Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347575
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2023-10-02
Brief Title:
Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function a Pilot Study in Spinal Cord Injured Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
CAVERSTIM
Brief Summary:
The main objective of the study is to assess the safety and tolerability of cavernous nerve electrical stimulation in patients with spinal cord injured SCI by assessing and measuring complications
As the secondary objectives despite the limited cohort size this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse as well as to assess patients satisfaction using
Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device
Subjective assessment of the erectile function with validated questionnaires
1 A 6-item self-report instrument assessing male erectile function Erectile Function domain of the International Index of Erectile Function IIEF-EF
2 A log-diary five item questionnaire completed after each sexual attempt Sexual Encounter Profile SEP
3 A self-reporting measure that scores erection hardness on a 4-point scale Erection Hardness Score EHS
4 The Global Assessment Question GAQ
In addition the study aims to refine the method of implantation step-by-step delineation of all technical approaches for device implantation including duration of surgical procedure blood loss methods to access the periprostatic region tissue dissection device placement and fixation prior to planning for larger scale clinical investigation
As the secondary objectives despite the limited cohort size this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse as well as to assess patients satisfaction using
Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device
Subjective assessment of the erectile function with validated questionnaires
1 A 6-item self-report instrument assessing male erectile function Erectile Function domain of the International Index of Erectile Function IIEF-EF
2 A log-diary five item questionnaire completed after each sexual attempt Sexual Encounter Profile SEP
3 A self-reporting measure that scores erection hardness on a 4-point scale Erection Hardness Score EHS
4 The Global Assessment Question GAQ
In addition the study aims to refine the method of implantation step-by-step delineation of all technical approaches for device implantation including duration of surgical procedure blood loss methods to access the periprostatic region tissue dissection device placement and fixation prior to planning for larger scale clinical investigation
Detailed Description:
Depending on the location and whether the spinal cord lesion is complete or not oral medications phosphodiesterase type 5 PDE5-Is inhibitors eg Viagra may be more or less effective in improving erectile function When these drugs are not sufficiently effective the second-line pharmacological treatment for SCI patients consists of intracavernous injections Treatment by intracavernous injections is responsible for additional constraints Indeed a titration must be carried out in a doctors office important to minimize the risk of priapism Specific learning of the injection technique must also be implemented for the patient andor his partner the identification of the injection site laterally in the cavernous bodies at an angle of 90 with respect to the long axis of penis avoiding the urethra and subcutaneous veins and aseptic handling The use of intracavernous injections is often abandoned by patients due to a high level of discomfort complicated self-injection or lack of spontaneity during sexual intercourse In patients with SCI intracavernous injections of prostaglandin E1 fail to induce a sufficiently rigid erection in 20 of them Vacuum device is another option Nevertheless it may be perceived as cumbersome and lacking of spontaneity In case of failure or lack of acceptance of intracavernous injections and vacuumdevice the penile implant which consists of a pair of malleable or inflatable cylinders surgically implanted in the cavernous bodies previously destroyed surgically is the third-line treatment However penile implants have an increased risk of infection in patients with SCI according to two large studies Thus effective acceptable and safe treatment alternatives are sought by patients with SCI who are insufficiently responsive to oral treatments
The concept of electro-neurostimulation therapy to activate the cavernous nerves for erectile dysfunction was introduced two decades ago Despite its recognized potential and the first promising studies confirming the feasibility of peri-prostatic cavernous nerve stimulation this technology has not yet been developed The difficulty lies in the complex anatomy of the human cavernous nerve Indeed it is difficult to identify the optimal site for stimulation because the human cavernous nerve is not visible on a macroscopic scale and extends from the pelvic plexus to the penis through a peri-vesical and peri-prostatic neuroplexus whose anatomy is complex In addition the course of the cavernous nerve is subject to strong interindividual variability In addition to these intrinsic anatomical problems other difficulties are encountered during the surgical intervention such as the presence of overlying tissues connective tissue and potential bleeding obstructing the operative field thus making the optimal placement of the implants complex The main difficulty in applying neurostimulation to the treatment of erectile dysfunction is therefore to identify the stimulation site to place the stimulation electrodes in optimal contact with the cavernous nerve
A practical solution was invented by a patch with twelve electrodes This solution was designed to promote extensive contact with the cavernous nerve The concept was developed to allow implantation of the electrodes regardless of the visibility of the cavernous nerve bundles This concept makes it possible to globally cover the anatomical region of interest where the cavernous nerve is supposed to be located while taking into account the great heterogeneity of its course This approach then guarantees optimal contact of at least a few electrodes with the cavernous nerve and thus offers optimal stimulation conditions
The multi-electrode patches will be implanted during a robotic laparoscopic surgical procedure A stimulation test will be performed during the operation to ensure that the patient responds to stimulation erectile response before the device is permanently implanted Following the recovery of the patient the selection of the stimulation parameters will be carried out on an outpatient basis in order to identify the electrodes which gives the best erectile response The electrodes in contact with the cavernous nerve bundles causing the maximum erectile response will then be selected and recorded for stimulationtherapy
The concept of electro-neurostimulation therapy to activate the cavernous nerves for erectile dysfunction was introduced two decades ago Despite its recognized potential and the first promising studies confirming the feasibility of peri-prostatic cavernous nerve stimulation this technology has not yet been developed The difficulty lies in the complex anatomy of the human cavernous nerve Indeed it is difficult to identify the optimal site for stimulation because the human cavernous nerve is not visible on a macroscopic scale and extends from the pelvic plexus to the penis through a peri-vesical and peri-prostatic neuroplexus whose anatomy is complex In addition the course of the cavernous nerve is subject to strong interindividual variability In addition to these intrinsic anatomical problems other difficulties are encountered during the surgical intervention such as the presence of overlying tissues connective tissue and potential bleeding obstructing the operative field thus making the optimal placement of the implants complex The main difficulty in applying neurostimulation to the treatment of erectile dysfunction is therefore to identify the stimulation site to place the stimulation electrodes in optimal contact with the cavernous nerve
A practical solution was invented by a patch with twelve electrodes This solution was designed to promote extensive contact with the cavernous nerve The concept was developed to allow implantation of the electrodes regardless of the visibility of the cavernous nerve bundles This concept makes it possible to globally cover the anatomical region of interest where the cavernous nerve is supposed to be located while taking into account the great heterogeneity of its course This approach then guarantees optimal contact of at least a few electrodes with the cavernous nerve and thus offers optimal stimulation conditions
The multi-electrode patches will be implanted during a robotic laparoscopic surgical procedure A stimulation test will be performed during the operation to ensure that the patient responds to stimulation erectile response before the device is permanently implanted Following the recovery of the patient the selection of the stimulation parameters will be carried out on an outpatient basis in order to identify the electrodes which gives the best erectile response The electrodes in contact with the cavernous nerve bundles causing the maximum erectile response will then be selected and recorded for stimulationtherapy
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