Complications of GreenLight Laser vs Transurethral Resection of the Prostate for Treatment of Lower Urinary Tract Symptoms: Meta-analysis of Randomized Trials.

OBJECTIVE: To compare perioperative outcomes and complications between GreenLight and transurethral resection of the prostate (TURP) for benign prostatic hyperplasia. METHODS: A systematic review and random effects meta-analysis of randomized trials comparing GreenLight with TURP was completed. Primary outcomes included periprocedural milestones, 12 predefined complications, Clavien-Dindo class III-V complications, reoperations (all-cause), and a composite of reoperations and readmissions. Metaregression assessed the relationship between patient- and study-level factors with periprocedural outcomes and reoperation rates. RESULTS: The review included 13 randomized trials with 1757 patients (839 GreenLight; 918 TURP). Procedure time was 10 minutes (95% CI: 5 to 15; P < .001) longer with GreenLight, while catheterization time (mean difference=-1.3days; 95% CI: -1.7 to -0.9; P<.001) and hospital stay (mean difference=-2.1days; 95% CI: -2.5 to -1.7; P<.001) were shorter. Bleeding-related complications, including clot retention (risk ratio [RR]=0.12; 95% CI: 0.05 to 0.32; P<.001) and transfusion (RR=0.26; 95% CI: 0.12 to 0.58; P = .001), as well as sexual dysfunction (RR=0.66; 95% CI: 0.45 to 0.98; P = .04), were less frequent with GreenLight. All other complications occurred at similar frequencies between groups. The risks of reoperation (RR: 1.17; 95% CI: 0.82 to 1.66; P = .38) and reoperation or readmission (RR: 1.05; 95% CI: 0.76 to 1.44; P = .79) did not differ. CONCLUSION: GreenLight achieved shorter catheterization times and hospital stays with lower rates of sexual dysfunction and bleeding-related complications compared to TURP.

Contemporary surgical and procedural management of benign prostatic hyperplasia.

Interventions for benign prostatic hyperplasia have evolved from transurethral resection of the prostate and simple prostatectomy to a myriad of office-based and operating-room procedures. The contemporary approach involves matching the right procedure to the right patient, choosing on the basis of prostate characteristics, patient preference, and urologist expertise. This review details currently available and guideline-backed surgical and procedural treatments.

Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial.

PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

Effect of pulse width variations on sacral neuromodulation for overactive bladder symptoms: A prospective randomized crossover feasibility study.

INTRODUCTION/BACKGROUND: The pulse width (PW) parameter in sacral neuromodulation (SNM) is understudied, with no evidence-based guidance available on optimal PW for urinary indications. The aim of this prospective, randomized, single-blinded, 3 × 3 cross over design study was to estimate the effect of two PW settings (60 µs, 420 µs) compared to the industry standard (210 µs) on SNM efficacy, quality of life, and device parameters in patients who were stable and satisfied with their SNM treatment. METHODS/MATERIALS: Eligible patients were previously implanted and had urge incontinence or urgency-frequency with satisfaction on SNM at time of enrollment. Patients completed a 3-day voiding diary, validated questionnaires, and device interrogations with sensory threshold assessment at baseline and after a 4-week period on each of the three PW settings, to which they were randomized. Eighteen participants completed the study, as called for by power analysis. RESULTS: Eighteen patients were enrolled in the study. Mean age was 68 years and implant duration at the time of participation was 4.4 years. While PW variations did not produce significant differences in overall objective outcomes, device parameters, including sensory threshold amplitude and battery life differed significantly. Shortened PW necessitated higher amplitude while conserving battery life. Stimulus sensation location, quality, and intensity did not differ between PW. Standard PW was chosen by 11 patients after the study, 5 chose extended, and 2 chose shortened. Those who chose alternative PW achieved significant reductions in urinary frequency from enrollment -2.23 voids/day (p = 0.015). Upon sub-analysis, patients reporting "much better" or "very much better" on extended PW achieved significant reductions in urinary frequency and nocturia at 5.6 and 0.4, compared to 8.5 and 2.16 at baseline (p = 0.005, p = <0.001). Whereas those reporting "much better" or "very much better" on shortened PW achieved significant reductions in urinary frequency at 5.15 compared to 7.35 (p = 0.026). There were no adverse events or complications. CONCLUSIONS: Overall SNM effectiveness was unchanged with alternative PW; however, 39% of patients preferred alternative to standard PW and achieved significant improvements in urinary symptoms with such. Shorter PW can also provide savings in estimated battery life without sacrificing therapeutic efficacy.

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder.

OBJECTIVE: To evaluate the impact of cognitive impairment (CI) diagnoses on sacral neuromodulation (SNM) outcomes in older patients. MATERIALS AND METHODS: We completed a retrospective review of all patients aged ≥55 years who underwent test-phase SNM (peripheral nerve evaluation (PNE) or stage 1) for overactive bladder (OAB) between 2014 and 2021 within a large multi-regional health system. Patient demographics, relevant comorbidities, CI diagnoses (dementia or mild CI), and SNM procedures were recorded. Logistic regression modeling was performed to evaluate the impact of CI on SNM implantation rates. RESULTS: Five-hundred and ten patients underwent SNM test phase (161 PNE, 349 Stage 1) during the study period. The mean age was 71.0(8.5) years, and most (80.6%) were female. Overall, 52(10.1%) patients had a CI diagnosis at the time of SNM, and 30 (5.8%) were diagnosed at a median of 18.5 [9.25, 39.5] months after SNM. Patients with CI diagnoses were older, with more comorbidities, and were more likely to undergo PNE. Univariable comparison found no difference in implantation rate based on pre-SNM CI (85.4% vs. 76.9%, p = 0.16). Multivariable analysis identified PNE (OR 0.43, 95% CI 0.26-0.71), age (OR 0.96, 95%CI 0.93-0.98), and prior beta-3 agonist use (OR 0.60, 95% CI 0.37-0.99) but not CI or dementia as independent negative predictors of implantation. Implanted patients had a median follow-up of 25 [12.0, 55.0] months. Explant and revision rates did not differ according to CI. CONCLUSION: Patients with OAB and CI diagnoses proceed to SNM implant at rates similar to patients without CI diagnoses. A diagnosis of CI should not necessarily exclude patients from SNM therapy for refractory OAB.

Medication Discontinuation Following Transurethral Prostatectomy: an Unrecognized Effectiveness Measure?

PURPOSE OF REVIEW: Freedom from medication is a common goal for patients undergoing surgical treatment of benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS). Knowing medication discontinuation rates following various forms of transurethral prostatectomy may aid patient counseling and assessing the comparative effectiveness of different approaches. This review examined discontinuation rates of BPH/LUTS medications following transurethral prostatectomy. RECENT FINDINGS: Rates of BPH/LUTS medication use after transurethral resection of the prostate varied from 15% to 55%, and discontinuation rates were 54-95% across medications and follow-up periods. For laser prostatectomy, approximately 18% of patients continued medications postoperatively and discontinuation rates ranged from 53% to 75%. Minimal data on holmium laser enucleation existed. For reference, medication discontinuation rates after transurethral needle ablation or microwave therapy were only 15-28%. No recommendations or best practices inform the use of medical therapy following BPH surgery. Rates of BPH/LUTS medication use following transurethral prostatectomy are considerable.

Comparative Effectiveness of Transurethral Prostate Procedures at Enabling Urologic Medication Discontinuation: A Retrospective Analysis.

OBJECTIVE: To test the hypothesis that transurethral prostate procedures (TUPPs) eliminating tissue result in greater medication discontinuation and lower de novo initiation rates than procedures inducing tissue necrosis. METHODS: Retrospective review of all men undergoing first time TUPPs at a large tertiary center from 2001 to 2016 was completed. Procedure type and urologic medication use before, 3-12 months after, and greater than 12 months after TUPP were analyzed with simple open prostatectomy as a comparator. Tissue-eliminating TUPPs included transurethral resection of the prostate and laser prostatectomy. Tissue-necrosing procedures included microwave therapy (transurethral microwave therapy) and radiofrequency ablation (transurethral needle ablation), which were grouped in analyses. Medication types were 5-alpha reductase inhibitors (5ARI), alpha blockers, anticholinergics, and beta-3 agonists (B3A). RESULTS: A total 5150 TUPPs were analyzed. Preoperative medication use significantly varied across TUPPs for 5ARI (P <.01), alpha-blockers (P .01), and anticholinergics (P .047), but not B3A (P .476). Transurethral resection of the prostate and laser prostatectomy were associated with significantly higher medication discontinuation rates and lower resumption and initiation rates compared to tissue-necrosing procedures. Relative to TUPPs, simple prostatectomy had significantly higher medication discontinuation, as well as the lowest resumption and initiation rates. CONCLUSION: Tissue-eliminating benign prostatic hyperplasia procedures were associated with better medication discontinuation, resumption, and de novo initiation rates compared to tissue-necrosing benign prostatic hyperplasia procedures.

Electrical stimulation of the pudendal nerve promotes neuroregeneration and functional recovery from stress urinary incontinence in a rat model.

The pudendal nerve can be injured during vaginal delivery of children, and slowed pudendal nerve regeneration has been correlated with development of stress urinary incontinence (SUI). Simultaneous injury to the pudendal nerve and its target muscle, the external urethral sphincter (EUS), during delivery likely leads to slowed neuroregeneration. The goal of this study was to determine if repeat electrical stimulation of the pudendal nerve improves SUI recovery and promotes neuroregeneration in a dual muscle and nerve injury rat model of SUI. Rats received electrical stimulation or sham stimulation of the pudendal nerve twice weekly for up to 2 wk after injury. A separate cohort of rats received sham injury and sham stimulation. Expression of brain-derived neurotrophic factor (BDNF) and ßII-tubulin expression in Onuf's nucleus were measured 2, 7, and 14 days after injury. Urodynamics, leak point pressure (LPP), and EUS electromyography (EMG) were recorded 14 days after injury. Electrical stimulation significantly increased expression of BDNF at all time points and ßII-tubulin 1 and 2 wk after injury. Two weeks after injury, LPP and EUS EMG during voiding and LPP testing were significantly decreased compared with sham-injured animals. Electrical stimulation significantly increased EUS activity during voiding, although LPP did not fully recover. Repeat pudendal nerve stimulation promotes neuromuscular continence mechanism recovery possibly via a neuroregenerative response through BDNF upregulation in the pudendal motoneurons in this model of SUI. Electrical stimulation of the pudendal nerve may therefore improve recovery after childbirth and ameliorate symptoms of SUI by promoting neuroregeneration after injury.

Motor Response Matters: Optimizing Lead Placement Improves Sacral Neuromodulation Outcomes.

PURPOSE: We sought to determine the usefulness of motor responses during sacral neuromodulation lead placement by testing the hypothesis that a greater number of motor responses during intraoperative electrode testing would be associated with more durable therapy. MATERIALS AND METHODS: We retrospectively reviewed all sacral neuromodulation lead placements at a large academic center from 2010 to 2015. Included in study were all unilateral sacral lead placements for which the presence or absence of a motor response was documented discretely for each electrode. Motor responses were quantified into separate subscores, including bellows and toe response subscores (each range 0 to 4) for a possible maximum total score of 8 when combined. Revision surgery was the primary outcome. Univariate and multivariate analyses were performed for factors associated with lead revision. RESULTS: A total of 176 lead placements qualified for analysis. Mean ± SD cohort age was 58.4 ± 15.9 years, 86.4% of the patients were female and 93.2% had undergone implantation for overactive bladder. Median followup was 10.5 months (range 2 to 36). Overall 34 patients (19%) required lead revision. Revision was negatively associated with the total electrode response score (p = 0.027) and the toe subscore (p = 0.033) but not with the bellows subscore (p = 0.183). Predictors of revision on logistic regression included age less than 59 years at implantation (OR 5.5, 95% CI 2-14) and a total electrode response score less than 4 (OR 4.2, 95% CI 1.4-12.8). CONCLUSIONS: Fewer total electrode responses and specifically fewer toe responses were associated with sacral neuromodulation lead revision. These data suggest that placing a lead with more toe responses during testing may result in more durable sacral neuromodulation therapy.

Removal of Sacral Nerve Stimulation Devices for Magnetic Resonance Imaging: What Happens Next?

INTRODUCTION: Sacral neuromodulation (SNM) devices (Medtronic, Minneapolis, MN, USA) are not approved to undergo magnetic resonance imaging (MRI) of sites other than the head. When MRIs are required, devices are often removed prior to imaging. We reviewed the prevalence of device removal for MRI at a large academic institution and the subsequent clinical course of these patients. METHODS: A retrospective review of all SNM explants from 2009-2015 was performed. Cases explanted for MRI were analyzed to collect demographics, clinical characteristics, and postremoval management. Descriptive statistics were calculated. RESULTS: Ninety patients underwent SNM device removal, with 21 (23%) occurring for MRI. At explant, 20 patients (95%) were female and median age was 66 years. Suboptimal symptom control from SNM was noted in seven (33%) of these patients preoperatively. Of those explanted, six (29%) required MRI for neurologic and 10 (48%) for orthopedic concerns. The remaining MRI indications included abdominal masses (10%), genitourinary disease (5%), surveillance for prior malignancy (5%), and cardiac disease (5%). Only 16 (76%) patients explanted ultimately underwent MRI. MRI results impacted clinical management in 9/16 (56%) of the imaged patients. Only two (10%) of explanted patients underwent device replacement. CONCLUSIONS: In patients receiving SNM therapy, device removal for MRI is most commonly due to orthopedic and neurologic pathologies. About half of the MRIs performed impacted non-GU clinical management. It is of paramount importance to confirm the necessity of MRI before removing a functional SNM device. Since SNM replacement was rare in this cohort, research is needed on the safety of various MRI types with SNM devices in vivo.

Sacral Neuromodulation Device Heating During Lumbar and Pelvic Magnetic Resonance Imaging-a Phantom Study.

OBJECTIVE: To evaluate radiofrequency-induced temperature rises associated with performing lumbar and pelvic magnetic resonance imaging (MRI) studies with an implanted sacral neuromodulation device using a phantom model. MATERIALS AND METHODS: An accepted phantom model of radiofrequency-induced heating in human tissue was used to measure the temperature rise in the stimulator lead electrodes and impulse generator under the conditions used during routine clinical lumbar and pelvic MRIs in a 1.5Tesla MRI scanner. Testing configurations included an intact device (tined lead connected to generator), an intact lead, and a lead fragment (model of lead fracture). Variations in the position of the phantom relative to the scanner were also tested. RESULTS: During testing with the intact device or the lead fragment no significant heating was detected. In contrast, the isolated intact lead model showed heating up to 5°C. CONCLUSION: These tests provide preliminary evidence that the risk of heating is low for clinical lumbar and pelvic MRI at 1.5-Tesla with an intact sacral neuromodulation device system and with a fractured lead. However, there is a significant temperature change in the intact lead model.

Real-Time Changes in Brain Activity during Sacral Neuromodulation for Overactive Bladder.

PURPOSE: We performed functional magnetic resonance imaging to identify changes in brain activity during sacral neuromodulation in women with overactive bladder who were responsive to therapy. MATERIALS AND METHODS: Women recruited into the study had nonneurogenic refractory overactive bladder, responded to sacral neuromodulation and had had a stable program for at least 3 months with no subsequent overactive bladder treatment. Enrolled patients completed validated symptom and quality of life instruments before functional magnetic resonance imaging. Stimulus settings were recorded, devices were switched off for a 5-day washout and instruments were repeated. Three functional magnetic resonance imaging scans with simultaneous sacral neuromodulation stimulation were performed below, at and above stimulus sensory threshold using a block design. This yielded brain activity maps represented by changes in blood oxygenation level dependence. A total of 5 stimulator off and 4 stimulator on cycles of 42 seconds each were imaged. Group analysis was done using a single voxel p value of 0.05 with a false-positive error of 0.05 on cluster analysis. RESULTS: Six of the 13 patients enrolled completed functional magnetic resonance imaging. Median age was 52 years (range 36 to 64). Urinary symptoms and voiding diary data worsened with washout. Overall brain activation generally progressed with increasing stimulation amplitude. However, activation of the right inferior frontal gyrus remained stable while deactivation of the pons and the periacqueductal gray matter only occurred with subsensory stimulation. Sensory stimulation activated the insula but deactivated the medial and superior parietal lobes. Suprasensory stimulation activated multiple structures and the expected S3 somatosensory region. All devices had normal impedance after functional magnetic resonance imaging. CONCLUSIONS: Functional magnetic resonance imaging confirmed that sacral neuromodulation influences brain activity in women with overactive bladder who responded to therapy. These changes varied with stimulus intensity.

Impact of Age and Comorbidities on Use of Sacral Neuromodulation.

PURPOSE: We investigated the influence of patient age on sacral nerve stimulation trial outcomes, device implantation and treatment durability. MATERIALS AND METHODS: We analyzed a database of all sacral nerve stimulation procedures performed between 2012 and 2014 at a high volume institution for associations of patient age with sacral nerve stimulation indication, trial stimulation success, device revision and device explantation. RESULTS: In a cohort of 356 patients those with nonobstructive urinary retention and urgency-frequency were younger than patients with urgency urinary incontinence. Trial stimulation success did not differ by age in stage 1 and percutaneous nerve evaluation trials (p = 0.51 and 0.84, respectively). Logistic regression identified greater odds of trial success in females compared to males (OR 2.97, 95% CI 1.32-6.04, p = 0.009) and for urgency urinary incontinence compared to urgency-frequency (OR 3.02, 95% CI 1.39-6.50, p = 0.006). In analyzed patients there were 119 surgical revisions, including battery replacement, and 53 explantations. Age was associated with a decreased risk of revision with 3% lower odds per each additional year of age (OR 0.97, 95% CI 0.95-0.98, p <0.0001). While age did not influence explantation, for each body mass index unit there was a 5% decrease in the odds of explantation (OR 0.95, 95% CI 0.91-0.98). CONCLUSIONS: In contrast to previous studies, older patients experienced no difference in the sacral nerve stimulation response in stimulation trials and no difference in the implantation rate. Furthermore, age was modestly protective against device revision. This suggests that age alone should not negatively predict sacral nerve stimulation responses.

Patterns of hardware related electrode failures in sacral nerve stimulation devices.

PURPOSE: Abnormal electrical impedance in sacral nerve stimulation devices is a cause of device failure. Currently, there is scant literature evaluating the incidence and management of this problem. We evaluated the presentation, characteristics and management of sacral nerve stimulation devices with abnormal electrical impedance. MATERIALS AND METHODS: A total of 565 patients were permanently implanted with sacral nerve stimulation devices using a tined lead between 2003 and 2011. Devices were interrogated postoperatively and at followup. Abnormal electrical impedance was classified as open circuit--impedance greater than 4,000 Ω or short circuit--impedance less than 50 Ω and/or equivalence of impedance. Details on presentation, characteristics and management were recorded. RESULTS: Of the 565 patients 72 (12.7%) experienced a total of 86 abnormal electrical impedance events, of which 57 (66.2%) were open circuits and 28 (32.5%) were short circuits. One event (1.1%) was a simultaneous open and short circuit. Short circuits presented earlier than open circuits (median 3.5 months, IQR 2-7.5 vs 15, IQR 5.5-30.5, p <0.0001) and required surgical intervention more often (75.0% vs 54.3%, p = 0.09). Patient specific factors, such as trauma history and change in body mass index class, were not associated with abnormal electrical impedance. No electrode failure patterns could be identified. CONCLUSIONS: Abnormal electrical impedance occurred in approximately 13% of cases permanently implanted in our series. Short circuits presented earlier and often required surgical intervention. Open circuits presented later and may have potentially been secondary to microfractures that accumulate with time at the sacral plate, resulting in later presentation. Almost a third of patients with abnormal electrical impedance associated with clinical inefficacy were treated conservatively, primarily with reprogramming.

Improvement of bowel dysfunction with sacral neuromodulation for refractory urge urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Sacral nerve stimulation (SNS) is approved for urologic indications in the USA and, recently, fecal incontinence. This study described concomitant bowel dysfunction and improvements in bowel and urinary symptoms and quality of life (QOL) in women with refractory urge urinary incontinence (UUI) receiving SNS. METHODS: Women (N = 36) with refractory UUI receiving SNS were prospectively enrolled. Surveys and exams were completed at baseline and follow-up, with symptom and QOL scores measured using validated scales (0-100, none-worst). RESULTS: A total 24 women were followed up at a median of 4.0 months post-implantation. Of these, 20 (83%) had bowel dysfunction, 13 (54%) used bowel medications at baseline, and 11 (45%) continued them after SNS. The mean/median urinary (54.8 to 32.6) and bowel (23.4 to 14.1) symptom scores improved significantly, as did urinary (64.2 to 14.3) but not bowel (2.4 to 0.0) QOL scores. CONCLUSIONS: Bowel dysfunction is common in women with refractory UUI. SNS improves urinary symptoms and QOL, but improvement in bowel symptoms does not translate into significant QOL changes.

Improved sexual and urinary function in women with sacral nerve stimulation.

OBJECTIVES: Urinary and sexual function improve following sacral nerve stimulation (SNS) for refractory overactive bladder. No significant associations between these changes have been found. Whether improvements in sexual function are independent of or secondary to improvements in urinary function remains unclear. The aim of this study was to analyze changes in urinary and sexual function in a homogeneous sample of patients undergoing SNS for urge urinary incontinence and subsequently identify associations between the two. MATERIALS AND METHODS: A prospective database was created. Enrollees underwent a full history and physical examination at the first office visit. Multiple-day voiding diaries with validated and investigator-designed questionnaires were administered at baseline and follow-up as standard implantation procedures and to assess changes in urinary and sexual function, respectively. Analyses were completed using data from patients who were sexually active at baseline and follow-up. RESULTS: Statistically significant improvements in urinary and sexual function occurred according to multiple metrics. Patient global impression scales categorized all patients' urinary conditions as improved, with most being less severe. Validated urinary symptom and quality of life scores improved significantly. After treatment, most patients were incontinent less often with sexual activity and felt less restricted from sexual activity by fear of incontinence. Validated quantification of sexual function demonstrated significant improvements in overall sexual function, arousal, and satisfaction. No significant associations between changes in urinary and sexual function were noted; however, trends appeared to exist between the two. CONCLUSIONS: Improved sexual function was not significantly associated with improved urinary function after SNS despite apparent trends between the two. Larger samples are required to definitively demonstrate this conclusion.