Effect of Modified Vacuum in Patients with Peyronie’s Disease and Erectile Dysfunction

Document Type : Original Article


1 Medical Department, General Surgery Resident of Tehran University of Medical Science,Tehran,Iran

2 Urology Ward, Mostafakhomeini Hospital,Shahed University of Medical Science, Tehran, Iran

3 Medical Department,General Surgeon,Isfahan University of Medical Science,Isfahan,Iran


Peyronie's disease (PD) is a penile disease that is characterized by penile pain, curvature, shortening, and plaque in the penis, which usually ends up in erectile dysfunction (ED). This study assesses the efficacy of modified vacuum therapy in patients with PD and ED. The basic principle of the study is similar to modeling performed during penile implant surgery.
This study was performed on 43 Patients who practiced with three different vacuum cylinders for 30 minutes, 3 times a day for 3 months. First, the second and third months with the smallest, medium, and biggest cylinders were used, respectively. Parameters were recorded before the beginning of the study at the end of each month. Assessment includes the number and size of the plaque, angle of penile curvature (by erection induced with vacuum constriction device (VCD)), pain during erection, the status of morning erection, quality of an erection, and various previous treatments. There was a clinically and statistically significant improvement in the angle of curvature, size, and number of plaques. 
A total of 43 patients with a mean age of 56.3 years(40-74) participated in the study. There was a significant reduction in plaque size and curvature. The mean of plaque size and curvature was 1.39cm and 31.28 degrees, respectively, at the presentation, which was reduced to 0.64 (0-3)cm and 11.6 degrees, respectively, at the study's end. At the end of the study, 30(69.7%) patients were satisfied with the outcome and wanted no further treatment. There was no significant side effect observed in patients using the device.
We recommend using a modified vacuum device with the mentioned method for PD and ED with curvature less than 45 degrees and plaque size less than 2cm. It is safe to use in all stages of the disease and can help patients to attain erection with VCD.


  • Peyronie's Disease (PD) is a connective tissue disorder involving the growth of fibrous plaques in the soft tissue of the penis
  • The average age of onset of PD in white men is about 53 years.
  • There are several surgical techniques for PD including excision of plaque, incisions, graft, plication of the penis, and penile prosthesis.



Peyronie’s Disease (PD) is a connective tissue disorder involving the growth of fibrous plaques in the soft tissue of the penis. PD symptoms include pain, shortening, penile curvature, and a variable degree of erectile dysfunction. The cause is unknown, although abnormal wound healing due to minor sexual trauma will develop fibrotic tissue replacement at traumatized sites due to an underlying genetic predisposition (1,2). Fibrotic tissue will gradually tighten the penis even stony hard due to calcification. Due to the low flow of blood circulation in the tissues of the penis, which will decrease the ability to transfer fibroblasts so fibrotic tissue reuptake of plaque will be deranged, and the plaque will remain there (3). 

The incidence of symptomatic disease is estimated to be about 5%. The average age of onset of PD in white men is about 53 (range 19-83) years. Symptomatic PD is estimated at about 0.4% to 9% (4,5).

Incident of PD associated with ED is estimated to be around 70% (6). PD treatment includes both non-surgical and surgical treatments. Surgical treatment is indicated in stabilized Peyronie (more than 12 months) in which the patients, despite having a good erection, are unable to make intercourse due to deformity. Nonsurgical treatment such as oral treatment, intralesional injection, topical treatment, and vacuum pumping. Conservative treatment is considered inpatient, and we are aiming to reduce curvature, pain, and penile shortening in the patient (5). There are several surgical techniques for PD, including excision of plaque, incisions, graft, plication of the penis, and penile prosthesis, none of which is considered a gold standard treatment. Using a vacuum device will increase blood circulation to the genital and stretched fibrotic. Vacuum pumping will mechanically stretch the tunica and provide lengthening at the contracted site as well. The concept of the molding technique, which had been used in penile surgery to reduce the curvature after insertion of the penile prosthesis for PD, could be helpful in the management of PD by trying to mechanically straighten the penis with the use of VCD (7). A similar study has been also implicated by Raheem et al., as conservative management in PD (8).



A total of 60 patients were enrolled in the study with PD who were suffering from ED as well. The mean age was 56.3 years, range 40-74. Exclusion criteria were potency, absence of penile curvature, previous penile surgery, and physical/mental inability to use the device. 

After taking a history, physical examination, and diagnosis of the PD and ED by a urologist, a form was given to all patients to announce their agreement to participate in the project. All study procedures were approved by the Shahed Medical University ethics committee. All patients were trained to obtain sufficient awareness about all the procedures before entering the study and signed the ethical form. The patient questionnaire to the notice of the subjects (number and size of the plaque, angle of penile curvature, pain during erection, status of morning erection, quality of an erection, and various previous treatments) were filled out by the project manager. Patients were given a flexible penis to show approximate penis curvature, and VCD was used to assess the curvature by inducing erection and maintaining it by placing a constrictive ring at the penis base. Finally, the exact amount of the angle was achieved using Goniometer. Patients were advised to use a modified vacuum device. All patients were trained by the project manager on the proper use of the device. The device includes 3 cylinders (figure 1). All patients were advised to use the device by putting the penis into the cylinder and vacuum pumping it until full erection was achieved and maintaining it for half an hour three times a day without the constrictive ring to stretch and expand the penis. Patients were advised to use the small, medium, and large cylinders in the first, second, and third months respectively. All patients were recommended not to increase vacuum pressure if they feel pain but try to achieve and maintain a full painless erection for half an hour. Patients were advised to complete a daily diary to monitor their pump use and assess compliance. All patients were revisited at the end of each month, and treatment progress was recorded. During 3 months, the patients used a vacuum device (Hamrah VCD, Hamrah medico-engg group, Tehran, Iran). The study was approved by the local ethics committee.

Regarding the status of erection, the physician was asking about the status of morning erection from the patients. Whether horizontal, above, or below (when the patient is standing). Then more precise questioning was done according to the patient's response to see whether it was above horizontal, fully rigid, or just above horizontal and if it was below horizontal, it was flaccid or had a mild erection, as it is shown in Table 1. The type of study was case series.

All data were analyzed with the software of SPSS 20 and calculated with the adjustment of frequency distribution tables, and descriptive statistics criteria and variables of research have been described with the usage of analytical statistics, paired T-test, VAS score examination assumed examination analyzed, and we reached the goals. The test was conducted with a confidence interval of 95%.

We used the following formula to determine the sample size:


n=((Z 1-α/2+Z 1-β)² (δ1²+δ2²))/((μ1-μ2)²)


Figure 1. The Hamrah vacuum device


Table 1. change in plaque size – curvature before and after treatment

After using vacuum

Before using vacuum


0.64(0.94) (0-3) (p<0.001)        

1.39(1.03) (0-3)

Plaque size mm (SD)(min/max)

11.6(17.7) (10-80) (p<0.001)        

31.28(15.4) (10-80)

Mean curvature (SD) (min/max)

5.9 (4.98) (0/20)(p<0.001)

27.6 (10.38) (10/45)

The mean reduction of curvature


62.50(15/00) (50/80)


66.25 (13.7) (46/80)

The mean reduction of curvature >46





In this study, 60 patients entered, of whom 17 patients went out of the study due to the following reasons, failure to complete at least 90% of the exercise session (10 patients), discomfort and pain during pumping (5 patients), and dislike the method (2 patients).

A total of 43 patients completed the study. The mean age was 56.3 years (40-74 years).

Regarding previous treatment, 15 patients had received no treatment before using the vacuum, 28 patients were treated with vitamin E and verapamil, and 1 patient gave a history of shock wave therapy.

At presentation, the mean (range) of plaque size was 1.39 (0-3)cm. The mean (range) of curvature was 31.28 (10-80) degrees. Of 43 patients who completed the study mean (range) reduction in plaque size and curvature were 0.64 (0-3)cm and 11.6 (10-80) degrees, respectively, which is of significant value (p-value<0.001). The improvement in plaque size had a close relationship with the size of plaque at presentation and had a better outcome in patients with lower numbers of plaque (Table 2) and plaque smaller than 2cm (Table 3). The change in plaque size and penile curvature was not significantly associated with patients’ age.

The curvature changes directly related to its severity at presentation and demonstrated significant (p-value<0.001) improvement in patients with curvature less than 45 degrees.

Before the start of therapy, 7 patients (16.3%) had pain. And 36 patients (83.7 %) had no pain. All patients had no pain at the end of the study.

There is a significant improvement in morning erection following the use of a vacuum device on a 95 percent Confidence interval (p-value<0.001) in patients with a horizontal erection in the morning. At the end of the study, eight patients were able to do intercourse with 5 alpha-reductase inhibitors, 30 patients were using VCD for intercourse, and 5 patients, despite having full rigid erections with VCD, were unable to have successful intercourse due to severe penile curvature.    

 At the end of the study period, 30 (69.7%) patients were satisfied with the outcome. They wanted no further treatment, 10(23.2%) patients continue to practice with VCD in the hope of getting more improvement in the long term, two (4.6%) stopped further treatment, and one (2.6%) patient went under surgery for correction of curvature followed by using VCD to induce and maintain an erection. All patients experience vacuum pumping acceptable and without any major complications. Three patients experienced minor bruising and ecchymosed, which was improved by two weeks of rest.


Table 2. Plaque number before and after using a vacuum

Absolute frequency after using vacuum

Absolute frequency

Before using vacuum

Number of plaques

20 (46.5%)

2 (4.7%)


19 (44.2%)

30 (69.8%)


4 (9.3 %)

5 (11.6%)


0 (0%)

4 (9.3%)


0 (0%)

2 (4.7 %)





Table 3. Plaque size classification based on recovery

Plaque size

Relative frequency(number of plaque)

Condition after treatment

0-2 cm


Completely cure

2-3 cm


Less than 2 cm

3cm <


No difference



Table 4. Morning erection before and after using a vacuum


Absolute Frequency

Before using vacuum

Absolute Frequency

Afterusing vacuum

Loose (complete flaccid)

9 (20.9%)

2 (4.7%)

Sub horizontal

25 (58.1%)

8 (18.6%)


9 (20.9%)

22 (51.2%) (P<0.001)

Above the horizontal

0 (0%)

11 (25.6%)

Full rigid

0 (0%)

0 (0%)




Several controversial treatments have been introduced in PD with no confirmed therapeutic effect in clinical trials (9,11). In this study, we evaluate the effect of modifying vacuum devices to mechanically straighten the penis and decrease plaque size. Patients with PD and ED are candidates for penile prosthesis, and surgery is the last remaining option to restore sexual function. Surgery is considered the only treatment for these patients (12). It may be considered over-treatment, while the nonsurgical option is unlikely to be effective once the disease stabilizes. Moreover, most of our patients had no therapeutic effect from their previous medical treatments. Based on our experience, we have been using vacuum pumping for the last 17 years to treat patients with PD and ED. The same study was done by Levin et al. in which he used a penile extender device to treat PD with promising results (13).

These studies help give hope to patients who are worried about the future of their disease, which would be observed in half of the patients (13). The vacuum device is easy to use and can help patients get involved directly in their treatment program. It may affect a satisfactory rate to increase improvement as they avoid surgery. Regular vacuum pumping would mechanically straighten the penis and its fibrotic band, causing the remodeling of fibrous plaque leading to the straightening of the penis (14). Vacuum pumping with the usual vacuum device with a routine size cylinder will cause negative pressure on all penis surfaces and expand the penis in all directions, which is not appropriate for straightening penile curvature. However, its generalized effect reduces the curvature and size of the plaque. We try to act more precisely by using different size cylinders. Mentioning pressure formula (the molecule in area unit), we used the small cylinder, which by vacuum pumping will pull the penis forward from its distal end (glans) and will striate the penis (it will not have the side expansion). It not only implements traction force on fibrotic bands but also increases blood circulation as well (15).

By gradually increasing cylinder size, in addition to striating the penis, it becomes expanded as well. At the end of the practice, using a constrictive ring at the base of the penis patient could also benefit from its effect on his erectile dysfunction. 

We did not observe any particular predictor for successful outcomes, so all patients can try vacuum device pumping to treat Peyronie's disease even if they are waiting for surgery. Patients with plaque smaller than 2cm and penile curvature of fewer than 45 degrees had a higher success rate than patients with a larger plaque and a higher degree of curvature. Raheem et al. also observed better responses in patients with soft plaque (8). We did not perform ultrasonography but it is possible that patients with calcified plaque would have less likely to respond to this type of therapy or may need a longer duration of practice. Most of the patients with penile curvature of more than 45 degrees decided to continue practicing with the device in the hope of getting improvement in the longer term.

Erectile function and the quality of nocturnal penile tumescence also improved in our patients. Raheem et al. did not observe any significant sexual improvement (8).In our study, 69.7% (30) of patients were satisfied with the outcome and wanted no further treatment; patients were able to have a good erection with VCD sufficient for intercourse by using a constrictive ring at the base of the penis (15).

If deformity was not a major obstacle to vaginal penetration. The pain was observed in 7(16.3%) patients at the start of the study. And 36 (83.7%) patients had no pain. All patients had no pain at the end of the study, so we did not have any significant comment on this issue because it is the natural course of PD. Raheem et al. also report spontaneous pain resolution in all their patients, which is unrelated to the therapy (8).

This is the first study to describe the use of a modified vacuum device in PD and ED. Studies with more modifications, more patients, and longer duration if practicing with VCD need to have a better impression of its effects on PD. 



Treatment of patients who present with Peyronie's disease and erectile dysfunction with vacuum pumping is safe and effective. This method not only enables the patient to have an erection by using a ring at the base of the penis to maintain an erection, but it also improves the patient’s sexual ability and significant reduction in plaque numbers, plaque size, and curvature of the penis. The patient is directly involved in treatment (request for surgery decrease). Some predictors of successful outcome include presenting curvature below 45 degrees and presenting plaque size below 2cm.


Authors’ contributions 

All authors had an equal contribution.



We would like to express our appreciation for the Urology Research Center. 


Conflict of interest

Fereydon Khayyamfar owns the patent on the VCD described in this report. He has received financial support as a member of the Hamrah medico-engg group (manufacturer and seller of studied VCD). The other authors declare no potential conflict of interest.



There is no funding.


Ethical statement 

Not applicable. 


Data availability 

Data will be provided by the corresponding author on request. 



ED       Erectile dysfunction 

PD       Peyronie’s disease

VCD    Vacuum constriction device  

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