Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Mar 7, 2016

Keywords

ClinConnect Summary

This clinical trial is looking for ways to help men who have had surgery for prostate cancer and are experiencing erectile dysfunction (ED). The study will test two different methods to support sexual rehabilitation, which aims to improve sexual function after surgery. To participate, men should be between the ages of 70 and 76, have early-stage prostate cancer, and have had a radical prostatectomy (a type of surgery to remove the prostate) within the last nine months. They should also have had moderate erectile function before their surgery.

Participants in this study can expect to receive support and guidance as they work through the sexual rehabilitation process. They will be asked to complete questionnaires and may start using penile injections as part of their treatment. It’s important to note that men who had certain nerve damage during surgery or who have specific medical conditions may not be eligible for the trial. This study is actively recruiting participants, and it aims to help improve the quality of life for men recovering from prostate cancer surgery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score \</=8; or Pathologic Stage 3 with Gleason score =/\< 7)
• • As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution
• • As per medical record, ≤ 9 months post-RP
• • As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)
• • As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
• • In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English
• Exclusion Criteria:
• • Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.
• • Currently on or has a history of being an Androgen Deprivation Therapy (ADT)
• • Has any indication of Prostate-Specific Antigen (PSA)
• • As per self report, specific injection phobia
• • In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
• • As per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.