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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: ISRCTN
Last refreshed on: 20 June 2023
Main ID:  ISRCTN60774878
Date of registration: 04/04/2017
Prospective Registration: No
Primary sponsor: Dr. Alessandro Littara
Public title: Penis enlargement surgery, a report of 355 cases
Scientific title: Penile lengthening and girth enhancement surgery, a report of 355 cases
Date of first enrolment: 10/01/2013
Target sample size: 355
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN60774878
Study type:  Observational
Study design:  Retrospective cohort analysis (Other)  
Phase:  Not Applicable
Countries of recruitment
Italy
Contacts
Name: Claudia    Schmid
Address:  Blumar Medica srl Viale Vittorio Veneto 14 20125 Milan Italy
Telephone:
Email:
Affiliation: 
Name: Alessandro    Littara
Address:  Blumar Medica srl Viale Vittorio Veneto 14 20125 Milan Italy
Telephone: +393356844939
Email: androweb@icloud.com
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Penile hypoplasia and/or normal penile size
Urological and Genital Diseases
Penile hypoplasia and/or normal penile size
Intervention(s)

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.
Primary Outcome(s)
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.
Secondary Outcome(s)
Erectile function, as measured using the the IIEF test at baseline and 12 months, is collected through patient chart review.
Secondary ID(s)
N/A
Source(s) of Monetary Support
Investigator initiated and funded
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
This study does not require ethics approval.
Results
Results available: Yes
Date Posted:
Date Completed: 22/12/2015
URL:
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