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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
  Purpose

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.


Condition Intervention
Penile Injection Therapy
Erectile Dysfunction
Radical Pelvic Surgery
Other: Questionnaires.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Penile Injection Anxiety

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 126
Study Start Date: February 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Participants that are starting penile injections therapy.
Other: Questionnaires.
Questionnaires.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants that are starting penile injections therapy.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582231

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Christian Nelson, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582231     History of Changes
Other Study ID Numbers: 07-001
Study First Received: December 21, 2007
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Penile injection therapy
Erectile dysfunction
Radical pelvic surgery
Penile Injection Anxiety

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on November 20, 2014