Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Tariq Ismail


Contact details

University Hospital Birmingham NHS Trust
B15 2TH
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

ED1/2004, Version 2: 25 March 2005

Study information

Scientific title


Study hypothesis

Sildenafil after anterior resection for rectal cancer is efficacious in the management of erectile dysfunction.

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Erectile dysfunction


Sildenafil versus placebo

Intervention type



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

50 subjects per group (100 in total)

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Birmingham NHS Trust
B15 2TH
United Kingdom

Sponsor information


University Hospital Birmingham NHS Foundation Trust (UK)

Sponsor details

B15 2TH
United Kingdom
+44 (0)121 472 1311

Sponsor type




Funder type


Funder name

Pfizer Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2008 results in

Publication citations

  1. Results

    El-Bahnasawy MS, Ismail T, Elsobky E, Alzalouey EI, Bazeed MA, Prognostic factors predicting successful response to sildenafil after radical cystoprostatectomy., Scand. J. Urol. Nephrol., 2008, 42, 2, 110-115, doi: 10.1080/00365590701571563.

Additional files

Editorial Notes