Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Sponsor

Coloplast A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02348112

Collaborator

(none)

416

Enrollment

Locations

Actual Duration (Months)

15.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Altis Sling Device: Transobturator or Retropubic Sling

Detailed Description

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress incontinence who are clinically indicated for surgical intervention with a mesh sling.

Study Design

Study Type:

Observational

Actual Enrollment :

416 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Altis Sling Subjects will have an Altis sling placed to treat stress urinary incontinence.	Device: Altis 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. Other Names: Altis Single Incision Sling System
Transobturator or Retropubic Sling Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.	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.

Arm

Intervention/Treatment

Altis Sling

Subjects will have an Altis sling placed to treat stress urinary incontinence.

Device: Altis 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.

Other Names:

Altis Single Incision Sling System

Transobturator or Retropubic Sling

Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.

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.

Outcome Measures

Primary Outcome Measures

Observed device and/or procedure-related serious adverse events through 36 months. [36 months]
Observed device and/or procedure-related serious adverse events through 36 months.
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months. [6 months]
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.

Secondary Outcome Measures

Observed rates for the following: organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary or neuromuscular problems [36 months]
To demonstrate that the rate of device and/or procedure related adverse events defined as organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems associated with use of Altis SIS is non-inferior compared to the rate associated with use of transobturator and/or retropubic slings at 36 months.
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50%. [12, 18, 24, and 36 months]
To demonstrate a reduction from baseline in 24 hour pad weight of at least 50%.
Quality of Life assessment [6, 12, 18, 24, and 36 months]
Measured through the following questionnaires: Patient Global Impression of Improvement (PGI-I), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), Surgical Satisfaction Questionnaire (SSQ-8), Visual Analog Scale for Pain (VAS Pain)
Observed adverse events of the index procedure [6, 12, 18, 24, and 36 months]
To assess the rates, severity, and relatedness of all observed adverse events (including mesh exposure and erosion) associated with both study groups at 6 months, 12 months, 18 months, 24 months, and 36 months.
Observed revision/re-surgery [6, 12, 18, 24, and 36 months]
To assess the rates all revisions/re-surgeries observed associated with both study groups at 6 months, 12 months, 18 months, 24 months, and 36 months.
Observed effectiveness for subjects considered dry (pad weight less than or equal to 4.0 grams) [6, 12, 18, 24, and 36 months]
To assess the effectiveness for subjects considered dry (pad weight less than or equal to 4.0 grams)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

The subject is female and at least 18 years of age.
The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
The subject has confirmed stress urinary incontinence through cough stress test or urodynamics.
The subject has failed two non-invasive incontinence therapies (such as Kegal exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.

Exclusion Criteria:

The subject has an active urogenital infection or active skin infection in region of surgery.
The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
The subject is having a concomitant pelvic floor procedure.
The subject has incontinence due to neurological causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinsons disease, or similar conditions).
The subject had a prior surgical stress urinary incontinence treatment.
The subject has undergone radiation or brachy therapy to treat pelvic cancer.
The subject has urge predominant incontinence by MESA assessment.
The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
The subject is pregnant and/or is planning to get pregnant in the future.
The subject has a contraindication to the surgical procedure of the product Instructions for use (IFU).
The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	Pelvic Solutions Center	Denver	Colorado	United States	80218
3	Urology Specialists, LLC	Hialeah	Florida	United States	33016
4	Rosemark Women Care Specialists	Idaho Falls	Idaho	United States	83404
5	Women's Health Advantage	Fort Wayne	Indiana	United States	46825
6	Boston Urogynecology Associates	Cambridge	Massachusetts	United States	02138
7	Baystate Health System	Springfield	Massachusetts	United States	01199
8	Female Pelvic Medicine & Urogynecology	Grand Rapids	Michigan	United States	49503
9	Adult and Pediatric Urology & Urogynecology	Omaha	Nebraska	United States	68114
10	University of Nevada	Las Vegas	Nevada	United States	89102
11	Albany Medical Center	Albany	New York	United States	12208
12	Associated Urologists of North Carolina	Cary	North Carolina	United States	27511
13	Novant Health	Charlotte	North Carolina	United States	28210
14	Carolina Urology Partners	Gastonia	North Carolina	United States	28054
15	FirstHealth Urogynecology	Hamlet	North Carolina	United States	28345
16	Associated Urologists of North Carolina	Raleigh	North Carolina	United States	27612
17	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
18	Akron Urogynecology Associates	Akron	Ohio	United States	44313
19	Cleveland Clinic	Cleveland	Ohio	United States	44195
20	Genesis Healthcare	Zanesville	Ohio	United States	43701
21	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
22	The Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania	United States	18103
23	Institute of Female Pelvic Medicine & Reconstructive Surgery	North Wales	Pennsylvania	United States	19454
24	Lexington Urology	West Columbia	South Carolina	United States	29169
25	Sanford Health	Sioux Falls	South Dakota	United States	57105
26	The Group for Women	Virginia Beach	Virginia	United States	23456
27	CHUS Hopital Fleurimont	Sherbrooke	Quebec	Canada	J1H 5N4