The primary objective of this study is to evaluate the anatomical success of the GYNECARE PROLIFT + M* system in women with symptomatic ICS POP-Q Stage III or IV, requiring surgical correction of pelvic organ prolapse (POP). Secondary objectives…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There will be one primary effectiveness end-point:
* POP-Q score at 12 months post-procedure. Success will be determined by
achievement of a POP-Q score of ICS Stage *1, without further surgical
re-intervention for POP.
Secondary outcome
* Summary of ICS Stages at 3 and 36 month visits.
* Summary of treated compartment ICS POP-Q stage at 3, 12 and 36 months.
* Proportion of subjects with the leading edge within the hymen (i.e. all POP-Q
values to be less than 0) and without further re-intervention for POP at 12 and
36 months.
* Mean scores and change from baseline in PFDI-20 scores at 3, 12 and 36 month
visits including sub scores (POPDI, CRADI and UDI).
* Proportion of subjects with a change from baseline * 45 points in the PFDI-20
summary score at 12 and 36 months.
* Mean scores and change from baseline in PFIQ-7 at 3, 12 and 36 month visits
including sub-scores (POPIQ, CRAIQ and UIQ).
* Proportion of subjects with a change from baseline * 36 points in the PFIQ-7
summary score at 12 and 36 months.
* Days to return to normal activities (walking, driving, work, household
activities and sexual intercourse).
* EuroQol (EQ-5D health state) mean change from baseline at 3 and 12 months
visit (overall using the EQ-5D index score, and also for each individual item).
* In subjects sexually active at baseline, assessment of sexual function using
PISQ-12 assessed at 12 and 36 month visits (mean scores and change from
baseline).
* Incidence of new onset dyspareunia, resolution or continuance of pre-existing
dyspareunia
* Incidence of mesh contraction, as determined by pain on palpation of mesh
during pelvic examination at 3, 12 and 36 months.
* Incidence of vaginal wall stiffness, as determined by the investigator on
physical examination at 3, 12 and 36 months.
* Total time in the operating room.
* Length of procedure (from time of first incision to time of last suture).
* Nights in hospital (from date of admission to date of discharge; based on
actual data and *readiness for discharge*).
* Pain score 24 hours post surgery and at the 1 month visit, measured using
Visual Analog Scale (VAS).
* Subject global impression assessed on a 5 point Likert scale at 3, 12 and
36-month visits.
* Surgical satisfaction question assessed at 3 and 12 month visits.
Background summary
The Clinical Investigator Brochure summarises the technical, pre-clinical and
clinical information available to support the clinical investigation of
GYNECARE PROLIFT+M* Pelvic Floor System. Many women with Pelvic Organ Prolapse
POP seek an alternative to non-surgical interventions of pelvic floor exercises
and pessary support. Synthetic meshes have been used with increasing frequency
in gynecologic surgery over the past 30 years. These synthetic meshes have been
demonstrated to be an effective alternative treatment for POP.
Currently the GYNECARE PROLIFT Pelvic Floor System is licensed and marketed in
Europe for the treatment of POP. Whilst successful anatomical results are being
reported following the placement of the device, there is a need to reduce the
incidence of mesh-related complications such as mesh retraction and stiffness
leading to pain, including dyspareunia. Replacing the existing polypropylene
mesh (GYNECARE GYNEMESH PS) with a lighter weight composite mesh (GYNECARE
GYNEMESH M), it is anticipated that there will be reduction in these symptoms.
Therefore, the purpose of this study is to evaluate the clinical performance of
the PROLIFT+M system in women with symptomatic ICS POP-Q Stage III or IV,
requiring surgical correction of POP.
Study objective
The primary objective of this study is to evaluate the anatomical success of
the GYNECARE PROLIFT + M* system in women with symptomatic ICS POP-Q Stage III
or IV, requiring surgical correction of pelvic organ prolapse (POP).
Secondary objectives include the evaluation of patient reported outcomes
(PFDI-20, PFIQ-7, PISQ-12, Euro-QOL), length of procedure, length of hospital
stay, post-operative pain, return to normal activities, and peri- and
post-operative complications.
Study design
This study is a prospective, multi-centre, single-arm design. Subjects will be
assessed prior to surgery, during and after the procedure, and at 1, 3, 12 and
36 months post-procedure.
Intervention
GYNECARE PROLIFT.
Study burden and risks
Risk & Benefit Assessment
The GYNECARE PROLIFT+M systems are indicated for tissue reinforcement and long
lasting stabilization of fascial structures of the pelvic floor in vaginal wall
prolapse where surgical treatment is intended, either as a mechanical support
or bridging material for the fascial defect. Clinical studies have shown the
system provides improvement in stabilization of vaginal prolapse. Reported
adverse events for this device urinary tract infection, urinary incontinence,
voiding dysfunction, vaginal
atrophy, mesh exposure, anterior prolapse, pain, and dyspareunia.
Potential Benefits of GYNECARE PROLIFT+M Systems:
The device is intended for surgical repair of pelvic floor prolapse. Through a
transvaginal approach, gynecologists can offer a treatment option with the
following possible benefits and advantages.
1. Reinforcement of weakened tissue, suspension of unsupported structures or a
combination of both.
2. Offers a minimally invasive treatment.
3. Presents a minimal number and degree of observed adverse events from prior
clinical experience.
4. Provides an alternative treatment option for physicians and their patients.
Urogynecologists are the primary practitioners in the medical care of women
with pelvic floor prolapse. Gynecological procedures for the treatment of
pelvic floor prolapse are associated with certain risks. These risks are
outline in section 10 of the protocol. Additionally, there are potential risks
that may be directly associated with the device. These risks are as follows:
Potential Risks of GYNECARE PROLIFT+M Systems
Mesh exposure is a common complication, which can be managed by excision and
closure. Mesh retraction ("shrinkage") is less common but is considered more
serious than mesh exposure. It can cause vaginal anatomic distortion with pain,
which may also have a negative impact on sexual function. The scar plate that
forms with in-growth of tissue into the mesh can cause stiffness in the vagina
that can further impact sexual function in a negative manner.
In an effort to minimize mesh retraction and reduce mesh stiffness, the
GYNECARE GYNEMESH M Mesh is being studied.
Conclusion
Clinical experience with the Prolift system has demonstrated promising
anatomical results with improvements in POP-related symptoms. Overall,
complications are low, but generally related to the mesh. In order to improve
the device, a lighter-weight mesh has been introduced into the system and this
will be evaluated in the proposed clinical study.
Kirkton Campus_Simpson Parkway
EH54 0AB Livingston
GB
Kirkton Campus_Simpson Parkway
EH54 0AB Livingston
GB
Listed location countries
Age
Inclusion criteria
1. 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.
2. Age ><= 18 years.
3. 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.
Exclusion criteria
1. Additional surgical intervention for POP repair concurrent to the Gynecare Prolift +M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrophy in a non-Gynecare Prolift+M treated compartment).
2. Previous repair of pelvic organ prolapse involving insertion of mesh.
3. Previous hysterectomy within 6 months of scheduled surgery.
4. Experimental drug or experimental medical device within 3 months prior to the planned procedure.
5. 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.
6. Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
7. History of chemotherapy or pelvic radiation therapy.
8. Systemic disease known to affect bladder or bowel function (e.g. Parkinson*s disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
9. Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvadynia).
10. Nursing or pregnant or intends future pregnancy.
11. 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.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL19722.098.07 |