The effects of transurethral needle ablation and resection of the prostate on pressure flow urodynamic parameters: analysis of the United States randomized study.

PURPOSE: We evaluated the effects of transurethral needle ablation and prostate resection on pressure flow urodynamic parameters in men with benign prostatic hyperplasia (BPH), compared symptomatic and objective parameters of efficacy 6 months after initial treatment, and determined whether urodynamic assessment may predict symptomatic improvement. MATERIALS AND METHODS: We enrolled 121 patients with clinical BPH, American Urological Association symptom index of 13 or greater and maximum urinary flow of 12 ml. per second or less in a randomized study comparing transurethral needle ablation to prostate resection at 7 institutions in the United States. Patients underwent baseline and followup assessments at 6 months, including pressure flow studies. RESULTS: Patients who underwent each procedure had statistically and clinically significant improvement in symptom index, BPH impact index and quality of life score. After needle ablation and prostate resection maximum flow improved from 8.8 to 13.5 (p<0.0001) and 8.8 to 20.8 ml. per second (p<0.0001), detrusor pressure at maximum flow decreased from 78.7 to 64.5 (p = 0.036) and 75.8 to 54.9 cm. water (p<0.001), and the Abrams-Griffiths number decreased from 61.2 to 37.2 (p<0.001) and 58.3 to 10.9 (p<0.001), respectively. At 6 months the differences in transurethral needle ablation and prostate resection were significant in terms of maximum flow (p<0.001) and the Abrams-Griffiths number (p<0.001) but not detrusor pressure at maximum flow or symptom assessment tools. The presence or absence of urinary obstruction at baseline did not predict the degree of symptomatic improvement in either treatment group. CONCLUSIONS: Transurethral needle ablation and prostate resection induce statistically and clinically significant improvement in various quantitative symptom assessment questionnaires at 6 months. The parameters of free flow rates and invasive pressure flow studies also significantly improve after each treatment. However, transurethral prostate resection induces a significantly greater decrease in the parameters of obstruction. Baseline urodynamic parameters do not predict the degree of symptomatic improvement and they may not be helpful in patient selection for transurethral needle ablation.

A prospective, randomized 1-year clinical trial comparing transurethral needle ablation to transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia.

PURPOSE: We assess the 1-year efficacy and safety of transurethral needle ablation of the prostate compared to transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A prospective, randomized clinical trial of 121 men 50 years old or older with symptomatic BPH was performed at 7 medical centers across the United States. Of the men 65 (54%) were treated with transurethral needle ablation of the prostate and 56 (46%) underwent transurethral resection of the prostate. Mean and percentage changes from baseline and between cohorts for American Urological Association (AUA) symptom score, AUA bother score, quality of life score, peak urinary flow rate and post-void residual urine volume were measured at 1, 3, 6 and 12 months following treatment. Length of procedure, hospitalization, type of anesthesia, post-procedure catheterization, side effects and sexual function were compared. RESULTS: Transurethral needle ablation and resection resulted in a statistically significant improvement in AUA symptom, bother and quality of life scores, peak urinary flow rate and post-void residual. At 1-year followup, needle ablation and resection were equally effective in enhancing quality of life. Needle ablation had less effect on sexual function, with resection being associated with a greater incidence of retrograde ejaculation. Needle ablation could be performed as an outpatient procedure with local anesthesia while resection required anesthesia and hospitalization. Needle ablation was associated with markedly fewer side effects than resection. CONCLUSIONS: Compared to transurethral resection of the prostate, transurethral needle ablation of the prostate is an efficacious, minimally invasive treatment for symptomatic BPH that is associated with few side effects.

Transurethral needle ablation for benign prostatic hyperplasia: 12-month results of a prospective, multicenter U.S. study.

OBJECTIVES: To report the safety and efficacy of the transurethral needle ablation (TUNA) procedure for the treatment of clinical benign prostatic hyperplasia (BPH). METHODS: One hundred thirty patients with BPH were enrolled in two identical protocols and treated by the TUNA procedure. Entry criteria included an American Urological Association symptom index (AUA SI) of 13 points or higher and a peak flow rate of 12 mL/s or less. Patients were followed up for 12 months. Efficacy parameters included the AUA SI, AUA problem index, BPH impact index (BPH II), quality of life (QOL) score, and peak flow rate. At each visit, side effects were elicited. Follow-up data are available for 93 patients at 12 months. All patients were given intraurethral lidocaine augmented by oral and/or parenteral sedation. No patient received spinal or general anesthesia. RESULTS: All patients tolerated the procedure well, and there were no deaths. Forty-one percent of patients (n = 53) had a catheter placed immediately after the procedure. At 12 months, the AUA SI had decreased from 23.7 to 11.9 (P < 0.0001) and the BPH II from 7.5 to 2.5 (P < 0.0001), whereas the peak flow rate had increased from 8.7 to 14.6 mL/s (P < 0.0001). Irritative voiding symptoms were noted in 20 patients (16%) at some point during follow-up. Two patients reported erectile dysfunction, and 1 reported retrograde ejaculation. CONCLUSIONS: In this prospective study of 130 patients with clinical BPH and lower urinary tract symptoms, TUNA provided substantive and lasting improvement according to AUA SI, BPH II, and QOL scores as well as peak flow rate over 1 year. The TUNA procedure was well tolerated, with few major side effects and complications noted. Longer follow-up is needed to document the maintenance of clinical benefit beyond 12 months.

Balloon expanded titanium prostatic urethral stent.

A new balloon expanded titanium prostatic urethral stent has been devised for the treatment of outflow obstruction. This stent is inserted under endoscopic guidance and endourethral anesthesia. We have treated 9 male patients in urinary retention with a mean follow-up of eighteen months. Six of our 9 patients had a good and prolonged response to stenting. Complications were minimal and the procedure was well tolerated. We believe that the balloon expandable titanium stent is a viable alternative for the treatment of urinary retention particularly in the very ill patient.

Prolongation of response to DMSO by heparin maintenance.

Dimethylsulfoxide (DMSO) is an effective treatment of symptomatic patients with detrusor mastocytosis but it is associated with frequent relapses. A group of patients (N = 25) followed for twelve months showed a relapse rate of 59 percent. Our experience with a combination of DMSO and heparin has suggested that the relapse rate may be lower. Heparin is a glycosaminoglycan that may afford protection to the urothelium and may reduce the relapse rate. It is better tolerated than DMSO or a combination of DMSO and heparin and does not produce garlic halitus. It is not associated with coagulation anomalies when administered intravesically. To determine whether or not maintenance therapy with intravesical heparin may reduce relapses we have treated a similar cohort of 25 patients with monthly instillations of 10,000 IU of heparin over a twelve-month period. Both groups were comparable in age, duration of symptoms, severity of symptoms, and response to DMSO. At twelve months only 20 percent of the heparin-treated group had relapsed versus 52 percent of the control group. Furthermore 6 patients (24%) in the follow-up group failed to respond to retreatment with DMSO while all of the heparin maintenance group continued to respond to one or more treatments with DMSO. Thus, it seems that heparin maintenance produces a significant reduction in the relapse rate of patients who respond to DMSO and reduces the number of patients requiring alternative therapy.

Preserving Sexual Function after Urologic Surgery in Men: How to preserve fertility and reduce the risk of testicular malignancy.

Recent changes in urological treatment, such as early orchiopexy and adolescent variococelectomy, can help to preserve fertility and reduce the risk of testicular malignancy. Nerve-sparing operations have been developed for cancer of the prostate, bladder, and testicle to prevent or reduce their sequelae of impotence and retrograde ejaculation. These new advances must be embraced with caution so as not to compromise patients' chances for curative treatment.

Endoscopic balloon dilation of the prostate: early experience.

Coaxial balloon dilation catheters recently have been introduced for transurethral dilation of the prostate. We applied endoscopically a specially designed high pressure, large diameter balloon catheter to patients with benign prostatic hyperplasia or primary bladder neck hyperplasia who presented with symptomatic, cystoscopic and urodynamic evidence of obstruction. We report our preliminary experience with 42 patients: 28 with benign prostatic hyperplasia and 14 with bladder neck hyperplasia. Six months after dilation 46% of the patients demonstrated at least a 25% improvement in subjective (symptom score) and objective (corrected peak flow rate) parameters, while 6 (21%) experienced excellent (greater than 50%) symptomatic improvement despite unchanged corrected peak flow rates and 3 (11%) showed significant (greater than 50%) improvement in corrected flow rate alone. At 1, 3, 6 and 12 months the symptom scores decreased by 70, 67, 61 and 59% (median) from pre-treatment levels. Men with benign prostatic hyperplasia fared better than those with primary bladder neck hyperplasia (74 versus 58% decrease at 6 months). Objective evaluation by corrected peak flow rates demonstrated 25, 24, 28 and 2% median improvement at 1, 3, 6 and 12 months, respectively. Patients with primary bladder neck hyperplasia had substantially greater increases than those with benign prostatic hyperplasia (47 versus 27% at 6 months). Immediately after dilation the serum prostate specific antigen level increased by at least 1.5 ng. per ml. in 16 of 22 patients, indicating significant tissue trauma. Complications included mild bleeding and pain for the initial 24 hours and transient urinary retention in 2 patients. Our experience demonstrates the safety of an endoscopic approach to balloon dilation of the prostate that allows the urologist to maintain a central role in the assessment of a new approach to the treatment of obstructed voiding dysfunction.

A controlled study of dimethyl sulfoxide in interstitial cystitis.

To evaluate the effectiveness of dimethyl sulfoxide in the treatment of patients with biopsies suggestive of interstitial cystitis, 33 patients underwent a controlled crossover trial. Patients were allocated randomly to receive 50 per cent dimethyl sulfoxide or placebo (saline). The medication was administered intravesically every 2 weeks for 2 sessions of 4 treatments each. Response was assessed urodynamically and symptomatically. Thirty women and 3 men (mean age 48 years and mean duration of symptoms 5.5 years) were entered into the study. No significant side effects to dimethyl sulfoxide were noted. When assessed subjectively, 53 per cent of dimethyl sulfoxide treated patients were markedly improved compared to 18 per cent of the placebo treated patients. Of the dimethyl sulfoxide group 93 per cent had objective improvement versus 35 per cent of the placebo group. Thus, dimethyl sulfoxide proved to be superior to placebo in the objective and subjective improvement of patients with interstitial cystitis.

Increased mast cells of the bladder in suspected cases of interstitial cystitis: a possible disease marker.

Mast cells reportedly have been increased in the detrusor muscle bundles of the bladder in patients with interstitial cystitis. In 30 patients with suspected interstitial cystitis quantification of mast cells within the muscularis and submucosa was done. The results were compared to those obtained from a variety of normal bladder specimens removed surgically (16 specimens) and at autopsy (15), and from bladders with a variety of miscellaneous inflammatory conditions (20). In patients with suspected interstitial cystitis the number of mast cells was increased significantly (p less than 0.001) compared to the 3 control groups. This finding suggests that quantification of mast cells in the muscularis may be a useful marker in the histopathological evaluation of bladder biopsies in patients with suspected interstitial cystitis.

Urodynamic studies in interstitial cystitis.

Urodynamics, although not diagnostic of IC, are useful in the differential diagnosis of painful voiding disorders and provide a convenient way to quantitate response to therapy. They may prove useful as prognostic indicators of response to treatment and are of value in those patients in whom surgery is considered. Our studies suggest that IC is a progressive disease if not treated and that early diagnosis may improve response to treatment. Although similar information can be gathered by other means, we find urodynamics reliable, reproducible, and quantifiable and a valuable tool in the diagnosis, treatment, and follow-up of patients with IC.

Extension of carcinoma of prostate along perineal needle biopsy tract.

Malignant seeding on the needle tract of a perineal prostatic biopsy is a rare complication. A review of the literature revealed only 7 cases. Herein another case is reported. Our patient, like all other cases reported, suffered from high-grade, high-stage disease and the perineal extension did not upstage his disease. We believe that perineal seeding is a reflection of the malignant potential of the prostatic malignancy and in no way detracts from the usefulness of this tool in the diagnosis and staging of the disease.

Hormonal parameters in incidental varicoceles and those causing infertility.

The gonadotropin responses to a 4-hour infusion of gonadotropin-releasing hormone (GnRH), the prolactin (PRL) responses to a bolus injection of thyrotropin-releasing hormone (TRH), and seminal plasma dihydrotestosterone (DHT) levels were assessed before and 6 to 12 months after varicocelectomy was performed in 56 infertile men with varicoceles and sperm densities less than 30 X 10(6)/ml. The men were divided into four groups, determined by their sperm densities and hormonal parameters. Groups I (18 men) and II (12 men) had sperm densities less than 10 X 10(6)/ml, and groups III (16 men) and IV (10 men) had sperm densities of 11 to 30 X 10(6)/ml. The men from groups I and III had excessive preoperative gonadotropin and PRL responses, and lower-than-normal seminal plasma DHT levels. The men in groups II and IV had normal hormonal values. After operation, 12 of the men from group I and 11 from group II had improvements in seminal and hormonal parameters. The other men in these two groups and all of the men in groups II and IV had no changes in seminal and hormonal parameters after operation. This study indicates that an assessment of these hormonal parameters may be useful in predicting which men with varicoceles are likely to have an improvement in sperm density after varicocele repair.

Hormonal parameters of men with varicoceles before and after varicocelectomy.

The gonadotropin responses to a 4-hour infusion of gonadotropin-releasing hormone (GnRH) and seminal plasma dihydrotestosterone (DHT) and testosterone levels were assessed before and 6 to 12 months after varicocelectomy in 22 men with varicoceles. Twelve men were severely oligozoospermic (sperm densities less than 10 X 10(6)/ml), whereas 10 men had sperm densities between 11 and 30 X 10(6)/ml. Each man had excessive gonadotropin responses to GnRH and lower than normal seminal plasma DHT levels preoperatively. Eight of the 12 severely oligozoospermic men and 6 of the other 10 men had postoperative improvements in sperm density. These men (responders) had normalization of gonadotropin response and seminal plasma DHT levels. The nonresponders had identical hormonal parameters before and after surgery. These results indicate that the pantesticular defect in hormonal synthesis and spermatogenesis, seen in some men with varicoceles, can be reversible.

Clean intermittent catheterization in myelomeningocele children less than 3 years old.

Clean intermittent catheterization was instituted in 34 myelodysplastic children in an attempt to improve upper urinary tract changes, reflux, recurrent urinary tract infections or inefficient bladder evacuation. Compliance was excellent and no serious complications were encountered. Upper tract changes and reflux responded favorably to the procedure and the incidence of urinary tract infections decreased. The use of clean intermittent catheterization even in neonates is feasible and safe, and produces excellent preservation of urinary tract integrity.