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

NCT07140588 | Not Yet Recruiting

• 1 other identifier: 2026-4614
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bladder Cancer Requiring Cystectomy; Erectile Dysfunction Following Radical Prostatectomy

Keywords

Bladder cancer; Nerve grafting; The genitofemoral nerve; radical cystectomy; radical prostatectomy; Erectile function; International Index of Erectile Function-5; Short Form McGill Pain Questionnaire; Clinical Evolution of Erectile Function

Outcome Measures

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

  Through study completion, an average of 18 months (5 different time points)

Secondary Outcomes (15)

• Clinical Evolution of Erectile Function (CEEF)

  4 weeks post- NR-RC

• Clinical Evolution of Erectile Function (CEEF)

  3 months post- NR-RC

• Clinical Evolution of Erectile Function (CEEF)

  6 months post- NR-RC

• Clinical Evolution of Erectile Function (CEEF)

  12 months post- NR-RC

• Clinical Evolution of Erectile Function (CEEF)

  18 months post- NR-RC

Study Arms (1)

Nerve Restoring Radical Cystectomy.

EXPERIMENTAL

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

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

Interventions

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

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

Nerve Restoring Radical Cystectomy.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Victor McPherson, MD, MSc, FRCSC

CONTACT

1-514-340-8222 ext 23536; victor.mcpherson@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Division of Urology, Department of Surgery McGill University

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: August 24, 2025

Record last verified: 2025-08