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.
Patients undergoing standard of care radical cystectomy for bladder cancer
Patients must have preoperative erectile function with a baseline IIEF score of ≥17
Patients with previous pelvic surgery
Patients with previous pelvic radiotherapy
Patients aged < 18 years at diagnosis
Legally incapable patients
Single group
Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.
Procedure/SurgeryPatients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.
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
Clinical Evolution of Erectile Function (CEEF)
A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).
Clinical Evolution of Erectile Function (CEEF)
A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).
Clinical Evolution of Erectile Function (CEEF)
A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).
Clinical Evolution of Erectile Function (CEEF)
A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).
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