Treatment of erectile dysfunction in patients with Peyronie's disease using sildenafil citrate

Abstract

Erectile dysfunction (ED) has frequently been associated with Peyronie's Disease (PD) and may further compromise coitus. This is a retrospective analysis of ED in patients with PD since the release of sildenafil citrate (SC) focusing specifically on our patients' responses to SC. One-hundred seventy six patients with PD were evaluated between April 1998 and May 2001. All patients received a complete medical and sexual history, physical exam, penile duplex ultrasound (PDU, with 30–90 mg of papaverine) to assess penile vascular integrity, plaque dimensions, and erect penile deformity. Based on these findings, appropriate treatment options were offered for their PD and their ED including SC, which was offered to 73 men. Patient response to SC was specifically assessed during patient office interview and via a mailed EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) questionnaire. Seventy (39.8%) and 104 (59.1%) patients complained of decreased erectile capacity (ie rigidity) occurring before and after the onset of PD, respectively. Only two patients reported no change of erectile capacity. In all, 103 (58.5%) patients complained of significant reduction in sexual function due to diminished rigidity and sought treatment for their ED. Of the ED treatment options available, 73 (70.9%) patients were given a prescription for SC. Forty-eight (75.0%) patients returned the EDITS questionnaire while four of 73 (5.5%) patients did not fill their prescription and five of 73 (6.8%) did not engage in sexual activity following an initial trial of SC due to side effects (flushing, headaches). Based upon the EDITS response, 34 of 48 (70.8%) patients reported that they were either very satisfied or somewhat satisfied, five of 48 (10.4%) patients were neither satisfied nor dissatisfied, and nine of 48 (18.8%) patients were somewhat dissatisfied or very dissatisfied with the effectiveness of SC in enhancing their erectile response. No patient reported worsening of PD deformity or an increase in penile pain. The 30 patients who were not prescribed SC chose the following options to enhance rigidity: eight (7.8%) underwent prosthesis placement, four (3.9%) opted for vacuum constriction device (VCD), four (3.9%) chose intracorporal injections, and 14 (13.6%) used no adjunctive therapy. Erectile dysfunction is a problem associated with PD and all typical treatment options are acceptable. However, to our knowledge, there is no published study reviewing the efficacy of SC in patients with ED associated with PD. There appears to be no contraindication to using SC as being the least invasive and most convenient treatment option for ED with PD. Although the potential risk of coital trauma to the erect penis with PD is present, there is no evidence from this study that erections and coitus enhanced specifically by SC resulted in worsening deformity or progression of the PD. EDITS questionnaire results reveal that SC is an agent that allowed successful coitus in 70.8% of males with PD.

Introduction

Peyronie's disease has been described as a localized connective tissue disorder affecting the tunica albuginea resulting in a fibrous inelastic scar. While the etiology of this disorder still remains unclear, the pathophysiology is characterized by an initial inflammatory phase with associated lymphocytic and plasmacytic infiltration of the tunica albuginea that may lead to fibrosis, calcification and plaque formation.1,2 This fibrous plaque may alter penile anatomy and dramatically affect sexual function as well as quality of life in men who are afflicted with this disorder.1,2 The incidence of Peyronie's disease has been reported in 0.39–3% of men with the majority of affected patients being between the ages of 40 and 70.1,2 The actual prevalence of this disorder, however, is probably higher due to patient embarrassment, refusal to seek treatment, presence of the disorder in men who are not concerned with their erectile deformity/dysfunction, and the presence of a deformity that does not interfere with coitus. Recently, however, more physicians are diagnosing Peyronie's disease since the advent of effective oral therapy for erectile dysfunction (ie sildenafil citrate, Pfizer, New York) as patients have become more willing to discuss their erectile dysfunction and seek treatment.1,2

Erectile dysfunction has been recognized for some time to be associated with PD. Recent reports have suggested the prevalence of ED to some degree with PD to be up to 80%.3 ED may be due to several factors in men with PD prior to any medical or surgical treatment including vascular insufficiency (arterial, venous, or both) and structural alterations making coitus difficult or impossible including severe curvature, shortening, and indentations causing a ‘hinge-effect’. There may also be a significant psychogenic component to the ED in many men with PD which could clearly contribute to diminished erectile response.

In recent years, public awareness and emphasis on this aspect of life has increased since the release of sildenafil citrate. SC is a potent and selective phosphodiesterase type 5 isoenzyme inhibitor which results in an increase of cavernosal smooth muscle levels of cyclic guanosine monophosphate(cGMP) resulting in an improved penile erection. A recent study reported that 67.6% of patients with ED of various etiologies taking SC achieved an erection suitable for sexual intercourse.4 However, physicians and patients have been reluctant to use SC for ED in patients with PD due to the warning found in the package insert which states: ‘Viagra [SC] should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease)’. This warning was required since men with ED associated with PD were not specifically evaluated during the clinical trials prior to Food and Drug Administration (FDA) approval. Therefore, our goal with this retrospective study is to evaluate the safety and efficacy of SC in patients with ED associated with PD.

Materials and methods

Between April 1998 and May 2001, 176 patients were evaluated in our offices for PD. A thorough history and physical exam was performed on each patient paying particular attention to the patients sexual history. A baseline self-administered sexual questionnaire focusing on PD was completed by all patients during the initial visit. All patients also underwent a penile duplex ultrasound (PDU) to assess penile vascular integrity, plaque dimensions and erect penile deformity (with 30–90 mg of papaverine) using a previously described technique for men with PD.5 Based on the results of the duplex ultrasound, history and physical exam, treatment options were offered to patients to address complaints of diminished or inadequate erectile capacity as well as their penile deformity.

Before a treatment was chosen, however, specific questions were asked as to the patients' grading of their erectile capacity (grade 0–10 with 8 being able to achieve intromission without any aid) before and since developing PD. To determine the quality of their sexually induced penile rigidity at the time of presentation, patients were asked the following question: ‘If your penis had no deformity, would the rigidity that you currently experience when sexually aroused be adequate for vaginal penetration and be maintained through sexual intercourse?’ In those men who felt their rigidity was inadequate and did not have a deformity which would make coitus impossible, several treatment options were offered for their ED including SC. If a trial of SC failed or could not be taken, intracavernosal injections or intraurethral instillation therapy were offered as well as VCD or penile prosthesis implantation.

With respect to erectile insufficiency, 73 patients were given a prescription for sildenafil citrate and were presented with oral as well as written instructions regarding the use and potential side effects of this treatment including the potential to exacerbate their PD by causing stronger erections that may increase the risk of penile injury during coitus. If little or no response was seen following one to two trials using 50 mg tablets, patients were then directed to try 100 mg of SC four to six times to ensure an adequate trial. Patients with advanced cardiac disease and those taking any form of organic nitrate medications were not offered SC.

All patients who elected to trial sildenafil citrate were sent an EDITS questionnaire to assess their satisfaction with SC as a treatment option for their ED. Unfortunately, pretreatment validated questionnaires such as the International Index of Erectile Function (IIEF) were not routinely offered and therefore were not included in this analysis. A separate post-treatment questionnaire was also sent to the partners. The patients and their partners were asked to fill out the individual surveys separately without consulting each other and without comparing answers. The questionnaire evaluated patient satisfaction with SC, ease of using SC, partner satisfaction, how natural the erection felt, and the likelihood of continuing to use this treatment. The items on the questionnaire involved a scale of 1–5 with 1 and 2 being very and somewhat satisfied, respectively.6 Statistical analysis was then performed using the Pearson chi-square test to evaluate any possible correlation between the effectiveness of SC (EDITS questionnaire) and the type of vascular insufficiency found on PDU.

Results

One hundred seventy six men with PD between the ages of 18 and 72 y (mean age 51) have been seen since the release of SC. Seventy (39.8%) patients complained of decreased erectile capacity before the onset of PD while 104 (59.1%) patients complained of decreased erectile capacity after the onset of PD. Only two patients reported no change with respect to their sexual function. One-hundred and three (58.5%) patients complained of significant reduction of sexual function due to diminished penile rigidity and were offered treatment for their ED. The other 71 (40.3%) patients noted some decrease in their erectile capacity, but were overall satisfied with their sexual function and did not seek any further treatment specifically to enhance their erections.

Of the 103 patients who sought treatment for their ED, 73 (70.9%) patients were given six 50 mg sample tablets of SC as well as a prescription and instructions regarding the use and side effects of SC. These 73 patients were subsequently sent an EDITS questionnaire between 3 and 24 months after initiating SC therapy to evaluate their satisfaction with this treatment option. Four of 73 (5.5%) patients, however, did not fill their prescription and five of 73 (6.8%) patients could not tolerate the side effects of SC (ie headache, 2 and flushing, 3) and were unable to engage in any sexual activity while on SC. These nine patients were excluded from our data analysis of erectile response to the drug. Forty-eight of 64 (75.0%) patients of an average age of 55.9 y returned the EDITS questionnaire. Thirty-four of 48 (70.8%) patients were either satisfied or very satisfied with the effectiveness of SC to enhance their erectile response. Five of 48 (10.4%) patients were neither satisfied nor dissatisfied, and nine of 48 (18.8%) patients were somewhat dissatisfied or very dissatisfied with the use of SC (See Table 1). Thirty-two of 48 (66.7%) of patients reported that they were either very likely or moderately likely to continue using SC in the future.

Table 1 EDITS questionnaire results

Assessment of penile vascular integrity of men treated with SC during duplex ultrasound revealed decreased average peak systolic velocity (<30 cm/s being consistent with arterial insufficiency) in 27 of 64 (42.2%) patients, venous insufficiency (defined as average end diastolic velocity >4.5 cm/s) in 13 of 64 (20.3%) patients, mixed arterial and venous insufficiency in three of 64 (4.7%) patients and no vascular insufficiency in 21 of 64 (32.8%) patients.5 With regard to questionnaire responders (Table 2), duplex ultrasound revealed decreased peak systolic velocity in 21 of 48 (43.8%) patients. Venous insufficiency was found to be present in 10 of 48 (20.8%) patients. Only two of 48 (4.2%) patients were found to have a mixed arterial and venous insufficiency. Fifteen of 48 (31.3%) patients revealed neither arterial nor venous insufficiency on PDU. Our results also reveal that 90% of those with venous insufficiency were satisfied with SC whereas only 52.4% with arterial insufficiency were satisfied with their response to SC for coitus.

Table 2 Comparison of PDU vascular findings and response to SC*

Twenty-five of 64 (39.1%) partners returned the partner version of the EDITS questionnaire. Fifteen of 25 (60.0%) partners reported that they were either very satisfied or somewhat satisfied, seven of 25 (28.0%) partners were neither satisfied nor dissatisfied, and three of 25 (12.0%) partners were either somewhat dissatisfied or very dissatisfied with the use of SC as a treatment option for their partners ED (Table 1). No specific comments were offered by the partners to elaborate on their satisfaction response.

Of the 103 patients that sought treatment for their ED as a result of PD, 30 were not given a prescription for SC. Fourteen (13.6%) patients chose not to pursue any treatment for their ED while eight (7.8%) underwent penile prosthesis placement, four (3.9%) chose intracorporal injections, and four (3.9%) opted for VCD. All reported that they were satisfied with their choice of treatment during follow-up. No specific questionnaires were used for this group.

Discussion

Peyronie's disease is a disorder that may cause significant psychosexual effects and result in ED or exacerbate organic causes of ED. The etiology of ED in patients with PD may therefore stem from the fibrous plaque which may alter penile anatomy, and/or vascular and psychogenic factors. It must be noted that PD and ED are two distinct entities which must be assessed and potentially treated separately. This study specifically evaluated the treatment of ED associated with PD in patients that presented to our office after the release of SC focusing primarily on our experience with SC. Weidner and associates have reported that, out of 222 patients, 70 (31.5%) patients complained of not being able to perform intercourse. However, in the literature, it has been reported that up to 80% of patients with PD may have concurrent ED.7 This wide range of ED associated with PD in the literature may be due to patient selection as well as the methods used for evaluating ED, which included physician–patient interaction during office visits or validated questionnaires such as the IIEF. Our study revealed that 103 of 176 (58.5%) patients with PD specifically sought treatment for their ED. An additional 71 of 176 (40.3%) patients also reported some decrease in erectile capacity, but these patients did not seek treatment. Because of this association between PD and ED, a large number of patients with PD will need and potentially seek treatment for ED.

In this study, we evaluated our experience with SC as a first-line medical treatment for ED in men with PD. All patients received a penile duplex ultrasound with papaverine injection which provided a dynamic functional assessment of penile anatomy, plaque dimensions, and penile vasculature. Lopez et al have reported that 36% of patients with impotence secondary to PD were found to have arterial insufficiency, while 59% were found to have veno-occlusive dysfunction.3 Our previous report on 99 consecutive men with PD evaluated with duplex ultrasound revealed 52% of patients had arterial insufficiency, and 8% had venous insufficiency.5 This study reveals that, of the patients with ED associated with PD that tried SC, 42.2% were found to have arterial insufficiency by PDU while only 20.3% revealed veno-occlusive dysfunction. In another study by Jarow et al, they recently reported that patients with psychogenic and vascular etiologies for ED had a better response to SC than those with neurologic etiologies but did not examine men with PD and ED.8 Also, because many men with PD have a psychogenic component of ED secondary to the penile plaque, pain and deformity, and at the same time may have risk factors associated with vascular insufficiency, we expected our patients treated with SC to respond similarly to men with vascular etiologies for their ED.3,5

According to our results, it appears that the lowest satisfaction rate and the highest dissatisfaction rate were reported in men with an arterial component to their ED according to PDU findings (Table 2). This would suggest that men with more advanced arterial-inflow disorders would be less likely to respond to SC for treatment of their ED. Statistical analysis does reveal that patients with either venous insufficiency or no vascular insufficiency were more likely to be satisfied with SC than patients with arterial insufficiency (P<0.05; Pearson chi-square test). However, given that it is an effective and safe first-line treatment for ED (Process of Care9), we would still recommend a trial of SC, but advise cautioning the patient regarding expectations, particularly if they have such vascular risk factors as diabetes or advanced hypertension where vascular changes within the penis may result in a diminished response to SC.

A psychogenic component may also contribute to ED in patients with PD. Our results reveal that 86.7% of patients with no vascular insufficiency on PDU were satisfied with the use of SC. This result is similar to that found in men with psychogenic ED without PD who underwent a trial of SC.10

Sexual dysfunction may also occur in men with PD due to the physical deformity of the erect penis. These patients with severe curvature deformities which prevent them from intromission were not offered SC. Rather, these patients were offered treatment of their deformity with intralesional injections of verapamil and straightening procedures. However, patients who presented with lesser deformities (<90°) as well as diminished erectile capacity limiting their ability to accomplish intromission were offered SC for their ED and other modalities including oral vitamin E and/or colchicine, or verapamil injections for their penile deformity. All patients who were given a trial of SC were sent an EDITS questionnaire to evaluate the effectiveness of this treatment option.

We received a 75.0% (48/64) response rate to the survey which revealed that 34 of 48 (70.8%) of patients were either very satisfied or somewhat satisfied with their response to SC. Because up to 80% of patients with PD may have concurrent ED, SC may be a very effective first-line agent for these patients. SC is easy to use, has good patient (70.8%) and partner (60.0%) satisfaction rates, and is well tolerated.

Conclusions

Erectile dysfunction associated with PD is a problem with not only physical but also psychological effects. When considering treatment options for patients with ED, the first line option used should be safe, minimally invasive and reasonably successful. To our knowledge, there has been no published report on the effectiveness of using SC as a potential first-line agent for treating ED associated with PD. This retrospective study reveals that up to 70.8% of patients who were given a trial of SC were either very or somewhat satisfied with this treatment option according to the EDITS questionnaire. No patient experienced an injury to their penis during coitus while taking SC nor was any worsening of deformity noted during the treatment period. This therapy should be strongly considered as primary medical therapy for those presenting with ED associated with PD.

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Correspondence to L A Levine.

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Levine, L., Latchamsetty, K. Treatment of erectile dysfunction in patients with Peyronie's disease using sildenafil citrate. Int J Impot Res 14, 478–482 (2002). https://doi.org/10.1038/sj.ijir.3900912

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Keywords

  • Peyronie's disease
  • erectile dysfunction
  • sildenafil citrate
  • EDITS questionnaire

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