Mesh-associated pain syndrome: predictors for continence and prolapse mesh removal surgery in a single centre.

OBJECTIVE: Over the last two decades one of the main surgical treatment for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) surgery was the insertion of non-absorbable mesh to restore continence and prolapse respectively. Over time complications arose including mesh-associated pain syndrome (MAPS), mesh exposure, mesh, erosion, chronic bladder/vaginal infections, and dyspareunia. Consequently, women chose surgical mesh removal to counter these problems. However, little is known about the demographics, medical co-morbidities, mesh types involved and the timing from mesh insertion to mesh removal. This retrospective study will look at which of these factors may be closely associated with mesh removal surgery. DESIGN: Retrospective evaluation. SETTING: Female Pelvic Medicine and Reconstructive Surgery (FPMRS) Clinic at University College London Hospitals NHS Foundation Trust. POPULATION: All patients presenting to the FPMRS Clinic between June 2011 to December 2019, requesting mesh removal surgery with a history of MAPS and other mesh complications were included in this study. METHODS: Patient demographics including age, ethnicity, obstetric history, and medical co-morbidities; type of mesh/anatomical route used; onset of symptoms; and time from insertion to removal were recorded. MAIN OUTCOME MEASURES: Determination of correlation coefficients between patient demographics, patient reported symptoms and mesh removal surgery. RESULTS: Three hundred and forty-five women with a history of MAPS were included in the study. Women in the 40-60 year old cohort accounted for 54.4% of mesh removal surgery; 54.8% had a BMI under 30 and almost 90% were Caucasian. 96.5% had had children, with over 77% having had a vaginal delivery. 91.9% of patients reported other health conditions including 18.8% with a concomitant history of mental health problems and 15.4% with a history of heart disease. Over 80% of women undergoing mesh removal surgery had a continence mesh (49% retropubic and 32% obturator continence mesh) removed, whereas 20% had an abdominal prolapse and/or vaginal prolapse mesh removed. The average time from mesh insertion to mesh removal was seven years, with the prevalence of mesh removal surgery averaging 85% (range 50-100%) depending on the comorbidity determined. CONCLUSIONS: All women presented to the clinic with a history of MAPS and other comorbidities which may have influenced their decision to pursue mesh removal surgery. There were no specific predictors, other than chronic pain associated with mesh, determining which women underwent surgery, though those with continence mesh were more likely to do so.

Management of chronic primary pelvic pain syndromes.

Management of chronic pelvic pain (CPP) remains a huge challenge for care providers and a major burden for healthcare systems. Treating chronic pain that has no obvious cause warrants an understanding of the difficulties in managing these conditions. Chronic pain has recently been accepted as a disease in its own right by the World Health Organization, with chronic pain without obvious cause being classified as chronic primary pain. Despite innumerable treatments that have been proposed and tried to date for CPP, unimodal therapeutic options are mostly unsuccessful, especially in unselected individuals. In contrast, individualised multimodal management of CPP seems the most promising approach and may lead to an acceptable situation for a large proportion of patients. In the present review, the interdisciplinary and interprofessional European Association of Urology Chronic Pelvic Pain Guideline Group gives a contemporary overview of the most important concepts to successfully diagnose and treat this challenging disease.

Patient-tailored healthcare and tibial nerve neuromodulation in the treatment of patients with overactive bladder symptoms.

PURPOSE: The aim of this study was to demonstrate features predictive of treatment response for patient-tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors. MATERIALS AND METHODS: This study was designed as a follow-up study based on parameter settings and patients' preferences during the pilot and extended study of the implantable tibial nerve stimulator (RENOVA™ iStim system). For this study, we compared all treatment parameters (stimulation amplitude, frequency, and pulse width) and usage data (duration of treatment) during the different follow-up visits. RESULTS: We obtained usage data from a total of 32 patients who were implanted with the system between February and September 2015. Age, sex, body mass index (BMI) and previous experience with percutaneous tibial nerve stimulation (PTNS) treatment were considered as possible prediction factors for treatment success. However, only BMI was considered a statistically significant prediction factor (p = 0.042). A statistically significant increase in mean treatment level was seen in the responder group during the 3 month follow-up visit (mean: 6.7 mA, SD 0.416) as compared with the initial system activation visit (mean: 5.8 mA, SD 0.400) (p = 0.049). No other visits demonstrated statistically significant changes in both groups (responders and nonresponders) during the defined timepoints. CONCLUSION: This data underscores the need to use patient-tailored OAB treatment. BMI was found to be a negative predictive factor for treatment success. However, it was not possible to develop a specific responder model. A model predicting response to treatment could be useful for implementing shared decision making.

3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome.

PURPOSE: We evaluated the 3-year safety and efficacy of the BlueWind Medical RENOVA™ iStim system for the treatment of overactive bladder syndrome. MATERIALS AND METHODS: All patients who previously underwent implantation with the RENOVA system were offered continued participation. The primary long-term study end point was to evaluate the safety profile based on incidence of serious adverse events (system and/or procedure related), which was measured by the impact and frequency of serious adverse events. The secondary end points included clinical improvement compared to baseline and quality of life improvement compared to baseline at 36 months, which was measured by 3-day voiding diary and quality of life questionnaires at certain time points. RESULTS: Of the 34 patients with overactive bladder syndrome who previously underwent implantation with the RENOVA system 20 consented to continuation in this 3-year followup study. Mean patient age was 56.1 years and 80% (16) of the study cohort was female. The overall treatment success rate was 75% at 36 months in the per protocol (16) and the intent to treat (20) analyses. In total, 73% of the patients reported improvement in health related quality of life scores above the minimal important difference of 10 points. CONCLUSIONS: This 3-year followup study using the BlueWind RENOVA iStim system for the treatment of overactive bladder syndrome symptoms confirms the long-term good safety profile with no technical failures reported. Lasting treatment efficacy is mirrored by a sustained positive impact on patient quality of life.

Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long-term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2-year outcomes. METHODS: A total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow-up visits. Adverse events (AEs) are reported in all implanted subjects. RESULTS: At 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device-related AEs. CONCLUSIONS: The Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device-related AEs. Subjects reported continued satisfaction with their therapy.

An International Continence Society (ICS) report on the terminology for female pelvic floor fistulas.

INTRODUCTION: The terminology for female pelvic floor fistulas (PFF) needs to be defined and organized in a clinically based consensus Report. METHODS: This Report combines the input of members of the International Continence Society (ICS) assisted at intervals by external referees. Appropriate core clinical categories and a sub-classification were developed to give a coding to definitions. An extensive process of 19 rounds of internal and external review was involved to examine each definition, with decision-making by collective opinion (consensus). RESULTS: A terminology report for female PFF, encompassing 416 (188 NEW) separate definitions, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in different specialty groups involved in female pelvic floor dysfunction and PFF. Female-specific imaging (ultrasound, radiology, and magnetic resonance imaging) and conservative and surgical PFF managements as well as appropriate figures have been included to supplement and clarify the text. Interval (5-10 years) review is anticipated to keep the document updated and as widely acceptable as possible. CONCLUSION: A consensus-based terminology report for female PFF has been produced to aid clinical practice and research.

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.

AIMS: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. METHODS: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). RESULTS: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. CONCLUSIONS: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.

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

BACKGROUND: Overactive bladder is a chronic condition affecting lower urinary tract function that has a significant negative impact on QoL. OBJECTIVE: Evaluation of the BlueWind implantable tibial nerve system performance and safety in refractory OAB. DESIGN, SETTING, AND PARTICIPANTS INTERVENTION: A 6-month multi-center prospective intervention study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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. RESULTS AND LIMITATIONS: 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%). CONCLUSIONS: The BlueWind implantable tibial nerve stimulator is a safe, minimally invasive system that affords OAB patients significant improvements. PATIENT SUMMARY: 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.

Three month clinical results with a rechargeable sacral neuromodulation system for the treatment of overactive bladder.

AIMS: The primary aim of the RELAX-OAB study is to confirm the safety and efficacy of the Axonics r-SNM System, a miniaturized, rechargeable SNM system. METHODS: A total of 51 OAB patients were implanted in a single-stage implant procedure. These results represent the 3-month outcomes. Subject outcomes were evaluated using 3-day bladder diaries and quality of life questionnaires. RESULTS: A total of 31 of 34 patients (91%) that responded during an initial trial period ("Test Responders") continued to benefit from therapy with the Axonics r-SNM System at 3-months, defined as symptom improvement of ≥50% reduction in urinary voids or incontinence episodes or a return to <8 voids per day. Subjects who were Test Responders showed a statistically and clinically meaningful improvement in all aspects of quality of life (ICIQ-OABqol). No serious device-related adverse events (SADEs) occurred, and there were no unanticipated adverse events (UAEs). One subject was explanted due to an infection at the implant site and 19.6% of subjects experienced device related adverse events, most notably discomfort due to stimulation, which was resolved with reprogramming. CONCLUSIONS: The Axonics r-SNM System provides safe and effective SNM therapy with objective improvement in 91% of subjects. The data also demonstrates a significant improvement in all domains of quality of life. This miniaturized, rechargeable system is designed to last 15 or more years and is expected to provide clinical and cost benefits over current non-rechargeable systems by eliminating replacement surgeries.

Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder.

AIMS: The RELAX-OAB study is designed to confirm the safety, efficacy, and technical performance of the Axonics r-SNM System, a miniaturized, rechargeable SNM system approved in Europe and Canada for the treatment of bladder and bowel dysfunction. The purpose of this article is to describe study subjects' ability to charge the rechargeable neurostimulator and to document their neurostimulator program settings and recharge interval over time. METHODS: Fifty-one OAB patients were implanted in a single-stage procedure. These results represent the 3-month charging experience for 48 subjects who completed the 3-month follow-up. Recharge intervals were estimated using therapy stimulation settings and subject experience was evaluated using questionnaires. RESULTS: Forty-seven of forty-eight (98%) subjects were able to successfully charge their device prior to follow-up within 1-month post-implant. At 3-month post-implant, 98% of subjects were able to charge prior to their follow-up visit. Average stimulation amplitude across all subjects was 1.8 mA (±1.1 mA). A total of 69% of subjects had ≥14-day recharge intervals (time between charging) and 98% of subjects had ≥7-day recharge interval. No charging related adverse events occurred. CONCLUSIONS: Study subjects were able to charge the Axonics r-SNM System and stimulation settings provided 2 weeks of therapy between recharging for most subjects. Subject satisfaction indicates that subjects are satisfied with rechargeable SNM therapy.

Demand and capacity to integrate pelvic organ prolapse and genital fistula services in low-resource settings.

INTRODUCTION AND HYPOTHESIS: There is a need for expanded access to safe surgical care in low- and middle-income countries (LMICs) as illustrated by the report of the 2015 Lancet Commission on Global Surgery. Packages of closely-related surgical procedures may create platforms of capacity that maximize impact in LMIC. Pelvic organ prolapse (POP) and genital fistula care provide an example. Although POP affects many more women in LMICs than fistula, donor support for fistula treatment in LMICs has been underway for decades, whereas treatment for POP is usually limited to hysterectomy-based surgical treatment, occurring with little to no donor support. This capacity-building discrepancy has resulted in POP care that is often non-adherent to international standards and in non-integration of POP and fistula services, despite clear areas of similarity and overlap. The objective of this study was to assess the feasibility and potential value of integrating POP services at fistula centers. METHODS: Fistula repair sites supported by the Fistula Care Plus project were surveyed on current demand for and capacity to provide POP, in addition to perceptions about integrating POP and fistula repair services. RESULTS: Respondents from 26 hospitals in sub-Saharan Africa and South Asia completed the survey. Most fistula centers (92%) reported demand for POP services, but many cannot meet this demand. Responses indicated a wide variation in assessment and grading practices for POP; approaches to lower urinary tract symptom evaluation; and surgical skills with regard to compartment-based POP, and urinary and rectal incontinence. Fistula surgeons identified integration synergies but also potential conflicts. CONCLUSIONS: Integration of genital fistula and POP services may enhance the quality of POP care while increasing the sustainability of fistula care.

A standard for terminology in chronic pelvic pain syndromes: A report from the chronic pelvic pain working group of the international continence society.

AIMS: Terms used in the field of chronic pelvic pain (CPP) are poorly defined and often confusing. An International Continence Society (ICS) Standard for Terminology in chronic pelvic pain syndromes (CPPS) has been developed with the aim of improving diagnosis and treatment of patients affected by chronic pelvic pain syndromes. The standard aims to facilitate research, enhance therapy development and support healthcare delivery, for healthcare providers, and patients. This document looks at the whole person and all the domains (organ systems) in a systematic way. METHODS: A dedicated working group (WG) was instituted by the ICS Standardisation Steering Committee according to published procedures. The WG extracted information from existing relevant guidelines, consensus documents, and scientific publications. Medline and other databases were searched in relation to each chronic pelvic pain domain from 1980 to 2014. Existing ICS Standards for terminology were utilized where appropriate to ensure transparency, accessibility, flexibility, and evolution. Consensus was based on majority agreement. RESULTS: The multidisciplinary CPPS Standard reports updated consensus terminology in nine domains; lower urinary tract, female genital, male genital, gastrointestinal, musculoskeletal, neurological aspects, psychological aspects, sexual aspects, and comorbidities. Each is described in terms of symptoms, signs and further evaluation. CONCLUSION: The document presents preferred terms and definitions for symptoms, signs, and evaluation (diagnostic work-up) of female and male patients with chronic pelvic pain syndromes, serving as a platform for ongoing development in this field. Neurourol. Urodynam. 36:984-1008, 2017. © 2016 Wiley Periodicals, Inc.

Development of a Unifying Target and Consensus Indicators for Global Surgical Systems Strengthening: Proposed by the Global Alliance for Surgery, Obstetric, Trauma, and Anaesthesia Care (The G4 Alliance).

After decades on the margins of primary health care, surgical and anaesthesia care is gaining increasing priority within the global development arena. The 2015 publications of the Disease Control Priorities third edition on Essential Surgery and the Lancet Commission on Global Surgery created a compelling evidenced-based argument for the fundamental role of surgery and anaesthesia within cost-effective health systems strengthening global strategy. The launch of the Global Alliance for Surgical, Obstetric, Trauma, and Anaesthesia Care in 2015 has further coordinated efforts to build priority for surgical care and anaesthesia. These combined efforts culminated in the approval of a World Health Assembly resolution recognizing the role of surgical care and anaesthesia as part of universal health coverage. Momentum gained from these milestones highlights the need to identify consensus goals, targets and indicators to guide policy implementation and track progress at the national level. Through an open consultative process that incorporated input from stakeholders from around the globe, a global target calling for safe surgical and anaesthesia care for 80% of the world by 2030 was proposed. In order to achieve this target, we also propose 15 consensus indicators that build on existing surgical systems metrics and expand the ability to prioritize surgical systems strengthening around the world.

Sacral neuromodulation outcomes in male patients with chronic urinary retention.

OBJECTIVES: To assess the outcome of two-stage sacral neuromodulation (SNM) in men with chronic urinary retention (CUR) and factors affecting the response. MATERIAL AND METHODS: Data were collected from 21 male patients with complete or partial CUR who underwent two-stage SNM between 2006 and 2014. The implanted lead was connected to a temporary battery (stage-1) and they were assessed over a period of 3-12 weeks. Those who had a residual volume of ≤100 mL, had an implantable pulse generator sited (stage-2). Patients were followed up at 3 and 6 months initially, and 12 monthly thereafter. The following parameters were analyzed: age, onset of symptoms, precipitant causes for CUR, type of retention, associated voiding dysfunction and opiate intake. RESULTS: Surgery was the main precipitating cause of CUR in 5 (24%) patients. Stage-1 SNM restored complete efficient voiding in 14 patients (66.7%) out of the 21 patients. The only parameter studied that showed a positive correlation with a successful outcome to SNM was the age of the patient, with a higher success rate in younger males (median age 37 years [p = 0.025]). There was no other significant finding when looking at other parameters studied. Stage-2 was carried out in 13 out of 14 successful stage-1 patients. SNM restored complete voiding or improved bladder emptying in all patients implanted with a battery, and this was sustained until the battery needed to be replaced with a mean follow up of 34 ± 23.7 months except in two cases that had removal after traumatic accidents. CONCLUSION: Stage-1 SNM was successful in 66.7% of male patients with CUR. Once stage-2 was performed, successful voiding was maintained until the battery needed to be replaced. SNM success was better in men under a median age of 43 years. Further studies are encouraged to study this group of patients.

Optimizing the duration of assessment of stage-1 sacral neuromodulation in nonobstructive chronic urinary retention.

OBJECTIVES: The duration of test stimulation using two-stage sacral neuromodulation (SNM) is not studied. This study will determine the restoration of normal bladder sensation and resultant voiding in chronic urinary retention (CUR) after stage-1 SNM. MATERIALS AND METHODS: Two-stage SNM used in 24 female patients with CUR. After stage-1 SNM, patients were assessed over an eight-week period and asked to record the restoration of normal bladder sensation and voiding. Qualitative and quantitative statistics were used to assess the outcomes and the influence of prognostic factors. RESULTS: The mean age of patients was 37.0 ± 9.7 years. Normal bladder sensation was restored on the same day as switching on the battery after stage-1 in seven patients (29.2%), while in 17 patients it occurred between day 2-31 (mean: nine days). Similarly, the mean onset of voiding was also nine days (range: 2-31 days). After day 15, 21% of patients voided. The mean lag time between the restoration of bladder sensation and voiding was 3.6 days. By day 17, a cumulative percentage of 90% of patients had a normalized bladder sensation and 80% had commenced voiding. Infection of the externalized lead occurred in only one case. There were no correlations between the outcome parameters with age (p > 0.05), symptom duration, or concomitant diagnosis of overactive bladder or chronic pelvic pain (p = 0.418, p = 0.114). CONCLUSION: Stage-1 SNM may be left in situ for up to four weeks to ensure the maximum chance of restoring normal bladder function in this complex group of patients.

Postoperative outcomes and urodynamic findings after continence mesh removal.

OBJECTIVE: To analyze urodynamics findings and patient-reported outcomes after removal of a mid-urethral mesh because data regarding outcomes following mesh removal vary in different studies, and mesh removal itself may have risks. METHODS: Women who were referred to the Female Pelvic Medicine and Reconstructive Surgery Department of University College London Hospital and underwent vaginal removal of a continence mesh between January 2014 and January 2020, were included. Patient clinical data and results of video-urodynamics investigations performed 4 months after mesh removal were collected and analyzed retrospectively. RESULTS: In all, 204 patients were included in the study. After mesh removal, 80.5% of patients reported recurrent stress urinary incontinence (SUI), 10.1% reported prolapse symptoms, 8% reported voiding dysfunction and 2.9% reported overactive bladder (OAB) symptoms. Video-urodynamics investigations confirmed the presence of SUI (67.6%), mixed urinary incontinence (14.3%), detrusor overactivity (DO) (6.8%) and voiding dysfunction in one patient. In two women a urethral stricture was described, and 10 women were deemed to have a significant cystocele. CONCLUSION: Recurrence of SUI was the most frequent finding after continence mesh removal, both symptomatically and objectively. Women seldom reported OAB symptoms, but urodynamics showed evidence of DO despite this. On the other hand, voiding dysfunction was often reported but less often proven on urodynamics.

What are the health needs of women with female genital mutilation going through menopause?

Female genital mutilation is widely recognised as a practice that causes grave, permanent damage to the genital anatomy and function. The literature has documented its impact on physical, sexual, emotional, and mental wellbeing, and this has informed the development of guidelines and recommendations for managing women with female genital mutilation. There has, though, been little, if any, focus on how women with female genital mutilation experience menopause. A literature search did not return any published research on the topic and there are currently no clinical guidelines for managing the menopause in women who have undergone female genital mutilation. This review calls attention to this gap by exploring the clinical implications that the loss of natural hormones has on the vulvovaginal tissues, as well as on urogenital and sexual function. Psychological aspects of the experience of women with female genital mutilation going through menopause are also explored, as well as common barriers they face in accessing adequate healthcare. Finally, we offer a set of recommendations for clinical practice, including the need to improve current care pathways, and potential directions for future research.

The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease.

Huntington's disease (HD) is a fatal autosomal dominant neurodegenerative disease involving progressive motor, cognitive and behavioural decline, leading to death approximately 20 years after motor onset. The disease is characterised pathologically by an early and progressive striatal neuronal cell loss and atrophy, which has provided the rationale for first clinical trials of neural repair using fetal striatal cell transplantation. Between 2000 and 2003, the 'NEST-UK' consortium carried out bilateral striatal transplants of human fetal striatal tissue in five HD patients. This paper describes the long-term follow up over a 3-10-year postoperative period of the patients, grafted and non-grafted, recruited to this cohort using the 'Core assessment program for intracerebral transplantations-HD' assessment protocol. No significant differences were found over time between the patients, grafted and non-grafted, on any subscore of the Unified Huntington's Disease Rating Scale, nor on the Mini Mental State Examination. There was a trend towards a slowing of progression on some timed motor tasks in four of the five patients with transplants, but overall, the trial showed no significant benefit of striatal allografts in comparison with a reference cohort of patients without grafts. Importantly, no significant adverse or placebo effects were seen. Notably, the raclopride positron emission tomography (PET) signal in individuals with transplants, indicated that there was no obvious surviving striatal graft tissue. This study concludes that fetal striatal allografting in HD is safe. While no sustained functional benefit was seen, we conclude that this may relate to the small amount of tissue that was grafted in this safety study compared with other reports of more successful transplants in patients with HD.

Pregnancy in women with Fowler's syndrome treated with sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: Our aim was to determine the impact of pregnancy on sacral neuromodulation (SNM) and vice versa in patients with Fowler's syndrome (FS), which is typified by chronic urinary retention (CUR). METHODS: We performed a retrospective study of pregnancy in patients with FS who underwent a two-stage SNM implantation. Data were obtained using a standard questionnaire and clinical interview. RESULTS: There were a total of ten patients with 13 pregnancies. The SNM was switched off in ten of the 13 pregnancies, with CUR recurring in nine of the ten pregnancies and recurrent urinary tract infections (UTI) occurring in four of these pregnancies (more than three UTI in the pregnancy). Those in whom the device was left on continued to void normally. One woman had a first trimester miscarriage, eight pregnancies went to term, and four deliveries were premature. Caesarean section was performed in eight pregnancies for obstetric reasons. Four pregnancies resulted in a vaginal delivery. There were no congenital anomalies reported. Following delivery, four of nine women experienced dysfunction of their SNM device when it was switched back on. CONCLUSION: Turing off the SNM during pregnancy results in recurrence of CUR, with an increased risk of recurrent UTI associated with preterm delivery. This did not impact foetal well-being. The option of keeping the SNM on during pregnancy should therefore be considered, and as caesarean section affects the SNM device, we advise that caesarean section should only be performed for obstetric reasons.

Myofascial Pelvic Pain: Best Orientation and Clinical Practice. Position of the European Association of Urology Guidelines Panel on Chronic Pelvic Pain.

CONTEXT: Despite the high prevalence of a myofascial pain component in chronic pelvic pain (CPP) syndromes, awareness and management of this component are lacking among health care providers. OBJECTIVE: To summarize the current state of the art for the management of myofascial pain in chronic primary pelvic pain syndromes (CPPPS) according to scientific research and input from experts from the European Association of Urology (EAU) guidelines panel on CPP. EVIDENCE ACQUISITION: A narrative review was undertaken using three sources: (1) information in the EAU guidelines on CPP; (2) information retrieved from the literature on research published in the past 3 yr on myofascial pelvic pain; and (3) expert opinion from panel members. EVIDENCE SYNTHESIS: Studies confirm a high prevalence of a myofascial pain component in CPPPS. Examination of the pelvic floor muscles should follow published recommendations to standardize findings and disseminate the procedure. Treatment of pelvic floor muscle dysfunction and pain in the context of CPP was found to contribute to CPP control and is feasible via different physiotherapy techniques. A multidisciplinary approach is the most effective. CONCLUSIONS: Despite its high prevalence, the myofascial component of CPP has been underevaluated and undertreated to date. Myofascial pain must be assessed in all patients with CPPPS. Treatment of the myofascial pain component is relevant for global treatment success. Further studies are imperative to reinforce and better define the role of each physiotherapy technique in CPPPS. PATIENT SUMMARY: Pain and inflammation of the body's muscle and soft tissues (myofascial pain) frequently occurs in pelvic pain syndromes. Its presence must be evaluated to optimize management for each patient. If diagnosed, myofascial pain should be treated.