Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000390482
Ethics application status
Approved
Date submitted
17/07/2007
Date registered
24/07/2007
Date last updated
24/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
AMS miniaturo™-I system for treatment of Urinary Urge Incontinence
Scientific title
Performance of the miniaturo™-I system for treatment of Urinary Urge Incontinence to improve the number of leaking episodes
Universal Trial Number (UTN)
Trial acronym
miniaturo™-I system for UUI treatment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female patients with Urinary Urge Incontinence 1972 0
Condition category
Condition code
Renal and Urogenital 2070 2070 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The period of the study is 12 months (1 year). The research itself will last for several more years until all patients are recruited and have completed the study.

The miniaturo ™-I therapy involves two stages:
a. miniaturo™-I test system (MTS-I) - An ambulatory procedure in which the miniaturo™-I (temporary) test system (MTS-I) is evaluated for at least 48 hours to allow you to experience the effects of stimulation on your symptoms and make an informed choice about the risks and benefits of pursuing the therapy.

b. Surgical implantation of the system - permanent implantation of the miniaturo™-I system in suitable patients where the MTS-I test was successful.

Patients who get relief from their urinary incontinence symptoms with the test system would then be offered the long-term implant.
Before patient will try the test system the principal doctor will go through the patient medical history and will ask the patient to have an urodynamics test. This testing involves taking pressure measurements form the bladder and urethra (the tube from which we urinate) using a small catheter and from the vagina or rectum using a second small catheter while the bladder is filled with sterile water. The test is routinely performed on women with bladder control problems. The patient will be given one dose of an antibiotic before the urodynamics testing in order to minimise the chance of getting a urinary tract infection. this test would need to be repeated if it has not been done within the last 6 months. The doctor will also collect a blood and urine sample to test for urinary tract infection and blood will be taken (about 2 to3 teaspoons or 10-15ml) from an arm vein. These samples will be processed in the hospital laboratory and samples will be destroyed as per routine tests. These are routine examinations done to patients diagnosed with Urinary Incontinence.
miniaturo™-I Test System (MTS-I) is the first step of miniaturo ™-I therapy. The MTS-I consists of electrical stimulating device, about the size of a cigarette lighter that is worn on a pouch belt around the patient waist. The electrostimulator delivers mild intermittent electrical pulses to the pelvic muscles. The lead would be placed in a very small cut near the vagina. This procedure will be performed under local or general anaesthetic to minimise discomfort. After placement of this trial system patient will need to wear it for at least 48 hours.

After being connected to the test system the doctor will set the best stimulation level, using a communication system, according to patient's sensations (comfortable, but aware of the stimulation). Once individual settings have been programmed, the patient will receive an explanation about how to use the temporary device.

The patient will be asked to wear the system for at least 48 hours and record in the Urinary Incontinence diary how the therapy affects the urinary related symptoms. the symptoms may improve or even completely disappear. Whenever an event of discomfort is felt, the patient is asked to turn the system OFF using the safety magnet that will be given to the patient, and immediately contact the treating doctor. Before the patient will go home she will be asked to spend a couple of hours in the clinic just to make sure that the stimulation is comfortable and not painful.
During the MTS-I test the patient will be asked not to alter her daily fluid intake and to record her bladder symptoms in the diary. the patient will be asked not to take a bath or a shower in order to avoid getting the system wet or pulling the lead out by accident. The patient will be asked to avoid sexual intercourse during the test period to prevent lead displacement.

The test procedure has several advantages.
• It’s a temporary procedure in which the patient can learn whether the miniaturo™-I therapy can help you without committing to a long-term treatment.
• It allows the patient to “test drive” the miniaturo™-I therapy.
• It allows the patient to feel what stimulation is like.

At the end of the 48 hour test, the system is removed by the doctor while the patient is still in hospital. Based on the results of the patient test trial, the doctor may recommend an implantable miniaturo™-I system to improve your bladder symptoms.

miniaturo™-I implantation
The implantation of the miniaturo™-I system is the beginning of the second stage of the study. The electrostimulator and stimulation lead are both implanted under the skin under local or general anaesthetic (depending upon the patient choice after discussion with the Anaesthetist). Doctors usually implant the miniaturo ™-I system in two steps: First, the stimulation lead and then the electrostimulator. This entire procedure typically takes 25 to 40 minutes and is performed in the operating theatre. The patientwill be prescribed antibiotic medication in order to reduce the risk of infection after the surgery and can go home the same day if feeling comfortable.

In order to implant the system, the doctor will make two small cuts:
One 4 cm cut in your lower abdomen just above the pubic bone, where the electrostimulator is positioned; the second a tiny cut, where the stimulation lead tip is inserted near the vaginal opening.

System activation visit
Two weeks after the procedure, the patient will return to your clinic, where the doctor will remove the sutures and will set the stimulation levels for you, using a communication system connected to a laptop computer. The stimulation level will be set according to patient's sensations (comfortable, but aware of the stimulation).
The patient will receive a safety magnet that allows her to control the internal device by switching it ON or OFF (identical to the one used during MTS-I procedure) if you feel it is necessary.


Follow up visits
The patient will be asked to attend follow-up visits 1, 3, 6 and 12 months after the activation of the implanted system. Each visit will last approximately 20 minutes at the doctor’s clinic. Between the visits the patient will be asked to complete the Urinary Incontinence diary for 3 consecutive days to record how the treatment affects her voiding symptoms.
The change in symptoms will be estimated according to the patient personal impressions. The patient symptoms may remain the same, worsen, improve, completely disappear or may not alter. It is unexpected though possible that the sensations would be worse. During these visits, the patient will be asked to fill in a quality of life questionnaire. Additionally, the patient may discuss her urinary symptoms with her doctor and decide whether the stimulation levels need adjustment. If so, the doctor will be able to make the necessary changes.

Once the study is over the patient will continue to be followed up by her doctor every six months for a period of 5 years. The sponsor will collect the data collected in these visits.
Other than the above visits, the patient are not expected to need to visit the GP more often than for her usual treatment.
Intervention code [1] 1893 0
Treatment: Devices
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3160 0
Improvement in number of leaking episodes/day.
Timepoint [1] 3160 0
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 [1] 4900 0
1. Clinical success rate. Clinical success is defined as the effect of the miniaturo™-I treatment on improvement of the following symptoms:
a. Leaking episodes/day
b. Number of voids/day
c. Degree of urgency prior to void (number of moderate to severe episodes)
d. Percent of patients with a >50% improvement in frequency and/or urgency at 3, 6,and 12 months
Timepoint [1] 4900 0
At 3, 6 and 12 months
Secondary outcome [2] 4901 0
2. Improvement in Quality of Life as measured on questionnaire
Timepoint [2] 4901 0
Secondary outcome [3] 4902 0
3. The number of serious device related adverse events
Timepoint [3] 4902 0
Within the first 3 months post intervention.
Secondary outcome [4] 4903 0
4. SAE
Timepoint [4] 4903 0
At 6 and 12 months.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2216 0
Commercial sector/Industry
Name [1] 2216 0
Industry-American Medical Systems Holdings Inc
Country [1] 2216 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
American Medical Systems Australia
Address
Country
Australia
Secondary sponsor category [1] 1999 0
Commercial sector/Industry
Name [1] 1999 0
American Medical Systems Holdings Inc
Address [1] 1999 0
Country [1] 1999 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4053 0
Royal Hospital For Women
Ethics committee address [1] 4053 0
Barker Street, Randwick NSW 2031
Ethics committee country [1] 4053 0
Australia
Date submitted for ethics approval [1] 4053 0
Approval date [1] 4053 0
Ethics approval number [1] 4053 0
Ethics committee name [2] 4054 0
Sydney Adventist Hospital
Ethics committee address [2] 4054 0
185 Fox Valley Road, Wahroonga NSW 2076
Ethics committee country [2] 4054 0
Australia
Date submitted for ethics approval [2] 4054 0
Approval date [2] 4054 0
Ethics approval number [2] 4054 0

Summary
Brief summary
The purpose of this project is to determine whether miniaturo™-I, a new medical device, is safe and effective to use for the treatment of female Urinary Urge Incontinence (UUI). UUI (also called overactive bladder or unstable bladder) is characterized by a sudden need to urinate (Urgency), followed by a strong contraction of the bladder, resulting in involuntary leakage of urine. Usually increased frequency and Nocturia symptoms are part of this condition
Frequency - increased daytime frequency is the complaint of voiding too often by day.
Nocturia is the complaint of voiding twice or more at night.
UUI can have a profound effect on patients’ quality of life (QOL) producing social, psychological, occupational, domestic, physical and sexual problems.
This distressing condition can influence anyone at any age. Worldwide, UUI syndrome is estimated to affect about 17 million people in the developed world. People with UUI symptoms do not seek help for their condition for many reasons including embarrassment and lack of awareness that the symptoms are abnormal at any age and can be managed effectively.
miniature™-system is an experimental, electrical stimulator system which is not registered or approved for use for treatment for Urinary Urge Incontinence in Australia. The system consists of an electrostimulator and a stimulation lead which are both implanted under the skin. The stimulator delivers mild electrical pulses via the stimulation leads to the pelvic floor muscles.
The study will last for a period of about 1 year. However, once the study is over, you will continue to be looked after by your doctor for a period of up to 5 years after the surgery.

Although there are many treatment options for patients with UUI syndrome, all have limitations and some are associated with significant side effect that may reduce acceptance by UUI patients.
The miniaturo™-I is designed to provide an innovative solution for treatment of UUI to patients who have found other conservative treatments ineffective or not well tolerated. The miniaturo™-I therapy provides mild electrical stimulation to the pelvic floor transferred by an implantable system. The implantation procedure is a short and minimal risk procedure. We hope to bring symptom relief and improved quality of life to UUI patients.

The safety of the system will be determined by counting the number of problems that occur during the study, such as pain or discomfort, or more serious problems that might need admission to hospital.
Improvement after implant of the miniaturo™-I therapy was demonstrated in various aspects of quality of life based on patient’s questionnaire.

A total of 30 patients will be recruited to this study worldwide and up to 20 of them will be recruited in Australia.
You are invited to participate in the study, because your physician believes that the condition from which you suffer may benefit from application of the device under investigation.

This study is being conducted internationally by the manufacturer of the device:

American Medical Systems, Inc.
Tel: +1 952 930 6000
Fax: +1 952 930 6007
Who specialises in developing and marketing of advanced implantable devices. They will pay your medical expenses to the centre to include you in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27707 0
Address 27707 0
Country 27707 0
Phone 27707 0
Fax 27707 0
Email 27707 0
Contact person for public queries
Name 11082 0
Ann Duncan
Address 11082 0
Royal Melbourne Hospital
Royal Parade
Parkville Melbourne VIC 3050
Country 11082 0
Australia
Phone 11082 0
03 5974 2245
Fax 11082 0
Email 11082 0
[email protected]
Contact person for scientific queries
Name 2010 0
Ann Duncan
Address 2010 0
Royal Melbourne Hospital
Royal Parade
Parkville Melbourne VIC 3050
Country 2010 0
Australia
Phone 2010 0
03 5974 2245
Fax 2010 0
Email 2010 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.