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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 : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Device: Restorelle Direct Fix A Device: Restorelle Direct Fix P Procedure: Native Tissue Repair Anterior Procedure: Native Tissue Repair Posterior

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Study Type : Observational
Actual Enrollment : 810 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
Actual Study Start Date : August 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Device or Procedure related AEs of interest [ Time Frame: 36 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162615


  Show 48 Study Locations
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: James Lukban, DO The Pelvic Solutions Center
Principal Investigator: Jan-Paul Roovers, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT02162615     History of Changes
Other Study ID Numbers: SU014
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Keywords provided by Coloplast A/S:
Pelvic Floor Disorder
Pelvic Organ Prolapse
Sexual Dysfunction
Mesh
POP
Transvaginal
Anterior
Posterior
Apical
Uterine Prolapse
Cystocele
Rectocele
Enterocele
Vaginal Vault Prolapse
Native Tissue Repair
Repair Augmented with Mesh
Pathological Conditions, Anatomical
Restorelle Direct Fix
Vaginal Mesh
Transvaginal Mesh

Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical