Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02162615
Registration number
NCT02162615
Ethics application status
Date submitted
11/06/2014
Date registered
13/06/2014
Date last updated
27/01/2022
Titles & IDs
Public title
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
Query!
Scientific title
Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
Query!
Secondary ID [1]
0
0
SU014
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse
0
0
Query!
Condition category
Condition code
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Fetal medicine and complications of pregnancy
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Childbirth and postnatal care
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Treatment: Devices - Restorelle Direct Fix A
Treatment: Devices - Restorelle Direct Fix P
Treatment: Surgery - Native Tissue Repair Anterior
Treatment: Surgery - Native Tissue Repair Posterior
Restorelle Direct Fix A - Anterior/Apical prolapse repair with Restorelle Direct Fix A
Native Tissue Repair Anterior - Anterior/Apical prolapse repair with native tissue only
Restorelle Direct Fix P - Posterior/Apical prolapse repair with Restorelle Direct Fix P
Native Tissue Repair Posterior - Posterior/Apical prolapse repair with native tissue only
Treatment: Devices: Restorelle Direct Fix A
Treatment: Devices: Restorelle Direct Fix P
Treatment: Surgery: Native Tissue Repair Anterior
Treatment: Surgery: Native Tissue Repair Posterior
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Recurrence of Prolapse
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 Month
Query!
Primary outcome [2]
0
0
Rate of device and procedure related serious adverse events
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
12 Month
Query!
Secondary outcome [1]
0
0
Recurrence of Prolapse
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 Month
Query!
Secondary outcome [2]
0
0
Recurrence of Prolapse
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
36 Month
Query!
Secondary outcome [3]
0
0
Recurrence of Prolapse
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
36 Month
Query!
Secondary outcome [4]
0
0
Device or Procedure related AEs of interest
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
36 months
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/11/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
810
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
Centre for Advanced Reproductive Endosurgery - St Leonards
Query!
Recruitment hospital [2]
0
0
Mater Pelvic Health - Pimlico
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
4812 - Pimlico
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Delaware
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Idaho
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nebraska
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Dakota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Leuven
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Ontario
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Quebec
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Lille
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Nimes
Query!
Country [26]
0
0
Netherlands
Query!
State/province [26]
0
0
Amsterdam
Query!
Country [27]
0
0
Netherlands
Query!
State/province [27]
0
0
Bilthoven
Query!
Country [28]
0
0
Netherlands
Query!
State/province [28]
0
0
Breda
Query!
Country [29]
0
0
Netherlands
Query!
State/province [29]
0
0
Haarlem
Query!
Country [30]
0
0
Netherlands
Query!
State/province [30]
0
0
Maastricht
Query!
Country [31]
0
0
Netherlands
Query!
State/province [31]
0
0
Nieuwegein
Query!
Country [32]
0
0
Netherlands
Query!
State/province [32]
0
0
Zwolle
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Coloplast A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02162615
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Jan-Paul Roovers, MD
Query!
Address
0
0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02162615
Download to PDF