Pelvic Organ Prolapse
Conditions
Keywords
Pelvic Floor Disorder, Pelvic Organ Prolapse, Sexual Dysfunction, Mesh, POP, Transvaginal, Anterior, Posterior, Apical, Uterine Prolapse, Cystocele, Rectocele, Enterocele, Vaginal Vault Prolapse, Native Tissue Repair, Repair Augmented with Mesh, Pathological Conditions, Anatomical, Restorelle Direct Fix, Vaginal Mesh, Transvaginal Mesh
Brief summary
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.
Interventions
DEVICERestorelle Direct Fix A
DEVICERestorelle Direct Fix P
PROCEDURENative Tissue Repair Anterior
PROCEDURENative Tissue Repair Posterior
Sponsors
Coloplast A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female at least 18 years of age * 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 * 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) * Subject is willing to provide written informed consent * Subject is willing and able to comply with the follow-up regimen
Exclusion criteria
* Subject is pregnant or intends to become pregnant during the study * Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis * Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical) * Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area * Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months) * Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica) * Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis * Subject has uncontrolled diabetes mellitus (DM) * Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit) * Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis) * Subject is not able to conform to the modified dorsal lithotomy position * Subject is currently participating in or plans to participate in another device or drug study during this study * Subject has a known sensitivity to polypropylene * Subject has had previous prolapse repair with mesh in the target compartment(s) * Subject is planning to undergo a concomitant prolapse repair in a non-target compartment with anything other than native tissue repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Prolapse | 12 Month | Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging. |
| Rate of device and procedure related serious adverse events | 12 Month | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Prolapse | 12 Month | Recurrent prolapse is measured anatomically by leading edge of prolapse in the target compartment at or beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging. |
| Device or Procedure related AEs of interest | 36 months | — |
Other
| Measure | Time frame |
|---|---|
| Additional adverse events | 36 months |
| Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7 | 36 months |
| Subjects experiencing vaginal bulge | 36 months |
| Rates of revision and/or re-surgery | 36 months |
Countries
Australia, Belgium, Canada, France, Netherlands, United States
Outcome results
None listed