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Biomedical subjects

H Lepor

Publications and source records attributed to H Lepor.

At least 19 recordsLinked to original sources
PubMed2002

Is sildenafil failure in men after radical retropubic prostatectomy (RRP) due to arterial disease? Penile duplex Doppler findings in 174 men after RRP.

Sildenafil is frequently the first-line treatment for post-radical retropubic prostatectomy (RRP) erectile dysfunction (ED) with maximum treatment satisfaction rates of 43%-80%. The etiology of erectile dysfunction after RRP has been attributed to psychogenic, vascular, veno- occlusive or nerve injury causes. The purpose of this study was to gain insight into the penile duplex Doppler arterial parameters in men with ED after RRP who failed sildenafil. The purpose was to assess whether sildenafil failure after RRP is associated with underlying corporal arterial disease. A total of 174 consecutive men presenting with sildenafil refractory ED after nerve-sparing RRP underwent color duplex penile Doppler evaluation with vasoactive injection. Mean age was 59.6 y and mean time from surgery was 11.6 months. Some 81% (141/174) of the men had no pre-operative ED (PED). Significant differences in penile duplex Doppler parameters for arterial disease were seen between men with and without PED. In men without PED, 19% (27/141) manifested arterial insufficiency. However, in men with PED, 50% (16/33) demonstrated arterial disease. Nerve sparing status did not affect the presence of arterial disease. Sildenafil refractory erectile dysfunction after RRP in men without PED is not predominantly associated with penile Doppler parameters consistent with arterial insufficiency.

Aged↗
PubMed2001

Predicting continence following radical prostatectomy.

Stress urinary incontinence is a recognized complication following radical prostatectomy. Fortunately, in the hands of experienced surgeons, the overwhelming majority of men ultimately regain urinary continence following the procedure. Most men regain urinary continence 3 to 12 months after the prostatectomy. We have developed and validated a continence index that is administered at the time of catheter removal after radical prostatectomy. This index identifies those men who rapidly regain continence and men who will have permanent incontinence after prostatectomy. The study population was stratified into tertile groups based on the continence scores. At 3 months, 96%, 82%, and 68% of men in the highest, mid, and lowest tertile groups reported using no pads or one small pad. Based on these observations, we recommend initiating biofeedback immediately postoperatively in men with continence scores of 14 or less. At 1 year, 100%, 98%, and 87% of the men in the highest, mid, and lowest tertile group reported using no pads or only one small pad. Men who have continence scores greater than 14 can be assured that they will regain urinary continence within 1 year. To our knowledge, this index is the only validated instrument that predicts the return of urinary continence after radical prostatectomy.

Humans↗
PubMed2001

Chemoprevention trials in men with prostate-specific antigen failure or at high risk for recurrence after radical prostatectomy: Application to efficacy assessment of soy protein.

This article discusses the basic elements of chemoprevention trial designs using cohorts of men following radical prostatectomy who either have prostate-specific antigen (PSA) failure indicative of recurrence or are at high risk for recurrence (positive surgical margins, extracapsular extension, seminal vesicle invasion, positive lymph nodes, Gleason score of greater than or equal to 8, preoperative serum PSA less than 20 ng/mL). Two ongoing randomized, double-blind, placebo-controlled clinical trials with soy protein as intervention in these 2 populations are described. In the trial with men at high risk for recurrence, participants started intervention within 4 months after surgery and were followed for up to 2 years; primary endpoints were PSA failure rate and time-to-PSA failure. In the trial with men with PSA failure (PSA 0.1 to 2.0 ng/mL), participants received treatment for 8 months and the primary endpoint is rise in PSA over time. The strengths and limitations of these designs are discussed and interim experience using studies with soy protein as the intervention agent are summarized.

Cohort Studies↗
PubMed2001

Long-term, open-label, phase III multicenter study of tamsulosin in benign prostatic hyperplasia.

OBJECTIVES: To investigate the long-term efficacy and safety of tamsulosin in patients with benign prostatic hyperplasia and to monitor the increases and decreases in therapeutic response over time. Tamsulosin, a uroselective alpha-adrenergic receptor antagonist for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia, targets alpha(1A)-adrenergic receptors of prostatic smooth muscle with greater affinity than the vascular alpha(1B) receptors. Since the alpha(1A)-adrenoceptor subtype mediates prostatic smooth muscle tension, alpha(1A)-adrenoceptor antagonists may diminish toxicity, with few unwanted effects on blood pressure, while still providing efficacious treatment. METHODS: This study extended two 13-week trials and one 40-week extension trial for an additional 64 weeks. On study entry, all patients (n = 949) received 0.4 mg/day tamsulosin. Baseline values were taken from either those of the previous trials for patients who had been treated with tamsulosin or the first visit of this study for patients not previously exposed to the drug. The primary efficacy parameters were the changes in the total American Urological Association (AUA) symptom score, mean peak urinary flow rate (Qmax), and percentage of patients having 25% or greater improvement in the total AUA symptom score and 30% or more improvement in the Qmax. Safety was assessed primarily on the incidence and severity of adverse events and discontinuations due to adverse events. RESULTS: Improvements from baseline were seen in all primary efficacy parameters and were maintained throughout the study. The changes from baseline for the total AUA symptom score and Qmax were statistically significant (P <0.001) at all 3-month intervals. Tamsulosin was well tolerated, and the incidence of adverse events did not increase over time. The mean sitting vital signs did not vary from baseline or relative to the treatment duration. CONCLUSIONS: Tamsulosin was safe and effective in long-term treatment (longer than 1 year) of benign prostatic hyperplasia.

Adrenergic alpha-Antagonists↗
PubMed2001

Anastomotic strictures following radical prostatectomy: insights into incidence, effectiveness of intervention, effect on continence, and factors predisposing to occurrence.

OBJECTIVES: To examine the incidence, effectiveness of intervention, effect on continence, and factors predisposing to the occurrence of anastomotic strictures following radical retropubic prostatectomy. METHODS: Between January 1994 and June 1999, 753 radical retropubic prostatectomies were performed by a single surgeon. Anastomotic strictures were managed by dilatation followed by a self-catheterization regimen. Dilatations were repeated unless more than three dilatations were required over a 9-month interval. A control group representing a randomly selected group of men who did not develop anastomotic strictures was identified. The largest width of the midline vertical abdominal scar was measured. RESULTS: Of the 753 radical retropubic prostatectomies, 36 (4.8%) developed an anastomotic stricture. The mean time interval between the surgical procedure and diagnosis of the stricture was 4.22 months. Of the 26 cases of anastomotic strictures with at least 1-year follow-up, 24 (92.3%) were managed successfully by dilatations alone. No baseline characteristics before surgery were associated with the development of a stricture. The maximal scar width was the only factor that was associated with the development of a stricture in this study. Men with a maximal scar of greater than 10 mm were eight times more likely to develop strictures than men with smaller scars. The percentage of men who required protective pads 1 year following radical retropubic prostatectomy in the control and stricture groups was 12.5% and 46.2%, respectively. CONCLUSIONS: Anastomotic strictures are relatively rare following radical prostatectomy and have a negative effect on the development of continence. Most men are successfully managed with dilatations alone. The development of anastomotic strictures in some men appears to be related to a generalized hypertrophic wound-healing mechanism.

Anastomosis, Surgical↗
PubMed2001

Comparison of two different doses of preoperative recombinant erythropoietin in men undergoing radical retropubic prostatectomy.

OBJECTIVES: To determine whether the response to recombinant erythropoietin is dose dependent in men undergoing radical prostatectomy and to elucidate the relative cost-effectiveness of two dosing regimens. METHODS: A prospective, open-label study comparing the effectiveness, cost, and safety of two different doses of recombinant erythropoietin was performed in men undergoing radical retropubic prostatectomy. The first 100 men received 600 IU/kg (high dose) of epoetin alfa. A second group of 100 men received 300 IU/kg (low dose). All men received two doses of erythropoietin on preoperative days 14 and 7, provided their baseline hematocrit levels were less than 48%. Hematocrit levels were measured at baseline (more than 14 days before surgery), at the time of anesthesia induction, in the recovery room postoperatively, on the first postoperative day, and on the morning of discharge. RESULTS: The mean increase in hematocrit from baseline to induction for the high and low-dose groups was 4.50 and 4.69, respectively (P = 0.7225). Six men (6%) in the high-dose group and seven (7%) in the low-dose group required allogenic blood transfusions. The mean cost of high and low-dose epoetin alfa was $1218 and $656, respectively. The cost per percentage point increase in hematocrit in the low-dose group was significantly less than in the high-dose group. No thromboembolic events occurred in the high or low-dose group. CONCLUSIONS: In men undergoing radical retropubic prostatectomy, the administration of epoetin alfa on preoperative days 14 and 7 was a safe and effective treatment strategy for reducing the risk of allogenic blood transfusions. The 300 IU/kg dosing regimen was significantly more cost effective than the 600 IU/kg dosing regimen.

Cost-Benefit Analysis↗
PubMed2001

Efficacy of first-generation Cavermap to verify location and function of cavernous nerves during radical prostatectomy: a multi-institutional evaluation by experienced surgeons.

OBJECTIVES: To evaluate, using five experienced surgeons, the efficacy of the first-generation Cavermap Surgical Aid to identify the cavernous nerves intraoperatively and to predict the recovery of sexual function. This study was not designed to determine whether this device improves the ability to preserve the nerves or improve outcome. METHODS: Fifty men younger than 60 years old (mean age 52.5 years; range 43 to 59) with clinically localized prostate cancer (76% T1c, mean Gleason score 6, prostate-specific antigen level less than 10 ng/mL) underwent nerve-sparing radical prostatectomy (90% bilateral). Intraoperatively, the Cavermap device was used to test for the presence of the cavernous nerves once the neurovascular bundle was identified visually and to determine whether the nerves were intact after the prostate was removed. Erectile function was evaluated using the International Index of Erectile Function; men were considered potent if they were able to achieve unassisted intercourse in at least one half of their attempts. RESULTS: Before the removal of the prostate, the tumescence response to stimulation of the neurovascular bundle was 87.8%; when tissue not containing the neurovascular bundle was stimulated, no tumescence response occurred in 54%. After prostatectomy, a bilateral response to stimulation occurred in 90%, a unilateral response in 5%, and no response in 5%. Postoperatively, 71% of the patients were potent at 12 months. In the patients who demonstrated bilateral stimulation after removal of the prostate, 78% were potent at 12 months. CONCLUSIONS: After radical prostatectomy performed by experienced surgeons, patient-reported potency rates in men younger than 60 years of age were high. Cavermap stimulation demonstrated an 87.8% sensitivity and 54% specificity in locating the neurovascular bundle as identified by experienced surgeons. The lack of specificity of this first-generation device limits its application for deciding which structures can be safely preserved or excised. Because virtually all patients demonstrated a positive response after removal of the prostate, the value of stimulation to predict the recovery of sexual function is yet to be determined.

Adult↗
PubMed2001

Early removal of urinary catheter after radical retropubic prostatectomy is both feasible and desirable.

OBJECTIVES: To determine the feasibility and desirability of removing the urinary catheter 7 days after radical retropubic prostatectomy. METHODS: Between February 28, 2000 and October 5, 2000, 184 men underwent radical retropubic prostatectomy by a single surgeon. Of these men, 97% underwent gravity cystography under fluoroscopic control on postoperative day (POD) 7. The indwelling urinary catheter was removed on POD 7 if no evidence of extravasation was observed on cystography. Patients completed a self-administered questionnaire at the time of catheter removal to capture the degree of bother from incisional pain and the indwelling urinary catheter during the recovery period. The level of urinary continence was determined at 3 months after radical retropubic prostatectomy. RESULTS: One hundred thirty-five of the cystograms (75%) had no evidence of extravasation. The indwelling catheters were removed in 130 (97%) of 135 cases. The body weight, surgical specimen weight, presence or absence of intraoperative anastomotic extravasation, volume of pelvic drainage recorded from the Hemovac drain, and creatinine level of the pelvic drainage fluids did not predict the finding of extravasation on the POD 7 cystogram. Fifteen percent of the men whose catheters were removed on POD 7 developed acute urinary retention. At 3 months, 72% of men required no or a single protective pad, and 87% indicated they experienced no or slight bother from incontinence. These continence outcomes are comparable with a historical control group by the same surgeon who underwent catheter removal on POD 14. Forty-five percent of the men reported the catheter caused moderate to severe bother, compared with only 19% of men who indicated moderate to severe bother from incisional pain. In retrospect, 95.6% of men indicated willingness to undergo cystography on POD 7 with the intent of early catheter removal. CONCLUSIONS: The results of our study suggest that most men will have no extravasation on a cystogram performed on POD 7 and that removing the catheter at this time in these cases does not increase the risk of complications or compromise overall urinary continence. The urinary catheter is a significant bother and limits physical activity during the postoperative period. Cystography and early removal of the catheter is both feasible and desirable and should be offered to men after radical retropubic prostatectomy.

Catheters, Indwelling↗
PubMed2001

Volume-specific cutoffs are necessary for reproducible application of prostate-specific antigen density of the transition zone in prostate cancer detection.

OBJECTIVES: To determine the effect of prostate volume on the specificity of prostate-specific antigen density (PSAD) and PSAD of the transition zone (PSA-TZ) in the detection of prostate cancer. METHODS: Between February 1994 and April 1998, transrectal ultrasound-guided prostate needle biopsies were performed in 235 men with serum prostate-specific antigen (PSA) levels between 4.0 and 10.0 ng/mL. The PSAD and PSA-TZ specificities were calculated at 95% sensitivity cutoff levels generated from the whole group, as well as from cohorts stratified by transition zone index or prostate volume. RESULTS: Statistical significance was noted between the benign (n = 176) and prostate cancer (n = 59) groups for all tested PSA parameters. At 95% sensitivity, PSA-TZ carried a specificity of 37.5% compared with 29.6% for PSAD. When applying a single 95% sensitivity cutoff derived from the entire group to individual volume-stratified cohorts, the specificity decreased to 0% in glands less than 30 g in size. A 95% sensitivity PSA-TZ cutoff generated individually for volume-stratified cohorts of glands less than 30, 30 to 40, and 40 to 60 g resulted in more consistent specificity of 28.2%, 35.2%, and 45.7% for each cohort, respectively. CONCLUSIONS: Unlike whole group-derived cutoffs, the use of volume-specific PSA-TZ cutoffs allows consistently high specificity in all volume-stratified cohorts. The discrepancies in the PSA-TZ and PSAD specificities in published reports are likely due to the application of published cutoffs to populations of differing prostate volumes. The use of volume-specific cutoffs results in reproducible specificity in populations with differing prostate volume distribution, and thereby definitively resolves the differences in PSA-TZ specificity reported in published reports.

Biomarkers, Tumor↗
PubMed2001

Is repeat prostate biopsy for high-grade prostatic intraepithelial neoplasia necessary after routine 12-core sampling?

OBJECTIVES: To determine whether repeat biopsy is necessary when the diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) is made with a 12-core biopsy. Repeated biopsy has been recommended for individuals with HGPIN noted on sextant prostate biopsy because of the high likelihood of cancer detection. Recently, we have recommended the routine use of 12 cores, rather than 6, to improve cancer detection. METHODS: The charts of all patients undergoing prostate biopsy during a 2-year period at the Manhattan Veterans Administration Medical Center were reviewed. Patients diagnosed with HGPIN on a 12-core biopsy were identified, and those undergoing a repeat 12-core biopsy within 1 year of the initial biopsy were evaluated to determine the rate of cancer detection. RESULTS: A total of 619 men underwent biopsy during the study period. Of 103 men diagnosed with HGPIN, 43 underwent a repeat biopsy within 1 year at the discretion of the managing urologist. The mean age and median prostate-specific antigen level of those undergoing a repeat biopsy was 65.5 years and 5.37 ng/mL, respectively. At the time of the repeat biopsy, 1 patient was found to have cancer (2.3%), 20 had HGPIN (46.5%), 20 had benign pathologic findings (46.5%), and 1 patient (2.3%) had atypical small acinar proliferation. CONCLUSIONS: A repeat biopsy after the diagnosis of HGPIN on 12-core prostate biopsy rarely results in cancer detection. In the absence of other factors increasing the suspicion of cancer, immediate repeat biopsy for HGPIN diagnosed on a 12-core biopsy is unnecessary.

Aged↗
PubMed2001

Radical retropubic prostatectomy. Preoperative management.

The morbidity of radical prostatectomy is minimized by identifying men who are at significant cardiovascular risk and excluding them from the procedure. Preoperative management designed to minimize surgical and medical complications and exposure to allogenic blood products increases the benefit-to-risk ratio of radical prostatectomy over other treatment options for localized prostate cancer.

Anesthesia↗
PubMed2001

Radical retropubic prostatectomy.

Historically, radical prostatectomy is a surgical technique associated with significant morbidity. The ability to minimize intraoperative bleeding and preserve continence and potency requires a comprehensive understanding of pelvic anatomy, meticulous surgical technique, and appropriate surgical instruments. The anatomic radical retropubic prostatectomy first described by Walsh in 1982 represents a technique in evolution. The detailed surgical approach for anatomic radical retropubic prostatectomy described in this article represents the author's technique that has been developed after performing over 2,000 radical prostatectomies since 1986. The step by step illustrations and description of technique are designed to aid the urologic surgeon develop an efficient approach to this surgical procedure.

Humans↗
PubMed2001

Analysis of apical soft tissue margins during radical retropubic prostatectomy.

PURPOSE: We determine the use of information gained with intraoperative biopsy and frozen section analysis of the apical soft tissue margin during nerve sparing radical retropubic prostatectomy. MATERIALS AND METHODS: A separate 2 to 3 mm. circumferential biopsy was obtained from the apical soft tissue margin, and was sent for frozen and permanent section analysis during radical retropubic prostatectomy in 95 men with clinically localized adenocarcinoma of the prostate. A single pathologist examined the surgical and apical soft tissue margin specimens for evidence and extent of benign or malignant prostate tissue. Urinary continence was evaluated at catheter removal and 3 months postoperatively. RESULTS: Of the patients 26% had positive surgical margins, of which 64% were positive apical margins. Permanent section of the apical soft tissue biopsy revealed no prostate in 39%, benign prostate in 54% and prostate cancer in 7% of patients. Because of the frozen section finding of adenocarcinoma in 3 patients, the apical soft tissue margin was further resected until the specimen was negative for malignancy. The apical soft tissue margin was the only positive margin site in 2 of these 3 patients. Positive surgical and apical margins, and percent tumor volumes greater than 26% on prostatectomy specimen had a significantly higher likelihood for positive apical soft tissue margins. The pathological finding of a positive apical margin on the surgical specimen had sensitivity, specificity, and positive and negative predictive values of 57%, 86%, 25% and 96%, respectively, for detecting prostate cancer on the apical soft tissue biopsy. Of the apical soft tissue biopsies 54% contained an element of benign prostatic tissue, although 92% of them contained benign tissue in less than 25% of the total specimen. Mean continence score in the men with and those without benign prostate tissue on apical soft tissue biopsy was 15.6 and 14.4, respectively (p = 0.15). The percent of men who required no protective pads for urinary continence at 3 months was 53% and 65% for those who had no prostate and those who had benign prostate tissue, respectively, in the apical soft tissue margin. CONCLUSIONS: Excising and submitting an additional 2 to 3 mm. of apical soft tissue margin for permanent section analysis after prostate removal during radical prostatectomy represent an effective method for decreasing residual prostate tissue. Attempts at maximizing urethral length when dividing the prostato-urethral junction likely increases the chance of leaving residual prostate without improving continence.

Adult↗
PubMed2001

Intraoperative and postoperative complications of radical retropubic prostatectomy in a consecutive series of 1,000 cases.

PURPOSE: We critically examined the intraoperative and postoperative complications associated with radical retropubic prostatectomy in the modern era. MATERIALS AND METHODS: Between April 18, 1994 and July 13, 2000, 1,000 men underwent radical retropubic prostatectomy performed by a single surgeon. The whole inpatient hospital medical record of 909 patients, the outpatient charts of 955 and a self-administered patient survey completed by 679 were reviewed by 2 data managers not involved in surgical management or followup care. In all 1,000 cases at least 1 of the 3 data sources was reviewed. RESULTS: Mean patient age was 60.3 years. In 73%, 99.8% and 95.7% of cases serum prostate specific antigen was 10 ng./ml. or less, disease was clinical stage T1 or T2 and Gleason score was 7 or less, respectively, while 19.9% of pathological specimens showed positive margins. There were 8 intraoperative complications (0.8%). All 5 rectal injuries and the single ureteral injury were detected during the initial surgical procedure and repaired without sequelae. Only 14 men (1.4%) had any other complications during hospitalization. Until postoperative day 30, 4 pulmonary emboli (0.4%) with or without deep vein thrombosis and 5 myocardial infarctions (0.5%) developed. There were no intraoperative or in-hospital postoperative deaths and only 1 postoperative death secondary to myocardial infarction during the initial 30 days. Reexploration was done for hemorrhage and a disrupted anastomosis in 3 and 2 cases, respectively. Mean hospitalization was 2.3 days, 9.7% of patients required allogenic blood transfusion and 15 (1.5%) were rehospitalized. CONCLUSIONS: Our series represents a rigorous assessment of the complications associated with radical retropubic prostatectomy. It shows that in the hands of an experienced urological surgeon, this procedure is associated with minimal intraoperative and postoperative morbidity. Of the patients 98% had no intraoperative or postoperative complications. Our series enables appropriate contemporary comparisons to be made with laparoscopic prostatectomy and radiation therapy. This outcomes analysis implies that radical retropubic prostatectomy cannot be assumed to have greater morbidity than radiation therapy and it sets a high standard for those advocating laparoscopic radical prostatectomy.

Blood Loss, Surgical↗