Condition category
Urological and Genital Diseases
Date applied
23/03/2017
Date assigned
04/04/2017
Last edited
03/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Dr. Alessandro Littara

Sponsor details

via cappellini 11
Milan
20124
Italy

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes