Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

Coloplast A/S48 sites in 6 countries810 target enrollmentAugust 2014

ConditionsPelvic Organ Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Coloplast A/S
Enrollment: 810
Locations: 48
Primary Endpoint: Rate of device and procedure related serious adverse events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

November 6, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Coloplast A/S

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Rate of device and procedure related serious adverse events

Time Frame: 12 Month

Recurrence of Prolapse

Time Frame: 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.