Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections.

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

About this trial

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.

Eligibility criteria

Qualifiers

Patients undergoing standard of care radical cystectomy for bladder cancer

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

Disqualifiers

Patients with previous pelvic surgery

Patients with previous pelvic radiotherapy

Patients aged < 18 years at diagnosis

Legally incapable patients

Trial design

Treatments tested in this trial

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

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations