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

AIMS: Sacral 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. METHODS: All 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. RESULTS: A 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). CONCLUSION: SNM 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-in-human implantation of a mid-field powered neurostimulator at the sacral nerve: Results from an acute study.

INTRODUCTION: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. MATERIALS AND METHODS: A first-in-human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. RESULTS: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. CONCLUSIONS: The results from this acute first-in-human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid-field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.

A populational-based survey on the prevalence, incidence, and risk factors of urinary incontinence in older adults-results from the "SABE STUDY".

AIMS: To estimate the prevalence and incidence of urinary incontinence (UI) and identify the associated risk factors in a cohort of elderly individuals in Brazil. METHODS: In 2006, individuals aged ≥60 years were selected from the SABE Study (Health, Well-being, and Aging). The dependent variable was reported UI in 2009. UI was assessed using the International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form (ICIQ-UI SF). Incidence was measured in units of 1000 person-years, and Cox regression was applied for data analysis. Multivariate analysis was used to assess risk factors for UI. Incidence risk ratio (IRR) was used for comparison. RESULTS: This is the first study to examine the incidence of UI in Brazilian elderly individuals. In total, 1413 individuals were included; the mean age was 74.5 years, and 864 (61.8%) participants were female. The risk of UI was greater among women with cancer (other than skin) and among those with diabetes. In men, the risk of UI was greater for those in Instrumental Activities of Daily Living (IADL) category "5-8" and those who self-reported a "fair" health status. The prevalence of UI was 14.2% and 28.2% for men and women, respectively. The incidence rate of UI was 25.6 and 39.3 (×1000 person-years) for men and women, respectively. CONCLUSIONS: The incidence rate of UI among older adults in the Brazilian community was high for elderly individuals. The identified risk factors were diabetes and IADL category 5-8 (women) as well as cancer (other than skin) and self-reported health status (male).

DOuble LOngitudinal Megapreputium Incision TEchnique: the DOLOMITE.

OBJECTIVE: To present a straightforward, reproducible technique with the basic principle of preserving all available outer penile shaft skin and using this to cover the dorsal side of the penis. The DOuble LOngitudinal Megapreputium Incision TEchnique is presented in a step-by-step fashion. MATERIALS AND METHODS: Six consecutive patients with a mean age of 13.3 months (range, 7-25) underwent this reconstruction between 2006 and 2011. The technique starts with 2 longitudinal incisions, the first on the ventral side, and the second on the dorsal side of the penis. After hinging the penile skin to the dorsal side, redundant inner preputial tissue is resected using diagonal incisions. Dartos is spared. A comparison with previously reported techniques and a concise review of existing literature are provided. RESULTS: The final cosmetic results, after an initial period of edematous swelling of the ventral aspect of the penis, were good in all patients. The bilateral diagonal scars on the penile shaft became inconspicuous over time. Voiding normalized. No complications occurred. CONCLUSION: The DOuble LOngitudinal Megapreputium Incision TEchnique provides a straightforward and reproducible surgical correction for congenital megaprepuce.

GAG layer replenishment therapy for chronic forms of cystitis with intravesical glycosaminoglycans--a review.

AIMS: Glycosaminoglycan (GAG) layer replenishment is a cornerstone in the therapy of interstitial cystitis (IC). During the last years intravesical GAG layer replenishment has proven to be an effective treatment for overactive bladder (OAB), radiation cystitis, and recurrent urinary tract infections (UTIs). METHODS: Examination of different substances available for intravesical GAG replenishment and evaluation of the evidence for the treatment of the above-mentioned conditions. RESULTS: We searched the Medical Literature Analysis and Retrieval System Online (MEDLINE) database for studies on intravesical GAG replenishment. A total of 27 clinical studies remain relevant to this topic, many of them with mixed patient selection and suboptimal definition of symptom improvement/success. Two placebo controlled studies with hyaluronic acid failed to show superiority and have not been published. One active controlled randomized study has been published showing that chondroitin sulphate 0.2% has a clear benefit for OAB patients. Another study with chondroitin sulphate 2.0% failed to show statistically significant evidence, but was underpowered. CONCLUSIONS: A short number of randomized controlled studies confirm efficacy of intravesical GAG layer replenishment therapy. Concluded from the study background (which comprises also uncontrolled studies), so far chondroitin sulphate 0.2% is in favor for intravesical GAG layer replenishment therapy. In general, large-scale trials are urgently needed to underline the benefit of this type of therapy.

Quality of life in complete spinal cord injury patients with a Brindley bladder stimulator compared to a matched control group.

AIMS: To determine the effects on Quality of Life (QoL) of a Brindley procedure, which combines a sacral dorsal root rhizotomy to treat neurogenic detrusor overactivity with sacral anterior root stimulation to enable micturition, defecation, and penile erections in complete spinal cord injury (SCI) patients compared to a matched Control Group. METHODS: Cross-sectional study. The Qualiveen questionnaire, SF-36 questionnaire, and multiple choice questions about urinary continence and urinary tract infections were sent to 93 patients who had a Brindley stimulator implanted in the Netherlands and a matched Control Group of 70 complete SCI patients with neurogenic detrusor overactivity. Primary study outcomes were Specific Impact of Urinary Problems score and general QoL index of the Qualiveen. RESULTS: Response rates were 78% and 40% for patients with a Brindley stimulator and controls, respectively. Stimulators were still used for micturition in 46 (63%). These patients had a significant better Specific Impact of Urinary Problems score, general QoL index (Qualiveen), and continence rate, and less urinary tract infections compared to the Control Group. Patients also benefited of the rhizotomy with regard to QoL and continence rate if the stimulator was not used anymore. The subscales of the SF-36 had better scores for the patients who used their stimulator as compared to those who did not use the stimulator and compared to the Control Group. CONCLUSIONS: The Brindley stimulator for complete spinal cord injury patients improves Quality of Life, continence, and urinary tract infection rate compared to a matched Control Group.

Role and current situation of TURP in patients with elevated PSA.

OBJECTIVES: The aim of this review is to evaluate the place of transurethral resection of the prostate (TURP) in patients with elevated and/or rising prostate specific antigen (PSA). The role of TURP in these patients is assessed in symptomatic as well as in asymptomatic patients. METHODS: Current literature (1987-2009) was reviewed with regard to this specific population. This research was performed using the Medline online search tools. RESULTS: Initially, possible therapeutic strategies other than TURP could be used in patients with elevated and/or rising PSA values and no sign of proven prostate cancer. Consequently, the value of TURP in patients with elevated and/or rising PSA and no proven prostate cancer is discussed. In this setting, TURP can be executed with or without concomitant prostate biopsies. Furthermore, TURP can be proposed to patients with and without lower urinary tract symptoms. CONCLUSIONS: In this review, we evaluated the role of TURP in patients with elevated and/or rising PSA values and no proven prostate cancer. We believe TURP has a place in this particular population even in patients without lower urinary tract symptoms. This strategy is well founded on solid ground after an extensive review of the available literature. In most cases, a TURP will result in a normalization of PSA as well as a symptomatic benefit. Additionally, this procedure will allow histological evaluation which might show a possible life threatening prostate cancer in some patients.

Considerations for the management of urgency symptoms in patients with overactive bladder syndrome.

INTRODUCTION: Traditionally, urinary frequency and/or urgency incontinence have been the primary outcome measurements for the symptom complex of overactive bladder (OAB). However, urgency, by definition, precedes urgency incontinence, and drives frequency and nocturia in OAB and should be considered in this pivotal role. MATERIALS AND METHODS: Review of published literature on this topic. RESULTS: The management of urgency is evolving as of major clinical importance to patients. Recent use of diary-based urgency metrics has advanced our knowledge of the presence and nature of urgency symptoms, the impact on QoL and the response to treatment options. CONCLUSION: It is logical that the management of the number of urgency episodes and the degree of urgency, as well as the impact and bother associated with this core symptom are all taken into consideration along with patient interpretation to facilitate an effective outcome.

Medium-term experience of sacral neuromodulation by tined lead implantation.

OBJECTIVE: To describe patient selection for sacral neuromodulation, also known as Interstim therapy, and the results of tined-lead implantation in the medium term. PATIENTS AND METHODS: In all, 49 patients, 39 with refractory overactive bladder symptoms and 10 with urinary retention, were implanted with the tined lead under local anaesthesia. The mean (sd) test period was 12.4 (5.8) days. Patients were implanted when they had a > or = 50% improvement in voiding diary variables during the test period. The mean follow-up for implanted patients was 15.5 (7.9) months. Changes in voiding variables were compared using a t-test. RESULTS: Ten patients had a one-stage and 39 a two-stage implant; of the latter group, 31 (80%) had a positive response and eight (21%) did not. In all, 31 patients were included in the follow-up. At the last follow-up, 28 (90%) patients had a >50% improvement in diary variables and three (10%) did not. In 21 patients with urgency symptoms the mean (sd) number of voids decreased from 11.7 (8.9)/day at baseline to 7.3 (3.4)/day (P = 0.1); the voided volume increased from 160.2 (70.7) mL to 231.1 (119.5) mL (P = 0.001); and the number of leakages decreased from 9.5 (8.7) to 3.3 (2.2)/day (P = 0.17). In the 10 patients with retention, the number of catheterizations decreased from 5.44 (1.6)/day with a volume of 297.6 (76.8) mL, to 1.2 (1.7)/day and 111.6 (158.1) mL; the mean number of voids increased from 3.7 (3.8)/day with a volume of 123.3 (141.7) mL, to 4.2 (2.4)/day and 248.3 (146.0)mL. There were no significant differences in the variables in the patients with retention. Seven patients had an adverse event. There was one incomplete electrode migration that was treated conservatively. CONCLUSION: This new minimally invasive approach gives positive results in the medium term. Two-stage testing with the tined lead seems more reliable than the classic percutaneous nerve evaluation. The lead anchoring method seems sufficient for fixing the electrode in the medium term.

Predictive factors for nocturia in elderly men: a cross-sectional study in 21 general practices.

OBJECTIVE: To measure the prevalence of nocturia in general practice and to determine which factors are associated with nocturia. SUBJECTS AND METHODS: Data were collected from 3048 elderly men, who completed a questionnaire that was sent to every man aged 55-75 years in 21 general practices in Maastricht (the Netherlands). The symptom of nocturia was defined as two or more nocturnal voids. We investigated the prevalence of nocturia and the predictive relationships with the following factors: cerebrovascular disease, diabetes mellitus/insipidus (DMI), Parkinson's diseases, cardiovascular disease, hypertension, bladder/prostate cancer, kidney diseases, urinary bladder inflammation, congenital diseases (kidneys or prostate), using medical treatment for lower urinary tract symptoms, other treatment, psychological depression, symptoms suggestive of benign prostatic hyperplasia (BPH), and alcohol intake. RESULTS: Data from 2934 respondents were analysed; the prevalence of nocturia (two or more nocturnal voids) was 32.9% (965 men). The frequency of the number of nocturnal voids was: zero in 588 (20.0%), one in 1344 (45.8%), two in 611 (20.8%), three in 208 (7.1%), four in 70 (2.4%), and five or more in 76 (2.6%), with 37 values missing. A multivariate logistic regression analysis showed that nocturia in elderly men was significantly related to bladder/prostate cancer, cerebrovascular disease, treatment of voiding disorders, and moderate alcohol consumption. Next to these, BPH had a significant relationship with nocturia, especially in respondents with DMI and hypertension. Cardiovascular disease or hypertension was significantly related to nocturia, mutually replacing each other as a risk factor. CONCLUSION: Nocturia in elderly men is be related to many sources of potential risk factors: earlier urological diseases, cardiovascular and cerebrovascular diseases, BPH, DMI and behavioural habits. Some of these sources may interact and generate especially high risk in some groups for nocturia.