Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections. (NCT07140588) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections.
10 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events measured by the Clavian-Dindo classification
Timeframe: Through study completion, an average of 18 months (5 different time points)
Trial details
NCT IDNCT07140588
SponsorSir Mortimer B. Davis - Jewish General Hospital