CLINICAL TRIAL / NCT06217328
RESTORE: An RCT to Evaluate the Efficacy of the Revi System
- Interventional
- Active
- NCT06217328
Contact Information
- Jinxuan Shi
A Prospective Randomized Control Trial to Compare the Efficacy of the Revi System Therapy on Versus Off in Relieving Urinary Urge Incontinence Episodes.
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
Prospective, multi-center, open label, post market, randomized controlled trial
To demonstrate superiority of Revi System therapy vs. non active therapy in the treatment
of UUI
Treatment Arm:
Device: Revi System Subjects will be implanted with a Revi System and activation of
therapy will occur ~4 weeks post implantation and continue for the duration of the study.
Control Arm:
Device: Revi System - Delayed Activation Subjects will be implanted with a Revi System
and activation of therapy will be delayed until 4 months post implantation. At this time
the Revi System will be activated to begin therapy and will continue for the duration of
the study.
Randomization in a 1:2 ratio into either the "control group" or the "treatment group"
will be performed in blocks of 3 or 6 randomly, across the study population by a central
randomization system. Randomization will be stratified by investigational site.
The study will consist of the following activities:
Visit 1 - Screening
- Potential subjects with UUI, who fulfil basic criteria will be informed of the study
and will be invited to sign an informed consent form.
- Demographic information (age, race, height and weight, leg circumference), medical
and surgical history and concomitant medication information will be collected.
- Study candidates will be asked to fill out various questionnaires
- Patients will be asked to complete a 3- consecutive day voiding diary.
- Urine sample will be collected, blood will be drawn and a full physical examination,
including a PVR measurement and uroflow (in men), will be performed.
Visit 2 - Randomization & Implantation
- 5 ± 4 weeks after starting the diary, eligible subjects will be randomized to either
the Treatment or Control (delayed activation) arms (2:1) and will undergo unilateral
implantation with the BlueWind Revi System
- Collection of AE and concomitant medication will be performed
Treatment Arm:
Visit 3 - Activation
- After a recovery period of 4-weeks post implantation, subjects will attend the
clinic to undergo physical examination and surgical wound check-up.
- Subjects will undergo parameter setting according to the individual patient
sensations and will be trained on the use of the system.
Visits 4-11 - Treatment optimization and follow up
- Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system
activation.
- A call visit will be performed at 18-months.
- All follow-up visits will require completion of a 3-day voiding diary by the patient
before coming to the visit.
- During each clinic visit, stimulation parameters and level of treatment will be
checked and adjusted as needed.
Control Arm:
• After a recovery period of 1-month post implantation, subjects will attend the clinic
to undergo physical examination and surgical wound check-up.
Visit 4 - Activation
- After a recovery period of 4-weeks post implantation, subjects will attend the
clinic to undergo physical examination and surgical wound check-up.
- Subjects will undergo parameter setting according to the individual patient
sensations and will be trained on the use of the system.
Visits 5-12 - Treatment optimization and follow up
- Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system
activation.
- A call visit will be performed at 18-months.
- All follow-up visits will require completion of a 3-day voiding diary by the patient
before coming to the visit.
- During each clinic visit, stimulation parameters and level of treatment will be
checked and adjusted as needed.
Gender
All
Age Group
21 Years and up
Accepting Healthy Volunteers
Accepts Healthy Volunteers
Inclusion Criteria:
1. Signed written informed consent.
2. Subject is at least 21 years old, with no plans to become pregnant during the trial.
If of child bearing potential and sexually active, negative pregnancy test and using
acceptable contraception.
3. Subject has been diagnosed with UUI for at least 6 months.
4. Subject experiences a minimum of four (4) leaking episodes associated with urgency,
with at least one episode per day for 2 days documented on a voiding diary for 3
consecutive days.
5. If used, subject should be on stable dose of antimuscarinics and/or beta-3
adrenergic agonists for at least 1 month prior to baseline and agree to remain on
stable medication consumption until the 24-month follow-up visit.
6. If used, subject should be on a stable dose of tricyclic antidepressants, Selective
Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake
Inhibitors (SNRI) for at least 3 months prior to baseline.
7. Subject agrees to attend all follow-up evaluations and is willing and capable to
completely and accurately fill out voiding diaries and questionnaires and is willing
to complete required exams and test
Exclusion Criteria:
1. Subject participation in a clinical investigation with an active treatment arm
within the past 90 days.
2. Subject is a high surgical risk with multiple illnesses or active general infections
that expose them to excessive bleeding or delayed or non-healing wounds. This
includes patients who need anticoagulation therapy that cannot be temporarily
stopped for the implantation procedure.
3. Subject with BMI >50.
4. Subject with any metal or other implant within 20cm distance of the area of BlueWind
Revi implantation site.
5. Subject variation in diuretics consumption within the last 6 months.
6. Subject has received botulinum toxin injections for OAB within the past 12 months.
7. Subject with previous urinary incontinence surgery or prolapse surgery within the
last 12 months.
8. Subject has had any spinal or genitourinary surgery within the last 6 months.
9. Subject had previous abdominoperineal resection of the rectum or radical
hysterectomy (female)/ prostatectomy (male).
10. Subject with diagnosis of BPH with outflow/obstructive predominant symptoms.
11. Subject has skin, peripheral edema, orthopedic or neurologic anatomical limitations
that preclude implantation or/and use of the device.
12. Subject with Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or injury
resulting in neuropathy and/or suspected neurogenic bladder.
13. Subject has recurrent urinary tract infections (3 or more infections in the last 6
months), or presence of urinary fistula, or urinary tract obstruction such as
cancer, urethral stricture or presence of urinary stone.
14. Subject with history of chemotherapy or pelvic radiotherapy that might have affected
bladder control or caused neuropathies (i.e. peripheral neuropathy).
15. Male subject who have obstructive Benign Prostatic Hyperplasia (BPH) or other lower
urinary tract obstructions.
16. Subject has open wounds or sores on the lower leg or foot or had previous, unhealed
trauma in the implant area or has pitting edema (≥2+) in the lower leg.
17. Subject has Venous or Arterial disease/insufficiency in the lower leg or Vasculitis
or dermatologic condition in the lower leg or infections near the implantation site
in the lower leg.
18. Subject has a documented history of allergic response to Platinum iridium, Titanium,
Zirconia, Gold, Silicone or Parylene.
19. Subject has other active implantable electronic device/s regardless of whether
stimulation is ON or OFF.
20. Subject has a life expectancy of less than 1 year.