RecruitingPhase 1ACTRN12607000390482

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

Performance of the miniaturo™-I system for treatment of Urinary Urge Incontinence to improve the number of leaking episodes

Sponsor

American Medical Systems Australia

Enrollment

30 participants

Start Date

Aug 1, 2007

Study Type

Interventional

Conditions

Female patients with Urinary Urge Incontinence

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.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new implantable device called miniaturo-I for women with urinary urge incontinence (UUI) — also known as overactive bladder. UUI causes a sudden, urgent need to urinate, often followed by accidental leaking. It can seriously affect daily life, sleep, and emotional wellbeing. The device is implanted under the skin and delivers gentle electrical pulses to the pelvic floor muscles to control bladder urges. This study will assess whether the device is safe and whether it reduces leakage and urinary urgency over about 1 year, with follow-up continuing for up to 5 years. You may be eligible if: - You are a woman aged 18 years or older - You have tried other treatments for overactive bladder for at least 6 months without adequate improvement (including lifestyle changes and medications) - You have confirmed overactive bladder (shown on bladder tests) - You have urge leakage more than 5 times per day - You urinate more than 10 times per day and at least 3 times per night You may NOT be eligible if: - You have an existing implanted device (such as a pacemaker) - You have had urinary incontinence surgery or pelvic surgery in the last 6 months - You have a neurological disease or disorder - You have a current urinary tract infection, bladder stone, or bladder cancer - You are pregnant or trying to become pregnant - You have morbid obesity, severe uncontrolled diabetes, or serious heart disease - You have received pelvic radiation or chemotherapy Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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 involve

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.

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12607000390482