Randomisation to topical corticosteroids or placebo for the treatment of the non-retractile foreskin
| ISRCTN | ISRCTN64387412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64387412 |
| Secondary identifying numbers | N0453141246 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 30/11/2015
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Barbara Rampersad
Scientific
Scientific
Central Manchester & Manchester Children's University Hospitals BH
Booth Hall Children's Hospital
Charlestown Road
Blackley
Manchester
M9 7AA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomisation to topical corticosteroids or placebo for the treatment of the non-retractile foreskin |
| Study objectives | To assess whether it is the corticosteroid alone or the gentle physical retraction combined with ointment that is responsible for the results previously observed with topical corticosteroid treatment of the non-retractile foreskin. Two steroid preparations are currently used within Manchester so the study will be carried out using both preparations to see if there is a significant difference between them. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Penile diseases |
| Intervention | Boys of 3 years and above who are referred to the outpatient clinic with a physiological non-retractile foreskin will be invited to participate in the study. The boys and their parent/carer will be interviewed by the primary investigator and given the patient information sheet. If they agree to participate in the study, written consent will be obtained. The patient will be randomised by the pharmacy department to receive either placebo, 1% hydrocortisone or 0.1% betnovate ointment. The parents will be instructed to apply the ointment to the tip foreskin every morning and evening for 6 weeks. The patients will be assessed by the primary investigator after 6 weeks. If the treatment has been successful, ie. the foreskin is retractile, no further treatment is given. If the treatment has been unsuccessful, ie. partial or no retraction, the patients will be offered corticosteroid ointment (0.1% betnovate as this is the more potent steroid) for a further 6 weeks, following which time they will be reassessed. After 6 months all patients will be reassessed and foreskin retractility will be graded (full/partial/no retraction). The code for which ointment each patient used will be broken at the end of the study. All patients with persistent problems such as infection or a non-retractile foreskin at the end of the study period will be offered circumcision. All results will be recorded on data sheets in the patient's records and on a confidential database. |
| Intervention type | Other |
| Primary outcome measure | Retraction of the foreskin |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2002 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Sex | Male |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Boys of 3 years and over with a physiological non-retractile foreskin |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Central Manchester & Manchester Children's University Hospitals BH
Manchester
M9 7AA
United Kingdom
M9 7AA
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
No information available
Unfunded
No information available
NHS R&D Support Funding
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 |
Editorial Notes
30/11/2015: no publications found on PubMed.
