Penis Traction Clinical Trials and Research Studies

The technique of Penis Traction and the Andropenis® Traction Device have been subjected to several clinical trials and research studies to examine their efficacy and safety in use, for different treatment objectives. The details of the studies and the results have been published in articles in international medical journals.

We quote below abstracts from just a few of these articles. To see a complete list of trials and research studies, and read the contents in full, please visit the Andro Medical website.

Penis Traction for Penile Enlargement 

1. A pilot phase-II prospective study to test the 'efficacy' and tolerability of a penile-extender device in the treatment of 'short penis'

(Published in the March 2009 issue of BJU International, the official journal of The British Association of Urological Surgeons - one of the world's most highly respected medical journals)

By Paolo Gontero, Massimiliano Di Marco, Gianluca Giubilei, Riccardo Bartoletti, Giovanni Pappagallo, Alessandro Tizzani and Nicola Mondaini
Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy
Correspondence to Paolo Gontero, Senior Lecturer and Consultant Urologist, Dipartimento di Discipline Medico Chirurgiche, University of Turin, Urologia 1, San Giovanni Battista Hospital, C.so Dogliotti, 14, Torino, Italy. e-mail: paolo.gontero@unito.it

Abstract

To assess a commonly marketed brand of penile extender, the Andro-Penis (Andromedical, Madrid, Spain), widely used devices which aim to increase penile size, in a phase II single-arm study powered to detect significant changes in penile size, as despite their widespread use, there is little scientific evidence to support their potential clinical utility in the treatment of patients with inadequate penile dimensions.

Patients and Methods

Fifteen patients were required to test the efficacy of the device, assuming an effect size of >0.8. Eligible patients were counseled how to use the penile extender for at least 4 h/day for 6 months. Penile dimensions were measured at baseline and after 1, 3, 6 and 12 months (end of study). The erectile function (EF) domain of the International Index of Erectile Function was administered at baseline and at the end of the study. Treatment satisfaction was assessed using an institutional unvalidated five-item questionnaire.

Results

After 6 months the mean gain in length was significant, meeting the goals of the effect size, at 2.3 and 1.7 cm for the erect and flaccid penis, respectively....The Erectile Function domain scores improved significantly at the end of study. Treatment satisfaction scores were consistent with acceptable to good improvement in all items, except for penile girth, where the score was ....'mild improvement'.

Conclusions

Penile extenders should be regarded as a minimally invasive and effective treatment option to elongate the penile shaft in patients seeking treatment for a short penis.

Recommended and US FDA Registered Penis Traction Device - click here

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2. Penile enlargement without surgery with the Andropenis

Scientific Research presented in the First Virtual Sexology and Hispanoamerican Sexual Education Congress (February-2001).

By Dr. Eduardo A. G?ez de Diego, 1998, Andrology Services, Madrid (Spain).

Introduction

The Andropenis® design is based on the principle of external traction

It is able to exert a gradual traction force of 600 to 1500 grams. The device consists of a plastic ring into which the penis is introduced and from where 2 dynamic metal rods originate the traction. In the upper part there is a plastic support where a silicone band holds the glans in place.

• An increase in the length of the penis in erection and flaccidity.
• An increase in the girth of the penis in erection and flaccidity.

These results will be analyzed statistically to be verified and quantified. See next.

2. Materials and methods:

Number of patients: 37 men, 22 to 60 years of age.

These men came from different cities in Spain. The patients enrolled in the study were healthy men with normal erection capabilities who never underwent penile surgery. Patients suffering from penile curvatures or other diseases were excluded from the study.

Traction device: The Andropenis® extender.

Traction Force: 600 gr during the 1st month, 900 gr during the 2nd month, 1100 gr during the 3rd and 4th month, and 1200 gr during 5th and 6th month.

Application period: 10 hours a day, every day of the month over a period of 3-6 months.

3. Results:

3.1.- Increase in length in erection:

The increase in the length of the penis in erection is proportional to the amount of time the device is worn. Such growth is lineal, as it can be observed in the chart. This translates into the following: the longer the time of use, the more length is obtained. The lineal correlation coefficient between time of use and increase in length in erection is 0.760 (p=0.000).

3.2.- Increment in length in the flaccid state :

The increment in length in the flaccid state is not related to the time of use of the device. Said increment is linear as in the graph shows. The longer the device is worn, the greater the increase in length. The coefficient of the linear correlation between the time of use and the increment in length in the flaccid state is 0.725 (p=0.000).

3.4.- The length increment doesn't depend on the age:

As a very interesting result, the study shows that the length increment doesn't depend on the age of the patient, since the linear correlation coefficient is not significant (r=0.008, p=0.961). In other words, the patient's age doesn't affect the length increment.

3.5.- Perimeter increment in erection:

In erection, the average increment of the perimeter was 0.8405 cm and the typical deviation s=0.5382. The average growth of the initial perimeter was 7.1743%.The confidence interval of 95% of the studied population was 0.6111;1.0200; that shows a minimal growth increment of 0.6111 cm.

3.6.- Perimeter increment in flaccid state:

The average increment of the perimeter in flaccid state was 0.8405 cm and the typical deviation s=0.6057. The average percentage of growth was 9.0741%. The confidence interval of the 95% of the studied population was 0.6386;1.0425, what shows a minimal perimeter growth increase of 0.6386 cm.

3.7.- Length increase in erection state depending on use:

Dividing the studied population in four subgroups, depending on the amount of time they used the Andropenis, we obtain the following results:

• After three month:
  The average length increment in erected state was 1.4118, obtaining an average growth of 10.5580% compared to the initial length.
• After four month:
  The average length increment in erected state was 1.8462, obtaining an average growth of 14.1113% compared to the initial length.
• After five month:
  The average length increment in erected state was 2.2750, obtaining an average growth of 16.6303% compared to the initial length.

4. Conclusions:

1. The use of the Andropenis® will increase the length of the penis, both in erect and flaccid state.
2. The increase in length, both in erection and flaccidity, is directly proportional to the time of use.
3. The increase in length both in erection and flaccidity does not depend on the natural size of the patient's penis.
4. The average length growth of the penis in cm/month in 95% of the patients lay between 0.4283 and 0.5163 in erection and between 0.4173 and 0.5495 in flaccidity.
5. The variances in the length of the penis in erection are more uniform than those in flaccidity, which tend to be more disparate.
6. The variance of the length of the penis in erection is not related to the age of the patient.
7. The use of the penile traction device will increase the perimeter of the penis, both in erection and flaccidity.
8. The average perimeter growth in cm/month in 95% of the patients was between 0.6111 and 1.0200 in erection, and between 0.6386 and 1.0425 in flaccidity.

The duration of treatments was of 3-6 months

Recommended and US FDA Registered Penis Traction Device - click here

Penis Traction for Bent or Curved Penis / Peyronie's Disease

1. Peyronie's disease - latest treatment options

A report by Wendy Hurn, Urology Specialist Practitioner, Bristol Royal Infirmary UK

Introduction:

In clinical practice, we observe a considerable number of men with penile curvature due to Peyronie's plaques. Peyronie's disease is a condition in which a plaque, or hard lump, builds on the penis in form of a fibrotic scar that develops within the tunica albuginea of the corpora cavernosa and may cause a curvature of the erect penis.

There is a variety of opinions, but a recent study seems to put the percentage rate of his incidence as high as 3,2%. However, it is difficult to estimate the exact number of men suffering from this disease, since many of them do not seek a doctor because they feel embarrassed or ashamed.

This area of scarring, or plaque, typically develops on the dorsal surface of the penis (dorsum), although it may also develop on the ventral side or on the lateral side of the penis. It may progress to calcification in approximately 30 % of the patients and that indicates that the scar is mature.

Peyronie's plaques can cause embarrassment and discomfort or even pain to the partner during sexual intercourse. If not treated, the disease may be a cause of serious erectile dysfunction and even produce a breakdown in the relationship.

Treatment options:

Initially, the first line of treatment was to "watch and wait" in order to find out if the curvature resolved itself and, in case it became worse, to give the patient a high dose of vitamin E daily. A vitamin E treatment is normally a long-term treatment of usually almost a year and may not produce any positive results.

In recent years, this treatment has been considered unsafe because of its side effects on blood pressure, leading in some cases to stroke and cardiac events. A recent Heart Outcomes Prevention Evaluation (HOPE) Study suggests such a conclusion, while many other studies continues to emphasize the overall benefits of vitamin E for the cardiovascular system.

There are surgical options available, such as the Nesbit's procedure (placation procedure) or the Lue procedure (venous graft); however, given the existence of side effects and risks, this may not always be the most appropriate way.

The innovative Andropenis® traction device represents an alternative method to surgery and demonstrated very positive results.

The device is placed by the patient himself after being carefully instructed about how to use it effectively. The device is small, robust and discreet and shall be worn during daytime. It cannot be worn during sleep due to nocturnal tumescence. It takes just a few moments to apply and should be worn for a period of time gradually building up to approximately 6-8 hours a day to produce the optimum effect. It works by gently stretching the penis and elongating the plaque, which in turn breaks it down. If worn as instructed, the first results should be recognized within 3-4 weeks, while full results will show up after approximately 3-6 months.

Currently there are 25 patients receiving therapy with the Andropenis® at the Bristol Royal Infirmary's Andrology clinic, one of several busy clinics which Urology Department is offering to men suffering from Peyronie's disease both conventional surgical procedures and penile prosthetics. The patients show different degrees of deviation; most of them having been submitted to daily treatment with the penile extender for three months or more and wearing the device during the waking hours. There has been a marked decrease of about 30-45% in degree of angulation, with a sensible reduction of discomfort and the possibility to resume sexual intercourse in most cases. The patients continue wearing the device and the evolution will be checked after six months of treatment. Two case studies will be described.....

Conclusion:

The election of the treatment method of the Peyronie's disease will be discussed between patient and specialist. For those patients who cannot or don't want to choose the surgical option, the Andropenis® represents a real alternative. It gives the patients autonomy and allows them to take some control over the situation, while getting positive results. As patient and doctor discuss the possible treatment options, it is extremely important to exhaustively inform the patient that the treatment with the Andropenis has to be considered an overall effective and viable treatment, and the physicians themselves will appreciate the potential benefits of this device after seeing the positive effects that their patients can achieve by using it.

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2. Penile Traction Therapy for Treatment of Peyronie's Disease: A Single-Center Pilot Study

(Published in the Journal of Sexual Medicine - Volume 5 Issue 6 of June 2008)
 

by Laurence A. Levine, MD,* Mark Newell, PhD, ? and Frederick L. Taylor, MD*
*Department of Urology, Rush University Medical Center, Chicago, IL, USA;
? Medway Research Institute, North Augusta, SC, USA
Correspondence to Laurence A. Levine, MD, 1725 W. Harrison Ave., Suite 352, Chicago, IL 60612. Tel: 312-563-5000; Fax: 312-563-5007; E-mail: drlevine@hotmail.com

ABSTRACT

Introduction.

 Peyronie's disease (PD) is a fibrotic disorder of the penis whose etiopathophysiology remains unclear. So far, there has been no known reliable nonsurgical treatment. This study reviews our experience with external penile traction therapy to correct the deformity associated with this disorder.
 

Aim.

To evaluate prolonged external penile traction as a nonsurgical treatment for PD.
 

Methods.

Ten men with PD completed this pilot study of traction therapy using a Penile Extender. Nearly all (90%) had failed prior medical therapy. Traction was applied as the only treatment for 2?8 hours/day for 6 months. All subjects underwent pre- and post-treatment physical examination including measurement of stretched flaccid penile length (SPL) and biothesiometry.
 

Main Outcome Measures.

Curvature and girth were measured during erection before and after treatment with dynamic duplex ultrasound. Assessment of erectile and sexual function was further assessed with the International Index of Erectile Function and Quality of Life Specific to Male Erection Difficulties (QOL-MED) questionnaires. At 3 and 6 months post-treatment, SPL was measured and subjective assessment of deformity by the patient was recorded.
 

Results.

Subjectively all men noted reduced curvature estimated at 10?40 degrees, increased penile length (1?2.5 cm) and enhanced girth in areas of indentation or narrowing.

Objective measures demonstrated reduced curvature in all men from 10?45 degrees; average reduction for the group was 33% (51?34 degrees). Penile Length increased 0.5?2.0 cm and erect girth increased 0.5?1.0 cm with correction of hinge effect in four out of four men. International Index of Erectile Function-erectile function domain increased 18.3?23.6 for the group. Changes in quality of life by QOL-MED were not found to be statistically significant in this small series. There were no adverse events including skin changes, ulcerations, hypoesthesia or diminished rigidity.

Conclusion.

 Prolonged daily external penile traction therapy is a new approach for the nonsurgical treatment of Peyronie's Disease. The therapy is potentially valuable given the response noted in this pilot study.

US FDA Registered Penis Traction Device Recommended for Curved Penile Erection