Restorelle® Mesh Versus Native Tissue Repair for Prolapse

• ClinicalTrials.gov Identifier: NCT02162615
• Recruitment Status: Completed
• First Posted: June 13, 2014
• Last Update Posted: January 27, 2022
• Sponsor: Coloplast A/S
• Information provided by (Responsible Party): Coloplast A/S

Tracking Information

• First Submitted Date: June 11, 2014
• First Posted Date: June 13, 2014
• Last Update Posted Date: January 27, 2022
• Actual Study Start Date: August 2014
• Actual Primary Completion Date: January 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 11, 2014)

• 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.
• Rate of device and procedure related serious adverse events [ Time Frame: 12 Month ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 11, 2014)

• Recurrence of Prolapse [ Time Frame: 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.
• Recurrence of Prolapse [ Time Frame: 36 Month ]
  Recurrent Prolapse is measured anatomically by leading edge of prolapse in the target compartment 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.
• Recurrence of Prolapse [ Time Frame: 36 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 interest [ Time Frame: 36 months ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 11, 2014)

• Additional adverse events [ Time Frame: 36 months ]
• Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7 [ Time Frame: 36 months ]
• Subjects experiencing vaginal bulge [ Time Frame: 36 months ]
• Rates of revision and/or re-surgery [ Time Frame: 36 months ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Restorelle® Mesh Versus Native Tissue Repair for Prolapse
• Official Title: Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.
• Condition: Pelvic Organ Prolapse

Intervention

• Device: Restorelle Direct Fix A
• Device: Restorelle Direct Fix P
• Procedure: Native Tissue Repair Anterior
• Procedure: Native Tissue Repair Posterior

Study Groups/Cohorts

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 17, 2018): 810
• Original Estimated Enrollment (submitted: June 11, 2014): 892
• Actual Study Completion Date: November 6, 2021
• Actual Primary Completion Date: January 15, 2020 (Final data collection date for primary outcome measure)

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)
• 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Canada, France, Netherlands, United States

Administrative Information

• NCT Number: NCT02162615
• Other Study ID Numbers: SU014
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Coloplast A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Coloplast A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jan-Paul Roovers, MD; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• PRS Account: Coloplast A/S
• Verification Date: January 2022