Urinary Incontinence Clinical Trial
Official title:
Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy
Verified date | March 2023 |
Source | Herlev and Gentofte Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate whether the use of intraoperative nerve monitoring during robotic-assisted radical prostatectomy (RARP) can predict and improve post-surgery urinary continence and erectile function.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 10, 2022 |
Est. primary completion date | June 3, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients that are planned to undergo either non-nerve or unilateral nerve sparring surgery. - Patients that deemed able to understand the protocol and to return for all the required post-treatment follow-up visits. Exclusion Criteria: - Incontinence prior to surgery - Diabetes - Known neurological disease that can affect urinary/erectile function - Condition with Pacemaker - Previous pelvic trauma - Previous pelvic surgery including transurethral resection of the prostate - Previous pelvic radiation therapy |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev and Gentofte Hospital | Herlev | Central Region |
Lead Sponsor | Collaborator |
---|---|
Herlev and Gentofte Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Return of continence following robotic-assisted radical prostatectomy | Difference in total International consultation on incontinence questionnaire (ICIQ)-score between the 2 groups after a follow-up of 1 year.
ICIQ is a self-reported survey and screening tool for incontinence. It consists of 3 questions regarding symptoms in the past 4 week, with an overall 0-21 score, where greater values indicate increased severity. Question 1 scores from 0-5, question 2 scores either 0,2,4 or 6 and question 3 scores from 0-10. Only the total score is evaluated. Furthermore there is 1 self-diagnostic question. |
12 months | |
Secondary | Return of erectile function following robotic-assisted radical prostatectomy | Difference in erection rates and sexual activity between the 2 groups after 12 months. Sexual activity defined as yes to the question "Within the last 3 months, have you been sexually active and attempted intercourse?" Erection is defined as a score of at least 17 on the IIEF-5 form and or a score of a least 3 on the EHS form with the use of either no assistance phosphodiesterase 5 inhibitors | 12 months | |
Secondary | Nerve function prior to removal of the prostate correlated to patient's preoperative urinary function | Correlation between nerve signal prior to removal of the prostate and preoperative urinary function | 1 day | |
Secondary | Nerve function prior to removal of the prostate correlated to patient's preoperative erectile function | Correlation between nerve signal prior to removal of the prostate and preoperative erectile function | 1 day | |
Secondary | Nerve function after removal of the prostate correlated to patient's postoperative urinary function | Correlation between nerve signal after removal of the prostate and postoperative urinary function | 12 months | |
Secondary | Nerve function after removal of the prostate correlated to patient's postoperative erectile function | Correlation between nerve signal after removal of the prostate and postoperative erectile function | 12 months | |
Secondary | Difference in the degree of incontinence between the two groups for incontinent patients. | Measured in gram on the 24-hour pad test | 12 months | |
Secondary | Difference in Time to continence between the two groups | Difference in Time to continence between the two groups | 12 months |
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