Urinary IncontinenceRELIEF-2NCT05449639
Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence
A study testing Relief implantation in people with Urinary Incontinence, run by Relief srl at 3 sites in Italy.
Trial summary
A second no-random open interventional pilot study sponsored by Relief srl Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Relief implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesItaly
- Study dates
- 17 Aug 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Casa di Cura San Camillo
Forte dei Marmi, Lucca, 55045
Massimo Cecchi, Dott., mascecchi@gmail.com
- Recruiting
Azienda Ospedaliero Universitaria Pisana UO Urologia
Pisa, 56124
Giorgio Pomara, Prof., g.pomara@ao-pisa.toscana.it
- Recruiting
Policlinico Universitario Campus Bio-Medico UOC Urologia
Roma, 00128
Rocco Papalia, Prof., rocco.papalia@unicampus.it
About this study
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
A second no-random open interventional pilot study sponsored by Relief srl
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Relief implantation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relief implantationDevice
The device will be implanted by endoscopic procedure by a standard resectoscope.
| Study group | Role | What they receive |
|---|---|---|
| Main group | Experimental | 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. Receives: Device: Relief implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
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.
Measured: 60 days
Secondary outcomes (1)
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start17 Aug 2022
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Relief srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449639
- Sponsor's protocol ID
- CIP-002
- Acronym
- RELIEF-2
- Status last verified
- Feb 2023
- First submitted
- 7 Jun 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05449639
- Acronym / sponsor ID
- RELIEF-2 / CIP-002
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Relief srlIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main group | Experimental | Device: Relief implantationA 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relief implantationThe device will be implanted by endoscopic procedure by a standard resectoscope. | Device | Main group |
Primary outcome
Absence of post-operative symptoms
Time frame: 90 days
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
Time frame: 60 days
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.
1 secondary outcome
Efficacy of the implantation on the disease
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relief implantation in people with Urinary Incontinence, run by Relief srl at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of post-operative symptoms (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.