Penile Injection Anxiety

January 4, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants that are starting penile injections therapy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Participants that are starting penile injections therapy.
Other: Questionnaires.
Questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Christian Nelson, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimated)

December 28, 2007

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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