Rectal CancerPhase 4NCT01421940
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
A Phase 4 study testing Udenafil in people with Rectal Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile… Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Udenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Oct 2013
- 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 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : 20-65
- Rectal cancer within 15cm from anal verge
- Patients with more than 5 points decreased IIEF-5 after operation
- Patients with sexual activity
Who cannot join
- Preoperative IIEF-5 : ≤14
- Recent MI, CVA, nitrate medication
- Severe cardiovascular disease, psychiatric disease
- Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- Renal dysfunction (Cr ≥2mg/dl)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University Medical Center
Daegu, 702-210
About this study
Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.
- Conditions
- Rectal Cancer
- Being tested
- Placebo drug, Udenafil
- Keywords
- Udenafil, rectal cancer, penile rehabilitation, total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drugDrug
After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.
UdenafilDrug
After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Individuals who take placebo after total mesorectal excision Receives: Drug: Placebo drug |
| Udenafil | Experimental | Individuals who take udenafil after total mesorectal excision Receives: Drug: Udenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
- IIEF-5 questionnaire is used to assess male erectile function
- IIEF-5 (5-item Version of the International Index of Erectile Function)is obtained by combining the scores of the responses to 5 questions. Each question is scored from 0-5 (1 questions is scored from 1-5) for IIEF-5 range of 1-25 points; lower numerical scores from the IIEF-5 questionnaire represnt greater severitt of erectile dysfunction.
Measured: Baseline, 12weeks, 24 weeks
Secondary outcomes (2)
Change from baseline in SEP Q2,Q3 and GEQ
- SEP Q2 (Sexual encounter profile Q2) and SEP Q3 (Sexual encounter profile Q3) are used to assess erectile function
- The efficaty of medication is followed by GEQ (Global efficacy question).
Measured: baseline, 12weeks, and 24 weeks
Number of patients with adverse events during 24 weeks of the study
Measured: Baseline through 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyu-Seog Choi, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421940
- Sponsor's protocol ID
- KNUHCRC002
- Status last verified
- Mar 2015
- First submitted
- 1 Aug 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SY, Choi GS, Park JS, Kim HJ, Park JA, Choi JI. Efficacy and safety of udenafil for the treatment of erectile dysfunction after total mesorectal excision of rectal cancer: a randomized, double-blind, placebo-controlled trial. Surgery. 2015 Jan;157(1):64-71. doi: 10.1016/j.surg.2014.07.007.
PubMed 25482466
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
- ClinicalTrials.gov ID
- NCT01421940
- Acronym / sponsor ID
- KNUHCRC002
- Conditions
- Rectal Cancer
- Keywords
- Udenafil, rectal cancer, penile rehabilitation, total mesorectal excision
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Aug 2011 (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.
Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo drugIndividuals who take placebo after total mesorectal excision |
| Udenafil | Experimental | Drug: UdenafilIndividuals who take udenafil after total mesorectal excision |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age : 20-65
- Rectal cancer within 15cm from anal verge
- Patients with more than 5 points decreased IIEF-5 after operation
- Patients with sexual activity
Key exclusion criteria (5 listed)
- Preoperative IIEF-5 : ≤14
- Recent MI, CVA, nitrate medication
- Severe cardiovascular disease, psychiatric disease
- Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- Renal dysfunction (Cr ≥2mg/dl)
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 |
|---|---|---|
| Placebo drugAfter total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks. | Drug | Control |
| UdenafilAfter total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks. | Drug | Udenafil |
Primary outcome
Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
Time frame: Baseline, 12weeks, 24 weeks
* IIEF-5 questionnaire is used to assess male erectile function * IIEF-5 (5-item Version of the International Index of Erectile Function)is obtained by combining the scores of the responses to 5 questions. Each question is scored from 0-5 (1 questions is scored from 1-5) for IIEF-5 range of 1-25 points; lower numerical scores from the IIEF-5 questionnaire represnt greater severitt of erectile dysfunction.
2 secondary outcomes
Change from baseline in SEP Q2,Q3 and GEQ
Time frame: baseline, 12weeks, and 24 weeks
Number of patients with adverse events during 24 weeks of the study
Time frame: Baseline through 24 weeks
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 10 Mar 2015.
- Derived from this study: PubMed 25482466Park SY, Choi GS, Park JS, Kim HJ, Park JA, Choi JI. Efficacy and safety of udenafil for the treatment of erectile dysfunction after total mesorectal excision of rectal cancer: a randomized, double-blind, placebo-controlled trial. Surgery. 2015 Jan;157(1):64-71. doi: 10.1016/j.surg.2014.07.007.
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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 Udenafil in people with Rectal Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
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 4 inclusion and 5 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 10 Mar 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week (time frame: Baseline, 12weeks, 24 weeks). 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 NCT01421940, which also lists 1 linked publication.
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 10 Mar 2015.