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Penile Injection Anxiety

Open (Enrolling)
Penile Injection Therapy, Erectile Dysfunction, Radical Pelvic Surgery

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Trial Information

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.

Inclusion Criteria:

- History of a radical pelvic surgery (cystectomy, prostatectomy, low anterior

- Participating in the injection therapy program

- Ability to provide informed consent

- Ability to converse, write and read English

Exclusion Criteria:

- History of or currently receiving radiation therapy,

- History of or currently receiving chemotherapy,

- History of or currently receiving hormone therapy.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Christian Nelson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2007

Completion Date:

December 2013

Related Keywords:

  • Penile Injection Therapy
  • Erectile Dysfunction
  • Radical Pelvic Surgery
  • Penile injection therapy
  • Erectile dysfunction
  • Radical pelvic surgery
  • Penile Injection Anxiety
  • Anxiety Disorders
  • Erectile Dysfunction



Memorial Sloan-Kettering Cancer Center New York, New York  10021