Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT05578157
Eligibility Criteria:
Inclusion Criteria:
1. Preoperative measurement:
* Aged 55 - 70 years
* Prostatecancer patients undergoing a non-/unilateral-nerve-sparing radical prostatectomy (RARP)
* Pre-operative IIEF-5 score \> 21
2. Postoperative measurement
* Inclusion criteria of pre-operative measurement
* Preoperative penile temperature increase during first nocturnal erection of minimally 0.4 degrees Celsius
* Post-operative IIEF-5 score \< 12 with absence of morning erections
Exclusion Criteria:
* Test subjects who are unwilling to sign informed consent
* Test subjects with erectile dysfunction before RARP (IIEF-5 score of below 22)
* (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II. These conditions might influence penile blood circulation and therefore the accuracy of the study outcomes.
* (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
* Usage of sleeping pills or benzodiazepines.
* Postoperative results will be excluded from the study in case of presence of nocturnal erections according to the RigiScan data.
Sex:
MALE
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT05578157
Study Brief:
Protocol Section:
NCT05578157