Sildenafil citrate effectively reverses sexual dysfunction induced by three-dimensional conformal radiation therapy.

Valicenti RK, Choi E, Chen C, Lu JD, Hirsch IH, Mulholland GS, Gomella LG.   Urology 2001 Apr;57(4):769-73

Department of Radiation Oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.

From March 1996 to April 1999, 24 men with median age of 68 years (range 51 to 77) had 3DCRT for localized prostate cancer (median prescribed dose to the planning target volume of 70.2 Gy). These men started taking sildenafil for relief of sexual dysfunction at a median time of 1 year after completing 3DCRT. We used the self-administered O'Leary Brief Sexual Function Inventory to evaluate in series SF and overall satisfaction at three time points. These points were (a) before initiation of all therapies (3DCRT or hormonal treatment [HT]) for prostate cancer, (b) before starting sildenafil (50 mg or 100 mg) but after completion of all therapies, and (c) at least 2 months afterward. Rates of SF were based on the number of men responding to a given question. Prior to all treatments, 20 (87%) of 23 men were sexually potent, with 8 (36%) of 22 fully potent (little or no difficulty for penetration at intercourse). After 3DCRT with or without HT and prior to sildenafil use, 13 (65%) of the 20 potent patients remained potent, with only 2 (11%) of 19 being fully potent. The use of sildenafil citrate resulted in 21 (91%) of 23 men being potent, with 7 (30%) being fully potent.

Treatment of erectile dysfunction with sildenafil citrate (Viagra) after radiation therapy for prostate cancer.

Kedia S, Zippe CD, Agarwal A, Nelson DR, Lakin MM.  Urology 1999 Aug;54(2):308-12

Department of Urology, The Cleveland Clinic Foundation, Ohio 44195, USA.

Baseline and follow-up data from 21 patients presenting with erectile dysfunction after radiation treatment for clinical T1-2 prostate cancer were obtained. Two patients had undergone iodine-125 seed implantation and the remaining 19 conformal external beam irradiation. All 21 patients were considered to have erectile dysfunction as assessed by the International Index of Erectile Function (IIEF) and were prescribed sildenafil at a dosage of 50 mg, with a titration to 100 mg if needed. The mean time between the completion of radiation therapy and initiation of sildenafil was 24.6 +/- 5.8 months.   On the CCEF questionnaire, 71% (15 of 21) of patients had a positive response, with a mean duration of 12.7 +/- 2.5 minutes of intercourse, and a corresponding spousal satisfaction rate of 71%. Twelve (80%) of the 15 responders required titration to the 100-mg dosage for maximal effect. The most common side effects seen were transient flushing (19%), abnormal color vision (14%), and headaches (10%). No patient discontinued the drug because of side effects.

Sildenafil citrate (Viagra) and erectile dysfunction following external beam radiotherapy for prostate cancer: a randomized, double-blind, placebo-controlled, cross-over study.

Incrocci L, Koper PC, Hop WC, Slob AK.   Int J Radiat Oncol Biol Phys 2001 Dec 1;51(5):1190-5

Department of Radiation Oncology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands

406 patients with complaints of erectile dysfunction and who completed radiation at least 6 months before the study were approached by mail. 3D-CRT had been delivered (mean dose 68 Gy). Sixty patients were included and entered a double-blind, placebo-controlled, cross-over study lasting 12 weeks. They received during 2 weeks 50 mg of sildenafil or placebo; at Week 2 the dose was increased to 100 mg in case of unsatisfactory erectile response.  Mean age was 68 years. For most questions of the IIEF questionnaire there was a significant increase in mean scores from baseline with sildenafil, but not with placebo. Ninety percent of the patients needed a dose adjustment to 100 mg sildenafil. Side effects were mild or moderate. CONCLUSION: Sildenafil is well tolerated and effective in improving erectile function of patients with ED after 3D-CRT for prostate cancer.

Erectile function after permanent prostate brachytherapy.

Merrick GS, Butler WM, Galbreath RW, Stipetich RL, Abel LJ, Lief JH.    Int J Radiat Oncol Biol Phys 2002 Mar 15;52(4):893-902

Schiffler Cancer Center, Wheeling Hospital, Wheeling,

Four hundred twenty-five patients underwent permanent prostate brachytherapy from April 1995 to October 1999. Two hundred nine patients who were potent before brachytherapy and who at the time of the survey were not receiving hormonal therapy were mailed the specific erectile questions of the International Index of Erectile Function (IIEF) questionnaire with a self-addressed stamped envelope. The questionnaire consisted of 5 questions, with a maximal score of 25. Of the 209 patients, 181 (87%) completed and returned the questionnaire. With a 6-year follow-up, 39% of patients maintained potency after prostate brachytherapy, with a plateau on the potency preservation curve. Postimplant preservation of potency (IIEF >/=11) correlated with preimplant erectile function (50.4% vs. 13.2% for preimplant scores of 2 and 1, respectively, p <0.001), patient age (57.4%, 38.2%, and 21.9% for patients <60, 60-69, and >/=70 years old, respectively, p <0.004), use of supplemental EBRT (52.0% vs. 26.4% for patients without and with EBRT, p <0.001), and a history of diabetes mellitus (41.4% vs. 0% for patients without and with diabetes, respectively, p = 0.017). Sixty-two patients used sildenafil, with 53 (85%) reporting a favorable response. When potent patients were grouped with the ED patients who used sildenafil, the 6-year actuarial rate of potency preservation was 92%. Including the 70 impotent patients who never used sildenafil, the actuarial 6-year rate of potency preservation with and without pharmacologic support was 54% and 39%, respectively. Most patients with brachytherapy-induced ED responded favorably to sildenafil. Although the 6-year actuarial incidence of potency preservation was 39%, 52% of patients not receiving supplemental EBRT maintained potency. In addition, with pharmacologic support, 92% of patients maintained potency.

Does one have a sexual life after prostate cancer treatment?

Cosset JM.   Cancer Radiother 2002 May;6(3):183-7

Institut Curie, 26, rue d'Ulm, 75005 Paris, France.

Nerve-sparing surgical techniques have been proposed, whenever reasonable. However, in spite of these surgical advances, data suggest that overall, the new irradiation techniques (conformal radiotherapy and brachytherapy) are responsible for less alteration of sexual life than surgery. Another potential advantage is that sildenafil (Viagra) is able to restore potency in a majority of cases after radiotherapy, while it is usually poorly effective after surgery.

Effect of sildenafil citrate on post-radical prostatectomy erectile dysfunction.

Feng MI, Huang S, Kaptein J, Kaswick J, Aboseif S.   J Urol 2000 Dec;164(6):1935-8

Department of Urology, Kaiser Permanente Medical Center, Los Angeles, California.

Between April 1998 and January 1999, 53 patients who had undergone radical retropubic prostatectomy and were prescribed oral sildenafil were surveyed using a confidential mail questionnaire. Of the patients 21 underwent bilateral and 15 unilateral neurovascular bundle sparing procedures, while in 17 a nonnerve sparing procedure was performed. All patients received 25 to 100 mg. sildenafil in a flexible dose escalation manner. Of the 21 patients who underwent a bilateral nerve sparing procedure 15 had a positive response. Of the 15 patients who had undergone a unilateral nerve sparing procedure 12 had a positive response, and only 1 of the 17 patients who had undergone a nonnerve sparing procedure responded to sildenafil. The most commonly reported adverse events of all causes were headaches (21%), flushing (8.3%), visual disturbance (6.3%) and nasal congestion (6.3%). CONCLUSIONS: Sildenafil is an equally effective treatment for erectile dysfunction after bilateral and unilateral nerve sparing procedures, and patient response to sildenafil is confirmed by the partners. However, patients who undergo nonnerve sparing procedures do not respond satisfactorily to sildenafil.

Treatment of erectile dysfunction after radical prostatectomy with sildenafil citrate (Viagra).

Zippe CD, Kedia AW, Kedia K, Nelson DR, Agarwal A.   Urology 1998 Dec;52(6):963-6

Department of Urology, The Cleveland Clinic Foundation, Ohio 44195, USA.

Baseline and follow-up data from 28 healthy patients presenting with erectile dysfunction after radical prostatectomy were obtained. Patients receiving any neoadjuvant/adjuvant hormones or adjuvant radiation therapy were excluded. Patients reported what their erectile status was before surgery, before sildenafil therapy, and after using a minimum of four doses of sildenafil. Both the patients and their spouses were interviewed using the Cleveland Clinic post-prostatectomy questionnaire, which includes questions about response to therapy, duration of intercourse, spousal satisfaction, side effects, and related topics. The patients were compared on the basis of the type of surgical procedure they had undergone-nerve sparing or non-nerve sparing. A positive response to sildenafil was defined as erection sufficient for vaginal penetration. RESULTS: Of the 15 patients who had bilateral nerve-sparing procedures, 12 (80%) had a positive response to sildenafil, with a mean duration of 6.92 minutes of vaginal intercourse. These 12 patients also reported a spousal satisfaction rate of 80%. All 12 of the responders had a positive response within the first three doses, and 10 of the 12 responded with the first or second dose. None of the 3 patients who had undergone a unilateral nerve-sparing procedure responded, nor did any of the 10 patients who had undergone a non-nerve-sparing procedure. The two most common side effects of the drug were transient headaches (39%) and abnormal color vision (11%). No patients discontinued the medication because of side effects. CONCLUSIONS: Successful treatment of erectile dysfunction in a patient after prostatectomy with sildenafil citrate may depend on the presence of bilateral neurovascular bundles. No patient who had undergone a non-nerve-sparing procedure responded. Whether patients who undergo unilateral nerve-sparing procedures will respond to sildenafil is still unclear because of the small number of patients in our study. These findings should encourage urologists to continue to perform and perfect the nerve-sparing approach. The ability to restore potency with an oral medication after radical prostatectomy will impact our discussion with the patient on the surgical morbidity of radical prostatectomy.

Sildenafil citrate after radical retropubic prostatectomy.

Lowentritt BH, Scardino PT, Miles BJ, Orejuela FJ, Schatte EC, Slawin KM, Elliott SP, Kim ED.

Scott Department of Urology, Baylor College of Medicine, Houston, Texas, USA.    J Urol 1999 Nov;162(5):1614-7

Erectile dysfunction continues to be a significant problem for men after radical retropubic prostatectomy despite nerve sparing techniques. Sildenafil citrate (Viagra) has proved effective for erectile dysfunction in many men. A total of 84 men were prescribed sildenafil after radical retropubic prostatectomy and asked to complete a series of questionnaires, including the International Index of Erectile Function (IIEF), on erectile function before and after sildenafil administration. : Of the 84 patients 45 (53%) had improved erections and 34 (40%) had improved ability for intercourse while taking sildenafil. Age and pathological stage also appeared to have a significant effect. CONCLUSIONS: Sildenafil improved erectile function and the ability to have intercourse in more than half of men after radical retropubic prostatectomy. Baseline postoperative erectile function, which is dependent on the degree of nerve sparing technique, significantly impacts the likelihood that patients will respond to sildenafil.

Prospective pilot study of sildenafil for treatment of postradiotherapy erectile dysfunction in patients with prostate cancer.

Weber DC, Bieri S, Kurtz JM, Miralbell R.  J Clin Oncol 1999 Nov;17(11):3444-9

Radiation Oncology Departments of the University Hospital, Geneva, Switzerland.

PURPOSE: Erectile dysfunction is a common late complication patients may experience after external-beam radiotherapy for prostate cancer. The efficacy and safety of oral sildenafil to correct sexual dysfunction caused by external-beam radiotherapy was studied in patients participating in our prospective trial. PATIENTS AND METHODS: Thirty-five assessable patients participated in this prospective pilot study. Using a 25-point scale based on the International Index of Sexual Function, erectile dysfunction was assessed weekly, during which time patients received sildenafil 100 mg orally once a week for 6 consecutive weeks. Response was defined as a score of 18 or more, corresponding to at least one successful attempt at sexual intercourse per week. RESULTS: Thirty patients (86%) completed the 6-week study. Seventy-seven percent of these patients had significantly improved erectile function, allowing recovery of full capacity for sexual intercourse. Of 27 patients not receiving concomitant hormone treatment, failure to respond was observed in only four patients (15%) compared with four (50%) of eight patients receiving hormonal treatment during the study. The time course of response was gradual, with 40%, 57%, 66%, 69%, and 74% responding at weeks 1 through 5, respectively. Therapy was generally well tolerated. The most frequently reported side effects in patients were flushing (37%), transient headache (17%), and dyspepsia (9%). No patient reported priapism, and no cardiovascular event or death was observed. After response, 12 patients (34%) reported the ability to achieve and maintain an erection sufficient for intercourse in the absence of sildenafil (ie, 24 hours to 6 days after taking the medication). CONCLUSION: This study suggests that oral sildenafil is well tolerated and can reverse erectile dysfunction after radiotherapy in a substantial proportion of prostate cancer patients.

Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment.

Jarow JP, Burnett AL, Geringer AM.   J Urol 1999 Sep;162(3 Pt 1):722-5

Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Overall satisfaction with sildenafil citrate for the entire patient population was 65% and response to prior therapies did not affect satisfaction. There was a significant positive correlation between baseline sexual function and response to sildenafil citrate but even patients with severe erectile dysfunction had a 41% satisfaction rate. Etiology of erectile dysfunction had a significant impact on satisfaction rate, with neurogenic causes of erectile dysfunction (diabetes, prostate surgery and so forth) having significantly lower rates than psychogenic or vasculogenic erectile dysfunction. CONCLUSIONS: Sildenafil citrate is a highly effective oral agent for the treatment of erectile dysfunction in clinical practice. The best predictors for response to sildenafil citrate therapy are baseline sexual function and etiology of erectile dysfunction. However, we could not identify any patient characteristic that would predict absolute failure for sildenafil citrate therapy. Therefore, all patients with erectile dysfunction who do not have specific contraindications should be considered for sildenafil citrate therapy.

The efficacy of sildenafil citrate (Viagra) in clinical populations: an update.

Carson CC, Burnett AL, Levine LA, Nehra A.  Urology 2002 Sep;60(2 Suppl 2):12-27

Department of Surgery, Division of Urology, University of North Carolina at Chapel Hill,

Although certain risk factors are known to be associated with erectile dysfunction (ED), the demographic and ED characteristics of the population of men with ED are quite diverse. Significantly improved erectile function was demonstrated for sildenafil compared with placebo for all efficacy parameters analyzed , regardless of patient age, race, body mass index, ED etiology, ED severity, ED duration, or the presence of various comorbidities. Long-term effectiveness was assessed in 3 open-label extension studies. Of those who continued long-term therapy (1 to 3 years) with sildenafil, >95% of patients reported that they were satisfied with the effect of treatment on their erections, and that treatment had improved their ability to engage in sexual activity. Findings from published accounts of sildenafil use in the clinical practice setting further demonstrated that sildenafil is an effective treatment for a wide range of patients with ED.