Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II)

NCT02288455 | Completed DMC

• 1 other identifier: TP13-101
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this investigation is to demonstrate the safety and efficacy of the GTU artificial urinary sphincter device in restoring continence in males who have confirmed urinary stress incontinence for a minimum of 12 months with primary etiology being radical prostatectomy or transurethral resection of the prostate (TURP).

Conditions

Male Stress Urinary Incontinence

Keywords

SUI, incontinence, sphincter

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint: Improvement in pad weight defined as at least 60% improvement in pad weight from baseline to 3-months post device activation as measured by the 24-hour pad weight tests.

  The primary efficacy endpoint is improvement in pad weight defined as at least 60% improvement in pad weight from baseline to 3-months post device activation as measured by the 24-hour pad weight tests.

  3 months

Secondary Outcomes (5)

• 1-Hour Pad Weight

  3 months

• Pad Usage

  3 months

• Quality of Life Assessment

  3 months

• Secondary Safety Endpoint: Summary of all adverse events

  3 months

• Primary Safety Endpoint

  3 months

Study Arms (1)

RELIEF II - GTU AUS

EXPERIMENTAL

Prospective, non-randomized multi-center study testing the safety and efficacy of the GTU Artificial Urinary Sphincter device in males with stress urinary incontinence.

Device: GTU Artificial Urinary Sphincter

Interventions

GTU Artificial Urinary Sphincter DEVICE

A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)

RELIEF II - GTU AUS

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males \> 21 years
• Willing/able to sign informed consent
• Has undergone radical prostatectomy or transurethral resection of the prostate or other prostate surgery prior to 6 months of the time of enrollment
• Primary stress urinary incontinence confirmed urodynamically as dominant form of UI
• Failed conservative incontinence treatment (see list below) for at least 6 months
• Pelvic exercises and bladder training
• Drug Therapy
• Biofeedback
• Electrical stimulation
• Behavioral therapy
• Subject has severe urinary incontinence defined by:
• a. One 24-hour pad weight test ≥300 gm
• Max urethral closure pressure \< 30 cm H2O
• Bladder capacity \> 250 ml
• Post void residual urine \< 50 ml

You may not qualify if:

• Subjects considered to be vulnerable
• Refuses or unable to sign the informed consent
• Cannot comply with study requirements, follow-up visits and tests
• Currently enrolled or plans to enroll in another investigational device or drug clinical trial or has completed an investigational study within 2 weeks
• Estimated life span \< 5 years
• Recent or planned surgeries within 3 months before or 12 weeks after the implant procedure
• Primary urge incontinence, mixed incontinence with a predominant urgency component, or urinary incontinence due to or complicated by bladder outlet obstruction
• Has had implantation of artificial urinary sphincter prosthesis, sling, or other urogenital implant
• Has had ProACT device explanted and the urethra is compromised as assessed by the investigator
• Demonstrated bladder outlet obstruction (BOO) as measured by the pressure flow cystometry
• Neurogenic bladder dysfunction not treatable/controllable by pharmacological or alternative methods
• Uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of \>12mmol/l (216. mg/dl) and a glycosylated hemoglobin (HbA1C) of \>9% (75mmol/mol) over the preceding 3 months
• Active abscess or infection
• Bladder neck or urethral stricture disease requiring \> 2 regular instrumentation or dilation proximal to or at the level of the urethral sheath
• Bladder cancer or transitional cell carcinoma requiring regular cystoscopy and/or rapidly progressive prostatic or testicular cancer

Sponsors & Collaborators

• GT Urological, LLC: lead

Study Sites (6)

Urology Centre

Port Macquarie, New South Wales, 2424, Australia

Location

South Coast Urology

Wollongong, New South Wales, 2525, Australia

Location

St George Hospital

Sydney, Australia

Location

nemocnice Ostrava

Ostrava, 708 52, Czechia

Location

Fakultni Thomayerova nemocnice

Prague, 140 59, Czechia

Location

Tauranga Urology Research Limited

Tauranga, New Zealand

Location

Study Officials

• Olivier Haillot

  Hôpitaux de Tours

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 11, 2014
• Study Start: October 1, 2014
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

NZ (1); AU (3); CZ (2)