Plain English Summary
Background and study aims
Many men worry that their penis is too small and some want them to be increased in size. Penile enhancement surgery is a type of medical procedure which involves increasing the length or girth of the penis. Penis enlargement surgery can have complications, and many men are unhappy with the results. The aim of this study is to look at men who have penis enlargement surgery as part of their normal care to look at how well the procedure works.
Who can participate?
Healthy men who are undergoing penis enlargement surgery.
What does the study involve?
Participants undergo surgery to increase the length or girth of their penises as part of normal care. Routine information is collected about each patient’s background, health and the size of their penis at the start of the study and then two, six and twelve months after they have their surgery. The researchers collect this information by reviewing medical records in order to see how effective the surgery has been.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
Blumar Medica (Italy)
When is the study starting and how long is it expected to run for?
October 2012 to December 2015
Who is funding the study?
Investigator initiated and funded (Italy)
Who is the main contact?
1. Dr Alessandro Littara (public)
2. Dr Claudia Schmid (scientific)
Trial website
Contact information
Type
Public
Primary contact
Dr Alessandro Littara
ORCID ID
http://orcid.org/0000-0003-0659-6178
Contact details
Blumar Medica srl
Viale Vittorio Veneto 14
Milan
20125
Italy
+393356844939
androweb@icloud.com
Type
Scientific
Additional contact
Dr Claudia Schmid
ORCID ID
Contact details
Blumar Medica srl
Viale Vittorio Veneto 14
Milan
20125
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Penile lengthening and girth enhancement surgery, a report of 355 cases
Acronym
Study hypothesis
The aim of this study is to report and evaluate the results and complications of penile enhancement surgery.
Ethics approval
This study does not require ethics approval.
Study design
Retrospective cohort analysis
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Penile hypoplasia and/or normal penile size
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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 measures
Erectile function, as measured using the the IIEF test at baseline and 12 months, is collected through patient chart review.
Overall trial start date
25/10/2012
Overall trial end date
22/12/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
355
Participant exclusion criteria
1. Men with unrealistic expectations
2. Psychiatric disorders
3. Systemic disorders
4. Bleeding disorders
5. Heart disease
Recruitment start date
10/01/2013
Recruitment end date
07/12/2015
Locations
Countries of recruitment
Italy
Trial participating centre
Blumar Medica
Viale Vittorio Veneto 14
Milan
20124
Italy
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated and/or analyzed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/01/2018
Participant level data
Other
Results - basic reporting
Publication summary