A randomised single-blind comparison of the effectiveness of Tristel Fuse (chlorine dioxide) as an office-based fluid soak, with Cidex OPA (ortho-phthaldehyde) using an automated endoscopic reprocessor (AER) as high-level disinfection for flexible cystoscopes.

OBJECTIVE: To compare the effectiveness, safety and cost of Tristel Fuse (chlorine dioxide) with Cidex OPA (ortho-phthaldehyde; 1,2-benzenedicarboxaldehyde) in an automated endoscopic reprocessor (AER) for high-level disinfection of flexible cystoscopes. PATIENTS AND METHODS: A randomised single-blind study comparing the high-level disinfectants Tristel Fuse as a simple office-based soak and Cidex OPA using an AER was performed. Participants were 'blinded' to the agent used for disinfection of the flexible cystoscopes. All patients had negative mid-stream urine at baseline, (MSU) no symptoms suggestive of urinary tract infection (UTI) on the day of investigation, no recent antibiotic use or current indwelling urinary catheter. Patients who underwent cystoscopic biopsy during the procedure were excluded. A urine analysis was done before and 3-5 days after cystoscopy and multiple equipment cultures were performed. The Urogenital Distress Inventory (UDI-6 + two questions from the 'long-form'), symptom and quality-of-life scores were assessed before and after cystoscopy as were ease-of-use assessments and a full cost analysis. RESULTS: In all, 180 of 465 screened participants were randomised 1:1 and the mean age was 72.1 years, 17% were females and 57% of procedures were performed for bladder tumour surveillance. The urine analysis was positive in 5.4% of patients in each group and 29% (Tristel) vs 20% (Cidex) of patients had urinary leukocyturia (p = ns) after cystoscopy. The turnover (minutes per cycle) was 7.5 (Tristel) vs 26.7 (Cidex). The per-procedure costs were $11.67 (American dollars) for Tristel Fuse and $21.82 for Cidex OPA with fixed costs of $4788 for Tristel Fuse and $60,514 for Cidex OPA. CONCLUSIONS: Tristel Fuse appears to be as effective and more cost-effective than Cidex OPA for high-level disinfection of flexible cystoscopes. This has significant cost implications for the office urologist.

Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years.

OBJECTIVE: To assess the durability of holmium laser enucleation of prostate in comparison to transurethral resection of the prostate (TURP). PATIENTS AND METHODS: Patients were enrolled in the present study between June 1997 and December 2000 and followed per protocol. All patients were urodynamically obstructed with a prostate volume of between 40 and 200 mL. At long-term follow-up, variables assessed included Benign Prostatic Hyperplasia Impact Index (BPHII), International Continence Society Short Form Male questionnaire (ICSmale-SF) and the International Index of Erectile Function (IIEF). Adverse events, including the need for retreatment, were specifically assessed. RESULTS: Thirty-one (14 holmium laser enucleation of the prostate [HoLEP] and 17 TURP) of the initial 61 patients were available, with 12 deceased and 18 lost to follow-up. The mean (range) follow-up was 7.6 (5.9-10.0) years and the mean (±sd) age at follow-up was 79.8 (±6.2) years. The mean (±sd) values (HoLEP vs TURP) were as follows: maximum urinary flow rate (Q(max)), 22.09 ± 15.47 vs 17.83 ± 8.61 mL/s; American Urological Association (AUA) symptom score, 8.0 ± 5.2 vs 10.3 ± 7.42; quality of life (QOL) score 1.47 ± 1.31 vs 1.31 ± 0.85; BPHII, 1.53 ± 2.9 vs 0.58 ± 0.79; IIEF-EF (erectile function), 11.6 ± 7.46 vs 9.21 ± 7.17; ICSmale Voiding Score (VS), 4.2 ± 3.76 vs 3.0 ± 2.41; ICSmale Incontinence Score (IS), 3.07 ± 3.3 vs 1.17 ± 1.4. There were no significant differences in any variable between the two groups beyond the first year. Of the assessable patients, none required re-operation for recurrent BPH in the HoLEP arm and three (of 17) required re-operation in the TURP arm . CONCLUSION: The results of this randomized trial confirm that HoLEP is at least equivalent to TURP in the long term with fewer re-operations being necessary.

A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence.

OBJECTIVE: To compare the efficacy of extracorporeal electromagnetic stimulation (ES) of the pelvic floor for treating stress urinary incontinence (SUI) vs sham ES. PATIENTS AND METHODS: In all, 70 women with urodynamically confirmed SUI were randomized to receive active (35) or sham (35) ES. The NeoControl chair (NeoTonus, Marietta, GA, USA) was used, and treatment consisted of three sessions per week for 6 weeks. data were collected before and after treatment on all women, including a 20-min provocative pad-test with a predetermined bladder volume (primary outcome measure), a 3-day bladder diary and 24 h pad-test. Circumvaginal muscle (CVM) rating score, perineometry using two separate instruments and video-urodynamics were also used, and the Urinary Incontinence Quality of Life Scale (I-QOL) and King's Health Questionnaires. Patients were fully re-evaluated 8 weeks after treatment, and the bladder diary, pad-test and questionnaires were repeated at 6 months. The urotherapist and physician were unaware to which treatment group the patient was assigned. RESULTS: In the overall group of 70 patients there were significant improvements in each of the primary and secondary outcome measures at 8 weeks. There were also significant improvements in primary and secondary outcome measures in the active treatment group when compared with baseline measures. At 8 weeks, there were improvements in the mean (sd) values for the 20-min pad-test, of 39.5 (5.1) vs 19.4 (4.6) g (P < 0.001); the 24-h pad-test, of 24.0 (4.7) vs 10.1 (3.1) g (P < 0.01); the number of pads/day, of 0.9 (0.1) vs 0.6 (0.1) (P < 0.01), the I-QOL score, of 63.7 (2.8) vs 71.2 (3.3) (P < 0.001); and King's Health Questionnaire score, of 9.6 (0.8) vs 6.9 (0.7) (P < 0.001). However, these improvements were not statistically significant when compared with the sham-treatment group. In those patients on active treatment who had a poor pelvic floor contraction at the initial assessment (defined by the CVM score and perineometry), there was a significant reduction (P < 0.05) in the 20-min pad-test leakage when compared with the sham-treatment group. CONCLUSIONS: ES was no more effective overall than sham treatment in this patient group. However, in those women who were unable to generate adequate pelvic floor muscle contractions, there was an objective improvement in provocative pad testing when compared to sham treatment.

An adjustable continence therapy device for treating incontinence after prostatectomy: a minimum 2-year follow-up.

OBJECTIVE: To evaluate the efficacy and safety of the ProACT (Uromedica, Inc., MN, USA) balloon device, an alternative for the surgical management of incontinence after prostatectomy. PATIENTS AND METHODS: The initial patients who received this device at our institution were evaluated, using urodynamics at baseline and at 6 months. Perioperative variables were recorded and pad usage, volume adjustments, an estimate of Incontinence Quality of Life (I-QoL) and adverse events were recorded at baseline, and 1, 3, 6, 12 and 24 months after surgery. RESULTS: In all, 37 patients were treated on this protocol between November 2001 and March 2005. Of these, 30 had had radical prostatectomy and seven holmium laser enucleation of the prostate. The mean (range) pad usage decreased from 2.81 (1-12) at baseline to 0.7 (0-4) pads at 24 months, and the I-QOL increased from 49.7 (4.5-77) to 81.3 (13.6-100) over the same period. At 24 months, 62% of 34 men were pad-free and 81% required one pad or less. Bilateral explantation was required in three patients (11%) for infection (one) and balloon migration (two). All other adverse events were mild and transient. CONCLUSIONS: The ProACT balloon device is an acceptable therapy for the surgical management of incontinence after prostatectomy.

Holmium laser enucleation of the prostate: results at 6 years.

OBJECTIVES: The issue of durability is an important concern when evaluating new surgical modalities. To date, only 24-mo data have been published on holmium enucleation of the prostate (HoLEP) despite its widespread use worldwide although 4-yr data exist for the earlier technique of holmium resection. This study addresses the issue of durability of HoLEP. METHODS: All patients who had undergone HoLEP and been evaluated in three prospective trials conducted at this institution between 1997 and 2002 were evaluated. Patients available at follow-up had data assessed on the International Prostate Symptom Score (IPSS), maximal flow rate (Qmax), quality of life (QOL), International Continence Society Male Short Form (ICS-SF), International Index of Erectile Function (IIEF), Benign Prostatic Hyperplasia Impact Index (BPHII), and continence questionnaire. RESULTS: The mean follow-up was 6.1 yr (range: 4.1-8.1 yr). The mean age of the patients at follow-up was 75.7 yr (range: 58-88 yr). Of 71 HoLEP patients originally studied on the protocol, 38 (54%) were available for analysis, 14 were deceased, and 19 were lost to follow-up. The mean IPSS for this group was 8.5 (range: 0-24) and Q(max) 19 ml/s (range: 6-28 ml/s). The QOL score was 1.8 (range: 0-5) and the BPHII 2.0 (range: 0-11). One patient (1.4%) had undergone reoperation, an additional HoLEP. Overall, 92% were either satisfied or extremely satisfied with their outcome. CONCLUSIONS: HoLEP is durable and most patients remain satisfied or extremely satisfied with the long-term outcome.

Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia.

OBJECTIVES: To compare the alternative energy sources of the holmium:yttrium-aluminum-garnet laser and bipolar plasmakinetic energy for endoscopic enucleation. METHODS: A prospective, randomized controlled trial was undertaken, with 20 patients assigned to each group. The preoperative and postoperative measures included transrectal ultrasound-assessed prostate volume, postvoid residual urine volume, and urodynamic evaluation findings. The intraoperative measures included procedure length, energy use, and specimen weight. All adverse events were recorded at each postoperative visit in a 1, 3, 6, and 12-month protocol. RESULTS: No differences were found in the preoperative characteristics between the two groups. The significant differences favoring holmium laser enucleation of the prostate compared with plasmakinetic enucleation of the prostate were seen in the operative time (43.6 versus 60.5 minutes), recovery room time (47.1 versus 65.6 minutes), and bladder irrigation requirement (5% versus 35%). The outcomes after holmium laser enucleation of the prostate and plasmakinetic enucleation of the prostate were in all other respects similar by the postoperative outcome measures assessed. CONCLUSIONS: Plasmakinetic enucleation of the prostate is a safe and technically feasible procedure for the enucleation of prostatic adenomata. Plasmakinetic enucleation of the prostate is limited by the longer operative and recovery room times, as well as a more pronounced postoperative irrigation requirement because of reduced visibility and a greater propensity for bleeding. The transfusion rates and catheterization and hospitalization times were similar. The optimal energy source for enucleation should still be considered the holmium laser, but bipolar energy can be considered by users already experienced with holmium laser enucleation of the prostate.

A randomised trial comparing holmium laser enucleation versus transurethral resection in the treatment of prostates larger than 40 grams: results at 2 years.

OBJECTIVE: To compare holmium laser enucleation of the prostate (HoLEP) with transurethral resection of the prostate (TURP) for treatment of men with bladder outflow obstruction (BOO) secondary to benign prostatic hyperplasia with a minimum of 24-month follow-up. PATIENTS AND METHODS: Sixty-one patients were randomised to either HoLEP or TURP. All patients had BOO proven on urodynamic studies pre-operatively (prostate size 40-200 g). One patient died before treatment, which left 30 patients in each group. Perioperative data, as well as symptom scores, Quality of Life (QoL) scores, and maximum urinary flow rates (Qmax) were obtained at one, three, six,12, and 24 months. Post-void residual volumes, transrectal ultrasound (TRUS) volumes, and pressure flow studies were obtained six months post-operatively. Continence and potency data were also recorded. RESULTS: There were no significant differences between the two surgical groups pre-operatively. Mean pre-operative TRUS volume was 77.8+/-5.6 g (42-152) in the HoLEP group and 70.0+/-5.0 g (46-156) in the TURP group. Patients in the HoLEP group had shorter catheter times and hospital stays. More prostate tissue was retrieved in the HoLEP group. At six months, HoLEP was urodynamically superior to TURP in relieving BOO. At 24 months, there was no significant difference between the two surgical groups with respect to American Urology Association scores, QoL scores, or Qmax values; however, two patients in the TURP group required re-operation. CONCLUSIONS: HoLEP has less perioperative morbidity and produces superior urodynamic outcomes than TURP, when treating prostates >40 g. At 24 months of follow-up, HoLEP is equivalent to TURP.

Holmium laser bladder neck incision versus holmium enucleation of the prostate as outpatient procedures for prostates less than 40 grams: a randomized trial.

PURPOSE: Bladder neck incision (BNI) is a common, minimally invasive treatment option for bladder outflow obstruction in men with a small prostate. We compared BNI using the holmium:YAG laser to holmium enucleation of the prostate (HoLEP) in a prospective, randomized, urodynamically based trial. MATERIALS AND METHODS: A total of 40 patients with urodynamic obstruction (Schafer grade 2 or greater) and a prostate of 40 gm or greater on transrectal ultrasound (TRUS) were randomized equally to holmium laser BNI (HoBNI) or HoLEP as an outpatient procedure. The outcomes assessed were operative time, catheter time and hospital time. American Urological Association and quality of life scores, and maximal urinary flow rates were measured at baseline, and 1, 3, 6 and 12 months postoperatively, while pressure flow studies and TRUS volume measurement were performed at baseline and 6 months. RESULTS: The 2 groups were well matched for all variables at baseline. HoBNI was significantly more rapid to perform than HoLEP (p <0.001). Two patients (10%) in the HoBNI group required recatheterization compared with none in the HoLEP group. There was no significant difference in catheter time (22.9 vs 23.2 hours) or hospital time (12.3 vs 13.7 hours) between the groups. Five patients remained obstructed urodynamically at 6 months. All were in the HoBNI group and 4 of the 5 men had a prostate that was greater than 30 gm. Four of these patients required HoLEP for persistent lower urinary tract symptoms. In the remaining unoperated patients there were no significant differences in American Urological Association and quality of life scores or in the maximal urinary flow rate at each assessment. At 6 months detrusor pressure at maximal urinary flow was significantly lower (p <0.05) and TRUS volume was significantly smaller (p <0.001) in the HoLEP group There was significantly more early stress incontinence postoperatively in the HoLEP group but no bladder neck contractures were detected. CONCLUSIONS: Relief of obstruction was better after HoLEP and fewer patients required recatheterization or reoperation, although more reported early postoperative stress incontinence. Catheter time, hospital time and perioperative morbidity were similar. HoBNI and HoLEP are safe and feasible as outpatient procedures in patients with a small prostate but HoBNI is more rapid to perform.