Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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20 June 2023 |
Main ID: |
ISRCTN60774878 |
Date of registration:
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04/04/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Penis enlargement surgery, a report of 355 cases
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Scientific title:
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Penile lengthening and girth enhancement surgery, a report of 355 cases |
Date of first enrolment:
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10/01/2013 |
Target sample size:
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355 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN60774878 |
Study type:
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Observational |
Study design:
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Retrospective cohort analysis (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Italy
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Contacts
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Name:
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Claudia
Schmid |
Address:
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Blumar Medica srl
Viale Vittorio Veneto 14
20125
Milan
Italy |
Telephone:
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Email:
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Affiliation:
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Name:
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Alessandro
Littara |
Address:
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Blumar Medica srl
Viale Vittorio Veneto 14
20125
Milan
Italy |
Telephone:
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+393356844939 |
Email:
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androweb@icloud.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male 2. Aged between 18 and 64 years old 3. In good health 4. No micropenis 5. Realistic expectations 6. Absence of psychiatric or systemic disorders
Exclusion criteria: 1. Men with unrealistic expectations 2. Psychiatric disorders 3. Systemic disorders 4. Bleeding disorders 5. Heart disease
Age minimum:
Age maximum:
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Penile hypoplasia and/or normal penile size Urological and Genital Diseases Penile hypoplasia and/or normal penile size
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Intervention(s)
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Study participants are regular patients that receive penile enhancement in normal care, i.e. no special procedures, devices or treatments are added or carried out for the purpose of the study.
Routine information is collected for each patient, including age, weight, height, marital status, type of procedure (penile lengthening, girth enhancement, or both), IIEF (International Index of Erectile Function) score, baseline penile length at rest, stretched length (as a proxy for erect length), penile girth at rest. The same measurements are repeated at 2, 6 and 12 month follow-up visits. IIEF is repeated at 12 months.
This data is then collected through retrospective chart review by the researcher.
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Primary Outcome(s)
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Penile length and/or girth, as measured in centimeters at baseline, patient discharge and 2, 6 and 12 months, is collected through patient chart review.
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Secondary Outcome(s)
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Erectile function, as measured using the the IIEF test at baseline and 12 months, is collected through patient chart review.
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Source(s) of Monetary Support
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Investigator initiated and funded
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Ethics review
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Status:
Approval date:
Contact:
This study does not require ethics approval.
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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22/12/2015 |
URL:
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