The aim of this postmarket study is to compare the safety and effectiveness of Coloplast Restorelle® transvaginal mesh products in the treatment of pelvic organ prolapse (POP) to traditional native tissue repair through 36 months of follow-up. This…
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Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Effectiveness Endpoint
The primary effectiveness endpoint is recurrent prolapse defined anatomically
as prolapse of the target compartment beyond the hymenal ring, or subjectively
as perception of protrusion or bulge of target compartment, or as retreatment
(including the introduction of a pessary after index procedure) of pelvic organ
prolapse in the target compartment at 12 months. If a subject fails any one of
the three components, she will be considered a failure for the primary efficacy
endpoint.
Prolapse of the target compartment beyond the hymenal ring will be determined
by POP-Q examination by an independent examiner.
Perception of protrusion or bulge of target compartment will be determined by
the PFDI-20, question 3 (*Do you usually have a bulge or something falling out
that you can see or feel in the vaginal area*) answering *yes* and =2 (i.e.
responses of *somewhat*, "moderately* or *quite a bit*).
Retreatment is defined as additional surgical treatment for POP or pessary use
in the target compartment since the index procedure. For the purposes of this
study surgical treatment is defined as anytime the subject returns to the
operating room.
The target compartment is defined as the compartment that meets all inclusion
criteria and no exclusion criteria for prolapse. For the treatment group, if
one or more compartments that meets the inclusion criteria for prolapse is not
treated with mesh, only the compartment treated with mesh will be considered a
target compartment. For the purposes of this protocol, a subject may have more
than one target compartment.
Primary Safety Endpoint
The primary safety endpoint is the proportion of device and procedure-related
serious adverse events (SAEs) at 12-months as determined by the Clinical Events
Committee.
Secondary outcome
The secondary effectiveness endpoints are:
1. Recurrent prolapse defined anatomically as prolapse of the target
compartment at or beyond the hymenal ring, or perception of protrusion or bulge
of the target compartment, or retreatment (including the introduction of a
pessary after index procedure) of pelvic organ prolapse in the target
compartment at 12 months.
2. Recurrent prolapse defined anatomically as prolapse of the target
compartment beyond the hymenal ring, or perception of protrusion or bulge of
the target compartment, or retreatment (including the introduction of a pessary
after index procedure) of pelvic organ prolapse in the target compartment at 36
months.
3. Recurrent prolapse defined anatomically as prolapse of the target
compartment at or beyond the hymenal ring or perception of protrusion or bulge
of the target compartment, or retreatment (including the introduction of a
pessary after index procedure) of pelvic organ prolapse in the target
compartment at 36 months.
If a subject fails any one of the three components of the endpoint, she will be
considered a failure for the secondary efficacy endpoint.
Prolapse of the target compartment at or beyond the hymenal ring will be
determined by POP-Q examination by an independent examiner.
Perception of protrusion or bulge of target compartment will be determined by
the PFDI-20, question 3 (*Do you usually have a bulge or something falling out
that you can see or feel in the vaginal area*) answering *yes* and =2 (i.e.
responses of *somewhat*, "moderately or *quite a bit*).
Retreatment is defined as additional surgical treatment for POP or pessary use
in the target compartment since the index procedure. For the purposes of this
study surgical treatment is defined as anytime the subject returns to the
operating room.
The target compartment is defined as the compartment that meets all inclusion
criteria and no exclusion criteria for prolapse. For the treatment group, if
one or more compartments that meets the inclusion criteria for prolapse is not
treated with mesh, only the compartment treated with mesh will be considered a
target compartment. For the purposes of this protocol, a subject may have more
than one target compartment.
Secondary Safety Endpoints
Secondary safety endpoints are defined as each of the following set of device
or procedure related adverse events (AEs) of interest of any severity at 36
months as determined by the CEC: mesh erosion into another organ, neuromuscular
problems (including groin and leg pain), pelvic pain, mesh exposure in the
vagina, infection (by type), stress urinary incontinence (worsening or de
novo), urge incontinence (worsening or de novo), difficulty emptying bladder
(worsening or de novo) and de novo dyspareunia.
Background summary
What is Restorelle Direct Fix (Restorelle)?
Restorelle Direct Fix has been cleared for use by the United States Food and
Drug Administration (FDA) to treat Pelvic Organ Prolapse (POP). The device has
also CE marking, which means that it can also be used within the European
Union. It is a non-absorbable mesh that is surgically implanted through the
vagina (transvaginally) by a doctor and once implanted into the body is
permanent.
The mesh acts as a support to the weak or damaged pelvic muscles to prop up the
muscles while new tissue grows into the mesh to provide strength and support,
preventing the pelvic organs from pushing into the vagina.
The United States Food and Drug Administration (FDA) has required this study to
collect information on the safety and effectiveness of Restorelle Direct Fix
and the surgical procedure to implant Restorelle. These results will be
compared to safety and effectiveness results with patients who have native
tissue repair for their pelvic organ prolapse treatment.
More background is described in the ICF Appendix C.
Study objective
The aim of this postmarket study is to compare the safety and effectiveness of
Coloplast Restorelle® transvaginal mesh products in the treatment of pelvic
organ prolapse (POP) to traditional native tissue repair through 36 months of
follow-up. This data will be used to support the 522 orders issued by the FDA
and a potential future call for a PMA.
* The Primary Effectiveness Objective is to assess superiority of transvaginal
mesh in the treatment of pelvic organ prolapse compared to native tissue repair
at 12 months
* The Primary Safety Objective is to assess non-inferiority of transvaginal
mesh in rates of device and procedure-related serious adverse events following
treatment of pelvic organ prolapse compared to native tissue repair at 12 months
* The Secondary Effectiveness Objectives are to assess non-inferiority of
transvaginal mesh in the treatment of pelvic organ prolapse compared to native
tissue repair at 12 months and 36 months
* The Secondary Safety Objectives are to assess non-inferiority of transvaginal
mesh in rates of specific adverse events following treatment of pelvic organ
prolapse compared to native tissue repair at 36 months
Additional Objectives:
* To assess changes in quality of life, symptoms and sexual satisfaction
associated with surgical reconstruction for pelvic organ prolapse compared to
native tissue repair
* To assess the effect of risk factors and comorbidities on clinical outcome
* To assess overall clinical outcomes by compartment and combined compartment
stratification
Study design
This study is a prospective, non-randomized, two-cohort, multi-center
post-market study comparing Restorelle mesh to native tissue repair (No Mesh)
in the treatment of pelvic organ prolapse. Subjects will be followed for 36
months, with scheduled follow-up visits at 2-months, 6 months, 12 months, 18
months, 24 months, and 36 months.
Intervention
Study participants will have their pelvic organ prolapse treated with:
* Restorelle Direct Fix only or
* Native tissue repair only or
* A combination of both Restorelle and native tissue repair
Prior surgery: urine test for infections, and, if applicable, pregnancy test.
Tests taking place per visit:
- pelvic exam * each visit (same as at baseline visit)
- questions asked about health * each visit
- complete up to 7 questionnaires to find out how your patient is doing - at
each visit:
* 2 months: one questionnaire
* 6 months: six questionnaires
* 12 months: seven questionnaires
* 18 months: five questionnaires
* 2 years: six questionnaires
* 3 years: six questionnaires
Study burden and risks
Because neither the devices nor procedures being studied in the Restorelle 522
Study are experimental, the doctor will conduct the surgery using his or her
standard surgical procedure.
Involvement in the study does not add surgical risks, but the surgery is major
surgery which includes risks and the doctor will review the risks with the
patient. Additionally, the devices and surgery may involve risks which are
currently unknown.
During the study visits, several questionnaires have to be filled out which
will ask very personal questions. There is a risk that answering these
questions may makes the patient feel embarrassed or uncomfortable.
The patient will visit the site 6 times in 3 years, where standard of care
would provide only 1 follow-up visit, though there is a trend in most Dutch
hospitals that this is already extended to the same 3 years after surgery.
West River Rd N 1601
Minneapolis MN 55411
US
West River Rd N 1601
Minneapolis MN 55411
US
Listed location countries
Age
Inclusion criteria
1. Subject is female
2. Subject is at least 18 years of age
3. Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba *0 and C* -1/2 tvl or Bp *0 and C* -1/2 tvl
4. Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of *somewhat*, "moderately or *quite a bit*)
5. Subject is willing to provide written informed consent
6. Subject is willing and able to comply with the follow-up regimen
Exclusion criteria
1. Subject is pregnant or intends to become pregnant during the study
2. Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
3. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
4. Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
5. Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
6. Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
7. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
8. Subject has uncontrolled diabetes mellitus (DM)
9. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
10. Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
11. Subject is not able to conform to the modified dorsal lithotomy position
12. Subject is currently participating in or plans to participate in another device or drug study during this study
13. Subject has a known sensitivity to polypropylene (Restorelle mesh arm only)
14. Subject has had previous prolapse repair with mesh in the target compartment(s)
15. Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue repair
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02162615 |
| CCMO | NL56561.018.16 |