Health Interventions in Men Undergoing Radical Prostatectomy
Withdrawn before enrolling · Not applicable
Conditions studied: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence
In brief
The goal of the study is to assess the impact of a health intervention, involving both diet and exercise modification, on outcomes following radical prostatectomy for the treatment of clinically localized prostate cancer. The specific urological outcomes expected to be improved are accelerated and/or improved recovery of erectile function (EF), as well as urinary continence, both very commonly affected by this surgery. Furthermore, as demonstrated by changes in responses to various questionnaires, an improvement in overall health-related quality of life is expected. Finally, an improvement in patients participating in the intervention groups in physical parameters, including body mass index (BMI), blood pressure (BP), and metabolic parameters, including serum glucose and cholesterol levels, is expected.
Key facts
- Study ID
- NCT01748110
- Run by
- Johns Hopkins University
- People needed
- 0
- Starts
- 2012-12-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2017-01-26
Who can join
Age: 40 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- men 40-65 years of age
- localized prostate cancer (clinical stage < T2b, Gleason grade < 7, pre-operative prostate specific antigen (PSA) < 10)
- scheduled to undergo curative nerve-sparing prostatectomy at the Johns Hopkins Hospital
You may not qualify if…
- in a stable relationship for at least 6 months
- moderately to severely impaired preoperative erectile function (IIEF-erectile function domain score < 16)
- answering less than 2-3 times or > to question #6 on the IIEF
- severe lower urinary tract symptoms International Prostate Symptom Score (IPSS) >20
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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