NCT01912586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

February 1, 2014

Enrollment Period

1.6 years

First QC Date

July 29, 2013

Last Update Submit

June 17, 2015

Conditions

Rectal TumorsErectile Dysfunction

Keywords

erectile dysfunctionlaparoscopic surgeryrectal cancersildenafilvacuum erection device

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT

    12 months

Study Arms (3)

Arm A

NO INTERVENTION

Patients receive no interventions for ED after laparoscopic surgery

Arm B

EXPERIMENTAL

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

Other: vacuum erection device

Arm C

EXPERIMENTAL

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

Interventions

vacuum erection deviceOTHER

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

Also known as: sildenafil
Arm BArm C

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (3)

  • Dowswell G, Ismail T, Greenfield S, Clifford S, Hancock B, Wilson S. Men's experience of erectile dysfunction after treatment for colorectal cancer: qualitative interview study. BMJ. 2011 Oct 18;343:d5824. doi: 10.1136/bmj.d5824.

    PMID: 22010127BACKGROUND

  • McGlone ER, Khan O, Flashman K, Khan J, Parvaiz A. Urogenital function following laparoscopic and open rectal cancer resection: a comparative study. Surg Endosc. 2012 Sep;26(9):2559-65. doi: 10.1007/s00464-012-2232-5. Epub 2012 Apr 5.

    PMID: 22476834BACKGROUND

  • Lange MM, van de Velde CJ. Urinary and sexual dysfunction after rectal cancer treatment. Nat Rev Urol. 2011 Jan;8(1):51-7. doi: 10.1038/nrurol.2010.206. Epub 2010 Dec 7.

    PMID: 21135876BACKGROUND

MeSH Terms

Conditions

Rectal NeoplasmsErectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

June 18, 2015

Record last verified: 2014-02

Locations

CN(1)