Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction; Rectal Tumors

Treatments: Other: vacuum erection device

Study type: Interventional

Funder types: Other

Identifiers

NCT01912586

NanFang2013035

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Arm A

No Intervention group

Description:

Patients receive no interventions for ED after laparoscopic surgery

Arm B

Experimental group

Description:

sildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks.

Treatment:

Other: vacuum erection device

Arm C

Experimental group

Description:

sildenafil 25mg/day nightly and together with using vacuum erection device to make erections for 10-15 minutes/day for 3 months after surgery within one or two weeks.

Treatment:

Other: vacuum erection device