A placebo controlled, flexible dose, randomised controlled trial to assess the efficacy of sildenafil citrate in men with erectile dysfunction after anterior resection for rectal carcinoma
| ISRCTN | ISRCTN86213744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86213744 |
| Secondary identifying numbers | ED1/2004, Version 2: 25 March 2005 |
- Submission date
- 15/07/2005
- Registration date
- 10/10/2005
- Last edited
- 13/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Tariq Ismail
Scientific
Scientific
University Hospital Birmingham NHS Trust
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Sildenafil after anterior resection for rectal cancer is efficacious in the management of erectile dysfunction. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Erectile dysfunction |
| Intervention | Sildenafil versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sildenafil citrate |
| Primary outcome measure | Erectile dysfunction domain score (sum of questions 1-5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire |
| Secondary outcome measures | 1. Responses to the Global Efficacy Assessment Questions (GEAQ) 2. Score of the responses to all the questions of the IIEF Questionnaire 3. Index score of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire 4. Event Log Variables: Percent of Attempts at Intercourse that were successful, Number of Successful Attempts per Week, Number of Attempts per Week 5. Cessation of treatment due to lack of efficacy or intolerable adverse events 6. Quality of life (EORTC QLQ-C30) 7. Responses to the Sexual Health/Quality of Life supplemental questionnaire (SHQL) |
| Overall study start date | 01/10/2005 |
| Completion date | 20/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 50 subjects per group (100 in total) |
| Key inclusion criteria | 1. Outpatients aged 18 years or over 2. Resection for tumours of the rectum, and where treatment has been completed 3. Diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less. Erectile dysfunction is defined as 'the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance' (Impotence National Institutes of Health [NIH] Consensus Conference, JAMA 1993, 270: 83-90). 4. In a stable relationship 5. Written informed consent obtained |
| Key exclusion criteria | 1. Unwilling or unable (i.e. not in a sexual relationship) to engage in sexual activity during the 12 week treatment period 2. Current prescription for and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, transdermal, inhaled) on either a regular or intermittent basis 3. Current prescription for nicorandil 4. History of intolerance or hypersensitivity to morphine (or to any other opiates) or to any component of the tablet formulations of sildenafil 5. Previously prescribed pharmacological treatment for ED (any other non-pharmacological treatment (e.g. vacuum devices) for ED must be terminated on or before the screening visit and must not be used at any time during the study) 6. Receipt of a new, or a change to existing, medication known to be causally associated with ED such as but not limited to beta-blockers, thiazide diuretics or antidepressants, within the two weeks prior to screening 7. Concomitant treatment, due to requirement of dosage adjustment, with ritonavir, other protease inhibitors, erythromycin, ketoconazole, cimetidine or other CYP3A4 inhibitors 8. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol 9. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study 10. Genital anatomical deformities that would significantly impair erections (e.g. severe penile fibrosis) 11. Predisposition to priapism 12. Active peptic ulcer 13. Requirement for a 25 mg starting dose of sildenafil, in the opinion of the investigator 14. Significant cardiovascular disease including cardiac failure, myocardial infarction, unstable angina, stroke, symptomatic or clinically significant cardiac arrhythmias in the last six months, uncontrolled hypertension, hypotension or history of postural hypotension, or judged by the investigator to be cardiovascularly unfit for sexual activity 15. Known history of retinitis pigmentosa 16. Any medical (including known history of major haematological, renal or hepatic abnormalities) or psychological condition or social circumstances that may increase risk to themselves or others by participating or would impair their ability to participate reliably in the study (unwilling or unable to complete Event Log worksheets or questionnaires consistently and accurately) 17. Intention to donate blood or blood products during the period of the study |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 20/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital Birmingham NHS Trust
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
University Hospital Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Harborne
Birmingham
B15 2TH
England
United Kingdom
| Phone | +44 (0)121 472 1311 |
|---|---|
| james.neuberger@uhb.nhs.uk | |
| Website | http://www.uhb.nhs.uk |
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Industry
Pfizer Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No |
