Erectile Dysfunction, Rectal Tumors
Conditions
Keywords
erectile dysfunction, laparoscopic surgery, rectal cancer, sildenafil, vacuum erection device
Brief summary
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.
Interventions
sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sexual function based on the (IIEF)-5 score and NPT | 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT | 12 months | Summarized according to assigned treatment group. |
Countries
China
Outcome results
None listed