Erectile Dysfunction Clinical Trial
Official title:
A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer
Although the high prevalence of erectile dysfunction (ED) was detected among male patients
after the treatment for colorectal cancer, published reports depicting the erectile
dysfunction experience of patients with colorectal cancer ot underpin service development
are insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal
cancer are not routinely offered information and treatment for erectile dysfunction.However,
investigations on patients after surgery for prostate cancer could provide some potentially
useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the
return of erections after nerve-sparing radical prostatectomy has been established, which
may benefit rectal cancer patients after surgery with ED.
Laparoscopic surgery, although technically demanding and associated with a long learning
curve, has the advantage of clear visualization for the smallest structures,including the
autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate
preservation of the pelvic autonomic nerves.
This study aimed to identify whether early intervention is effective at reducing the rate of
ED at 12 months.
Status | Completed |
Enrollment | 90 |
Est. completion date | June 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. 18 < Age < 70 2. Sexually active men without the consistent use of erectile aids pre-operatively 3. Rectal cancer confirmed by histology 4. Undergoing a bilateral nerve sparing laparoscopic rectal resection 5. IIEF-5 domain score > =20 before surgery 6. Presence of a female sexual partner 7. Willingness to participate in clinical research as evidenced by their signature on the informed consent form Exclusion Criteria: 1. Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months 2. Has taken or has been prescribed nitrate medication in any form in the last 6 months 3. Contraindication to sildenafil (e.g. nitrates, hypersensitivity) 4. Contraindication to vacuum erection device (e.g. coagulation abnormality, stick cell disease) 5. Men with a history of known penile deformity or Peyronie's disease 6. Pre or postoperative androgen therapy |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Department of General Surgery, Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
Dowswell G, Ismail T, Greenfield S, Clifford S, Hancock B, Wilson S. Men's experience of erectile dysfunction after treatment for colorectal cancer: qualitative interview study. BMJ. 2011 Oct 18;343:d5824. doi: 10.1136/bmj.d5824. — View Citation
Lange MM, van de Velde CJ. Urinary and sexual dysfunction after rectal cancer treatment. Nat Rev Urol. 2011 Jan;8(1):51-7. doi: 10.1038/nrurol.2010.206. Epub 2010 Dec 7. Review. — View Citation
McGlone ER, Khan O, Flashman K, Khan J, Parvaiz A. Urogenital function following laparoscopic and open rectal cancer resection: a comparative study. Surg Endosc. 2012 Sep;26(9):2559-65. doi: 10.1007/s00464-012-2232-5. Epub 2012 Apr 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in sexual function based on the (IIEF)-5 score and NPT | Summarized according to assigned treatment group. Erectile Dysfunction is defined by The International Index of Erectile Dysfunction(IIEF)-5 score and Nocturnal penile tumescence(NPT). | 3 months | No |
Primary | Changes in sexual function based on the (IIEF)-5 score and NPT | Summarized according to assigned treatment group. Erectile Dysfunction is defined by The International Index of Erectile Dysfunction(IIEF)-5 score and Nocturnal penile tumescence(NPT). | 6 months | No |
Primary | Changes in sexual function based on the (IIEF)-5 score and NPT | Summarized according to assigned treatment group. Erectile Dysfunction is defined by The International Index of Erectile Dysfunction(IIEF)-5 score and Nocturnal penile tumescence(NPT). | 12 months | No |
Secondary | Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT | Summarized according to assigned treatment group. | 12 months | No |
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