NCT00582231

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
18.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

19.2 years

First QC Date

December 21, 2007

Last Update Submit

April 21, 2026

Conditions

Radical Pelvic SurgeryPenile Injection TherapyErectile Dysfunction

Keywords

Penile injection therapyErectile dysfunctionRadical pelvic surgeryPenile Injection Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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).

    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.

Study Arms (1)

1

Participants that are starting penile injections therapy.

Other: Questionnaires.

Interventions

Questionnaires.OTHER

Questionnaires.

1

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants that are starting penile injections therapy.

You may qualify if:

  • 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

You may not qualify if:

  • History of or currently receiving radiation therapy,
  • History of or currently receiving chemotherapy,
  • History of or currently receiving hormone therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Christian Nelson, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

February 28, 2007

Primary Completion

April 20, 2026

Study Completion

April 20, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(1)