Adjustable transobturator male system (ATOMS) for stress urinary incontinence: the evidence is mounting.

OBJECTIVES: To evaluate the New Zealand clinical experience with the adjustable transobturator male system (ATOMS), a novel continence device in the management of all degrees of stress urinary incontinence (SUI), focusing on efficacy and safety outcomes. PATIENTS AND METHODS: A retrospective review of all ATOMS devices placed between May 2015 and November 2020 was conducted. Severity of SUI was assessed (pad usage) before and after surgery. SUI was defined as mild (1-<3 pads/day), moderate (≥3-5 pads/day) or severe (>5 pads/day). The primary outcome measures considered were the overall success rate (improvement in pad use) and the dry rate (with dry defined as either no or 1 safety pad/day). The number of outpatient adjustments and total filling volumes were also documented in each case. Additionally, we documented incidence and severity of device complications and an analysis of treatment failures. RESULTS: A total of 140 patients were reviewed, with the most common indication for ATOMS placement being SUI after radical prostatectomy (82.8%). Of the patients included, 53 (37.9%) had previous radiotherapy, with 26 (18.6%) patients having had a previous continence procedure performed. No intraoperative complications were noted. The median preoperative pad usage was 4 pads/day. After a median follow-up of 11 months, median postoperative pad usage reduced to 1 pad/day. In our cohort, 116 patients (82.9%) reported an improvement in their pad usage and were considered successful with 107 (76.4%) patients reporting themselves to be dry. Complications within the first 90-days after surgery occurred in 20 (14.3%) of patients. CONCLUSION: Treatment of SUI with the ATOMS is safe and effective. The option of long-term, minimally invasive adjustment to respond to patient needs is a significant advantage.

Intralesional steroid injection combined with bladder neck incision is efficacious in the treatment of recurrent bladder neck contracture.

OBJECTIVES: Bladder neck contracture (BNC) is a well-recognized complication following radical prostatectomy (RP). This problem may recur after failing initial endoscopic management. This study evaluated the efficacy of intralesional steroid injection combined with bladder neck incision (BNI) for recurrent BNC following RP. METHODS: Between November 2011 and March 2018, data from all men who underwent BNI and intralesional steroid injection for recurrent BNC from a single regional center were collected. BNC was diagnosed endoscopically and identified as recurrent if having previously failed endoscopic management with BNI alone. Follow up was initially performed at 3 months with an International Prostate Symptom Score and urinary flow rate. Patients were noted to be recurrence-free when discharged from follow up or after having undergone a continence procedure indicating stability of the contracture. RESULTS: Thirty patients underwent BNI and intralesional steroid injection for recurrent BNC over the study period. All patients had received prior endoscopic incision of BNC without lasting success. Seventy percent (21/30) of patients were recurrence-free post-procedure, and this increased to 83.3% (25/30) after a repeat procedure in four patients. All five patients who had previous salvage radiotherapy had their recurrent BNC successfully managed with one BNI and intralesional steroid injection. The mean follow up was 33.4 months (range 7-75). There were no adverse events recorded. CONCLUSIONS: BNI combined with injection of intralesional steroids is a simple, cost-effective intervention which requires no specialist equipment/skills outside the realm of a general urologist. It is safe and has an excellent success rate.

The penile clamp: medieval pain or makeshift gain?

INTRODUCTION AND OBJECTIVES: A significant number of men are affected by post-prostatectomy urinary incontinence. If symptoms persist after conservative measures fail men are left with three choices: additional surgery, drainage or absorbent devices, or a penile compression device. Our center encountered a number of men for whom additional surgery was too dangerous and for whom drainage or absorbent devices were too cumbersome. Our objective was to investigate the level of symptomatic improvement and ease of utility of a penile compression device (Dribblestop™, Rennich Industries, Ltd., Calgary, Canada) in this population. PATIENTS AND METHODS: Patients who were prescribed the penile compression device across 10 New Zealand Centers were contacted to complete an Incontinence Impact Questionnaire (IIQ-7) regarding symptomatic improvement before and after the use of the compression device. The data were then analyzed for improvement scores pre and post intervention. RESULTS: Eighteen men were contacted across 10 New Zealand centers. There was an 89% response rate for interview. The average pre-intervention IIQ-7 score was 67.3 out of 100. The average post-intervention IIQ-7 score was 26.8 out of 100. The reduction in average symptomatic score was 40.5 (P < 0.05). The interviewees found the device easy to use, felt more confident wearing the device, and had increased levels of physical activity with device in situ. CONCLUSION: This study demonstrates that men who used the penile compression device reduced their Incontinence Impact Questionnaire scores significantly. Further research into the side effect profile of the device is needed as its utility may be under appreciated.

A Valsalva leak-point pressure of >100 cmH2O is associated with greater success in AdVance™ sling placement for the treatment of post-prostatectomy urinary incontinence.

OBJECTIVES: To determine if there is a Valsalva leak-point pressure (VLPP) threshold that predicts for retro-urethral transobturator sling (RTS) success in men with post-prostatectomy urinary incontinence (UI). PATIENTS AND METHODS: The preoperative urodynamic parameters of all patients undergoing RTS (AdVance™) sling surgery over the last 5 years were analysed and compared with the postoperative outcomes. The sling was defined as having been successful if the patient no longer had to wear pads or merely used a pad to provide a sense of security. RESULTS: In all, 46 men with a mean (range) age of 65 (45-83) years, underwent AdVance™ sling surgery. 10 men had undergone holmium laser enucleation of the prostate, one a transurethral resection of the prostate and 35 radical prostatectomy. 11 men had a VLPP of ≤100 cmH2O. Of these 11 men, three had no, or minimal, improvement in their leakage and all three required a secondary procedure (artificial urinary sphincter, AUS). In the 35 men with a VLPP of >100 cmH2O there were three failures. One of these was successfully salvaged with a repeat sling, another with an AUS and one with ProACT™ balloons. The hazard ratio (HR) for failure with a VLPP of ≤100 cmH20 compared with a VLPP of >100 cmH2O was 4 (95% confidence interval 0.68-23.7). CONCLUSION: A VLPP of >100 cmH2O has a high degree of predictability for success for AdVance™ sling placement for men with post-prostatectomy UI.

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.

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.

Holmium laser resection of the prostate versus transurethral resection of the prostate: results of a randomized trial with 4-year minimum long-term followup.

PURPOSE: It has previously been shown that holmium laser resection of the prostate (HoLRP) is superior to transurethral resection of the prostate (TURP) with regard to perioperative morbidity and is equivalent to TURP in the short term. We present the long-term results of a randomized, prospective trial comparing HoLRP to TURP since information regarding the durability of holmium prostatectomy is lacking in the literature to date. MATERIALS AND METHODS: A total of 120 patients with urodynamic obstruction were randomized (April 1996 to August 1997) into 2 comparable groups and assigned to HoLRP or TURP. All patients were assessed preoperatively and followed prospectively at 3 weeks, 3, 6, 12, 24 and 48 months postoperatively with an American Urological Association symptom score, quality of life score, peak urinary flow rate, and questionnaires concerning sexual function and continence. Preoperative pressure flow studies, ultrasound prostatic volume assessment and post-void residual volume measurement were repeated at the 6-month visit. All adverse events were noted. RESULTS: Of 120 patients 73 completed the 48-month assessment. HoLRP and TURP resulted in significant improvements in all parameters. There was no difference between the 2 techniques in terms of urodynamic parameters, potency, continence and symptom scores at the 48-month assessment. HoLRP took significantly longer to perform but perioperative morbidity, catheter time, nursing contact time and hospital stay were significantly less for HoLRP compared to TURP. CONCLUSIONS: HoLRP and TURP give equivalent and satisfactory long-term results, with no differences noted in major morbidity. This confirms the durability of these 2 treatments. Peri-operative morbidity is less with HoLRP.