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Not yet recruiting NCT07140588

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

No phase Interventional Bladder Cancer Requiring Cystectomy Erectile Dysfunction Following Radical Prostatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery..
Who it may be relevant to
Registry conditions: Bladder Cancer Requiring Cystectomy, Erectile Dysfunction Following Radical Prostatectomy. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With Bladder Cancer Undergoing Radical Cystectomy

Overview

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.

Interventions

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

Primary outcome measures

  • Adverse events measured by the Clavian-Dindo classification [Time frame: Through study completion, an average of 18 months (5 different time points)]
Secondary outcome measures (12)
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 4 weeks post- NR-RC]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 3 months post- NR-RC]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 6 months post- NR-RC]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 12 months post- NR-RC]
  • Clinical Evolution of Erectile Function (CEEF) [Time frame: 18 months post- NR-RC]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 4 weeks post- NR-RC]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 3 months post- NR-RC]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 6 months post- NR-RC]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 12 months post- NR-RC]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 18 months post- NR-RC]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 4 weeks post- NR-RC]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 3 months post- NR-RC]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07140588 · 2026-4614

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗