Voiding Diary Parameters Research Articles

Efficacy and Safety of Low-Dose Intravesical OnabotulinumtoxinA Injections in Female Patients With Detrusor Overactivity With Detrusor Underactivity.

We assessed the effectiveness and safety of using intravesical onabotulinumtoxinA (onabotA; BOTOX) injection with a low dose (75 units) for treating urinary storage symptoms in patients with detrusor overactivity with detrusor underactivity (DODU) compared to using the standard 100 units of onabotA in patients with overactive bladder (OAB). This ambidirectional study included 121 female patients who received intravesical onabotA injections at our hospitals. A total of 87 patients with OAB and 34 patients with DODU were reviewed using a 3-day voiding diary, uroflowmetry, and questionnaires including the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score, and Patient Perception of Bladder Condition. Patients were evaluated at baseline, within 2 weeks of treatment, and beyond 3 months after treatment. Questionnaire scores of the DODU group demonstrated significant improvement in the short term, with a subsequent decline, but an overall improvement compared to baseline in the long term. Notably, the DODU group exhibited enhanced IPSS voiding scores after the treatment. In the OAB group, most questionnaire scores, excluding the IPSS voiding score, showed significant posttreatment improvement, which was sustained to some extent in the long term. Voiding diary parameters related to storage symptoms were enhanced in both groups. The maximum and mean flow rates decreased in the OAB group but increased in the DODU group, particularly in the short term (P=0.000). The postvoid residual volume increased in both groups after posttreatment, with a mitigated change in the long term. Safety assessments revealed manageable adverse events in both groups with comparable frequencies. Low-dose intravesical onabotA for DODU demonstrated a relatively shorter duration of efficacy than OAB. Nonetheless, the treatment improved both storage and voiding symptoms in patients with DODU without significant adverse effects.

A randomized controlled trial evaluating low-intensity shockwave therapy for treatment of persistent storage symptoms following transurethral surgery for benign prostatic obstruction.

Low-intensity shockwave therapy (Li-SWT) can improve bladder function through enhancement of angiogenesis and nerve regeneration and suppression of inflammation and overactivity. In this trial, we aimed to evaluate the efficacy of Li-SWT on persistent storage symptoms after transurethral surgery (TUS) for benign prostatic obstruction (BPO). Between July 2020 and July 2022, 137 patients with persistent storage symptoms; urgency episodes/24 h ≥ 1 and daytime frequency ≥8, for at least three months after TUS for BPO were randomly allocated to Li-SWT versus sham versus solifenacin 10 mg/day in 3:1:1 ratio. The primary end point was the percent reduction from baseline in overactive bladder symptom score (OABSS) at 3-month follow-up. The changes in 3-day voiding diary parameters, quality of life (QoL) score, peak flow rate and residual urine at 3 and 6-month follow-up were compared. Treatment-related adverse effects were also evaluated. Baseline data were comparable between groups. The percent reduction from baseline in OABSS at 3-month follow-up was significantly higher in Li-SWT compared to sham (-55% versus -11%), and it was comparable between Li-SWT and solifenacin-10 (-55% versus -60%). Li-SWT achieved significant improvement like solifenacin-10 in 3-day voiding diary parameters and QoL score at 3-month follow-up. This improvement remained comparable between Li-SWT and solifenacin-10 at 6-month follow-up. No adverse effects related to Li-SWT were noted apart from tolerable pain during the procedure. Solifenacin-10 was associated with bothersome adverse effects in 73% of the patients with 11.5% discontinuation rate. Li-SWT ameliorates persistent storage symptoms and promotes QoL after TUS for BPO, with comparable efficacy and better tolerance compared to solifenacin.

A Pilot Study of the Effect of Transcutaneous Spinal Cord Stimulation on Micturition-Related Brain Activity and Lower Urinary Tract Symptoms After Stroke.

Transcutaneous spinal cord stimulation (TSCS) is a novel neuromodulation modality developed to promote functional restoration in patients with neurological injury or disease. Previous pilot data suggest that lower urinary tract dysfunction (LUTD) due to stroke may be partially alleviated by TSCS. In this study, we examine the mechanism of this effect by evaluating bladder-related brain activity in patients before and after TSCS therapy and comparing it to healthy volunteers. Patients who developed storage LUTD after a stroke and healthy volunteers without LUTD were recruited. Patients and healthy volunteers underwent simultaneous urodynamics and functional MRI. Patients then completed 24 biweekly sessions of TSCS and underwent another simultaneous urodynamics-functional MRI study. Clinical outcomes were assessed using validated questionnaires and voiding diary. Fifteen patients and 16 healthy volunteers completed the study. Following TSCS, patients exhibited increased blood-oxygen-level-dependent activity in areas including periaqueductal grey, the insula, the lateral prefrontal cortex, and motor cortex. Prior to TSCS therapy, healthy controls exhibited higher blood-oxygen-level-dependent activity in 17 regions, including multiple regions in the prefrontal cortex and basal ganglia. These differences were attenuated after TSCS with no frontal brain differences remaining between healthy volunteers and stroke participants who completed therapy. Neuroimaging changes were complemented by clinically significant improvements in questionnaire scores and voiding diary parameters. TSCS therapy modulated bladder-related brain activity, reducing differences between healthy volunteers and stroke patients with LUTD. These changes, alongside improved clinical outcomes, suggest TSCS as a promising approach for LUTD management.

Efficacy of peripheral electrical nerve stimulation on improvements of urodynamics and voiding diary in patients with neurogenic lower urinary tract dysfunction: a systematic review and meta-analysis.

Peripheral electrical nerve stimulation is a routinely recommended treatment for non-neurogenic overactive bladder but has not been approved for patients with neurogenic lower urinary tract dysfunction (NLUTD). This systematic review and meta-analysis was to elucidate the efficacy and safety of electrostimulation and thus provide firm evidence for treating NLUTD. We systematically performed the literature search through PubMed, Web of Science, and Cochrane Library databases in March 2022. The eligible studies were identified across the inclusion criteria and the data on urodynamic outcomes, voiding diary parameters, and safety was collected to quantitatively synthesize the pooled mean differences (MDs) with 95% CIs. Subgroup analyses and sensitivity analyses were subsequently used to investigate the possible heterogeneity. This report was achieved in accordance with the preferred reporting items for systematic reviews and meta-analyses statement. A total of 10 studies involving 464 subjects and 8 studies with 400 patients were included for systematic review and meta-analysis, respectively. The pooled effect estimates indicated that electrostimulation could significantly improve urodynamic outcomes, including maximum cystometric capacity (MD=55.72, 95% CI 15.73, 95.72), maximum flow rate (MD=4.71, 95% CI 1.78, 7.65), maximal detrusor pressure (MD=-10.59, 95% CI -11.45, -9.73), voided volume (MD=58.14, 95% CI 42.97, 73.31), and post-void residual (MD=-32.46, 95% CI -46.63, -18.29); for voiding diary parameters, patients undergoing electrostimulation showed lower MDs of incontinence episodes per 24h (MD=-2.45, 95% CI -4.69, -0.20) and overactive bladder symptom score (MD=-4.46, 95% CI -6.00, -2.91). In addition to surface redness and swelling, no stimulation-related severe adverse events were reported else. The current evidence demonstrated that peripheral electrical nerve stimulation might be effective and safe for managing NLUTD, whereas more reliable data from large-scale randomized controlled trials are necessary to strengthen this concept.

Botulinum toxin for treating overactive bladder in men: A systematic review.

We sought to systematically review the literature on the use of botulinum toxin (BTX-A) injections in the bladder to treat overactive bladder (OAB) in men. A systematic review was performed to identify clinical trials on efficacy and safety of BTX-A injections in the detrusor for treatment of OAB in men published from inception to October 2020. Quality assessment was performed using the Cochrane Collaboration's tool for assessing risk of bias and study characteristics were extracted by two reviewers independently. After screening 75 abstracts, 12 trials were included in the qualitative synthesis, of which 6 were conducted exclusively in men (mean age: 66.7 years). Only two were randomized controlled studies and the remaining were observational studies, mostly case series. Total number of participants in each study ranged from 28 to 146. Therapeutic response to intravesical BTX-A injection was assessed differently across the studies, which used quality-of-life symptom questionnaires and voiding diary parameters. Urodynamics findings were reported separately for men before and after intravesical injection of BTX-A in two studies only. Pooling of outcome data was possible with adverse events reported after BTX-A by seven studies, which showed urinary tract infection, urinary retention, increased postvoid residual, de novointerstitial cystitis, and hematuria rates of 29.8%, 20.0%, 37.3%, 28.3%, and 12.4%, respectively. Limited information regarding the efficacy and safety of BTX-A bladder injections for male OAB from relatively low evidence is available. Further research is needed to better understand the risk-benefit profile of BTX-A in the male population.

Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology.

Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology.

Percutaneous tibial nerve stimulation versus sham efficacy in the treatment of refractory overactive bladder: outcomes following a shortened 6‐week protocol, a prospective randomized controlled trial

It is a prospective randomized controlled trial comparing the efficacy of percutaneous tibial nerve stimulation versus sham for a shortened 6-week protocol of treatment in management of refractory OAB in non-neurogenic adult patients. A total of 50 adults with refractory non-neurogenicoveractive bladder symptoms were randomized 1:1 to 6weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder symptom score as well as 3-day voiding diaries were completed at baseline and at 7th week, 3rd and 6th month. The 7th week, 3rd and 6th month symptom score assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation patients achieved statistically significant improvement in bladder symptoms with 52% reporting moderately improved responses compared to non-response of sham patients from baseline (P = 0.001). Voiding diary parameters after 6weeks of therapy showed that PTNS patients had statistically significant improvements in frequency, voided volume and urgency urinary incontinence episodes compared to sham. No serious device-related adverse events or malfunctions were reported. A shortened 6-week treatment protocol with PTNS appears to be successful and more effective than sham in the treatment of refractory OAB. PTNS therapy is safe and effective in treating OAB symptoms with 52% success rate following a shortened 6-week protocol. The duration of treatment with PTNS can be halved compared to the conventional 12weeks, which would make it more acceptable and cost effective for patients.

Efficacy of Transcutaneous Electrical Nerve Stimulation in the Management of Neurogenic Overactive Bladder: A Randomized Controlled Trial.

The aim of the study was to investigate the therapeutic effect of transcutaneous electrical nerve stimulation on neurogenic overactive bladder that is refractory to pharmacotherapy. This randomized trial recruited 83 participants with neurogenic overactive bladder that were nonresponsive to 3-mo first-line anticholinergic drug treatment. Participants were randomized into treatment and control groups. Transcutaneous electrical nerve stimulation current consisting of biphasic square wave with pulse durations of 150 μs and pulse frequency set at 20 Hz were applied to for 30 mins once a day for 90 days. Stimulation was provided over the lateral aspect of the sacrum bilaterally of the electrodes. Patients in the transcutaneous electrical nerve stimulation group stopped taking the anticholinergic drugs. The control group continued to receive anticholinergic drugs for 90 days. The participants' Overactive Bladder Symptom Score, the Medical Outcomes Study 36-Item Short-Form Health Survey scores, urodynamic values, and voiding diary data were assessed before and after the therapy. The transcutaneous electrical nerve stimulation treatment group had significantly decreased Overactive Bladder Symptom scores compared with the control group (P < 0.001); in addition, half of the Medical Outcomes Study 36-Item Short-Form Health Survey scores were significantly improved in the transcutaneous electrical nerve stimulation group (P < 0.05). The patients treated with transcutaneous electrical nerve stimulation improved significantly voiding diary parameters at P < 0.05. Similarly, urodynamic values at P < 0.05 favored the experimental group over the control group. Applying daily transcutaneous electrical nerve stimulation over the sacral region for 90 days to patient with neurogenic overactive bladder improved overactive bladder symptoms of patients whose response to anticholinergic drugs is far inferior. Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME. Upon completion of this article, the reader should be able to: (1) Determine the therapeutic effect of transcutaneous electrical nerve stimulation (TENS) on neurogenic overactive bladder (NOAB); (2) Demonstrate the effectiveness of reflex suppression of the bladder using the TENS applied over the sacral region as a stimulation location; and (3) Confirm the TENS method using biphasic square waves with pulse durations of 150 μs and pulse frequencies of 20 Hz as applied is shown to be superior to anticholinergic drugs in managing NOAB. Advanced. The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Does traditional pharmacotherapy augment behavioral modification in the treatment of nocturia?

To assess the efficacy of traditional first-line non-antidiuretic pharmacotherapy for nocturia in the real-world outpatient urology setting. We retrospectively analyzed voiding diaries from adult men treated for lower urinary tract symptoms (LUTS) at an outpatient urology clinic to identify pairs of voiding diaries with ≥1 nocturnal void at baseline and a corresponding follow-up diary completed within 1 year. We compared the odds of nocturia improvement (decrease of ≥1 nocturnal void) in patients started on LUTS pharmacotherapy versus behavioral modification alone. Two hundred and thirteen diary pairs from 93 patients were included. Fifty-seven diary pairs were identified from patients prescribed at least one LUTS drug on the initial visit and 156 diary pairs were identified from patients receiving behavioral modification alone. All standard voiding diary parameters were assessed, and only maximum voided volume differed at baseline (240 ml [interquartile range: 200-330 ml] vs. 280 ml [200-400 ml] with and without pharmacotherapy, respectively, p = 0.04). The odds of nocturia improvement did not significantly differ between pharmacotherapy and behavioral modification treatment groups (crude odds ratio [OR]: 1.16 [95% confidence interval: 0.63-2.16], p = 0.63; maximum voided volume [MVV]-adjusted OR: 1.19 [0.63-2.22], p = 0.59). In contrast, improvement in 24-h urinary frequency was more likely with pharmacotherapy versus behavioral modification alone (crude OR: 2.36 [1.22-4.56], p = 0.01; MVV-adjusted OR: 2.05 [1.05-4.01], p = 0.04). Results were consistent on subgroup analyses restricted to first diary pairs from each patient. Despite improvement in 24-h voiding frequency, there was no evidence that adjunctive pharmacotherapy provided a benefit in the treatment of nocturia in men receiving behavioral counseling.

Sacral neuromodulation in patients with refractory overactive bladder symptoms after failed Botulinum toxin therapy: Results in a large cohort of patients.

AimsSacral neuromodulation (SNM) and Botulinum toxin A (BoNT‐A) injections are well‐known third‐line treatment options in patients with refractory overactive bladder (OAB). Our aim is to evaluate the success rate of SNM in patients who received prior therapy with BoNT‐A injections.MethodsAll patients with OAB symptoms referred for SNM between 2006 and 2019 were included. History taking and 3‐day voiding diaries assessed the complaints and suitability for SNM. The success rate of SNM in patients who received prior BoNT‐A was compared with BoNT‐A naive patients. Success was defined as an improvement of 50% or greater in voiding diary parameters. Satisfaction was registered at their most recent visit.ResultsA total of 263 patients underwent SNM test stimulation, of which 75 (16 male/57 female) received prior BoNT‐A and 188 (46 male/142 female) were BoNT‐A naive. Success rate for SNM in BoNT‐A naive patients was 72.9% and in BoNT‐A patients 66.7% (p = 0.316). Success rate after ≤2 BoNT‐A injections was 68.5%, compared to 61.1% after ≥3 injections (p > 0.05). Success rate in patients perceiving lack of efficacy of BoNT‐A was 67.4% (p > 0.05), subjected to temporary CISC was 73.7% (p > 0.05) and with temporary effect of BoNT‐A was 50% (p > 0.05). In 86% of BoNT‐A patients the system was still activated and used to their satisfaction at their last follow‐up visit (mean FU, 40.70 months).ConclusionSNM in patients with refractory OAB who failed prior BoNT‐A is an excellent approach. The number of injections nor reason of BoNT‐A discontinuation have predictive value for success with SNM.

First-line treatment posterior tibial nerve stimulation in patients with interstitial cystitis/bladder pain syndrome.

IntroductionThe aim of this study was to determine the effects of first-line treatment posterior tibial nerve stimulation (PTNS), applied once a week for a 12 week period, as a treatment modality for patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).Material and methodsA total of 39 female patients with IC/BPS were enrolled in the study. Patients had one 30-minute session of PTNS per week for 12 weeks and symptoms were assessed before and after the treatment sessions by the use of a voiding diary, visual analog scale (VAS) for pain, O'Leary-Sant interstitial cystitis symptom index (ICSI), and O'Leary-Sant interstitial cystitis problem index (ICPI).ResultsThe mean age of the patients was 38.9 ±7.1 years. The improvements in voiding diary parameters after 12 weeks of PTNS treatment were statistically significant compared to baseline but the changes in nocturia, and average voiding volume were not statistically significant. Mean parametric improvements after 12 weeks of PTNS treatment compared to baseline included a daytime frequency decrease by 3.8 voids daily, urgency episodes decrease by 4.7 episodes daily, nocturia decrease by 0.3 voids and voided volume improvement by a mean of 8.4 ml. The difference for ICSI, ICPI and VAS between baseline and the 12th week of PTNS treatment scores demonstrated statistically significant improvements in pain severity, symptom and problem index.ConclusionsThe findings in this study demonstrated the improvements of voiding diaries, ICSI, ICPI and VAS scores in patients with IC/BPS after 12 weeks PTNS. PTNS treatment is a beneficial firs-line treatment option to IC/BPS symptom amelioration.

522 - Percutaneous tibial nerve stimulation versus sham efficacy in the treatment of refractory overactive bladder: Outcomes following a shortened 6-week protocol, a prospective randomized controlled trial

It is a prospective randomized controlled trial comparing the efficacy of percutaneous tibial nerve stimulation versus sham for a shortened 6-week protocol of treatment in management of refractory OAB in non-neurogenic adult patients. A total of 50 adults with refractory non-neurogenic overactive bladder symptoms were randomized 1:1 to 6 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder symptom score as well as 3-day voiding diaries were completed at baseline and at 7th week, 3rd and 6th month. The 7th week, 3rd and 6th month symptom score assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation patients achieved statistically significant improvement in bladder symptoms with 52% reporting moderately improved responses compared to non-response of sham patients from baseline (P = 0.001). Voiding diary parameters after 6 weeks of therapy showed that PTNS patients had statistically significant improvements in frequency, voided volume and urgency urinary incontinence episodes compared to sham. No serious device-related adverse events or malfunctions were reported. A shortened 6-week treatment protocol with PTNS appears to be successful and more effective than sham in the treatment of refractory OAB. PTNS therapy is safe and effective in treating OAB symptoms with 52% success rate following a shortened 6-week protocol. The duration of treatment with PTNS can be halved compared to the conventional 12 weeks, which would make it more acceptable and cost effective for patients.

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients. We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant. We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups. TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.

The Value of Ambulatory Urodynamics in the Evaluation of Treatment Effect of Sacral Neuromodulation

Objectives: To assess the improvement of symptoms by sacral neuromodulation (SNM) in an objective way by carrying out an ambulatory urodynamic study (ambulatory-UDS). Until now, successful treatment has been defined as a ≥50% improvement recorded on voiding diaries. Voiding diaries are a patient reported outcome tool. A tool with less bias is desired to evaluate the treatment results before an expensive permanent system is implanted. Methods: Between 2002 and 2015, a total of 334 patients with lower urinary tract symptoms were included consecutively in an ambulatory-UDS database. From this database, a subgroup of patients was selected which underwent SNM. Results: In 51 patients, an ambulatory-UDS was performed both at baseline and during the SNM test period. A positive treatment outcome after test stimulation based on the patients’ voiding diary, correlated (p < 0.0001) with an improvement on ambulatory-UDS. Twenty-six of the 30 patients, who have showed improvement of more than 50% on voiding diary parameters and who had subjective improvement of their symptoms, showed an early improvement on ambulatory-UDS. Conclusions: Ambulatory-UDS can be used in clinical decision making, as it is associated with voiding diary improvement during the SNM test period. Using ambulatory-UDS to confirm success could in the future justify the shortening of the test period.

A pilot randomized-controlled trial of the urodynamic efficacy of mirabegron for patients with neurogenic lower urinary tract dysfunction.

To determine the effectiveness of mirabegron in patients with neurogenic lower urinary tract dysfunction. Randomized, double-blind, placebo-controlled study. Canadian patients with spinal cord injury (SCI) or multiple sclerosis (MS) with urinary symptoms and incontinence were recruited. Patients were randomized to mirabegron 25 mg (or an identical placebo) for 2 weeks at which point a dose escalation to mirabegron 50 mg (or an identical placebo) was maintained for 8 weeks. Urodynamics were performed before and after treatment. The primary outcome measure was maximum cystometric capacity (MCC). Intention to treat analysis and ANCOVA models (with adjustment for baseline values) were used and marginal means (MM) are reported; P-value <0.05 was considered significant. Sixteen (9 SCI and 7 MS) patients were randomized to mirabegron and 16 (10 SCI and 6 MS) to placebo. At study completion, there was no significant difference in MCC between mirabegron and placebo (MM 305 vs 369 mL, P = 0.20). There was no significant difference in volume at first neurogenic detrusor overactivity (NDO, MM 167 vs 137 mL, P = 0.14) and peak pressure of NDO (MM 69 vs 82 cmH2 O, P = 0.25). There was no significant difference in pad weights or voiding diary parameters. There was a significantly lower symptom burden among those treated with mirabegron (total neurogenic bladder symptom score MM 29 vs 34, P = 0.047). Among patients with SCI or MS, we demonstrated non-significant trends towards improvement in some urodynamic parameters with mirabegron 50 mg compared to placebo, and a significantly lower neurogenic bladder symptom burden.

Optimal Lead Positioning in Sacral Neuromodulation: Which Factors Are Related to Treatment Outcome?

Sacral neuromodulation (SNM) is a well-established treatment for overactive bladder (OAB) and non-obstructive urinary retention (NOR). During test stimulation, the lead is positioned along the third sacral nerve, which ideally results in a response in all four contact points (active electrodes). However, it is unclear whether the position of the lead (depth, angle, deflection) and the number of active electrodes is related to the outcome of SNM. All patients who underwent test stimulation using the tined lead between January 2011 and September 2016 were included in this retrospective study. Success was defined as >50% improvement in voiding diary parameters compared to baseline. The correlation between lead position and outcome of test stimulation was evaluated. The lead position was determined by evaluating the depth, angle and deflection with respect to the sacral foramen. Binary logistic regression was used in order to determine the predictive value of these factors. We included 189 patients of whom 105 were diagnosed with OAB and 84 with NOR. After a SNM test period of 4 weeks, 111 patients (59%) were successful and received a permanent implant. The position of the lead and the number of active electrodes did not predict success of test stimulation in neither the OAB group nor the NOR. However, lateral deflection of the lead was associated with finding more active electrodes (p = 0.01). In our study, the position of the lead or the number of active electrodes did not predict the outcome of SNM test stimulation. However, the impact of lead positioning and number of active electrodes on long-term outcome remains to be proven.

Potential Biomarkers for Diagnosis of Overactive Bladder Patients: Urinary Nerve Growth Factor, Prostaglandin E2, and Adenosine Triphosphate.

PurposeThis study aimed to investigate potential biomarkers for the diagnosis of overactive bladder (OAB).MethodsA total of 219 subjects were enrolled and divided into 2 groups: OAB subjects (n=189) and controls without OAB symptoms (n=30). Three-day voiding diaries and questionnaires were collected, and urinary levels of nerve growth factor (NGF), prostaglandin E2, and adenosine triphosphate were measured and normalized to urine creatinine (Cr). Baseline characteristics and urinary levels of markers were analyzed. A receiver-operator characteristic (ROC) curve was used to analyze the diagnostic performance of urinary markers. Urinary levels of markers according to subgroup and pathogenesis of OAB were evaluated. Correlation analyses were used to analyze the relationship between urinary levels of markers and voiding diary parameters and questionnaires.ResultsThere was no difference between the 2 groups with regards to age, sex ratio, or urine Cr (P>0.05). The urinary levels of NGF/Cr were higher in OAB subjects than in controls (P<0.001). Urinary NGF/Cr was a sensitive biomarker for discriminating OAB patients (area under the curve=0.741; 95% confidence interval, 0.62–0.79; P=0.001) in the ROC curve. The urinary levels of NGF/Cr were significantly higher in OAB subjects than in controls regardless of subgroup or pathogenesis. Correlation analysis demonstrated urinary urgency was significantly related to urinary NGF/Cr level (correlation coefficient, 0.156). Limitations include a relatively wide variation of urinary markers.ConclusionsUrinary NGF is a potential biomarker that could serve as a basis for adjunct diagnosis of OAB.

A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints.

Overactive bladder is a chronic condition affecting lower urinary tract function that has a significant negative impact on QoL. Evaluation of the BlueWind implantable tibial nerve system performance and safety in refractory OAB. A 6-month multi-center prospective intervention study. Objective assessment was done by voiding diary parameters including voids/day, volume voided/day, urgency assessment, leaking episodes/day, pads used/day, leak severity, and clinical success defined as a ≥50% reduction in the number of leaks/day or number of voids/day or number of episodes with degree of urgency >2 or a return to <8 voids/day on a 3 Day diary. Subjective assessment was based on OAB-q including HRQL and symptom severity score. Safety was evaluated by adverse event (AE) analysis. Thirty-four of the 36 implanted subjects completed the study. One subject withdrew voluntarily and one developed inflammation necessitating removal of the system. In the remaining subjects, 71% experienced clinical success at 6 months. Leaks/day, leak severity, and pad changes/day decreased significantly over time with 27.6% of urge incontinence subjects that became "dry." Voids/day, degree of urgency, volume/void, pads changed improved significantly. All quality of life aspects (concern, coping, sleep, and social) improved as well as symptom severity scores measured by the OAB-q. Adverse events included: implant site pain (13.9%), suspected infection (22.2%), and procedural wound complications (8.3%). The BlueWind implantable tibial nerve stimulator is a safe, minimally invasive system that affords OAB patients significant improvements. The performance and safety of the BlueWind RENOVA™ implantable tibial nerve neuromodulator for OAB was tested. Our preliminary results demonstrate that the system has a low risk safety profile and may be considered an effective treatment option for OAB management.

MP77-07 SAFETY AND EFFICACY OF BOTULINUM TOXIN A TREATMENT FOR PATIENTS WITH DETRUSOR OVERACTIVITY AND INADEQUATE CONTRACTILITY

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-neurogenic Voiding Dysfunction II1 Apr 2016MP77-07 SAFETY AND EFFICACY OF BOTULINUM TOXIN A TREATMENT FOR PATIENTS WITH DETRUSOR OVERACTIVITY AND INADEQUATE CONTRACTILITY Shu-Yu Wu, Chung-Cheng Wang, and Hann-Chorng Kuo Shu-Yu WuShu-Yu Wu More articles by this author , Chung-Cheng WangChung-Cheng Wang More articles by this author , and Hann-Chorng KuoHann-Chorng Kuo More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1921AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Botulinum toxin A (BoNT-A) significantly improves OAB symptoms and urodynamic parameters. However, increased PVR volume and risk of urinary tract infection (UTI) after treatment remain concerns among frail elderly patients. This study retrospectively analyzed the therapeutic efficacy and safety in OAB patients who had a baseline PVR >100 mL or VE <67% and received intravesical BoNT-A 100 U injections. METHODS A total of 21 patients with urodynamically proven DHIC and 21 age-matched controlled patients with urodynamic DO were selected from our previous clinical trials. Patients with DHIC should have a PVR of >100 mL but <250 mL, or a VE of less than 67% (voided volume <67% of maximal bladder capacity) at baseline. Patients with DO should have a PVR<50 mL and VE >67% at baseline. Patients were treated with suburothelial injections of 100 U BoNT-A (Allergan, Irvine, CA, USA) in 10 mL, 0.5 mL in each injection, total 20 injections in the bladder body, sparing the trigone. All patients were evaluated at baseline, 2 weeks, and 1, 3, and 6 months after treatment. Treatment results were assessed with global response assessment (GRA), OAB symptom score (OABSS), USS, patient perception of bladder condition (PPBC), and voiding diary parameters. Procedure-related AEs were recorded during the follow-up period after BoNT-A treatment. RESULTS The mean age of DHIC and OAB patients were 71.2±8.2 and 70.9±14.1 years, respectively. The changes of measured parameters from baseline to 6 months in the two groups. The subjective symptom scores after BoNT-A all showed significantly improved in both groups and no difference between groups. However, the changes of urgency episodes per 3 days were only noted in OAB patients after BoNT-A injection. UUI was significantly improved at 3 months and frequency episode was significantly improved at 6 months in OAB patients, but not in DHIC patients. Interestingly, there was no increase of bladder capacity or voided volume in either group. Qmax showed no significant change after BoNT-A injection in either group. PVR increased in DHIC patients at 2 and 4 weeks, but not at 3 and 6 months after BoNT-A injection. However, in OAB patients, the significant increase of PVR was noted at 2 months and lasted to 6 months. Adverse events in the DHIC and OAB patients showed no significant difference between DHIC and OAB. Among these patients, the therapeutic efficacy lasted for a mean of 2.3 months and 4.5 months in DHIC and OAB patients, respectively. CONCLUSIONS Patients with DHIC do not increase the risk of large PVR or decrease of VE after 100 U BoNT-A injection. However, the therapeutic efficacy was significantly diminished in DHIC patients. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e1018 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Shu-Yu Wu More articles by this author Chung-Cheng Wang More articles by this author Hann-Chorng Kuo More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results.

The aim of this study is to determine the sustained therapeutic efficacy and treatment intervals for PTNS in NOAB with MS, offering periodic additional treatments during 1 year in patients who completed an initial course of 12 consecutive weekly sessions. A total of 34 patients enrolled to the PTNS treatment and 21 patients completed the 1 year PTNS treatment with a tapering protocol of 6, 9, and 12 months of therapy, respectively. After 12 weeks of therapy, PTNS was applied at 14 day intervals for 3 months, 21 day intervals for 3 months, and 28 day intervals for 3 months. The patients completed a 3-day voiding diary at 3rd, 6th, 9th, and 12th month. The patients requested to complete validated questionnaires (ICIQ-SF, OAB-V8, OAB-q SF) were carried out within 3-month intervals thereafter during their enrolment in the study. A total of 21 patients were enrolled in the study. Of these 5 (23.8%) were men and 16 (76.2%) women. The improvements for all voiding diary parameters were significant in the 6th, 9th, and 12th months when compared with baseline. Mean values between baseline and 12 month parameters suggested that daytime frequency decreased by 5.4 voids daily, urge incontinence decreased by 3.4 episodes daily, urgency episodes decreased by 7.4 episodes daily, nocturia decreased by 2.6 voids, and voided volume improved by a mean of 72.1 cc. These results have demonstrated NOAB symptom improvement in MS patients can be achieved with 12 weekly PTNS treatments which show excellent durability over 12 months. Neurourol. Urodynam. 36:104-110, 2017. © 2015 Wiley Periodicals, Inc.