Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162615
• Other study ID #: SU014
• Status: Completed
• Start date: August 2014
• Est. completion date: November 6, 2021

Study information

• Verified date: January 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: November 6, 2021
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Restorelle Direct Fix A

• Restorelle Direct Fix P

Procedure:
• Native Tissue Repair Anterior

• Native Tissue Repair Posterior

Locations

Country	Name	City	State
Australia	Mater Pelvic Health	Pimlico	Queensland
Australia	Centre for Advanced Reproductive Endosurgery	St Leonards	New South Wales
Belgium	UZ Leuven	Leuven
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Hôpital Maisonneuve-Rosemount	Montreal	Quebec
Canada	CHUS-CRC	Sherbrooke	Quebec
France	CHRU Lille	Lille
France	CHU Nimes	Nimes
Netherlands	AMC Medical Center	Amsterdam
Netherlands	Bergman Clinics	Amsterdam
Netherlands	Bergman Clinics	Bilthoven
Netherlands	Amphia Hospital	Breda
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Maastricht UMC	Maastricht
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	ISALA	Zwolle
United States	Sherry Thomas, M.D.	Agoura Hills	California
United States	Akron Urogynecology Associates	Akron	Ohio
United States	The Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Central Texas Urogynecology and Continence Center	Austin	Texas
United States	Montefiore Medical Research Center	Bronx	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Novant Health Urogynecology	Charlotte	North Carolina
United States	Carilion Clinic New River Valley	Christiansburg	Virginia
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Scott D. Lauer, DO, PA	Colleyville	Texas
United States	SurgOne Pelvic Solutions Center	Denver	Colorado
United States	Female Pelvic Medicine & Urogynecology Institute of MI	Grand Rapids	Michigan
United States	Women's Pelvic Health and Continence Center	Hamlet	North Carolina
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	Beyer Research	Kalamazoo	Michigan
United States	Center for Women's Health of Lansdale	Lansdale	Pennsylvania
United States	Atlantic Health System	Morristown	New Jersey
United States	Integrity Medical Research	Mountlake Terrace	Washington
United States	Swan Urogynecology	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Center for Urogynecology and Pelvic Surgery, Christiana Care Health System	Newark	Delaware
United States	The Female Pelvic Health Center	Newtown	Pennsylvania
United States	The Group for Women	Norfolk	Virginia
United States	Adult & Pediatric Urology, PC	Omaha	Nebraska
United States	Andrew Shapiro	Owings Mills	Maryland
United States	Premier Medical Group of Hudson Valley, PC	Poughkeepsie	New York
United States	Sanford Research	Sioux Falls	South Dakota
United States	Baystate Health System	Springfield	Massachusetts
United States	Stanford University	Stanford	California
United States	MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery	Washington	District of Columbia
United States	Novant Health Clinical Research	Winston-Salem	North Carolina
United States	Wellspan Urogynecology and Pelvic Reconstructive Surgery	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional adverse events		36 months
Other	Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7		36 months
Other	Subjects experiencing vaginal bulge		36 months
Other	Rates of revision and/or re-surgery		36 months
Primary	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.	12 Month
Primary	Rate of device and procedure related serious adverse events		12 Month
Secondary	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.	12 Month
Secondary	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.	36 Month
Secondary	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.	36 Month
Secondary	Device or Procedure related AEs of interest		36 months