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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02162615




Registration number
NCT02162615
Ethics application status
Date submitted
11/06/2014
Date registered
13/06/2014
Date last updated
27/05/2020

Titles & IDs
Public title
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
Scientific title
Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
Secondary ID [1] 0 0
SU014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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


Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence of Prolapse - 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.
Timepoint [1] 0 0
12 Month
Primary outcome [2] 0 0
Rate of device and procedure related serious adverse events
Timepoint [2] 0 0
12 Month
Secondary outcome [1] 0 0
Recurrence of Prolapse - 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.
Timepoint [1] 0 0
12 Month
Secondary outcome [2] 0 0
Recurrence of Prolapse - 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.
Timepoint [2] 0 0
36 Month
Secondary outcome [3] 0 0
Recurrence of Prolapse - 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.
Timepoint [3] 0 0
36 Month
Secondary outcome [4] 0 0
Device or Procedure related AEs of interest
Timepoint [4] 0 0
36 months

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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Centre for Advanced Reproductive Endosurgery - St Leonards
Recruitment hospital [2] 0 0
Mater Pelvic Health - Pimlico
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4812 - Pimlico
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Belgium
State/province [21] 0 0
Leuven
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Nimes
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amsterdam
Country [27] 0 0
Netherlands
State/province [27] 0 0
Bilthoven
Country [28] 0 0
Netherlands
State/province [28] 0 0
Breda
Country [29] 0 0
Netherlands
State/province [29] 0 0
Haarlem
Country [30] 0 0
Netherlands
State/province [30] 0 0
Maastricht
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nieuwegein
Country [32] 0 0
Netherlands
State/province [32] 0 0
Zwolle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Coloplast A/S
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02162615
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Lukban, DO
Address 0 0
The Pelvic Solutions Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications