Penis enlargement surgery, a report of 355 cases
| ISRCTN | ISRCTN60774878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60774878 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/03/2017
- Registration date
- 04/04/2017
- Last edited
- 06/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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)
Contact information
Public
Blumar Medica srl
Viale Vittorio Veneto 14
Milan
20125
Italy
 ORCID ID |
0000-0003-0659-6178 |
|---|---|
| Phone | +393356844939 |
| androweb@icloud.com |
Scientific
Blumar Medica srl
Viale Vittorio Veneto 14
Milan
20125
Italy
Study information
| Study design | Retrospective cohort analysis |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Penile lengthening and girth enhancement surgery, a report of 355 cases |
| Study objectives | The aim of this study is to report and evaluate the results and complications of penile enhancement surgery. |
| Ethics approval(s) | This study does not require ethics approval. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 25/10/2012 |
| Completion date | 22/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 355 |
| Total final enrolment | 355 |
| Key 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 |
| Key exclusion criteria | 1. Men with unrealistic expectations 2. Psychiatric disorders 3. Systemic disorders 4. Bleeding disorders 5. Heart disease |
| Date of first enrolment | 10/01/2013 |
| Date of final enrolment | 07/12/2015 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milan
20124
Italy
Sponsor information
Hospital/treatment centre
via cappellini 11
Milan
20124
Italy
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/04/2019 | 06/06/2023 | Yes | No |
Editorial Notes
06/06/2023: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
