The impact of cognitive impairment in urologic implants: a narrative review.

Background and Objective: With the general population aging and thus more patients developing bothersome erectile dysfunction, stress urinary incontinence and overactive bladder, there will likely be a higher demand for three common interactive implants in urology, the penile prosthesis, artificial urinary sphincter (AUS) and sacral neuromodulation (SNM). Further, the prevalence of mild and major neurocognitive disorders (also known as mild cognitive impairment and dementia, respectively) is expected to increase. While the aforementioned urologic implants have excellent short and long term outcomes, there are also known device issues such as malfunction or misuse that may require surgical removal and/or revision. The objective of this narrative review is to describe the association of cognitive impairment and urologic implants. Methods: We performed a search on PubMed between the years 1975-2023 for English language articles that reported on any type or severity of cognitive impairment and its association with penile prosthesis, AUS and/or SNM. While peer-reviewed published manuscripts were prioritized, abstracts that fit our search criteria were also included. Key Content and Findings: Data assessing outcomes of patients with cognitive impairment who undergo placement of a urologic implant are limited. There is an association between AUS failure or misuse with cognitive impairment. SNM is efficacious in this population in the short term. In patients who develop dementia, an inflatable penile prosthesis can be deflated via in-office needle puncture and an AUS can be deactivated. The Memory Alteration Test, Quick Screen for Mild Cognitive Impairment and the Saint Louis University Mental Status Examination are relatively quick screening tests with good sensitivity and specificity for mild cognitive impairment. Conclusions: While data on the association between urologic implants and cognitive impairment are sparse, there are tools that urologists can use to screen patients for cognitive impairment. With screening, urologists can provide appropriate preoperative counseling (including recommending against implantation) and can provide closer postoperative monitoring. Further study is required to assess which patients should be excluded from device implantation and how to properly assess for cognitive impairment in a manner that is both beneficial for the patient and convenient and efficient for a urologist.

Sacral neuromodulation for low anterior resection syndrome: current status-a systematic review and meta-analysis.

INTRODUCTION: It is estimated that approximately 70% of patients with rectal cancer who undergo surgery will suffer from Low Anterior Resection Syndrome (LARS). In the last decades, sacral neuromodulation (SNM) has been widely used in urinary dysfunction and in faecal incontinence refractory to medical treatment. Its application in LARS has been investigated and has shown promising results. The paper's aim is to present a systematic review and meta-analysis of the available literature and evaluate the therapeutic success of SNM in patients with LARS. METHODS: A systematic search was performed in international health-related databases: Cochrane Library, EMBASE, PubMed and SciELO. No restrictions on year of publication or language were applied. Retrieved articles were screened and selected according to set inclusion criteria. Data items were collected and processed for each included article and a meta-analysis was done according to the PRISMA guidelines. The primary outcome was the number of successful definitive SNM implants. Further outcomes included changes in bowel habits, incontinence scores, quality of life scores, anorectal manometry data and complications. RESULTS: A total of 18 studies were included, with 164 patients being submitted to percutaneous nerve evaluation (PNE) with 91% responding successfully. During follow-up of therapeutic SNM some devices were explanted. The final clinical success rate was 77% after permanent implant. Other outcomes, such as the frequency of incontinent episodes, faecal incontinence scores, quality of life scores were overall improved after SNM. The meta-analysis showed a decrease in 10.11 incontinent episodes/week; a decrease of 9.86 points in the Wexner score and an increase in quality of life of 1.56 (pooled estimate). Changes in anorectal manometry were inconsistent. Local infection was the most common post-operative complication, followed by pain, mechanical issues, loss of efficacy and haematoma. DISCUSSION/CONCLUSION: This is the largest systematic review and meta-analysis concerning the use of SNM in LARS patients. The findings support the available evidence that sacral neuromodulation can be effective in the treatment of LARS, with significant improvement in total incontinent episodes and patients´ quality of life.

Sacral neuromodulation in the management of non-obstructive urinary retention: Test phase and predictive factors.

AIM: The aim of this study is to evaluate the success of the test phase of sacral neuromodulation in management of chronic non-obstructive urinary retention and the factors predictive of good response. MATERIALS AND METHODS: This is a retrospective study carried out on a cohort of patients followed up in a tertiary University Hospital in France. Fifty-two patients with chronic non-obstructive urinary retention were included in this study. These patients were seen over the past 20 years, from the year 2000 to 2020. The initial evaluation of patients included a summary of medical and surgical history, age, BMI, history of pelvic floor disorders, initial voiding pattern, physical examination, voiding diary, initial uroflowmetry and a urodynamic study. Postoperative follow-up and analysis of complications were also carried out. RESULTS: A total of 52 patients were included in this study, 13 males and 39 females. Out of these patients, 17 patients (32.7%) with a median age of 47.3 years±18.1 benefited from definitive implantation of the sacral neuromodulation. The univariate analysis showed that age was the only significant variable in this study and the optimal age threshold was<58.5 years. CONCLUSION: SNM is a therapy with significant clinical benefits and low morbidity for patients with chronic non-obstructive urinary retention. The results obtained need to be confirmed with a prospective study with a larger number of patients.

Comparison of different types of therapy for overactive bladder: A systematic review and network meta-analysis.

To compare the efficacy and safety of different interventions [including antimuscarinics, mirabegron, OnabotulinumtoxinA, sacral neuromodulation (SNM) and peripheral tibial nerve stimulation (PTNS)] for treating idiopathic overactive bladder (OAB). PubMed, Embase, Cochrane Library, and other sources were searched for randomized controlled trials (RCTs) comparing interventions for overactive bladder from 1 January 2000 to 19 April 2021. A systematic review and network meta-analysis were performed by two authors independently. Fifty-five RCTs involving 32,507 patients were included in this analysis. Overall, antimuscarinics, mirabegron, OnabotulinumtoxinA, sacral neuromodulation, and peripheral tibial nerve stimulation were more efficacious than placebo, and sacral neuromodulation showed the best effect for reducing micturition frequency, urgency episodes and urgency urinary incontinence episodes. OnabotulinumtoxinA was the best intervention for achieving reductions of 100 and ≥50% in the number of urinary incontinence episodes/day, and peripheral tibial nerve stimulation was the best intervention for reducing urinary incontinence episodes. Antimuscarinics, mirabegron and peripheral tibial nerve stimulation had a similar efficacy for reducing micturition frequency, urinary incontinence episodes and urgency urinary incontinence episodes. The results revealed that all interventions examined herein were efficacious for managing adult overactive bladder syndrome compared with placebo. Furthermore, sacral neuromodulation and OnabotulinumtoxinA were the most efficient treatments for overactive bladder. Systematic review registration: [https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=251966], identifier [CRD42021251966].

Intermediate-term results of a prospective, multicenter study on remote programming sacral neuromodulation for refractory overactive bladder.

BACKGROUND: To evaluate the efficacy and safety of a novel remote programming sacral neuromodulation (SNM) system (BetterStim system) in the treatment of patients with refractory overactive bladder (OAB) for 3 years. METHODS: A total of 8 centers in China enrolled 84 patients with OAB. Following test stimulation 70 patients underwent implantation using BetterStim. All patients returned for follow-up at 3 and 6 months postoperatively. After that, the visits were conducted by telephone. Outcomes of voiding diaries, the overactive bladder symptom score (OABSS), questionnaires regarding OAB-related quality of life (OAB-qol), and adverse events (AEs) were evaluated at each visit. The clinical therapeutic success was defined as ≥50% improvement from baseline in any of the voiding diary variables or average voids/day return to normal voiding (<8 voids/day). The analysis is a modified Completers analysis. RESULTS: At the 36-month follow-up, the success rate was 79% for overall OAB symptoms, 69% for urge urinary incontinence (UUI) and 42% for urgency frequency (UF). The average number of voids/day decreased from 29.2±14.9 at baseline to 17.6±11.2 at 3 years, the average volume/void increased from 94.7±54.2 to 151.4±80.8 mL, the urgency reduced from 3.0±1.4 to 1.8±1.7 (all P<0.001). For patients with urge incontinence, mean leaking episodes/day decreased from 8.1±7.6 at baseline to 2.1±3.5 at three years (P<0.05). The devices were explanted in 8 (11.4%) patients. There were no remote programming-related AEs or device-related serious AEs that occurred. CONCLUSIONS: The Intermediate-term results demonstrated that BetterStim SNM system with remote programming is safe and effective for patients with refractory OAB.

Variable- versus constant-frequency sacral neuromodulation in black-zone overactive bladder patients: a study protocol for a multicenter, prospective, randomized, blind, self-controlled trial.

BACKGROUND: The curative effect of sacral neuromodulation (SNM), used to treat overactive bladder (OAB) patients, is definite. However, some patients still have recurrent symptoms after SNM and unsatisfactory symptom improvement after repeated adjustments of the stimulation parameters combined with oral drugs. These are referred to as black-zone OAB patients. The described SNM is the standard method, which involves a constant-frequency stimulation (CFS) of the patient's specific sacral nerve. A new treatment strategy, which combines the advantages of high-frequency and low-frequency stimulations to generate variable-frequency stimulation (VFS), has not yet undergone a formal randomized clinical trial. Therefore, we designed this clinical trial to evaluate the efficacy and safety of VFS-SNM and CFS-SNM in the treatment of black-zone OAB patients. METHODS: We designed a multicenter, prospective, randomized, blinded, self-controlled trial with a 12-week follow-up period. The trial randomly divides the enrolled patients into CFS-SNM and VFS-SNM groups. The main evaluation index is the comparative effectiveness of VFS-SNM and CFS-SNM at the last follow-up. The secondary evaluation indices include the change in the OAB symptom score, the quality of life (QOL) score, and the visual analog scale compared with the baseline period at each follow-up time point. DISCUSSION: Previous studies and our pre-experimental results suggest that black-zone OAB patients may benefit from VFS-SNM. Twelve weeks of VFS-SNM are effective in 40%, and the non-inferior cutoff value is 10% (80% power, 0.05 significance level, 20% loss to follow up). Thus, the calculated sample size is 37 cases each for CFS and VFS groups. The trial is expected to be carried out in 18 centers, but centers will be added or removed as appropriate depending on specific implementation conditions. Clinical researchers at each center will be responsible for screening qualified participants. This is the first randomized controlled trial to comprehensively evaluate the efficacy and safety of VFS-SNM in black-zone OAB patients, which will provide high-quality clinical evidence and may provide new clinical options for such patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000036677, registration date: 24 August 2020.

Sacral neuromodulation system for treating refractory overactive bladder.

Sacral neuromodulation (SNM) is a therapy system used to improve bladder function, including in people with overactive bladder (OAB). It is safe and can improve quality of life. SNM helps improve symptoms through direct modulation of nerve activity; it involves electrically stimulating the sacral nerves that carry signals between the pelvic floor, spinal cord and the brain and is thought to normalise neural communication between the bladder and brain. If patients with OAB do not respond to non-surgical and conservative options, minimally invasive procedures can be offered, including SNM. SNM is performed in two stages: the trial phase, to assess whether it would be effective in the long term; and permanent implantation. This year, the National Institute for Health and Care Excellence (NICE) released guidance on the Axonics SNM System® for treating refractory OAB. The Axonics System is rechargeable and lasts at least 15 years, minimising the need for repeat surgery. NICE suggests the Axonics System may have cost advantages for the NHS. Having more than one SNM therapy option available increases options for patients, offering them a choice of handsets and rechargeable versus non-rechargeable implants. Three case studies illustrate how the system works in practice.

Variable frequency stimulation of sacral neuromodulation in black-zone overactive bladder patients: a case report.

Overactive bladder (OAB) is a common urological disease, reducing patient quality of life (QoL). Sacral neuromodulation (SNM) is a treatment option used when conservative treatment is inadequate. However, constant frequency stimulation-SNM (CFS-SNM) may not be sufficiently effective in achieving targeted symptom reduction in some patients. For such black-zone patients, a different treatment strategy is needed. Variable frequency stimulation (VFS) has been used for deep-brain stimulation treatment in patients with Parkinson's disease with positive outcomes. Accordingly, in this study, we hypothesized the promising outcomes of VFS-SNM in black-zone OAB patients. Here, we evaluated the efficacy and safety of VFS-SNM viz-a-viz CFS-SNM in a black-zone patient with refractory OAB whose frequent micturition symptoms were not relieved after undergoing traditional conservative treatment. A 50-year-old male patient was treated with CFS-SNM at our hospital in October 2016, but his symptoms recurred after administering multiple medications and program-controlled parameter adjustments. We then treated the patient with VFS-SNM in March 2020. A 2-week follow-up through telephonic interviews was conducted; the improvements in voiding symptoms were evaluated by calculating the OAB symptom score (OABSS) and OAB-related QoL (OAB-QoL) score. We observed that OABSS was significantly lower after VFS-SNM than after CFS-SNM. Further, we observed that VFS-SNM significantly improved daytime and nocturnal micturition frequency, as evident from the reduced OABSSs from after CFS-SNM to after VFS-SNM. The main reason for patient dissatisfaction after CFS-SNM was the increased average daily micturition frequency and urgency. VFS-SNM controlled the micturition frequency to within the patient's acceptable range, significantly improving the patient's QoL (40% improvement in OAB-QoL score). To the best of our knowledge, this is the first case report on the use of VFS-SNM with positive outcomes in a black-zone OAB patient, suggesting that VFS-SNM is not inferior to CFS-SNM in the treatment of black-zone patients.

Impact of bladder dysfunction in the management of post radical prostatectomy stress urinary incontinence-a review.

Bladder dysfunction is a relatively common urodynamic finding post radical prostatectomy (RP). It can be the sole cause of post prostatectomy incontinence (PPI) or may be found in association with stress urinary incontinence (SUI). The aim of this review is to provide a comprehensive review of the diagnosis and different treatments of post RP bladder dysfunction. A comprehensive literature review using medical search engines was performed. The search included a combination of the following terms, PPI, detrusor overactivity (DO), detrusor underactivity (DU), impaired compliance, anticholinergic, onabotulinumtoxinA (Botox®) and sacral neuromodulation (SNM). Definitions, general overview and management options were extracted from the relevant medical literature. DO, DU and impaired compliance are common and may occur alone or in combination with SUI. In some patients the conditions exist pre RP, in others they arise due to denervation and surgical changes. DO can be treated with anticholinergics, Botox® and SNM. DO may need to be treated before SUI surgery. DU may be a contraindication to male sling surgery as some patients may go into urinary retention. Severely impaired bladder compliance may be a contraindication to SUI surgery as the upper tracts may be at risk. Each individual dysfunction may affect the outcome of PPI treatments and clinicians should be alert to managing bladder dysfunction in PPI patients.

The underactive bladder: diagnosis and surgical treatment options.

The underactive bladder (UAB)/detrusor underactivity (DU) is a relatively common condition. It is difficult to diagnose and can be difficult to manage. The aim of this review is to provide a review of the diagnosis and different surgical treatment options for UAB/DU. A comprehensive literature review using medical search engines was performed. The search included a combination of the following terms, UAB, DU, TURP, reduction cystoplasty, bladder diverticulectomy and sacral neuromodulation (SNM). Search results were assessed for their overall relevance to this review. Definitions, general overview and management options were extracted from the relevant medical literature. DU affects up to 45% of men and women >70 years of age. The symptoms of DU overlap significantly with overactive bladder (OAB) and bladder outlet obstruction (BOO). Urodynamic findings include low voiding pressure combined with slow intermittent flow and incomplete bladder emptying. Non-operative management for DU is acceptable; only 1 in 6 male patients may need a TURP and acute urinary retention (AUR) is rare. TURP for DU is feasible and is associated with good short and medium term outcomes, but over time, there is a return to baseline symptoms. Bladder diverticulectomy can also improve DU, but there is a paucity of guidelines on patient selection. SNM provides excellent outcomes for DU, but patient selection is important.

A retrospective analysis of sacral neuromodulation for female overactive bladder and interstitial cystitis/painful blader syndrome / 中华泌尿外科杂志

Objective To evaluate the effects of sacral neuromodulation (SNM) on female overactive bladder (OAB) and interstitial cystitis/ painful bladder syndrome (IC/PBS).Methods From May 2016 to April 2017,13 patients with OAB or IC/PBS who had been treated with SNM were assessed retrospectively.Among them,6 cases were OAB patients,and 7 cases were IC/PBS patients.The average age was 52.3 (42-67)years old,and the preoperative and postoperative 24 h urine frequency,night urination frequency and average voided volume were compared.Results Totally 13 patients underwent stage Ⅰprocedure.The operation time for stage Ⅰ was 52-125min(average 92 min).After an average follow-up of 3.6 weeks,stage 11 procedures were performed on responders.Four OAB patients accepted stage Ⅱ1 surgery (conversion rate:66.7％),and the 24h frequency and night urination frequency reduced from preoperative 22.5 and 5.2 times to postoperative 14.3 and 2.3 times (P ＜ 0.05) respectively,and average voided volume increased from 120.3ml to 166.4ml (P ＜ 0.05).Among 4 patients presenting IC/PBS who had underwent stage Ⅱ surgery (conversion rate:57.1％),VAS score and 24 h voiding frequency reduced from 7.3 and 21.6 to 3.8 and 16.8 (P ＜ 0.05),respectively.No adverse event,such as wound infection or electrode translocation was detected during an average follow-up of 8.3 months.Conclusions Stage Ⅰ procedure is crucial for the long term efficacy of SNM.Postsurgical wound management and parameter adjustment are equal essential in order to achieve a maximum benefits.SNM has advantages in minimal invasiveness and less bleeding,which provides a minimal invasive approach for the managemem of OAB and IC/PBS.

A retrospective analysis of sacral neuromodulation for female overactive bladder and interstitial cystitis/painful blader syndrome / 中华泌尿外科杂志

Objective To evaluate the effects of sacral neuromodulation (SNM) on female overactive bladder (OAB) and interstitial cystitis/ painful bladder syndrome (IC/PBS).Methods From May 2016 to April 2017,13 patients with OAB or IC/PBS who had been treated with SNM were assessed retrospectively.Among them,6 cases were OAB patients,and 7 cases were IC/PBS patients.The average age was 52.3 (42-67)years old,and the preoperative and postoperative 24 h urine frequency,night urination frequency and average voided volume were compared.Results Totally 13 patients underwent stage Ⅰprocedure.The operation time for stage Ⅰ was 52-125min(average 92 min).After an average follow-up of 3.6 weeks,stage 11 procedures were performed on responders.Four OAB patients accepted stage Ⅱ1 surgery (conversion rate:66.7％),and the 24h frequency and night urination frequency reduced from preoperative 22.5 and 5.2 times to postoperative 14.3 and 2.3 times (P ＜ 0.05) respectively,and average voided volume increased from 120.3ml to 166.4ml (P ＜ 0.05).Among 4 patients presenting IC/PBS who had underwent stage Ⅱ surgery (conversion rate:57.1％),VAS score and 24 h voiding frequency reduced from 7.3 and 21.6 to 3.8 and 16.8 (P ＜ 0.05),respectively.No adverse event,such as wound infection or electrode translocation was detected during an average follow-up of 8.3 months.Conclusions Stage Ⅰ procedure is crucial for the long term efficacy of SNM.Postsurgical wound management and parameter adjustment are equal essential in order to achieve a maximum benefits.SNM has advantages in minimal invasiveness and less bleeding,which provides a minimal invasive approach for the managemem of OAB and IC/PBS.