Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections. (NR-RC)

Sir Mortimer B. Davis - Jewish General Hospital

Status: Not yet enrolling

Conditions: Erectile Dysfunction Following Radical Prostatectomy; Bladder Cancer Requiring Cystectomy

Treatments: Procedure: Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.

Study type: Interventional

Funder types: Other

Identifiers

NCT07140588

2026-4614

Details and patient eligibility

About

This pilot study will evaluate the safety and 1-year erectile function recovery in 10 patients undergoing a novel Nerve Restoring Radical Cystectomy (NR-RC), which includes a genitofemoral nerve graft. Erectile function will be assessed using IIEF-5, SF-MPQ, and CEEF questionnaires at baseline and at multiple post-operative intervals (4 weeks, 3, 6, 12, and 18 months). Safety will be monitored through peri- and post-operative complications, and additional demographic and clinical data will be collected for analysis.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing standard of care radical cystectomy for bladder cancer
• Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Exclusion criteria

• Patients with previous pelvic surgery
• Patients with previous pelvic radiotherapy
• Patients aged < 18 years at diagnosis
• Legally incapable patients
• Patients who are unable to complete questionnaires and have no companion to help complete them
• Patients undergoing a concomitant cancer surgery
• Patients with pre-existing neurologic disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Nerve Restoring Radical Cystectomy.

Experimental group

Description:

Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.

Treatment:

Procedure: Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.