Bladder Cancer Requiring CystectomyNR-RCNCT07140588
Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections.
A study testing Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery. in people with Bladder Cancer Requiring Cystectomy and Erectile Dysfunction Following Radical Prostatectomy, run by Sir Mortimer B. Davis - Jewish General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer Requiring Cystectomy, Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Feb 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing standard of care radical cystectomy for bladder cancer
- Patients must have preoperative erectile function with a baseline IIEF score of ≥17
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With Bladder Cancer Undergoing Radical Cystectomy
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.
- Being tested
- Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.
- 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
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.Procedure or surgery
Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Patients undergoing radical cystectomy will receive a novel NR-RC procedure using a genitofemoral nerve graft to enhance erectile function recovery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 18 months (5 different time points)
Secondary outcomes (15)
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).
Measured: 4 weeks post- NR-RC
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).
Measured: 3 months post- NR-RC
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).
Measured: 6 months post- NR-RC
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).
Measured: 12 months post- NR-RC
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).
Measured: 18 months post- NR-RC
International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
Measured: 4 weeks post- NR-RC
International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
Measured: 3 months post- NR-RC
International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
Measured: 6 months post- NR-RC
International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
Measured: 12 months post- NR-RC
International Index of Erectile Function-5 (IIEF-5)
The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).
Measured: 18 months post- NR-RC
Short Form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)
Measured: 4 weeks post- NR-RC
Short Form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)
Measured: 3 months post- NR-RC
Short Form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)
Measured: 6 months post- NR-RC
Short Form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)
Measured: 12 months post- NR-RC
Short Form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)
Measured: 18 months post- NR-RC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer Requiring CystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor McPherson, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140588
- Sponsor's protocol ID
- 2026-4614
- Acronym
- NR-RC
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No