Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence

NCT05449639 | Unknown

• 1 other identifier: CIP-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

A second no-random open interventional pilot study sponsored by Relief srl

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  60 days

Secondary Outcomes (1)

• Efficacy of the implantation on the disease

  90 days

Study Arms (1)

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.

Device: Relief implantation

Interventions

Relief implantation DEVICE

The device will be implanted by endoscopic procedure by a standard resectoscope.

Main group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• flexible cystoscopy demonstrating sphincter dysfunction and excluding stenosis of the urethra or vesicourethral anastomosis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Relief srl: lead
• Donawa Lifescience: collaborator

Study Sites (3)

Casa di Cura San Camillo

Forte dei Marmi, Lucca, 55045, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana UO Urologia

Pisa, 56124, Italy

RECRUITING

Policlinico Universitario Campus Bio-Medico UOC Urologia

Roma, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: July 8, 2022
• Study Start: August 17, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)