N/A N=50 Treatment

A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Urinary Incontinence, Stress

Bottom Line

View on ClinicalTrials.gov: NCT00904969 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Jan 2018

Primary outcome: Primary: Procedural Endpoint: Procedure Time From First Incision to Closing. — 61.8 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: The AMS Male Transobturator Sling System (Device); AdVance Male Sling (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: American Medical Systems
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Procedural Endpoint: Procedure Time From First Incision to Closing.	61.8	—
PRIMARY Procedural Endpoint: Type of Anesthesia Used	41; 9	—
PRIMARY Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative	44	—
PRIMARY Procedural Endpoint: Rate of Foley Catheter Use - Post-operative	39	—
PRIMARY Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge	35; 5; 10	—
PRIMARY Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures	45; 37; 16; 9	—
PRIMARY Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection	50	—
PRIMARY Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning	5; 34; 11	—
PRIMARY Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively	49	—
SECONDARY Subject Satisfaction Endpoint: 1-Hour Pad Weight	78.4; 8.9; 23.6; 15.8; 21.0; 22.2	—
SECONDARY Subject Satisfaction Endpoint: 24-Hour Pad Weight	377.2; 108.0; 53.7; 42.0; 38.3; 73.0	—
SECONDARY Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)	34; 28; 29; 25; 34; 34	—
SECONDARY Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)	26; 28; 29; 26; 36; 36	—
SECONDARY Subject Satisfaction Endpoint: Pads Per Day Use	7; 20; 13; 8; 1; 33	—
SECONDARY Subject Satisfaction Endpoint: Quality of Life I-QOL Scores	50.3; 79.2; 79.4; 79.9; 82.4	—
SECONDARY Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores	15.7; 7.6; 7.6; 7.3; 7.5	—
SECONDARY Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores	20.1; 54.7; 55.9; 57.4; 57.3	—
SECONDARY Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status	12; 17; 12; 7; 12; 14	—
SECONDARY Procedural and Device Complication Rates	54	—

Summary

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.

Eligibility Criteria

Inclusion Criteria

The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
The subject is willing and able to give valid informed consent.
The subject is > 40 years of age.
The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
Internal sphincter contractility confirmed by endoscopic view.
The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
Pre-existing urological conditions, other than incontinence have been treated and are under control.
The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
The subject is a good surgical candidate.

Exclusion Criteria

The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
The subject has an atonic bladder.
The subject has a post-void residual > 75 cc.
The subject has detrusor-external sphincter dyssynergia.
The subject has a urinary tract infection (UTI).
The subject was treated with pelvic radiation within the last 6 months.
The subject currently has an inflatable penile prosthesis.
The subject self-catheterizes.
The subject has symptomatic or unstable bladder neck stricture disease.
The subject has a history of urethral strictures that may require repetitive instrumentation.
The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
The subject has a history of connective tissue or autoimmune conditions.
The subject has a compromised immune system.
The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00904969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.