Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital

About this trial

The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gleason grade ≥8

PSA ≥20

>pT2 on preoperative MRI imaging

Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Disqualifiers

Patients with previous pelvic surgery

Patients with previous pelvic radiotherapy

Patient with previous focal therapy for prostate cancer

Patients aged < 18 years at diagnosis

Trial design

Design model

Single group

Treatments tested in this trial

  • Intraoperative Somatic-Autonomic Nerve Grafting

    Procedure/Surgery

    A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: NR-RALPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events measured by the Clavian-Dindo classification

The primary outcome is specifically the safety of the operation 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 IV Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade V Death of a patient.

Time frame
Through study completion, an average of 18 months

Secondary outcomes

1

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).

Time frame
Screening pre-NR-RALP procedure
2

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).

Time frame
4-6 weeks post-NR-RALP procedure
3

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).

Time frame
3 months post-NR-RALP procedure
4

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).

Time frame
6 months post-NR-RALP procedure

Other outcomes

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