Transurethral microwave thermotherapy of the prostate without intravenous sedation: results of a single United States center using both low- and high-energy protocols. TJUH TUMT Study Group.

PURPOSE: Previous studies have indicated that high-energy transurethral microwave thermotherapy (TUMT) requires intravenous (IV) sedation and/or narcotics for patient tolerance. This study was performed to determine tolerability, patient acceptance, and efficacy of TUMT using both low- and high-energy protocols in a single United States university setting. MATERIALS AND METHODS: Between August 11, 1997 and October 28, 1999, 210 men (mean age 64.9 +/- 9.1 years) presenting with symptomatic benign prostatic hyperplasia (BPH) received treatment with a Prostatron TUMT using either the low-energy Prostasoft 2.O or high-energy Prostasoft 2.5 software. Each patient had digital rectal examination and prostate-specific antigen level consistent with BPH, American Urological Association symptom score > or = 15, and Qmax <15 mL/s. Each patient received TUMT with only ibuprofen 400 mg by mouth (PO), lorazepam 1.0 mg PO, and ketorolac 30 mg intramuscularly (IM) prior to TUMT. A few patients who were concerned about limited pain threshold received oxycodone 5 mg/acetaminophen 325 mg PO. Of 210 patients treated, 12-month efficacy data were available for analysis in 80 patients. RESULTS: Forty-eight men (mean age 65 +/- 9.2 years) received low-energy 2.0 software TUMT, and 32 men (mean age 65.1 +/- 9.2 years) were treated with high-energy 2.5 software. Mean prostatic volume was 44.3 +/- 23.9 mL and 60.7 +/- 26.4 mL for the 2.0 and 2.5 groups, respectively. Mean energy delivered was 108.8 +/- 50.4 kJ and 173.1 +/- 41.1 kJ for the 2.0 and 2.5 treatment groups, respectively. International Prostate Symptom Score decreased from 23 pre-TUMT to 8 post-TUMT and 21 pre-TUMT to 10 post-TUMT at 12 months in the 2.0 and 2.5 groups, respectively. Mean peak flow rate improved 31.9% from 9.1 mL/s pre-TUMT to 12.0 mL/s post-TUMT and 45.8% from 9.6 mL/s pre-TUMT to 14.0 mL/s post-TUMT at 12 months in the 2.0 and 2.5 groups, respectively. All but two patients tolerated treatment without IV sedation. One patient experienced intolerable rectal spasm, and treatment was terminated in another patient because of poorly controlled hypertension. CONCLUSIONS: Patients can be treated safely with TUMT using either low or high energy, with almost universal patient tolerance and without the need for IV sedation or narcotics, if they premedicated effectively using a PO/IM regimen. Patients experience significant relief of symptoms whether low- or high-energy TUMT is used; however, high-energy TUMT improves flow rate to a greater extent than does low-energy therapy.

Removal of UroLume endoprosthesis: experience of the North American Study Group for detrusor-sphincter dyssynergia application.

PURPOSE: We present the experience of the North American UroLume Multicenter Study Group with removal of the UroLume endoprosthesis. MATERIALS AND METHODS: A total of 160 neurologically impaired patients were enrolled in the North American UroLume Multicenter Study Group for detrusor external sphincter dyssynergia application. Analysis was performed in 2 groups of patients in which the device was removed during insertion and after implantation, respectively. RESULTS: Device retrieval was required during insertion in 21 patients (13%) mainly due to misplacement or migration in 17. Extraction was done with minimal complications and in all but 2 cases subsequent UroLume implantation was successful. Of 158 men with the device in place 31 (19.6%) required removal. In 34 procedures 44 devices were removed, mainly due to migration. Time from implantation to removal ranged from 4 days to 66 months (mean 22 months). The UroLume was removed en bloc in 20 cases and in parts or wire by wire in 19. The majority of patients had no or minimal complications after extraction. Only 2 patients had serious temporary complications, including bleeding and urethral injury, with no lasting consequences. No malignancy developed as a result of UroLume insertion. CONCLUSIONS: While there is a potential for urethral injury and bleeding, UroLume endoprosthesis removal is largely a simple procedure with minimal complications and consequences.

Long-term followup of the North American multicenter UroLume trial for the treatment of external detrusor-sphincter dyssynergia.

PURPOSE: We determine the long-term efficacy and safety of the UroLume stent as minimally invasive treatment for external detrusor-sphincter dyssynergia in spinal cord injured men. MATERIALS AND METHODS: A total of 160 spinal cord injured men with a mean age plus or minus standard deviation of 36.3 +/- 12.1 years (range 16 to 74) were prospectively treated with an endoprosthesis at 15 centers as part of the North American UroLume trial for external detrusor-sphincter dyssynergia. Urodynamic parameters, including voiding pressure, residual urine volume and bladder capacity, were compared before treatment and at 1, 2, 3, 4 and 5 years after treatment. RESULTS: Mean voiding pressure was 75.1 +/- 28.2 cm. water before treatment in the 160 patients, and 37.4 +/- 23.9 at year 1 in 97, 39.5 +/- 22.2 at year 2 in 84, 42.6 +/- 27.3 at year 3 in 61, 46.3 +/- 33.2 at year 4 in 57 and 44.2 +/- 28.9 cm. at year 5 in 41 after stent insertion (p <0.001). Residual urine volume decreased after stent placement and was maintained throughout the 5-year followup (p <0.001). Mean cystometric capacity remained constant from 269 +/- 155 before insertion to 337 +/- 182 ml. 5 years later (p = 0.17). Hydronephrosis and autonomic dysreflexia improved or stabilized in most patients with functioning stents. Stent explant was necessary in 24 patients (15%), of whom 4 (16.7%) had another stent implanted. CONCLUSIONS: The UroLume stent demonstrates long-term safety and efficacy for the treatment of external detrusor-sphincter dyssynergia. The outcome was similar in men with and without previous sphincterotomy.

Early predictors of bladder recovery and urodynamics after spinal cord injury.

Our purpose was to determine if intact perianal (S4-5) pin sensation (PPS) and bulbocavernosus (S2-4) reflex (BCR) shortly after spinal cord injury (SCI) are predictive of bladder function recovery. Twenty-eight SCI patients (aged 18-68 years, Frankel Classification A-D, spinal injury level C4-T12), admitted within 72 hours of injury, underwent evaluation of initial PPS and BCR. The presence of intact PPS and BCR were correlated with the patient's voiding function and urodynamic evaluation results 1 year postinjury. Of the 28 patients within 72 hours of SCI, PPS was intact in 17 (60%) and absent in 11(40%), while 15 patients (54%) demonstrated a positive BCR and 13 (46%) did not. One year after SCI, no patient with absent PPS voided unassisted, while of the 17 patients with preserved PPS, 11 (65%) were voiding spontaneously. Of these 11 patients, urodynamic evaluation revealed detrusor areflexia in 1 (9%), normal detrusor function in 2 (18%), and detrusor hyperreflexia in 8 (73%), with 3 of these 8 patients (38%) also demonstrating detrusor-sphincter dyssynergia. At 1 year postinjury, only 2 of 13 patients (15%) with an absent BCR voided spontaneously, while 9 of 15 patients (60%) with an intact BCR were able to void. Although PPS and BCR are moderately sensitive in predicting the return of spontaneous voiding, they cannot predict detrusor hyperreflexia and sphincter dyssynergia. Therefore, urodynamic study remains an essential component of initial urologic evaluation after SCI.

Molecular marker for development of interstitial cystitis in rat model: isoactin gene expression.

PURPOSE: To determine whether the differential expression of bladder smooth muscle isoactin can be used as a molecular marker for the development of interstitial cystitis (IC). METHODS: Three groups of five female Sprague-Dawley rats each underwent urethral catheterization and intravesical instillation of 0.5 ml. of 0.4N HCl. One group was sacrificed one, two and four weeks after the application of HCl, and their bladders harvested for histologic examination and evaluation using Northern blot analysis of bladder smooth muscle isoactins. Five control animals were sacrificed and their bladders harvested to establish isoactin gene expression of bladder smooth muscle in the normal state. The bladders of the rats in each group were excised, immediately frozen in liquid nitrogen, pooled, then stored -70 degrees C until needed for RNA isolation. Isoactin cDNA probes have been developed, therefore isoactin specific cDNA insert fragments were isolated and insert DNA was purified by gel electrophoresis. Total cellular RNA was isolated from 1.0 gm. of bladder smooth muscle from each group. After spectrophotometric quantification, Northern Blot analysis was performed using 2% agarose-formaldehyde gels and Biotrans nylon membranes. Two complete Northern Blot series were run on a single gel and blotted to a single membrane to eliminate gel and blotting discrepancies. RESULTS: Microscopic histologic analysis revealed detrusor mastocystosis and eosinophilia as has been noted in humans with chronic interstitial cystitis. Two weeks after the intravesical application of hydrochloric acid, the relative expression of gamma-smooth muscle isoactin was noted to increase by 1.7-fold, while alpha-smooth muscle isoactin expression increased by a factor of 9. These effects were seen to stabilize four weeks after acid application. CONCLUSIONS: The intravesical application of dilute HCl in rats results in a histologic appearance which mimics that seen in humans with interstitial cystitis. The appearance of detrusor mastocytosis and eosinophilia was accompanied by a relative decrease in the expression of gamma- and a relative increase in alpha-smooth muscle isoactin gene expression. This pattern of smooth muscle isoactin expression is consistent with a more immature and possibly synthetic smooth muscle phenotype, which may be responsible for the clinical presentation of those with IC. Northern blot analysis of bladder smooth muscle cells may serve as an effective marker for the development of interstitial cystitis in humans.

In-vivo whole bladder response to anticholinergic and musculotropic agents in spinal cord injured rats.

The purpose of this study was to compare the effect on urodynamic parameters of anticholinergic and musculotropic agents in sham injured and spinal cord injured (SCI) rats. A standard rat SCI model induced by impact trauma was employed. Cystometrograms were performed under urethane anesthesia four weeks after SCI. Bladder capacity and voiding pressure were determined at the point of micturition monitored urodynamically and visually. The effect of oxybutynin chloride (0.01-0.1 mg/kg), propantheline bromide (0.05-0.5 mg/kg) and flavoxate hydrochloride (0.1-1.0 mg/kg) were assessed independently in sham injured and SCI rats (n = 10 in each group). Bladder capacities were 0.6 +/- 0.2 and 7.1 +/- 1.6 ml in sham and SCI rats (p < 0.01), respectively. Maximal filling pressure was 17.5 +/- 5 mmHg in sham and 25 +/- 5 mmHg in SCI rats (p < 0.05). Bladder capacity increased with all three medications. Administration of oxybutynin, propantheline and flavoxate in sham rats resulted in bladder capacities of 0.88 +/- 0.3, 0.71 +/- 0.3 and 0.8 +/- 0.2 ml, respectively (p < 0.01). In SCI rats, these drugs resulted in bladder capacities of 9.8 +/- 1.1, 7.9 +/- 1.3 and 8.8 +/- 2.0 ml, respectively (p < 0.01). No significant change in maximum filling pressure occurred. We conclude that anticholinergic and musculotropic agents caused a similar increase in bladder capacity in both sham and SCI rats. Oxybutynin enhanced bladder capacity more than propantheline or flavoxate.

Fascial sling correction of kinked efferent limb in patients with continent diversion and catheterization difficulty.

PURPOSE: We determined the efficacy of using a rectus fascial sling to revise an angulated efferent limb in patients with continent urinary diversion and difficulty with intermittent catheterization. MATERIALS AND METHODS: Two spinal cord injured women who underwent modified Indiana pouch urinary diversion required revision of each efferent limb because of difficulty with catheterization. A strip section of anterior rectus sheath was harvested and used to fix the efferent limb in position, assuring freedom from angulation and facilitating catheterization. RESULTS: Both patients remained continent for more than 2 years postoperatively and neither had further difficulties with catheterization or required additional surgery. CONCLUSIONS: Use of the rectus fascial sling in continent urinary diversion enables fixation of the efferent limb to facilitate catheterization and enhance continence.

Analysis of tumor spillage during radical prostatectomy using RT-PCR of prostate specific antigen.

Recent reports have suggested the shedding of cancer cells during radical extirpation of tumors. Prostate cells can be expressed from the prostate ex vivo and found in the expressed prostatic secretions. We conducted an in vivo study to determine if prostate epithelial cells can be found in the operative site as determined by RT-PCR targeted at prostate specific antigen (PSA) and to correlate this with pathologic stage and outcome. We analyzed 14 consecutive radical retropubic prostatectomy procedures with a minimum 1-year follow-up. Intraoperatively, 5-10 ml of fluid (representing blood, urine, and irrigant) was aspirated from the operative field at three time points: after transaction of the dorsal vein complex, urethra, and bladder neck. Ficoll gradient fractionation was carried out on the specimens, and RNA was extracted from the cell pellet. Quality of RNA and presence of the PSA mRNA was determined by RT-PCR targeted at actin and PSA, respectively, using previously published primers. The medical records were reviewed for pathologic stage. There were nine patients with extraprostatic disease and five patients with organ confined disease. Five of 14 (36%) patients tested positive for prostate epithelial cells in the operative field at one or more points during radical prostatectomy. All five positive RT-PCR PSA assays were in patients with locally advanced disease, whereas all of the patients with organ-confined disease were negative for RT-PCR. This preliminary in vivo study suggests that locally advanced prostate cancer may be associated with PSA expressing cells in the operative field during radical prostatectomy. The clinical significance of this is unclear, but this finding suggests that shedding of cells in the operative field is more likely with locally advanced disease.

Urological symptomatology in patients with reflex sympathetic dystrophy.

PURPOSE: We determined the effect of reflex sympathetic dystrophy on lower urinary tract function. MATERIALS AND METHODS: A total of 20 consecutive patients (16 women and 4 men) with neurologically verified reflex sympathetic dystrophy was referred for voiding symptoms, including urgency, frequency, incontinence and urinary retention. No patient had had voiding symptoms before the initial trauma that induced reflex sympathetic dystrophy. Evaluation included medical history, physical examination, video urodynamic testing and cystoscopy. RESULTS: Mean patient age was 43.4 +/- 10.2 years (range 28 to 58) and mean duration of urological symptoms was 4.9 +/- 3.6 years (range 1 to 14). Urodynamic study demonstrated a mean cystometric bladder capacity of 417 +/- 182 ml. (range 120 to 700). The urodynamic diagnoses included detrusor hyperreflexia in 8 patients, detrusor areflexia in 8, sensory urgency in 3 and detrusor hyperreflexia with detrusor-external sphincter dyssynergia in 1. In 4 women genuine stress urinary incontinence was also documented urodynamically. CONCLUSIONS: Reflex sympathetic dystrophy may have a profound effect on detrusor and sphincter function.

Latex allergy manifested in urological surgery and care of adult spinal cord injured patients.

This report exemplifies the cases of two male and one female spinal cord injury (SCI) patients with latex allergy, two of whom had life threatening episodes of intraoperative cardiovascular collapse. The three patients were extensively exposed to latex products as a result of urinary management programs, and two developed marked hypotension immediately upon abdominal exploration during reconstructive urological surgery. The third case represents the development in a male of latex allergy to over 12 types of latex condoms manifest as penile dermatitis. In each of these cases, allergy and immunology consultation confirmed the latex allergy. The diagnosis of latex allergy was established using both Radioallergosorbert (RAST) testing and a skin test to the latex antigen. The two patients who experienced intraoperative cardiovascular collapse required resuscitation with intravenous fluids, epinephrine, and antihistamines. Because each episode of hypotension occurred during bowel manipulation with latex gloves, they were suspected of inducing anaphylaxis. In the third patient, latex allergy was suspected after the immediate resolution of allergic symptoms upon replacing latex condom catheters with those made of silicone. This is the first report of a life-threatening reaction to latex allergy in the SCI population. Measures instituted to prevent further latex-associated morbidity included the use of medical alert bracelets, self-administration epinephrine injection kits, and nonlatex appliances, including gloves, condoms, and urethral catheters. It is recommended that precautions against the development of anaphylaxis be undertaken in SCI patients with chronic exposure to latex-containing products.

Urinary dysfunction in Lyme disease.

Lyme disease, which is caused by the spirochete Borrelia burgdorferi, is associated with a variety of neurological sequelae. We describe 7 patients with neuro-borreliosis who also had lower urinary tract dysfunction. Urodynamic evaluation revealed detrusor hyperreflexia in 5 patients and detrusor areflexia in 2. Detrusor external sphincter dyssynergia was not noted on electromyography in any patient. We observed that the urinary tract may be involved in 2 respects in the course of Lyme disease: 1) voiding dysfunction may be part of neuro-borreliosis and 2) the spirochete may directly invade the urinary tract. In 1 patient bladder infection by the Lyme spirochete was documented on biopsy. Neurological and urological symptoms in all patients were slow to resolve and convalescence was protracted. Relapses of active Lyme disease and residual neurological deficits were common. Urologists practicing in areas endemic for Lyme disease need to be aware of B. burgdorferi infection in the differential diagnosis of neurogenic bladder dysfunction. Conservative bladder management including clean intermittent catheterization guided by urodynamic evaluation is recommended.