Clinical trial NCT02162615: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: 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
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 810
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.

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.


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

Primary outcomes:
measure: Recurrence of Prolapse
timeFrame: 12 Month
measure: Rate of device and procedure related serious adverse events
timeFrame: 12 Month
Secondary outcomes:
measure: Recurrence of Prolapse
timeFrame: 12 Month
measure: Recurrence of Prolapse
timeFrame: 36 Month
measure: Recurrence of Prolapse
timeFrame: 36 Month
measure: Device or Procedure related AEs of interest
timeFrame: 36 months
Other outcomes:
measure: Additional adverse events
timeFrame: 36 months
measure: Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7
timeFrame: 36 months
measure: Subjects experiencing vaginal bulge
timeFrame: 36 months
measure: Rates of revision and/or re-surgery
timeFrame: 36 months
Locations:
city: Agoura Hills
country: United States
facility: Sherry Thomas, M.D.
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: SurgOne Pelvic Solutions Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Newark
country: United States
facility: Center for Urogynecology and Pelvic Surgery, Christiana Care Health System
state: Delaware
city: Washington
country: United States
facility: MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery
state: District of Columbia
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Owings Mills
country: United States
facility: Andrew Shapiro
state: Maryland
city: Springfield
country: United States
facility: Baystate Health System
state: Massachusetts
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology Institute of MI
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Omaha
country: United States
facility: Adult & Pediatric Urology, PC
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Research Center
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of Hudson Valley, PC
state: New York
city: Charlotte
country: United States
facility: Novant Health Urogynecology
state: North Carolina
city: Hamlet
country: United States
facility: Women's Pelvic Health and Continence Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Clinical Research
state: North Carolina
city: Akron
country: United States
facility: Akron Urogynecology Associates
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Lansdale
country: United States
facility: Center for Women's Health of Lansdale
state: Pennsylvania
city: Newtown
country: United States
facility: The Female Pelvic Health Center
state: Pennsylvania
city: York
country: United States
facility: Wellspan Urogynecology and Pelvic Reconstructive Surgery
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Nashville
country: United States
facility: Swan Urogynecology
state: Tennessee
city: Austin
country: United States
facility: Central Texas Urogynecology and Continence Center
state: Texas
city: Colleyville
country: United States
facility: Scott D. Lauer, DO, PA
state: Texas
city: Christiansburg
country: United States
facility: Carilion Clinic New River Valley
state: Virginia
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
city: St Leonards
country: Australia
facility: Centre for Advanced Reproductive Endosurgery
state: New South Wales
city: Pimlico
country: Australia
facility: Mater Pelvic Health
state: Queensland
city: Leuven
country: Belgium
facility: UZ Leuven
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemount
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS-CRC
state: Quebec
city: Lille
country: France
facility: CHRU Lille
city: Nimes
country: France
facility: CHU Nimes
city: Amsterdam
country: Netherlands
facility: Bergman Clinics
city: Amsterdam
country: Netherlands
facility: AMC Medical Center
city: Bilthoven
country: Netherlands
facility: Bergman Clinics
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Zwolle
country: Netherlands
facility: ISALA
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan-Paul Roovers, MD
role: PRINCIPAL_INVESTIGATOR
References: