Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Nanfang Hospital of Southern Medical University
Sponsor:
Information provided by (Responsible Party):
Haijun Deng, MD, PhD, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01912586
First received: July 29, 2013
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Rectal Tumors
Erectile Dysfunction
Other: vacuum erection device
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • Changes in sexual function based on the (IIEF)-5 score and NPT [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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).

  • Changes in sexual function based on the (IIEF)-5 score and NPT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).

  • Changes in sexual function based on the (IIEF)-5 score and NPT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Summarized according to assigned treatment group.


Estimated Enrollment: 90
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm A
Patients receive no interventions for ED after laparoscopic surgery
Experimental: Arm B
sildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks.
Other: vacuum erection device
sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
Other Name: sildenafil
Experimental: 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.
Other: vacuum erection device
sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
Other Name: sildenafil

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912586

Contacts
Contact: Haijun Deng, MD, PhD +86 131 8909 6629 navyd999@163.com

Locations
China, Guangdong
Department of General Surgery, Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Haijun Deng, MD, PhD    +86-20-62787170    navyd999@163.com   
Principal Investigator: Haijun Deng, MD, PhD         
Principal Investigator: Xiangming Mao, MD         
Principal Investigator: Guoxin Li, MD, PhD         
Sub-Investigator: Hao Liu, MD, PhD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
  More Information

Publications:
Responsible Party: Haijun Deng, MD, PhD, Associate professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01912586     History of Changes
Other Study ID Numbers: NanFang2013035
Study First Received: July 29, 2013
Last Updated: February 28, 2014
Health Authority: China: Ministry of Health

Keywords provided by Nanfang Hospital of Southern Medical University:
erectile dysfunction
laparoscopic surgery
rectal cancer
sildenafil
vacuum erection device

Additional relevant MeSH terms:
Erectile Dysfunction
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014