Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217328
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-01-03
Brief Title:
RESTORE An RCT to Evaluate the Efficacy of the Revi System
Sponsor:
BlueWind Medical
Organization:
BlueWind Medical
Study Overview
Official Title:
A Prospective Randomized Control Trial to Compare the Efficacy of the Revi System Therapy on Versus Off in Relieving Urinary Urge Incontinence Episodes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency
Detailed Description:
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 12 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 21 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
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 12 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 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None