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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2027-12-31

Brief Summary

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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

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Detailed Description

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Patients will have baseline evaluation with International Index of Erectile Function-5 (IIEF-5) questionnaire and the Short Form McGill Pain Questionnaire (SF-MPQ)1, which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks, 3-, 6-, 12- and 18-months. Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Conditions

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Prostate Cancer Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NR-RALP

Nerve Grafting Technique in patients with High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy

Group Type EXPERIMENTAL

Intraoperative Somatic-Autonomic Nerve Grafting

Intervention Type PROCEDURE

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

Interventions

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Intraoperative Somatic-Autonomic Nerve Grafting

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:

1. Gleason grade ≥8
2. PSA ≥20
3. \>pT2 on preoperative MRI imaging
2. Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Exclusion Criteria

1. Patients with previous pelvic surgery
2. Patients with previous pelvic radiotherapy
3. Patient with previous focal therapy for prostate cancer
4. Patients aged \< 18 years at diagnosis
5. Legally incapable patients
6. Patients who are unable to complete questionnaires and have no companion to help complete them
7. Patients undergoing a concomitant cancer surgery
8. Patients with pre-existing neurologic disease

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No