Penile Injection Anxiety

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582231
First received: December 21, 2007
Last updated: January 31, 2014
Last verified: January 2014

December 21, 2007
January 31, 2014
February 2007
December 2014   (final data collection date for primary 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. [ 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00582231 on ClinicalTrials.gov Archive Site
To study the effects of penile injection therapy on the related domains of erectile dysfunction (IIEF), relationship satisfaction (RAS), sexual satisfaction (SEAR), and depression (HADS-D). [ 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. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
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Penile Injection Anxiety
Penile Injection Anxiety

The purpose of this study is to help us understand more about your experience with penile injection therapy. Many men become anxious when thinking about penile injections. We would like to understand more about this anxiety. You will be asked to fill out questionnaires before you start penile injection training, at each training visit, and then at your four month follow-up visit.

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
Not Provided
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Non-Probability Sample

Participants that are starting penile injections therapy.

  • Penile Injection Therapy
  • Erectile Dysfunction
  • Radical Pelvic Surgery
Other: Questionnaires.
Questionnaires.
1
Participants that are starting penile injections therapy.
Intervention: Other: Questionnaires.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
126
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of a radical pelvic surgery (cystectomy, prostatectomy, low anterior resection)
  • 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.
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582231
07-001
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Christian Nelson, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP