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Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence (RELIEF-2)

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Relief implantation
Sponsored by
Relief srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male patients aged from 45 to 85 years-old suffering from secondary Stress Urinary Incontinence (SUI) to prostate surgery in which medical and rehabilitative treatment have failed;
  2. women patients aged from 45 to 85 years-old suffering from SUI in which medical, rehabilitative and surgical treatment have failed;
  3. sterile urine culture;
  4. urodynamic test with evidence of sphincter dysfunction, Valsalva Leak Point Pressure (VLPP) < 60 cm H2O (water) and exclusion of detrusor over-activity;
  5. flexible cystoscopy demonstrating sphincter dysfunction and excluding stenosis of the urethra or vesicourethral anastomosis.

Exclusion Criteria:

  1. No-autonomous patients;
  2. People where the use of magnetic field is not suggested (i.e. patients with pacemaker).
  3. Patients with urinary infections;
  4. Patients with intolerances to the materials included in the sphincter or to expected drug subministration.
  5. Patients already participating a clinical study within the last 30 days.

Sites / Locations

  • Casa di Cura San CamilloRecruiting
  • Azienda Ospedaliero Universitaria Pisana UO UrologiaRecruiting
  • Policlinico Universitario Campus Bio-Medico UOC UrologiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main group

Arm Description

A second no-random open interventional pilot study sponsored by Relief srl. 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 device will be implanted by endoscopic procedure by a standard resectoscope. Up to 20 patients of both gender affected by severe stress urinary incontinence will be involved in the study by means of prospective enrollment.

Outcomes

Primary Outcome Measures

Absence of post-operative symptoms
The primary end-point regarding the tolerability and safety of the device will be verified by interviewing the patient about the appearance of post-operative irritative symptoms and the ease of use of the system. The outcome will be evaluated on the basis of the onset of any surgical complications according to the Clavien-Dindo classification. This classification (consisting of 7 grades such as I, II, IIIa, Illb, IVa, IVb, V) is widely used and has become the standard classification system for many surgical specialties.
Performance of the implantation
Implant performance will be assessed in terms of implant migration via an ultrasound at 10, 30 and 60 days after the application of the magnetic endourethral sphincter, in order to verify the correct positioning and stability of the device.

Secondary Outcome Measures

Efficacy of the implantation on the disease
The secondary end-point about the efficacy of the magnetic endourethral sphincter by the patient will be evaluated through the validated qualitative International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) administered before starting the procedure, at 10, 30, 60 and 90 days.

Full Information

First Posted
June 7, 2022
Last Updated
February 28, 2023
Sponsor
Relief srl
Collaborators
Donawa Lifescience
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1. Study Identification

Unique Protocol Identification Number
NCT05449639
Brief Title
Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence
Acronym
RELIEF-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relief srl
Collaborators
Donawa Lifescience

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (6/6, 100%), decent simplicity of the activation and de-activation system and restoring an acceptable urinary continence. The majority of patients (5/6, 83.4%) reported a good tolerability of the sphincter. Unfortunately, only 1/6 patient (16.7%) was able to complete the 28 days cycle with the urinary sphincter in place: in the other 5 patients (83.3%) 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 implantation/removal. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main group
Arm Type
Experimental
Arm Description
A second no-random open interventional pilot study sponsored by Relief srl. 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 device will be implanted by endoscopic procedure by a standard resectoscope. Up to 20 patients of both gender affected by severe stress urinary incontinence will be involved in the study by means of prospective enrollment.
Intervention Type
Device
Intervention Name(s)
Relief implantation
Intervention Description
The device will be implanted by endoscopic procedure by a standard resectoscope.
Primary Outcome Measure Information:
Title
Absence of post-operative symptoms
Description
The primary end-point regarding the tolerability and safety of the device will be verified by interviewing the patient about the appearance of post-operative irritative symptoms and the ease of use of the system. The outcome will be evaluated on the basis of the onset of any surgical complications according to the Clavien-Dindo classification. This classification (consisting of 7 grades such as I, II, IIIa, Illb, IVa, IVb, V) is widely used and has become the standard classification system for many surgical specialties.
Time Frame
90 days
Title
Performance of the implantation
Description
Implant performance will be assessed in terms of implant migration via an ultrasound at 10, 30 and 60 days after the application of the magnetic endourethral sphincter, in order to verify the correct positioning and stability of the device.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Efficacy of the implantation on the disease
Description
The secondary end-point about the efficacy of the magnetic endourethral sphincter by the patient will be evaluated through the validated qualitative International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) administered before starting the procedure, at 10, 30, 60 and 90 days.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients aged from 45 to 85 years-old suffering from secondary Stress Urinary Incontinence (SUI) to prostate surgery in which medical and rehabilitative treatment have failed; women patients aged from 45 to 85 years-old suffering from SUI in which medical, rehabilitative and surgical treatment have failed; sterile urine culture; urodynamic test with evidence of sphincter dysfunction, Valsalva Leak Point Pressure (VLPP) < 60 cm H2O (water) and exclusion of detrusor over-activity; flexible cystoscopy demonstrating sphincter dysfunction and excluding stenosis of the urethra or vesicourethral anastomosis. Exclusion Criteria: No-autonomous patients; People where the use of magnetic field is not suggested (i.e. patients with pacemaker). Patients with urinary infections; Patients with intolerances to the materials included in the sphincter or to expected drug subministration. Patients already participating a clinical study within the last 30 days. Patients that already have devices/solutions or part of them for the treatment of urinary incontinence.
Facility Information:
Facility Name
Casa di Cura San Camillo
City
Forte dei Marmi
State/Province
Lucca
ZIP/Postal Code
55045
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Cecchi, Dott.
Email
mascecchi@gmail.com
Facility Name
Azienda Ospedaliero Universitaria Pisana UO Urologia
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Pomara, Prof.
Email
g.pomara@ao-pisa.toscana.it
Facility Name
Policlinico Universitario Campus Bio-Medico UOC Urologia
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocco Papalia, Prof.
Email
rocco.papalia@unicampus.it

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The results of this study will be presented at appropriate conferences and presented for publication in peer-reviewed journals. The publication will be completed in line with the contract. The Study Sponsor will collect the data in such a way that no subjects can be identified and will monitor the study records. Participating subjects will not be identified by name in any published study reports.

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Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence

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