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

Central Manchester & Manchester Children's University Hospitals BH
Booth Hall Children's Hospital
Charlestown Road
Blackley
Manchester
M9 7AA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomisation to topical corticosteroids or placebo for the treatment of the non-retractile foreskin
Study objectivesTo 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) studiedUrological and Genital Diseases: Penile diseases
InterventionBoys 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 typeOther
Primary outcome measureRetraction of the foreskin
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/2002
Completion date01/01/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
SexMale
Target number of participantsNot provided at time of registration
Key inclusion criteriaBoys of 3 years and over with a physiological non-retractile foreskin
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2002
Date of final enrolment01/01/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Central Manchester & Manchester Children's University Hospitals BH
Manchester
M9 7AA
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

30/11/2015: no publications found on PubMed.