Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy

Prostate Cancer Clinical Trial

— PRP-NR  

Official title:

Pilot Trial: Pilot Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458855
• Other study ID #: 2024-4130
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Victor McPherson, MD
• Phone: 514-340-8222
• Email: victor.mcpherson[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 10 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).

Description:

The investigators are proposing a single arm prospective pilot study evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing the PRP-NR procedure. A total of 10 patients will undergo the PRP-NR procedure, which is a novel nerve grafting procedure which will utilize a graft of the ilioinguial nerve to perform a bilateral end to side connection between the dorsal penile nerve and the corpora cavernosa with the intent to restore erectile function. Participants will have a baseline evaluation with IIEF-5 and SF-MPQ questionnaires, and then will have re-evaluation with these questionnaires at their standard of care post operative visits at 4 weeks, 3-, 6-, 12-, 18- and 24- months. Post operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with persistent post prostatectomy erectile dysfunction more than 18 months from prostatectomy and which results in the inability to achieve intercourse with the aid of PDE5-I medications.

2. Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of =17 on self-reported assessment of historic function.

Exclusion Criteria:

1. Patients with previous pelvic radiotherapy

2. Patients aged < 18 years at diagnosis

3. Legally incapable patients

4. Patients who are unable to complete questionnaires and have no companion to help complete them

5. Patients with pre-existing neurologic disease

6. Patients with a history of bilateral surgeries for inguinal hernia repair.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Prostate Cancer

Intervention

Procedure:
• Post radical prostatectomy nerve restoration procedure (PRP-NR)
A somatic to autonomic nerve grafting procedure which will use a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is specifically the safety of the operation. This will be measured by adverse events as defined by the Clavian-Dindo classification.The measurement varies from Grade I (Best possible outcome) to Grade V (Worst possible outcome).	Grade I - Deviation from normal p/o course. No pharmacological or surgical treatment, endoscopic or radiological interventions were required. Acceptable therapeutic drugs such as anti-emetics, antipyretics, analgesics, diuretics,electrolytes, physiotherapy. Wound infections, small abscess requiring incision at bedside.; Grade II - Normal course altered. Pharmacological management other than in Grade I. Blood transfusions and total parenteral nutrition are also included.; Grade III - Complications that require intervention of various degrees. Grade IIIa are complications that require an intervention performed under local anaesthesia. Grade IIIb are interventions that require general or epidural anaesthesia.; Grade IV - Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade IVa are single organ dysfunction (including dialysis). Grade IVb is multi-organ dysfunction.; Grade V - Death of a patient.	Through study completion, an average of 2 years
Secondary	International Index of Erectile Function-5 (IIEF-5)	The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool.; Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).	4 weeks post PRP-NR
Secondary	International Index of Erectile Function-5 (IIEF-5)	The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool.; Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).	3 months post PRP-NR
Secondary	International Index of Erectile Function-5 (IIEF-5)	The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool.; Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).	6 months post PRP-NR
Secondary	International Index of Erectile Function-5 (IIEF-5)	The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool.; Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).	12 months post PRP-NR
Secondary	International Index of Erectile Function-5 (IIEF-5)	The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool.; Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).	18 months post PRP-NR
Secondary	International Index of Erectile Function-5 (IIEF-5)	The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool.; Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).	24 months post PRP-NR
Secondary	Short Form McGill Pain Questionnaire (SF-MPQ)	The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.; The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)	4 weeks post PRP-NR
Secondary	Short Form McGill Pain Questionnaire (SF-MPQ)	The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.; The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)	3 months post PRP-NR
Secondary	Short Form McGill Pain Questionnaire (SF-MPQ)	The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.; The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)	6 months post PRP-NR
Secondary	Short Form McGill Pain Questionnaire (SF-MPQ)	The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.; The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)	12 months post PRP-NR
Secondary	Short Form McGill Pain Questionnaire (SF-MPQ)	The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.; The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)	18 months post PRP-NR
Secondary	Short Form McGill Pain Questionnaire (SF-MPQ)	The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.; The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)	24 months post PRP-NR