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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks post- NR-RC |
| Clinical Evolution of Erectile Function (CEEF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor McPherson, MD, MSc, FRCSC | Contact | 1-514-340-8222 ext 23536 | victor.mcpherson@mcgill.ca |
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A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome). |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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) | 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) | 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) | 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) | 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) | 18 months post- NR-RC |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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