verified
- May 2014
- First submitted
- 26 Jan 2009
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Milani AL, Hinoul P, Gauld JM, Sikirica V, van Drie D, Cosson M; Prolift+M Investigators. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011 Jan;204(1):74.e1-8. doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20.
PubMed 20965491
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT00833001
- Acronym / sponsor ID
- 300-07-006
- Conditions
- Cystocele, Rectocele, Enterocele
- Keywords
- Anterior vaginal prolapse (medial, lateral,apical cystocele), Posterior vaginal prolapse (rectocele and/or enterocele), Vault prolapse (enterocele, uterine/vaginal vault prolapse)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jan 2009 (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.
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
Detailed description
Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: GYNECARE PROLIFT+M* Pelvic Floor Repair SystemGYNECARE PROLIFT+M* Pelvic Floor Repair System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair.
Key inclusion criteria (3 listed)
- Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently.
- Age > or = 18 years.
- Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.
Key exclusion criteria (12 listed)
- Additional surgical intervention for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment).
- Previous repair of pelvic organ prolapse involving insertion of mesh.
- Previous hysterectomy within 6 months of scheduled surgery.
- Experimental drug or experimental medical device within 3 months prior to the planned procedure.
- Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
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 |
|---|---|---|
| GYNECARE PROLIFT+M* Pelvic Floor Repair SystemAlso: ULTRAPRO* meshPre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber | Device | 1 |
Primary outcome
Pelvic Organ Prolapse Quantification (POP-Q) score
Time frame: 12 months post-procedure
11 secondary outcomes
Summary of treated compartment ICS POP-Q stage
Time frame: 3, 12, 24 and 36 months
Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP
Time frame: 12, 24 and 36 months
Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment
Time frame: Procedure to 36 months
Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI
Time frame: 3, 12, 24 and 36 months
Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ).
Time frame: 3, 12, 24 and 36 months
Days to return to normal activities (walking, driving, work, household activities and sexual intercourse)
Time frame: 1, 3, and 12 months
Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline
Time frame: 12, 24 and 36 months
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
Time frame: Baseline to 36 months
Adverse Events
Time frame: Procedure to 36 months
Determination of any exposures/erosions including location
Time frame: Procedure to 36 months
Summary of International Continence Society (ICS) Stages
Time frame: 3, 24, and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Results publication: PubMed 20965491Milani AL, Hinoul P, Gauld JM, Sikirica V, van Drie D, Cosson M; Prolift+M Investigators. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011 Jan;204(1):74.e1-8. doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20.
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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.
David Robinson, MD study director
Ethicon, Inc.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystocele and Rectocele, run by Ethicon, Inc. at 8 sites in 4 countries.
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 12 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Belgium, France, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pelvic Organ Prolapse Quantification (POP-Q) score (time frame: 12 months post-procedure). 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 NCT00833001, which also lists 1 linked publication.
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 May 2014.