Paul Miller

Use of the ASI Titanium Stent in the Management of Bladder Outflow Obstruction Due to Benign Prostatic Hyperplasia

An expandable titanium intraprostatic stent was inserted into 30 patients with infravesical obstruction due to benign prostatic hyperplasia (BPH). All of the men were considered unsuitable for transurethral resection of the prostate as a result of comorbid conditions. In 25 patients effective micturition was reestablished with this technique. In 21 of these men, who have been followed for longer than 1 year, the mean maximum flow rate at 1 year was 10.8 ml. per second and the mean residual urine was 56 ml. Although urinary tract infections occurred subsequent to stent insertion in 10 individuals, these resolved after appropriate antibiotic treatment and no stents have had to be removed for this reason. Followup cystoscopy or examination by electron microscopy of those stents that have been removed has shown partial epithelialization of the stent surface in a proportion of patients, and a minor degree of incrustation occurred in 1 case. We conclude that an expandable intraprostatic titanium stent is an acceptable alternative to transurethral resection of the prostate or long-term catheterization in this particular group of high risk patients.

Repeated pressure-flow studies in the evaluation of bladder outlet obstruction due to benign prostatic enlargement

Test‐retest reliability of repeated voids in pressure‐flow studies and the influence on maximum flow rate (QmaxpQ), detrusor pressure at maximum flow rate (pdetQmax), voided volume, and residual urine were studied. Also the agreement in interpretation of pressure‐flow tracings between investigators and a single blinded central reader acting as a quality control center (QCC) were assessed. In addition, correlations between pdetQmax and patient age, International Prostate Symptom Score (IPSS), free maximum flow rate (Qmax), and prostate volume were calculated. Using suprapubic pressure recording, 216 men with lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) were investigated in 11 centers. In each pressure‐flow study, three sequential voids were performed, and quality controlled recordings were analyzed for QmaxpQ and pdetQmax by the QCC. Trans‐ rectal ultrasound was used to measure the prostate volume. Mean QmaxpQ did not change, but pdetQmax decreased significantly in the second and third sequential voids. Using the Abrams‐Griffiths nomogram definition of obstruction, 125 patients (67%) were classified as obstructed from the first void, but only 111 patients (59%) from the third void. The agreement between the investigator assessment and that of a single blinded reader was good. There was no significant correlation between pdetQmax and patient age, IPSS, and Qmax, whereas a modest correlation was found between pdetQmax and prostate volume. In summary, there was no significant change in QmaxpQ, but pdetQmax decreased for the three consecutive voids, which can be explained by a decrease in outlet resistance. The agreement between the investigator and QCC interpretations shows the value of a standardized technique, supporting the feasibility of multicenter urodynamic studies. There is a modest, but statistically significant, correlation between detrusor pressure and prostate size, supporting the hypothesis that prostate size is a contributing factor in symptomatic BPH. Neurourol. Urodynam. 18:17–24, 1999.

IMPROVEMENT OF PRESSURE FLOW PARAMETERS WITH FINASTERIDE IS GREATER IN MEN WITH LARGE PROSTATES

PURPOSEnWe assess the effect of finasteride, a 5alpha-reductase inhibitor, on objective voiding parameters in men with lower urinary tract symptoms and benign prostatic enlargement on digital rectal examination (known as clinical benign prostatic enlargement) in a double-blind placebo controlled multicenter study using strict standard pressure flow study techniques.nnnMATERIALS AND METHODSnA modification of the Abrams-Griffiths nomogram was used by 1 reader to ensure that all patients met objective criteria for bladder outlet obstruction at baseline. After performing a pressure flow study patients with obstruction were randomized 2:1 to receive 5 mg. finasteride (81) or placebo (40) daily. A second pressure flow study was performed at month 12. At baseline and month 12 free urinary flow studies and transrectal ultrasound were performed, and International Prostate Symptom Score questionnaires were completed. Patients were treated between May 1994 and July 1996.nnnRESULTSnFinasteride caused a significant decrease (-8.1 cm. water) in detrusor pressure at maximum flow (p <0.05 versus placebo p = 0.02), increase (+1.1 ml. per second) in maximum flow rate (p <0.05 versus placebo p = 0.02) and decrease (-22.8%) in prostate volume (p <0.05 versus placebo p <0.001). Men with prostates larger than 40 cc had greater improvement in detrusor pressure at maximum flow (between group difference -14.5 cm. water, 95% confidence interval -26.2 to -2.6, p = 0.02) and maximum flow rate (mean treatment effect +1.6 ml. per second, 95% confidence interval -0.2 to 3.0, p = 0.02) compared to those with prostates 40 cc or less (between group differences not significant).nnnCONCLUSIONSnFinasteride treatment resulted in improvements in urodynamic parameters, which were greater in men with large prostates.

Continued improvement in pressure-flow parameters in men receiving finasteride for 2 years ☆

OBJECTIVESnTo assess the long-term effects of finasteride on pressure-flow parameters in men with urodynamically documented bladder outflow obstruction (BOO).nnnMETHODSnOne hundred twenty-one men with benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS) underwent a pressure-flow study (PFS) at 1 of 11 clinical centers. The PFS technique was standardized, and all tracings were read by a single reader unaware of the treatment group. Patients who were obstructed according to a modified Abrams-Griffiths nomogram were randomized to 5 mg finasteride (n = 81) or placebo (n = 40) for 12 months; all patients continuing into an open extension received finasteride during the second 12 months of therapy. Results of the initial 12-month study demonstrated the benefit of finasteride treatment on PFS parameters. To examine the continuing effects over time, an analysis of the data from 54 patients who completed 24 months of treatment with finasteride is provided.nnnRESULTSnDetrusor pressure at maximum flow (PdetQmax) continued to decrease during the second 12 months of therapy (decreases of 5.3 and 11.7 cm H2O at months 12 and 24, respectively). The percentage of patients obstructed by Abrams-Griffiths classification decreased from 76.2% at baseline to 66.7% at month 12 and 59.6% at month 24. An intention-to-treat analysis yielded similar results.nnnCONCLUSIONSnFinasteride improves urodynamic measures of obstruction in men with BPE and LUTS, with continued improvement during the second 12 months of therapy.

Cooled thermotherapy for the treatment of benign prostatic hyperplasia: durability of results obtained with the Targis System

OBJECTIVESnTo evaluate the durability of benefit associated with cooled high-energy thermotherapy (cooled thermotherapy) using the Targis System with data extending to 5 years after treatment.nnnMETHODSnAt three centers in Canada and the United Kingdom, 150 patients with benign prostatic hyperplasia underwent cooled thermotherapy with the Targis System. This was an outpatient procedure performed without general or regional anesthesia. Patients were followed up at 1 and 6 weeks, 3, 6, and 12 months, and yearly to 5 years.nnnRESULTSnPatients were evaluated at 1, 2, 3, 4, and 5 years after treatment (n = 132, 111, 90, 77, and 59, respectively). At these intervals, the American Urological Association symptom scores improved by 11.7 (57%), 12.1 (58%), 11.5 (53%), 10.1 (47%), and 10.6 (47%) points (P <0.0001 for each), the peak flow rates improved by a mean of 4.0 (57%), 4.0 (56%), 3.4 (48%), 3.3 (47%) and 2.4 (37%) mL/s (P <0.0001 for each), and quality-of-life scores improved by 2.6, 2.6, 2.5, 2.3, and 2.3 points (P <0.0001 for each). At least a 50% improvement in the American Urological Association symptom score was observed in 63% to 68% of patients available for follow-up at years 1, 2, and 3 and 50% and 51% of patients available for follow-up at years 4 and 5, respectively. Four patients required repeated microwave thermotherapy, 27 required subsequent invasive treatments, 1 permanent catheterization, 11 required alpha-blockers, and 1 antiandrogen therapy.nnnCONCLUSIONSnCooled thermotherapy with the Targis System produces durable improvements in symptoms, quality of life, and flow rates to at least 5 years after treatment.

Preferential heating using transurethral thermoablation (T3) improves clinical results

Transurethral microwave thermotherapy (TUMT) has been widely reported for the treatment of benign prostatic hyperplasia (BPH) but with variable results. This is likely due to the inability to develop and maintain high intraprostatic temperatures. The T3 device has a preferential heating pattern which prevents shutdowns as a result of rectal heating thus allowing continuous energy delivery throughout the therapy. High temperatures greater than 70 degrees Celsius are maintained resulting in extensive coagulative necrosis in the transitional zone. Treatment was performed in an outpatient clinic using topical anaesthesia with occasional low dose I.V. analgesia. One hundred and fifty-four patients have been treated in 3 centers using a similar protocol. Inclusion criteria required an AUA symptom score greater than or equal to 9 and a peak uroflow rate less than or equal to 12 ml/sec. Mean prostate size was 40.6 cc. One hundred and eighteen patients have been followed for at least 12 months, and 58 for 24 months. AUA symptom score decreased from a mean of 19.8 to 8.9 (12 M), and 7.6 (24 M). Improvement was seen in all 7 symptoms evaluated. Peak flow rates increased from a mean of 9.3 to 13.4 (12 M), and 13.1 (24 M). Improvement in symptom score and peak flow was observed across all prostate sizes. By 2 years, 15 patients had dropped out of the study, 8 for alternative treatment (6 TURP, 1 bladder neck incision, 1 urethrotomy) and 7 for administrative or other reasons. Treatment with the T3 device provides excellent improvement in symptoms, flow rates and patients satisfaction. T3 fulfills the criteria for an effective, minimally invasive, outpatient treatment for symptomatic BPH.

Holmium Laser Enucleation of the Prostate: Simulation-Based Training Curriculum and Validation

OBJECTIVEnTo evaluate the face, content, and construct validity of a novel virtual reality simulator for holmium laser enucleation of the prostate (HoLEP) and to assess its feasibility and acceptability as a training model.nnnMETHODSnThis prospective observational study recruited 53 participants, comprising of 3 groups: HoLEP experts (n = 11), intermediates (n = 24), and novices (n = 18). All participants received an educational package and a 15-minute familiarization exercise with the simulator. All participants then carried out a full enucleation on an identical 60 cm(3) virtual prostate. Performance was assessed using in-built simulator metrics, and a questionnaire was distributed assessing face and content validity, as well as feasibility, and acceptability. Novice, intermediate, and expert groups were compared using the Mann-Whitney U test.nnnRESULTSnConstruct validity data revealed significant differences in enucleation efficiency (grams enucleated per hour) when comparing experts to intermediates (P = .003), experts to novices (P <.001), and intermediates to novices (P = .001). Face validity was rated by experts as acceptable, with a mean score of 5.6 out of 10 when asked to rate the overall realism. Content validity questions showed that 85% of participants agreed that simulator-based assessment is essential for patient safety and 87% agreed that there was a role for a validated virtual reality simulator for use in HoLEP training.nnnCONCLUSIONnThis study established face, content, and construct validity for this novel virtual reality HoLEP simulator. The majority of participants also thought that it is a feasible and acceptable model for HoLEP training.