Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Study Overview
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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.

Official Title
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A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer

Conditions
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Rectal Tumors, Erectile Dysfunction

Intervention / Treatment
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* Other: vacuum erection device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 < Age < 70 Sexually active men without the consistent use of erectile aids pre-operatively Rectal cancer confirmed by histology Undergoing a bilateral nerve sparing laparoscopic rectal resection IIEF-5 domain score > =20 before surgery Presence of a female sexual partner Willingness to participate in clinical research as evidenced by their signature on the informed consent form Exclusion Criteria: Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months Has taken or has been prescribed nitrate medication in any form in the last 6 months Contraindication to sildenafil (e.g. nitrates, hypersensitivity) Contraindication to vacuum erection device (e.g. coagulation abnormality, stick cell disease) Men with a history of known penile deformity or Peyronie's disease Pre or postoperative androgen therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A<br>Patients receive no interventions for ED after laparoscopic surgery | |
| Experimental: Arm B<br>sildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks. | Other: vacuum erection device<br>* sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months<br>* Other names: sildenafil;|
| Experimental: Arm C<br>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. | Other: vacuum erection device<br>* sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months<br>* Other names: sildenafil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, laparoscopic surgery, rectal cancer, sildenafil, vacuum erection device