Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05650866




Registration number
NCT05650866
Ethics application status
Date submitted
28/11/2022
Date registered
14/12/2022
Date last updated
31/01/2024

Titles & IDs
Public title
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Scientific title
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction Following Radical Prostatectomy
Secondary ID [1] 0 0
CP-1.5400
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction Following Radical Prostatectomy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Activation of pro-erectile nerves within the pelvic plexus

Experimental: Implanted group - The study device will be implanted during the ongoing prostatectomy surgery. Participants will then be asked to activate it everyday.

No Intervention: Control group - Participants in the control group will undergo standard prostatectomy and will not be implanted with the study device.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of adverse events
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Occurrence of surgical complications
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Occurrence of device deficiencies
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Pain
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
Objective Device effectiveness
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Subjective Device effectiveness
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Erectile function recovery
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Delineation of the surgical implantation procedure
Timepoint [4] 0 0
6 months

Eligibility
Key inclusion criteria
- 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.
Minimum age
30 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/05/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
Australian Prostate Centre - North Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
3051 - North Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Comphya Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05650866
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fiona Joseph
Address 0 0
Country 0 0
Phone 0 0
+41 21 693 9517
Fax 0 0
Email 0 0
fiona.joseph@comphya.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05650866