Restorelle® Mesh Versus Native Tissue Repair for Prolapse

Sponsor

Coloplast A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02162615

Collaborator

(none)

810

Enrollment

Locations

87.2

Actual Duration (Months)

16.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Pelvic Organ Prolapse	Device: Restorelle Direct Fix A Device: Restorelle Direct Fix P Procedure: Native Tissue Repair Anterior Procedure: Native Tissue Repair Posterior

Study Design

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 :

Aug 1, 2014

Actual Primary Completion Date :

Jan 15, 2020

Actual Study Completion Date :

Nov 6, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Recurrence of Prolapse [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.
Rate of device and procedure related serious adverse events [12 Month]

Secondary Outcome Measures

Recurrence of Prolapse [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.
Recurrence of Prolapse [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.
Recurrence of Prolapse [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.
Device or Procedure related AEs of interest [36 months]

Other Outcome Measures

Additional adverse events [36 months]
Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7 [36 months]
Subjects experiencing vaginal bulge [36 months]
Rates of revision and/or re-surgery [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherry Thomas, M.D.	Agoura Hills	California	United States	91301
2	Stanford University	Stanford	California	United States	94305
3	SurgOne Pelvic Solutions Center	Denver	Colorado	United States	80218
4	Yale University School of Medicine	New Haven	Connecticut	United States	06520
5	Center for Urogynecology and Pelvic Surgery, Christiana Care Health System	Newark	Delaware	United States	19713
6	MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery	Washington	District of Columbia	United States	20010
7	Rosemark Women Care Specialists	Idaho Falls	Idaho	United States	83404
8	Andrew Shapiro	Owings Mills	Maryland	United States	21117
9	Baystate Health System	Springfield	Massachusetts	United States	01199
10	Female Pelvic Medicine & Urogynecology Institute of MI	Grand Rapids	Michigan	United States	49503
11	Beyer Research	Kalamazoo	Michigan	United States	49009
12	Adult & Pediatric Urology, PC	Omaha	Nebraska	United States	68114
13	Cooper University Hospital	Camden	New Jersey	United States	08103
14	Atlantic Health System	Morristown	New Jersey	United States	07960
15	Montefiore Medical Research Center	Bronx	New York	United States	10461
16	Premier Medical Group of Hudson Valley, PC	Poughkeepsie	New York	United States	12601
17	Novant Health Urogynecology	Charlotte	North Carolina	United States	28210
18	Women's Pelvic Health and Continence Center	Hamlet	North Carolina	United States	28345
19	Novant Health Clinical Research	Winston-Salem	North Carolina	United States	27103
20	Akron Urogynecology Associates	Akron	Ohio	United States	44333
21	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
22	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
23	The Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania	United States	18103
24	Center for Women's Health of Lansdale	Lansdale	Pennsylvania	United States	19446
25	The Female Pelvic Health Center	Newtown	Pennsylvania	United States	18940
26	Wellspan Urogynecology and Pelvic Reconstructive Surgery	York	Pennsylvania	United States	17403
27	Sanford Research	Sioux Falls	South Dakota	United States	57104
28	Swan Urogynecology	Nashville	Tennessee	United States	37203
29	Central Texas Urogynecology and Continence Center	Austin	Texas	United States	78758
30	Scott D. Lauer, DO, PA	Colleyville	Texas	United States	76034
31	Carilion Clinic New River Valley	Christiansburg	Virginia	United States	24073
32	The Group for Women	Norfolk	Virginia	United States	23502
33	Integrity Medical Research	Mountlake Terrace	Washington	United States	98042
34	Centre for Advanced Reproductive Endosurgery	St Leonards	New South Wales	Australia	2065
35	Mater Pelvic Health	Pimlico	Queensland	Australia	4812
36	UZ Leuven	Leuven		Belgium	3000
37	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2VT
38	Hôpital Maisonneuve-Rosemount	Montreal	Quebec	Canada	H1T 2M4
39	CHUS-CRC	Sherbrooke	Quebec	Canada	J1H 5N4
40	CHRU Lille	Lille		France	59037
41	CHU Nimes	Nimes		France	30029
42	Bergman Clinics	Amsterdam		Netherlands	1081
43	AMC Medical Center	Amsterdam		Netherlands	1105
44	Bergman Clinics	Bilthoven		Netherlands	3723 MB
45	Amphia Hospital	Breda		Netherlands	4819 EV
46	Spaarne Gasthuis	Haarlem		Netherlands	2035 RC
47	Maastricht UMC	Maastricht		Netherlands	6229 HX
48	St. Antonius Ziekenhuis	Nieuwegein		Netherlands	3435 CM
49	ISALA	Zwolle		Netherlands	8025 AB