Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

CompletedOBSERVATIONAL
Enrollment

416

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

September 30, 2021

Study Completion Date

September 30, 2021

Conditions
Stress Urinary Incontinence
Interventions
DEVICE

Altis Single Incision Sling

Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.

DEVICE

Transobturator or Retropubic Sling

Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.

Trial Locations (27)

12208

Albany Medical Center, Albany

18103

The Institute for Female Pelvic Medicine and Reconstructive Surgery, Allentown

19454

Institute of Female Pelvic Medicine & Reconstructive Surgery, North Wales

23456

The Group for Women, Virginia Beach

27103

Lyndhurst Clinical Research, Winston-Salem

27511

Associated Urologists of North Carolina, Cary

27612

Associated Urologists of North Carolina, Raleigh

28054

Carolina Urology Partners, Gastonia

28210

Novant Health, Charlotte

28345

FirstHealth Urogynecology, Hamlet

29169

Lexington Urology, West Columbia

33016

Urology Specialists, LLC, Hialeah

43701

Genesis Healthcare, Zanesville

44195

Cleveland Clinic, Cleveland

44313

Akron Urogynecology Associates, Akron

46825

Women's Health Advantage, Fort Wayne

49503

Female Pelvic Medicine & Urogynecology, Grand Rapids

57105

Sanford Health, Sioux Falls

68114

Adult and Pediatric Urology & Urogynecology, Omaha

73104

University of Oklahoma, Oklahoma City

80218

Pelvic Solutions Center, Denver

83404

Rosemark Women Care Specialists, Idaho Falls

89102

University of Nevada, Las Vegas

94305

Stanford University, Stanford

02138

Boston Urogynecology Associates, Cambridge

01199

Baystate Health System, Springfield

J1H 5N4

CHUS Hopital Fleurimont, Sherbrooke

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY