Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

Официальное название

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy

Обзор

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.

Вмешательства

• Устройство Activation of pro-erectile nerves within the pelvic plexus
  The study device is an active implantable device. The device activates the cavernous nerves by delivering electrical pulses, to trigger an on-demand erection. The daily delivery of electrical pulses to the cavernous nerves will also allow participants to recover natural erectile function.

Первичные конечные точки

• Occurrence of adverse events [Срок оценки: 6 months]
• Occurrence of surgical complications [Срок оценки: 6 months]
• Occurrence of device deficiencies [Срок оценки: 6 months]
• Pain [Срок оценки: 6 months]

Вторичные конечные точки (4)

• Objective Device effectiveness [Срок оценки: 6 months]
• Subjective Device effectiveness [Срок оценки: 6 months]
• Erectile function recovery [Срок оценки: 6 months]
• Delineation of the surgical implantation procedure [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Men of ages between 30-70 years;
• Men with indication for nerve-sparing prostatectomy surgery;
• Localised prostate cancer considered suitable for bilateral nerve sparing prostatectomy according to clinical criteria
• International Index of Erectile Function (IIEF-15) erectile function domain score equal to or greater than 26 prior prostatectomy;
• Men interested in minimizing the effect of radical prostatectomy on erectile function;
• Ability to read and understand patient information materials and willingness to sign a written informed consent.

Критерии исключения

• Men with neurological disease, including a history of spinal cord injury or trauma;
• IIEF-15 erectile function domain score less than 26 prior prostatectomy;
• Failure to demonstrate adequate nocturnal erectile function prior prostatectomy;
• History of erectile dysfunction, priapism and Peyronie disease;
• History of previous pelvic surgery, trauma or irradiation therapy;
• Currently have an active implantable device;
• Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions;
• Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation;
• Inability to understand and demonstrate device use instructions;
• Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications;
• Patient unwillingness to engage in sexual activity;
• Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function;
• Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months;
• Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study;
• Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 4 центра

• St. Vincent's Private Hospital — Fitzroy
• Royal Melbourne Hospital — Melbourne
• Australian Prostate Centre — North Melbourne
• Epworth HealthCare — Richmond

Идентификаторы

NCT: NCT05650866 · CP-1.5400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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