AMS miniaturo™-I system for treatment of Urinary Urge Incontinence

Phase 1

Recruiting

• Conditions: Female patients with Urinary Urge Incontinence; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12607000390482
• Lead Sponsor: American Medical Systems Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1.Patient who failed conservative treatments (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy) for at least 6 months.2.Overactive detrusor demonstrated on cystometry during the last 6 months or patients who are regarded as sensory urgency3.Urinary Urge Incontinence greater then 5 episodes per day4.Urinary frequency greater than 10 times/day and 3 times/night5.Patients with competent sphincter mechanism6.Patients with normally functioning upper urinary tract 7.Passing miniaturo-I Test System session

Exclusion Criteria

Exclusion criteria1.Previous participation in another study with any investigational drug or device within the past 3 months2.Any active implant (cardiac or other)3.Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months4.Any spinal or genitourinary surgery within the last 6 months5.Previous abdominoperineal resection of the rectum or radical hysterectomy within the last 6 months 6.Anatomical defects that preclude use of the device7.PVR> 100 ml8.VLPP > 100 cmH2O on urodynamic testing9.Primary pelvic pain syndrome10.Obvious clinically demonstrated genuine stress incontinence11.Presence of cystocele, enterocele or rectocele of grade 3 or 4 (if applicable)12.Any neurological disease or disorder13.Current urinary tract infection or chronic inflammation, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, urethritis, vesicourethral reflux, etc.)14.Pelvic radiotherapy and chemotherapy15.Morbid obesity 16.Severe uncontrolled diabetes17.Any severe heart disease18.Patients requiring frequent magnetic resonance imaging (MRI) exams19.Current pregnancy or attempting to get pregnant (female patient)20.Patient with uncontrolled bleeding coagulopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in number of leaking episodes/day.[Measured by comparing the baseline symptoms to those observed during the treatment at follow up visit taken place at 1, 3, 6 and 12 months post device activation, as recorded by the patinet in the voiding diary for 3 consecutive days, prior to the follow up visit.]

Secondary Outcome Measures

Name	Time	Method
1. Clinical success rate. Clinical success is defined as the effect of the miniaturo™-I treatment on improvement of the following symptoms:<br>a. Leaking episodes/day<br>b. Number of voids/day<br>c. Degree of urgency prior to void (number of moderate to severe episodes)<br>d. Percent of patients with a >50% improvement in frequency and/or urgency at 3, 6,and 12 months [At 3, 6 and 12 months];2. Improvement in Quality of Life as measured on questionnaire[];3. The number of serious device related adverse events [Within the first 3 months post intervention.];4. SAE[At 6 and 12 months. ]