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Restorelle® Mesh Versus Native Tissue Repair for Prolapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162615
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Last Update Posted : June 29, 2021
Sponsor:
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 June 29, 2021
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 17, 2018)
810
Original Estimated Enrollment
 (submitted: June 11, 2014)
892
Estimated Study Completion Date November 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
Removed Location Countries  
 
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
Responsible Party Coloplast A/S
Study Sponsor Coloplast A/S
Collaborators Not Provided
Investigators
Principal Investigator: James Lukban, DO The Pelvic Solutions Center
Principal Investigator: Jan-Paul Roovers, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Coloplast A/S
Verification Date June 2021