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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01275404
Eligibility Criteria:
Inclusion Criteria:
Part A
* Men who are 1 to 3 years post radical prostatectomy for early stage prostate cancer
* Participated in penile injection program
* Are able to speak, read, write and understand English well enough to complete study assessment and communicate with an English speaking therapist
Part B
* Men who are up to 9 months post radical prostatectomy.
* Had good erectile functioning pre-surgery (i.e., 24 or greater on the IIEF Erectile Function Domain (EFD) score), graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale) or have a score of 7 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment)
* Seen at MSKCC"s Sexual Medicine Rehabilitation Program (SMRP)
* Advised by the clinical staff of the SMRP to start penile injections.
Exclusion Criteria:
Part A
* Recurrence or progression of disease,
* Specific injection phobia (self report)
* A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review)
* Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a focus group
Part B
* Specific injection phobia (self report)
* A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review)
* Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a therapeutic session.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT01275404
Study Brief:
Protocol Section:
NCT01275404