Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05449639
Status:
RECRUITING
Last Update Posted:
2023-03-02
First Post:
2022-06-07
Brief Title:
Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence
Sponsor:
Relief srl
Organization:
Relief srl
Study Overview
Official Title:
Multicentric Pilot Study for the Application of a Magnetic Endourethral Sphincter for the Treatment of Secondary Stress Urinary Incontinence Damage to the Urethral Sphincter
Status:
RECRUITING
Status Verified Date:
2023-02
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:
RELIEF-2
Brief Summary:
A second no-random open interventional pilot study sponsored by Relief srl
Detailed Description:
The first pilot study where the device was implanted on 6 human patients for 28 days demonstrated that the magnetic urethral sphincter was successfully implanted and explanted in all patients 5 males and 1 female All the procedures have proven ease of implantation and removal 66 100 decent simplicity of the activation and de-activation system and restoring an acceptable urinary continence The majority of patients 56 834 reported a good tolerability of the sphincter Unfortunately only 16 patient 167 was able to complete the 28 days cycle with the urinary sphincter in place in the other 5 patients 833 the sphincter migrated into the bladder due to the lack of a hooking system which was not considered relevant in the design phase and during previous cadaver tests This migration seemed caused by an oversized external magnet producing a large force also in not optimized positioning and by the anatomic variability of patients urethral caliber In one patient the sphincter stayed perfectly in place for all the 28 days its position was checked after 10 days of the implantation by suprapubic ultrasound scan This patient referred excellent urinary continence also with the sphincter in the opened configuration without using the external magnet but by relying only on the valve flexibility without urinary leaks during daily activities and sport activities too No severe side effects or complications or infections occur after the migration of the device in the bladder and during its implantationremoval
The final analysis of data and questionnaires showed that to adapt the magnetic urethral sphincter to the clinical practice a re-design is necessary in order to improve the anchoring system and to optimize the magnetic activation system avoiding bladder migration of the device
In this framework Relief re-designed the device by optimizing the external magnet by improving the proximal anchoring system and by providing with a distal anchoring system The new design was validated by test bench and on cadaver anatomies
The primary objectives of the study were to assess the safety and reproducibility of the implantation of the magnetic endo-urethral sphincter if the procedure was well tolerated by the patients and if possible irritation symptoms due to the device presence emerged in patients with severe stress urinary incontinence where standard medical treatments failed
The final analysis of data and questionnaires showed that to adapt the magnetic urethral sphincter to the clinical practice a re-design is necessary in order to improve the anchoring system and to optimize the magnetic activation system avoiding bladder migration of the device
In this framework Relief re-designed the device by optimizing the external magnet by improving the proximal anchoring system and by providing with a distal anchoring system The new design was validated by test bench and on cadaver anatomies
The primary objectives of the study were to assess the safety and reproducibility of the implantation of the magnetic endo-urethral sphincter if the procedure was well tolerated by the patients and if possible irritation symptoms due to the device presence emerged in patients with severe stress urinary incontinence where standard medical treatments failed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None