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.

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 enucleation of the prostate: a comparison of efficiency measures at two institutions.

BACKGROUND AND PURPOSE: Holmium laser enucleation of the prostate (HoLEP) is perceived to be technically difficult, time consuming, and inefficient. We assessed the efficiency of HoLEP by documenting the technical features of the procedure at two hospitals located on different continents. PATIENTS AND METHODS: A retrospective analysis of all patients who underwent HoLEP at the Methodist Hospital of Indiana and Tauranga Hospital in New Zealand was performed. A series of 40 patients from the Indiana cohort were pair-matched, by the weight of prostate tissue retrieved, with 40 patients from the New Zealand cohort. Enucleation time and morcellation time were compared in the two groups. RESULTS: The mean weight of the tissue retrieved from the Indiana cohort was 27.1 g and that from the New Zealand cohort was 22.9 g (P = 0.41). The mean enucleation times were 47.6 minutes and 29.2 minutes, respectively (P < 0.001). The mean morcellation times were 9.9 minutes and 7.7 minutes (P = 0.201). The mean rates of enucleation were 0.58 g/min and 0.71 g/min (P = 0.17). The mean rates of morcellation were 3.4 g/min and 4.3 g/min (P = 0.20). The HoLEP efficiency increased as a function of gland size (R(2) = 0.56). CONCLUSIONS: Holmium laser enucleation of the prostate is a reproducible technique, as there is little variation in efficiency from one surgeon to another. Furthermore, the efficiency of HoLEP increases as prostate size increases, which suggests that HoLEP may be an ideal treatment for men with large prostates.

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.

Laparoscopic radical prostatectomy: early safety and efficacy.

BACKGROUND: To evaluate the initial results of laparoscopic radical prostatectomy at this institution. METHODS: Between January 2000 and September 2003, 30 patients underwent laparoscopic radical prostatectomy. Peri- and postoperative data were accumulated prospectively and maintained in a database. All patients have a minimum of 6 month follow up. RESULTS: There were no conversions to open surgery, and there were no re-operations. Mean operating time was 328 (195-490) min. There was one intraoperative rectal injury which was repaired laparoscopically. Three patients (10%) required blood transfusion. Postoperatively, there were two cases of respiratory depression, one case of haemoptysis and one upper gastrointestinal bleed. Two anastomotic leaks were successfully treated conservatively, one of which was the only readmission to hospital. There was one case of clot retention requiring manual irrigation of the bladder. Mean hospital stay was 2.75 (1-10) days, with six of the last 10 patients being discharged on the first postoperative day. Continence rates at 6 months are 83%. Positive surgical margins occurred in seven patients (23%). At 12 months of follow up, one patient (4.5%) has had biochemical recurrence. CONCLUSIONS: Our initial results are comparable to, or better than, the initial series in high volume centres. The procedure is feasible in appropriately selected cases in the Australasian environment.