What Is New in Neuromodulation?

Neuromodulation encompassing sacral and peripheral modalities is an established, effective, and safe higher-order treatment option approved in the USA for managing refractory overactive bladder, non-obstructive urinary retention, and fecal incontinence. This review highlights the most recent literature, indications, treatment durability, and the latest innovations in this field. Regarding sacral neuromodulation (SNM), recent work suggests improved parameters for optimal lead placement, increased data to support the lasting effects of treatment, and novel applications of this technology to other pelvic disorders. In addition, there are emerging technologies with smaller MRI compatible devices. Newer data on percutaneous tibial nerve stimulation (PTNS) suggests it may be more beneficial for certain patients. With new technology, implantable tibial nerve stimulators are ushering in a new frontier of nerve stimulation in the comfort of the patient's home.

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.

Transvaginal neobladder vaginal fistula repair after radical cystectomy with orthotopic urinary diversion in women.

AIM: We present the surgical management and outcomes of patients who underwent transvaginal neo-bladder vaginal fistula (NBVF) repair at our institution. METHODS: Between 2002 and 2012, eight patients underwent transvaginal NBVF repair. The surgical management entailed placing a Foley catheter into the fistula tract. A circumferential incision was made around the fistula tract after which a plane between the serosa of the neobladder and the vaginal epithelium was created. Interrupted polyglycolic acid sutures were used to close the fistula. An additional layer of vaginal wall, Martius, or omental flap was interposed before vaginal wall closure. A urethral catheter was placed for a minimum of 14 days and removed after a negative cystogram and pelvic exam with retrograde neobladder filling without leakage. RESULTS: All patients presented with a fistula following radical cystectomy with orthotopic ileal neobladder. Two patients had failed two prior transvaginal fistula repairs. A unilateral Martius flap was used in five patients and an omental flap was used in one patient. The surgery was successful in all patients. After a mean follow up of 33 months [4-117], five patients underwent or are waiting to undergo management of stress urinary incontinence with bulking agents. No patient had a recurrent fistula. CONCLUSIONS: Management of NBVF is challenging but cure is possible using a transvaginal approach. Most patients will suffer from incontinence after the repair because of a short and incompetent urethra. Patients should be counseled about the high probability of requiring a secondary procedure to achieve continence.

A career exploration didactic and simulation-based session increases student knowledge in and exposure to urology.

INTRODUCTION: Though urology attracts well-qualified applicants, students are not typically provided exposure to this smaller specialty until later in their medical education. While simulation-based training continues to supplement medical education, there is a lack of programming to teach specialty-specific procedural skills to medical students and those outside the specialty. We report a half-day simulation and didactic-based approach to increase exposure to urology to interested second-year medical students. METHODS: A half-day didactic- and simulation-based session was offered to second-year medical students (N=57). After a didactic-based overview of the specialty performed by urology providers and a surgical educator, the students participated in small-group simulations, including hands-on simulations. The students completed a post-curriculum survey measuring knowledge gains and soliciting feedback on the session. RESULTS: Students were 57.1% Caucasian, 66.7% female, with a mean age of 24.2 years; 80% stated they were potentially interested in pursuing a surgical specialty such as urology prior to the start of the session. Students reported pre- to post-curriculum gains in knowledge (mean=37%) about a career in urology and basic urologic procedures (p<0.001). Participants were also likely to recommend the curriculum to their peers (p<0.001). CONCLUSIONS: Given that exposure to urology in medical school is usually limited and offered later in training, a half-day didactic- and simulation-based experience for second-year students provides an early introduction and experience within the specialty and its common bedside procedures.

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.

Increasing patient preparedness for sacral neuromodulation improves patient reported outcomes despite leaving objective measures of success unchanged.

PURPOSE: We assessed how a group shared appointment influenced patient preparedness for sacral nerve stimulation for refractory overactive bladder and/or urge urinary incontinence. We also evaluated subjective and objective outcomes. MATERIALS AND METHODS: Patients considering sacral nerve stimulation were prospectively enrolled and invited to attend a group shared appointment. This 75-minute presentation included a question and answer period with an implanting surgeon and an implanted patient. Control patients received standard office counseling. A patient preparedness questionnaire was completed after the group shared appointment or office counseling. Response to treatment was determined using the postoperative satisfaction questionnaire, Patient Global Impression of Improvement (PGI-I) and voiding diaries. RESULTS: In our study 36 women with a mean ± SD age of 61 ± 15 years underwent sacral nerve stimulation. There was no significant difference in patient demographics between the 19 women who attended the group shared appointment and the 17 controls. Overall preparedness was greater in the shared appointment group (p = 0.043) with better understanding of the purpose of (p = 0.003) and alternatives to (p = 0.043) sacral nerve stimulation. Significantly more women in the shared appointment group than controls felt completely prepared (78.9% vs 29.4%, p = 0.003) and completely satisfied (78.9% vs 35.3%, p = 0.003) with sacral nerve stimulation as well as very much better (68.4% vs 17.6%, p = 0.002) according to the PGI-I. There was no difference between the groups in the number of women with a 50% or greater symptom reduction on voiding diary. CONCLUSIONS: Participating in a group shared appointment before sacral nerve stimulation improved patient preparedness and perceived outcomes of treatment, although there was no difference in objective outcomes based on voiding diary.

Simple sling incision for the treatment of iatrogenic bladder outlet obstruction.

INTRODUCTION AND HYPOTHESIS: Bladder outlet obstruction (BOO) is reported to occur in 15 % of women after anti-incontinence surgery. In the past, iatrogenic BOO from slings was treated with urethrolysis. However, urethrolysis is not without morbidity, including significant bleeding, urethral injury, and recurrent stress urinary incontinence (SUI). Several studies have shown simple sling incision to be as effective as urethrolysis with less morbidity and lower rates of recurrent SUI. [1-3] METHODS: We demonstrate the technique of transvaginal simple sling incision in two patients, one with a synthetic midurethral sling, and one with a biologic bladder-neck sling. RESULTS: Simple sling incision is an effective and less morbid treatment than urethrolysis for iatrogenic urethral obstruction; 70-90 % of women will have significant improvement in obstructive voiding symptoms. Recurrent SUI is seen in approximately 20 % of women after sling incision. CONCLUSIONS: This video shows that simple sling incision is an effective, simple, and safe treatment for women with iatrogenic BOO after sling surgery and should be used as a first-line treatment.

Purely transvaginal/perineal management of complications from commercial prolapse kits using a new prostheses/grafts complication classification system.

PURPOSE: Commercial prolapse mesh kits are increasingly used in the management of pelvic organ prolapse. We present our experience with the transvaginal/perineal management of synthetic mesh related complications from prolapse kits. In addition, we used the new ICS/IUGA (International Continence Society/International Urogynecological Association) prostheses/grafts complication classification system to report on our contemporary series. MATERIALS AND METHODS: A retrospective chart review of all patients who underwent surgical removal of transvaginal mesh for mesh related complications after prolapse kit use from November 2006 to April 2010 at 1 institution was performed. We report our contemporary series of mesh complications using the new ICS/IUGA prostheses/grafts complication classification system. Postoperative pain, degree of improvement and presence of continued symptoms were reported by patients at last followup. RESULTS: A total of 23 patients underwent transvaginal removal of mesh during the study period. Mean patient age was 61 years. Median period of latency to mesh related complication was 10 months (range 1 to 27). Indications for mesh removal included vaginal/pelvic pain (39%), dyspareunia (39%), vaginal mesh extrusion/exposure (26%), urinary incontinence (35%), recurrent pelvic organ prolapse (22%), bladder mesh perforation with recurrent urinary tract infection (22%), rectal mesh perforation (4%), ureteral perforation injury (4%), retained foreign body (surgical sponge) in the bladder (4%) and vesicovaginal fistula (9%), with most patients citing more than 1 reason. CONCLUSIONS: Although technically difficult in some cases, purely transvaginal mesh excision appears to be safe with resolution of almost all presenting symptoms. Although slightly cumbersome, the new ICS/IUGA prostheses/graft complication classification system can be used to report and more accurately characterize mesh complications.

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.

Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report.

PURPOSE: We evaluated the safety of a mid urethral sling postoperative care pathway using patient subjective reporting of force of stream to minimize length of stay and catheter placement. MATERIALS AND METHODS: Women undergoing solitary mid urethral sling surgery were prospectively enrolled in our study. Force of stream after the sling therapy protocol consisted of retrograde bladder filling with 300 ml fluid within 1 hour after surgery. Patients rated force of stream compared to baseline on a visual analog scale. Those with a force of stream of 50% or greater were immediately discharged home regardless of post-void residual urine volume. Only those unable to void and those rating force of stream less than 50% with post-void residual urine volume greater than 500 ml were discharged home with a catheter. Patients were telephoned within 1 week of surgery and seen 4 to 6 weeks postoperatively. The primary outcome was unexpected visits to the emergency room or office for voiding dysfunction or urinary retention. RESULTS: A total of 114 women were prospectively enrolled in our study, of whom 105 (92.1%) passed the protocol and were discharged home without a catheter. Of the patients 14 were discharged home with increased post-void residual urine volume (range 152 to 427 ml) but no catheter, representing those who would have been discharged with a catheter by many traditional voiding protocols. According to protocol 9 patients were discharged with a catheter. No patient presented to the emergency room or office in urinary retention or with voiding dysfunction before the scheduled visit. CONCLUSIONS: Patients who report a force of stream of 50% or greater can be safely and rapidly discharged home after an uncomplicated mid urethral sling procedure regardless of post-void residual urine volume. Scanned post-void residual urine volume does not add much value in those who can void. By following the force of stream after sling therapy protocol patients can be discharged home less than 3 hours after mid urethral sling surgery.

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.

The impact of urinary incontinence and its treatment on female sexual function.

Urinary incontinence is a prevalent disorder that negatively impacts not only women's overall quality of life but also female sexual function. Most of the literature suggests that women with urge urinary incontinence are more likely to report sexual complaints and dissatisfaction than women with stress urinary incontinence. Successful treatment of both stress urinary incontinence and urge urinary incontinence have been shown to improve overall female sexual function scores.

Fallopian tube prolapse presenting as a peritoneovaginal fistula.

INTRODUCTION: Peritoneovaginal fistula is an extremely rare cause of persistent vaginal leakage following a hysterectomy. Likewise, fallopian tube prolapse is an uncommon but known complication of hysterectomy. Fallopian tube prolapse resulting in peritoneal leakage has yet to be reported in the literature. CLINICAL CASE: A 27-year-old female presented with a two year history of continuous leakage per vagina. The leakage started shortly after an abdominal hysterectomy. Examination noted clear fluid emanating from a vaginal lesion located at the level of the vaginal cuff. An extensive workup ruled out vesicovaginal and ureterovaginal fistula. Surgical exploration noted that the lesion was a prolapsed fallopian tube, which was resected vaginally. DISCUSSION: This is the first reported case of peritoneovaginal fistula associated with a prolapsed fallopian tube. CONCLUSION: Vaginal resection of the fallopian tube remnant and reclosure of the vaginal cuff results in cure of the leakage.

The bladder epithelium and overactive bladder: what we know.

Although the urothelium has been traditionally thought of as a passive barrier between urine and detrusor muscle, new studies have shown that the urothelium is a highly specialized structure involved in antigen presentation, micturition reflex, metabolic secretion, inflammatory regulation, and sensory afferent functioning. Data from several laboratories have shown that the urothelium can respond to thermal, mechanical, and chemical stimuli. The earlier findings (activation of urothelial transient receptor potential channel vanilloid 1 producing the second messenger nitric oxide, which in turn triggers suburothelial sensory nerves) demonstrate how the urothelium acts as a transducer, releasing chemicals that target adjacent bladder cells and sensory neurons. We now know that bladder urothelium acts also as a transducer whereby afferent neurons, via urothelial mechanoafferent transduction, are involved in the micturition process and the pathogenesis of bladder disorders. This paper highlights the important role that the urothelium has in bladder pathophysiology.

Urologic applications of botulinum toxin.

The neuromuscular blocker botulinum toxin has a wide variety of medical applications, including overactive bladder and neurogenic detrusor overactivity in patients in whom drug therapy fails or is not well tolerated. Botulinum toxin therapy for these conditions has been shown to be safe and effective in several large multicenter randomized controlled trials. Off-label uses in urology include detrusor external sphincter dyssynergia and pelvic pain syndromes.

Evaluation of patients' perceptions of mesh usage in female pelvic medicine and reconstructive surgery.

OBJECTIVE: To evaluate if new patients presenting to a female pelvic medicine and reconstructive surgery clinic are aware of the US Food and Drug Administration (FDA) announcement regarding transvaginal mesh placement for pelvic organ prolapse repair and do they believe there is a mesh recall. METHODS: A voluntary anonymous 25-question survey was administered to new-clinic patients. Participants were aged at least 18 years and had either urinary incontinence or pelvic organ prolapse. Appropriate statistical tests were performed for continuous and categorical variables. Logistic regression was used for univariate and multivariable analysis. Significance was considered for P values <.05. RESULTS: Two hundred fourteen surveys were included for final analysis. Of the 214 patients, 157 (73.4%) had urinary incontinence as their sole presentation. Of 204 patients, 126 (61.8%) were aware the FDA-released information regarding mesh use in transvaginal surgery, and 88 of 169 (52%) believed there is a "recall" on mesh being used for transvaginal surgery. Of 156 patients, 108 (69.2%) listed television as a source of information. On multivariable analysis, television as a source was significantly associated with awareness of the FDA announcement (odds ratio, 7.12; 95% confidence interval, 2.69-18.84; P = .0001) and belief in a "recall" (odds ratio, 3.01; 95% confidence interval, 1.28-7.06; P = .01). CONCLUSION: Although almost 2 of 3 participants were aware of the FDA announcement, more than half falsely believed there was a recall. Television was significantly associated with both awareness of the FDA announcement and belief in a recall suggesting patients derive most of their perceptions from the television.

Mutation screen of LOXL1 in patients with female pelvic organ prolapse.

OBJECTIVES: The LOXL1 (lysyl oxidase-like 1) gene encodes a copper-dependent monoamine oxidase that catalyzes the deamination of a lysine residue in the cross-linking of tropoelastin monomers to form elastin. LOXL1-KO mice do not deposit normal elastic fibers in their genitourinary tract resulting in postpartum pelvic organ prolapse and lower urinary tract dysfunction with decreased bladder capacity and lower voiding pressure. We sought to identify which single nucleotide polymorphisms in the LOXL1 coding sequence play a role in female pelvic organ prolapse. METHODS: A total of 66 patients were screened, 48 in the case group and 18 in the control group. The 7 exons of LOXL1 were evaluated for any polymorphisms. RESULTS: Three missense sequence changes (Arg141Leu, Gly153Asp, and Ser159Ala) and 3 silent mutations (Asp292Asp, Ala320Ala, and Ile521Ile) were identified. None of these polymorphisms were found to differ significantly in frequency in the case group compared with the control group. CONCLUSIONS: Our findings do not support an association of any LOXL1 exonal single nucleotide polymorphisms with the diagnosis of female pelvic organ prolapse.

Surgically corrected urethral diverticula: long-term voiding dysfunction and reoperation rates.

OBJECTIVES: To present the largest reported cohort of women with urethral diverticula and to evaluate the surgical outcomes and long-term voiding symptoms after urethral diverticulectomy. Studies evaluating the outcomes after urethral diverticulectomy have been limited by small patient numbers and short-term follow-up. METHODS: Women who had undergone diverticulectomy at our institution from 1996 to 2008 were mailed surveys. Urinary bother was assessed using the Urogenital Distress Inventory 6-item questionnaire, and patients were asked to report subsequent urethral or vaginal surgery and the number of urinary tract infections within the previous year. To determine the rate of surgical recurrence, the charts of women not responding to the survey were reviewed. RESULTS: A total of 122 women were identified as having undergone urethral diverticulectomy during the study period. Of these, 13 (10.7%) had an eventual recurrence that required repeat surgical excision. Patients with a proximal diverticulum, multiple diverticula, or previous pelvic or vaginal surgery (excluding previous diverticulectomy) were more likely to develop recurrence (P = .01, P = .03, and P < .001, respectively). For the 61 women (50%) responding to our survey, the mean follow-up was 50.4 months. Of these 61 women, 24 (39.3%) had had a urinary tract infection within the previous year, with 14 (23%) women having had ≥3 within the previous year. Also, 16 (26.2%) had persistent pain or discomfort with urination. The mean ± SD total Urogenital Distress Inventory-6 score was 31.1 ± 25.5 for the survey responders. CONCLUSIONS: To our knowledge, our study represents the largest study with the longest follow-up after urethral diverticulectomy. Patients with proximal or multiple diverticula and those with previous pelvic surgery should be counseled appropriately regarding the risks of recurrence and persistent voiding dysfunction.

Role of prostate biopsy schemes in accurate prediction of Gleason scores.

OBJECTIVES: To determine whether improved prostate sampling by the extended biopsy scheme also improves the accuracy of the biopsy Gleason score (bGS). Because most prostate cancer cases are now detected at an early stage with a low prostate-specific antigen level, the bGS may be the most important factor in therapeutic decision-making. Sextant biopsy schemes had poor correlation with prostatectomy Gleason scores. Extended prostate biopsies have replaced the sextant scheme because of the former's greater cancer detection rate. METHODS: We identified 426 patients whose biopsy and prostatectomy specimens were reviewed at our center. To minimize the effect of stage migration, all patients before 1997 were excluded. Of the 426 included patients, 221 men had undergone sextant biopsy and 205 men extended biopsy before prostatectomy. The rate of grading concordance and the effect of different variables on the concordance rate was determined. RESULTS: The overall accuracy of the extended and sextant schemes was 68% and 48% (P <0.001), respectively. Upgrading of the bGS was significantly less likely with the extended scheme (17% versus 41%, P <0.001). The sextant biopsy was more likely to be upgraded for a bGS of 6 or less (44% versus 25%, P <0.002) and a bGS of 7 (14% versus 3%, P <0.02). On multivariate analysis, the biopsy scheme was the only independent predictor of accurate Gleason scoring (P <0.001) and age, prostate-specific antigen level, digital rectal examination findings, prostate size, clinical stage, and number of positive cores were not. CONCLUSIONS: The use of an extended prostate biopsy scheme significantly improves the correlation between the bGS and prostatectomy Gleason score and reduces the risk of upgrading to a worse Gleason group at prostatectomy.