MedPath

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Completed
Conditions
Pelvic Organ Prolapse
Registration Number
NCT02162615
Lead Sponsor
Coloplast A/S
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
810
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of device and procedure related serious adverse events12 Month
Recurrence of Prolapse12 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.

Secondary Outcome Measures
NameTimeMethod
Recurrence of Prolapse36 Month

Recurrent Prolapse 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 interest36 months

Trial Locations

Locations (48)

Sherry Thomas, M.D.

🇺🇸

Agoura Hills, California, United States

Stanford University

🇺🇸

Stanford, California, United States

SurgOne Pelvic Solutions Center

🇺🇸

Denver, Colorado, United States

Yale University School of Medicine

🇺🇸

New Haven, Connecticut, United States

Center for Urogynecology and Pelvic Surgery, Christiana Care Health System

🇺🇸

Newark, Delaware, United States

MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery

🇺🇸

Washington, District of Columbia, United States

Rosemark Women Care Specialists

🇺🇸

Idaho Falls, Idaho, United States

Andrew Shapiro

🇺🇸

Owings Mills, Maryland, United States

Baystate Health System

🇺🇸

Springfield, Massachusetts, United States

Female Pelvic Medicine & Urogynecology Institute of MI

🇺🇸

Grand Rapids, Michigan, United States

Scroll for more (38 remaining)
Sherry Thomas, M.D.
🇺🇸Agoura Hills, California, United States

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