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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Restorelle Direct Fix A Anterior/Apical prolapse repair with Restorelle Direct Fix A
  • Device: Restorelle Direct Fix A
Native Tissue Repair Anterior Anterior/Apical prolapse repair with native tissue only
  • Procedure: Native Tissue Repair Anterior
Restorelle Direct Fix P Posterior/Apical prolapse repair with Restorelle Direct Fix P
  • Device: Restorelle Direct Fix P
Native Tissue Repair Posterior Posterior/Apical prolapse repair with native tissue only
  • Procedure: Native Tissue Repair Posterior

More Details

Status
Completed
Sponsor
Coloplast A/S

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.