Rectal TumorsPhase 4NCT01912586
Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer
A Phase 4 study testing vacuum erection device in people with Rectal Tumors and Erectile Dysfunction, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Rectal Tumors, Erectile Dysfunction
- What is being tested?
- vacuum erection device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer
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.
- Conditions
- Rectal Tumors, Erectile Dysfunction
- Being tested
- vacuum erection device
- Keywords
- erectile dysfunction, laparoscopic surgery, rectal cancer, sildenafil, vacuum erection device
- Medical subject headings
- Rectal Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum erection deviceOther
Also called sildenafil
sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: vacuum erection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 12 months
Secondary outcomes (1)
Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT
Summarized according to assigned treatment group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal TumorsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haijun Deng, MD, PhD, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912586
- Sponsor's protocol ID
- NanFang2013035
- Status last verified
- Feb 2014
- First submitted
- 29 Jul 2013
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22010127McGlone 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.
PubMed 22476834Lange 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.
PubMed 21135876
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomised Controlled Trial of Early Intervention to Preserve Erectile Function After Laparoscopic Resection for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01912586
- Acronym / sponsor ID
- NanFang2013035
- Conditions
- Rectal Tumors, Erectile Dysfunction
- Keywords
- erectile dysfunction, laparoscopic surgery, rectal cancer, sildenafil, vacuum erection device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –Patients receive no interventions for ED after laparoscopic surgery |
| Arm B | Experimental | Other: vacuum erection devicesildenafil 25mg/day nightly without vacuum erection device for 3 months after surgery within one or two weeks. |
| Arm C | Experimental | Other: vacuum erection devicesildenafil 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vacuum erection deviceAlso: sildenafilsildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months | Other | Arm B, Arm C |
Primary outcome
Changes in sexual function based on the (IIEF)-5 score and NPT
Time frame: 3 months
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
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
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).
1 secondary outcome
Compliance and overall patient satisfaction based on the self reported compliance diary and IIEF-5 score and NPT
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Background: PubMed 22010127Dowswell 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.
- Background: PubMed 22476834McGlone 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.
- Background: PubMed 21135876Lange 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vacuum erection device in people with Rectal Tumors and Erectile Dysfunction, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sexual function based on the (IIEF)-5 score and NPT (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01912586, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.