Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Tumors Erectile Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm A

Patients receive no interventions for ED after laparoscopic surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm B

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

Group Type EXPERIMENTAL

vacuum erection device

Intervention Type OTHER

sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months

Arm C

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.

Group Type EXPERIMENTAL

vacuum erection device

Intervention Type OTHER

sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months

Interventions

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vacuum erection device

sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months

Intervention Type OTHER

Other Intervention Names

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sildenafil

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No