Penile Injection Anxiety
The treatment of erectile dysfunction (ED) following radical pelvic surgery has become an
increasingly important issue. For many men, oral medications for ED will not be effective
immediately postoperatively. These medications enhance the effect of nitric oxide secreted
from the cavernous nerves, however these nerves are usually transiently injured
intraoperatively diminishing the amount of nitric oxide available. Consequently, oral
medications are usually ineffective for up to 18 to 24 months postoperatively while the
cavernous nerves are healing. As a result, penile injection therapy is the primary treatment
for ED for those men. This treatment delivers intracavernosal vasodilators at the base of
the penis with a 29 gauge needle. This direct application produces consistent results and
has been found to be effective for 94% of injection users. Despite common sense and clinical
experience that indicates men become very anxious about penile injection therapy, anxiety
has rarely been assessed in studies of penile injection therapy. We have observed that men
who are initially reluctant about penile injection therapy are more likely to try this
treatment when they hear that the injection anxiety dissipates quickly, after only a few
injections. We unfortunately only have clinical observation to support our claim describing
the course of injection anxiety. This study would provide empirical data to support this
claim and this data will be used in describing the treatment and encouraging men to try
injection therapy.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
The general paradigm for assessing outcomes of the trial will be repeated measures analysis of variance (ANOVA) and mixed effects models. To assess the change of anxiety levels in men utilizing penile injection therapy following radical pelvic surgery.
Participants will be asked to complete questionnaires before the start of the penile injection training, at each training visit, and then again at the four month follow-up visit.
Yes
Christian Nelson, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
07-001
NCT00582231
February 2007
December 2013
Name | Location |
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Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |