Recommendations on the management of pudendal nerve entrapment syndrome: A formalised expert consensus.

BACKGROUND: Since the development and publication of diagnostic criteria for pudendal nerve entrapment (PNE) syndrome in 2008, no comprehensive work has been published on the clinical knowledge in the management of this condition. The aim of this work was to develop recommendations on the diagnosis and the management of PNE. METHODS: The methodology of this study was based on French High Authority for Health Method for the development of good practice and the literature review was based on the PRISMA method. The selected articles have all been evaluated according to the American Society of Interventional Pain Physicians assessment grid. RESULTS: The results of the literature review and expert consensus are incorporated into 10 sections to describe diagnosis and management of PNE: (1) diagnosis of PNE, (2) patients advice and precautions, (3) drugs treatments, (4) physiotherapy, (5) transcutaneous electrostimulations (TENS), (6) psychotherapy, (7) injections, (8) surgery, (9) pulsed radiofrequency, and (10) Neuromodulation. The following major points should be noted: (i) the relevance of 4+1 Nantes criteria for diagnosis; (ii) the preference for initial monotherapy with tri-tetracyclics or gabapentinoids; (iii) the lack of effect of opiates, (iv) the likely relevance (pending more controlled studies) of physiotherapy, TENS and cognitive behavioural therapy; (v) the incertitudes (lack of data) regarding corticoid injections, (vi) surgery is a long term effective treatment and (vii) radiofrequency needs a longer follow-up to be currently proposed in this indication. CONCLUSION: These recommendations should allow rational and homogeneous management of patients suffering from PNE. They should also allow to shorten the delays of management by directing the primary care. SIGNIFICANCE: Pudendal nerve entrapment (PNE) has only been known for about 20 years and its management is heterogeneous from one practitioner to another. This work offers a synthesis of the literature and international experts' opinions on the diagnosis and management of PNE.

Effects of prismatic adaptation on balance and postural disorders in patients with chronic right stroke: protocol for a multicentre double-blind randomised sham-controlled trial.

INTRODUCTION: Patients with right stroke lesion have postural and balance disorders, including weight-bearing asymmetry, more pronounced than patients with left stroke lesion. Spatial cognition disorders post-stroke, such as misperceptions of subjective straight-ahead and subjective longitudinal body axis, are suspected to be involved in these postural and balance disorders. Prismatic adaptation has showed beneficial effects to reduce visuomotor disorders but also an expansion of effects on cognitive functions, including spatial cognition. Preliminary studies with a low level of evidence have suggested positive effects of prismatic adaptation on weight-bearing asymmetry and balance after stroke. The objective is to investigate the effects of this intervention on balance but also on postural disorders, subjective straight-ahead, longitudinal body axis and autonomy in patients with chronic right stroke lesion. METHODS AND ANALYSIS: In this multicentre randomised double-blind sham-controlled trial, we will include 28 patients aged from 18 to 80 years, with a first right supratentorial stroke lesion at chronic stage (≥12 months) and having a bearing ≥60% of body weight on the right lower limb. Participants will be randomly assigned to the experimental group (performing pointing tasks while wearing glasses shifting optical axis of 10 degrees towards the right side) or to the control group (performing the same procedure while wearing neutral glasses without optical deviation). All participants will receive a 20 min daily session for 2 weeks in addition to conventional rehabilitation. The primary outcome will be the balance measured using the Berg Balance Scale. Secondary outcomes will include weight-bearing asymmetry and parameters of body sway during static posturographic assessments, as well as lateropulsion (measured using the Scale for Contraversive Pushing), subjective straight-ahead, longitudinal body axis and autonomy (measured using the Barthel Index). ETHICS AND DISSEMINATION: The study has been approved by the ethical review board in France. Findings will be submitted to peer-reviewed journals relative to rehabilitation or stroke. TRIAL REGISTRATION NUMBER: NCT03154138.

Assessment of Intermittent Self-Catheterization Procedures in Patients with Neurogenic Lower Urinary Tract Dysfunction: Dutch Translation and Validation of the Intermittent Catheterization Satisfaction Questionnaire, Intermittent Catheterization Acceptance Test, Intermittent Self Catheterization Questionnaire and Intermittent Catheterization Difficulty Questionnaire.

BACKGROUND: Intermittent self-catheterization (ISC) is by far the most appealing therapy to achieve a complete bladder emptying in patients with neurogenic lower urinary tract dysfunction (NLUTD). Four questionnaires have been developed in French in order to assess patient's satisfaction, difficulties and acceptance of this technique. OBJECTIVES: The aim of this study was to translate, culturally adapt and validate Dutch versions of the Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ), the Intermittent Catheterization Acceptance Test (ICAT), the Intermittent Self Catheterization Questionnaire (ISCQ) and the Intermittent Catheterization Difficulty Questionnaire (ICDQ). METHODS: (1) Translation and cross-cultural adaptation of the questionnaires were performed according to the standardized guidelines. (2) The test of the pre-final version was performed by a group of bilingual lay people by comparing the original version of the questionnaires and the back translated one, assessing the comparability of language and comparability of interpretation. (3) Problematic issues were reviewed for correction. (4) Reliability was examined by intra-class correlation coefficients (ICC) statistics and Cronbach alpha analysis. RESULTS: Pre-test by 45 raters who are fluent in the source language led to an adapted and improved version of the translated questionnaires. Fifty native Dutch-speaking patients performing ISC (>6 months) due to an NLUTD were prospectively included. InCaSaQ, ICAT, ISCQ and ICDQ showed good internal consistency (α respectively (test and re-test): 0.79-0.88, 0.88-0.92, 0.85-0.88, and 0.88-0.86) and reproducibility (ICC respectively 0.77, 0.84, 0.84, and 0.87). CONCLUSION: The translated versions of InCaSaQ, ICAT, ISCQ and ICDQ are reliable and valid, allowing self-reported assessment of satisfaction, acceptance, difficulties and quality of life related to ISC in Dutch-speaking patients with NLUTD.

Intermittent Catheterization Adherence Scale (ICAS): A new tool for the evaluation of patient adherence with clean intermittent self-catheterization.

AIM: Patients who have successfully acquired the intermittent self-catheterization (ISC) technique can be expected to use it on a long-term basis. The aim of the present study is to present a validated evaluation scale, referred to as the ICAS (Intermittent Catheterization Adherence Scale), which can be used to assess long-term patient adherence to prescribed ISC treatment. METHODS: The scale was validated in neurologic and non neurologic patients in an experienced French neurourology center, between September 2014 and February 2016. Eight items were chosen, providing a relatively objective insight into the degree to which patients reduce the frequency of their ISC procedures. Various factors, including the patients' understanding of the procedure, its relevance to their specific condition, as well as their acceptance of its psychological and inherently time-consuming drawbacks, were evaluated. The ISC construct validity and reproducibility, based on internal test-retest consistency and test-retest reliability, were measured using the Intra-class Correlation Coefficient (ICC). RESULTS: The ICAS was validated in 222 patients (133 females, 89 males, mean age 53 ± 11 years). The patients' comprehension of the questions was found to be good, and the questionnaire was well accepted. Cronbach's alpha was 0.73. The ICC test-retest consistency was also found to be good. CONCLUSION: The ICAS is a simple, acceptable, valid and reproducible test, and in some cases it may facilitate the medical follow-up of ISC patients. In the clinical environment, it is found to be a valuable tool, which can assist medical staff in the prevention of complications related to ISC non-compliance.

Intermittent catheterization acceptance test (I-CAT): A tool to evaluate the global acceptance to practice clean intermittent self-catheterization.

AIM: In certain cases, a patient's anxiety, fear, or misconceptions can represent significant obstacles to the learning of Clean Intermittent Self Catheterization (CISC), and little is known about these psychological barriers. The aim of the present study is thus to construct and validate an "Intermittent Catheterization Acceptance Test (I-CAT)" to evaluate the psychological acceptance of CISC. METHODS: A study was carried out in nine neuro-rehabilitation and urology departments in French university hospitals. Fifty-five items were identified, following a comprehensive review of the literature and cognitive debriefing interviews with patients. Following an initial expert panel meeting (EPM) with a French-speaking neuro-urology study group (GENULF), this list was refined and reduced to a draft I-CAT comprising 34 items. The face validity of the draft I-CAT was determined, and the results were then analyzed in a second EPM, leading to the elaboration of a second version of the I-CAT (23 items, 5 dimensions). Psychometric validation of this second version was established from a longitudinal, non-randomized study involving 201 neurological and non-neurological patients. Linguistic validation was carried out in English. RESULTS: Following the construct validity analyses, several items were deleted due to item overlap, ceiling effects, or poor content validity and 14 items were retained. Confirmatory factor analysis shows that this version has 2 dimensions. Cronbach's alpha was 0.93. The ICC demonstrated good test-retest reliability and satisfactory responsiveness. CONCLUSION: The upstream identification and solving of potential psychological barriers prior to the learning of CISC could improve patients' acceptance of this procedure.

Nocturnal Urinary Disorders and Multiple Sclerosis: Clinical and Urodynamic Study of 309 Patients.

PURPOSE: The aim of this study was to describe nocturia with or without leakage in a population of patients with multiple sclerosis. MATERIALS AND METHODS: This is a retrospective, single center study of 309 patients with multiple sclerosis who were followed at an experienced neurourology center between 2011 and 2013. All patients had daytime urinary symptoms associated with this disorder. Among the patients with nocturia 2 groups were defined, including those with isolated nocturia but without nocturnal urinary incontinence and patients with nocturia associated with nocturnal urinary incontinence. The control group comprised patients without nocturia. The clinical variables and urodynamic data studied were gender, age, EDSS (Expanded Disability Status Scale), the USP (Urinary Symptoms Profile) questionnaire overactive bladder score, bladder capacity, detrusor activity and volume at the first detrusor contraction. RESULTS: Of our patients 53.3% had nocturia, including 35.7% with nocturnal urinary incontinence. The average ± SD USP overactive bladder score was statistically greater in patients with nocturia than in controls (9.14 ± 4.3 vs 5.1 ± 3.5, p = 8.21E-17). Mean maximum cystometric capacity was statistically higher in the control group than in patients with nocturia (380.17 ± 113.79 vs 313 ± 128.4 ml, p = 5.60E-6). A similar outcome was found for the first contraction (mean 232.58 ± 146.05 vs 181.14 ± 100.11 ml, p = 0.041). CONCLUSION: Isolated nocturia or nocturnal urinary incontinence is a frequent problem encountered with multiple sclerosis. Our results suggest that an overactive detrusor is the main mechanism. Further studies are needed to verify the complications arising from nocturia.

Intermittent catheterization difficulty questionnaire (ICDQ): A new tool for the evaluation of patient difficulties with clean intermittent self-catheterization.

AIMS: Once a catheterization technique has been learned and acquired, psychological barriers have been overcome and a specific catheter has been selected, a patient will need to use clean intermittent self-catheterization (CISC) on a long-term basis. Over this long period of time, several technical or anatomical difficulties and local complications may be observed. The aim of this study was to construct and validate a specific test, referred to as the ICDQ (intermittent catheterization difficulty questionnaire), in order to evaluate and quantify patients' difficulties during CISC. METHODS: The questionnaire was validated in neurogenic patients. Thirteen items were chosen, concerning ease of catheter insertion and withdrawal, the presence of pain, limb spasticity, urethral sphincter spasms, and local urethral bleeding during catheterization. The frequency and intensity of these difficulties were scored. The comprehension, relevance, psychological and time consumption acceptance and face validity were evaluated. Reliability (internal consistency and test-retest reliability using the Intraclass Correlation Coefficient [ICC]) was carried out. RESULTS: The ICDQ was validated in 70 neurogenic patients (mean age 51.6 ± 13, 44 females, 26 males). Comprehension and acceptance of the questionnaire were good. Cronbach's alpha was α = 0.88. The ICC demonstrated good test-retest reliability. CONCLUSION: The ICDQ is a valid test for the evaluation of catheter use, and of patients' difficulties during CISC. However, in order to facilitate CISC, we propose the interpretation of ICDQ results, drug combinations such as the use of alpha-blockers or botulinum toxin injections in the external urethral sphincter, or a change of catheter.

Influence of a distraction task on pelvic floor muscle contraction.

AIMS: Attention may play a key role in the contraction of pelvic floor muscles in stressful situations, meaning that mental distraction may be involved in urinary incontinence. METHODS: Informed consent was obtained from 20 healthy volunteers. The electromyographic (EMG) activity of the external anal sphincter (EAS) was recorded during voluntary contraction elicited by local stimulation. The trials were carried out twice: combined (or not) with a mental distraction task (PASAT), Paced auditory serial additional test. Reaction time, latency between the stimulus and maximum EAS EMG activity, duration of the contraction, maximum EAS EMG activity, and the area under the EAS EMG activity curve were measured. RESULTS: The mental distraction task led to a 3.98 times greater reaction time (RT), (P = 0.00001 Wilcoxon's test). The RT increased from 217 (IQR: 170-270) to 779 msec (IQR: 550-1,025, P < 0.0001) when the EAS contraction was combined with PASAT. However, the maximum EAS EMG activity was weaker during PASAT than in the absence of a mental distraction task: 0.0850 mv versus 0.0701 mv, that is, 1.21 times weaker (P = 0.00077, Wilcoxon's test). Finally, when the two conditions (respectively with and without the mental distraction task) were compared, no significant difference was found in the area under the EAS EMG activity curve (0.0157 mv sec vs. 0.0162 mv sec, ratio 1.01, P = 0.52). CONCLUSIONS: The mental distraction task altered voluntary contraction of the pelvic floor muscles.

Sexual Dysfunction Management and Expectations Assessment in Multiple Sclerosis-Female (SEA-MS-F): creation and validation of a specific questionnaire.

INTRODUCTION: Until now, no questionnaire has been developed to study specific expectations concerning sexual dysfunction management and the availability of information on sexuality in the female population affected by multiple sclerosis (MS). Understanding and meeting the patient's expectations is an issue of considerable importance in the evaluation of medical care. AIM AND MAIN OUTCOME MEASURE: We present the development and validation of a specific questionnaire designed for women with MS in order to assess their expectations in terms of sexual dysfunction management: the SEA-MS-F (Sexual Dysfunction Management and Expectations Assessment in Multiple Sclerosis-Female). METHODS: This questionnaire was created and validated by an expert panel, using the Delphi method. The psychometric evaluation was obtained with a sample of 40 female MS patients. Cronbach's alpha index and principal component analysis were used to measure the questionnaire's internal consistency. RESULTS: A consensus on the questionnaire was reached with the Delphi method. The SEA-MS-F is fully compliant with the criteria for psychometric validation among female MS patients, and its internal consistency is excellent (Cronbach's alpha 0.948). CONCLUSION: The SEA-MS-F appears to be a useful tool that could be used either in routine medical situations or in prospective studies of MS in order to ascertain women's expectations concerning the management of their sexual dysfunction.

Need to void and attentional process interrelationships.

OBJECTIVES: To determine whether a strong urge to void could affect a person's attentional performance. To determine whether an attentional task could decrease a strong urge to void a prospective study was performed. SUBJECTS AND METHODS: Healthy adults were asked to perform two neuropsychological tests, the modified Paced Auditory Serial Addition Test (mPASAT) and the Psychology Experiment Building Language Continuous Performance Test (pCPT), under two different conditions: no need to void, and a strong urge to void defined by a score of >70/100 mm on a visual analogue scale. RESULTS: In all, 21 healthy volunteers were included. There was no statistical difference between the mPASAT scores from the two sessions (P = 0.57). The mean total error score of the pCPT increased with the individual's urge to void (P = 0.043). The mean omission score decreased, but was not statistically different (P = 0.129), the commission error score increased with the urge to void (P = 0.017), with a shorter reaction time for the inter-stimuli intervals of 1 (P<0.001) and 2 s (P = 0.036), suggesting a tendency to hurry. CONCLUSIONS: A strong urge to void can alter attentional performance, with a tendency to hurry, in healthy volunteers taking part in a sustained attention test pCPT involving the use of the anterior cingulate cortex.

Posterior vaginal wall pull down maneuver: a clinical test to diagnose intrinsic sphincter deficiency in women suffering from genuine urinary stress incontinence.

OBJECTIVES: To assess the predictive value of a simple clinical test (posterior vaginal wall pull down maneuver) in the diagnosis of intrinsic sphincter deficiency. METHODS: The present prospective study included 62 women suffering from stress urinary incontinence. Every patient underwent a urogynecological examination including multichannel urodynamic testing (cystometry, urethral pressure profile, Valsalva Leak Point Pressure measurement) and a clinical examination including posterior vaginal wall pull down maneuver. Posterior vaginal wall pull down maneuver was carried out with the bladder filled with 400 mL of saline in a supine position, and was obtained by means of a split speculum allowing gentle pull down traction of the posterior vaginal wall. Posterior vaginal wall pull down maneuver was considered as positive when a urine leak was observed during the manoeuvre. Intrinsic sphincter deficiency was urodynamically defined by maximum urethral closure pressure ≤20 cmH2 O. Correlations between positive/negative posterior vaginal wall pull down maneuver and urodynamic intrinsic sphincter deficiency were calculated. RESULTS: There was a statistical correlation between age and low maximum urethral closure pressure (P < 0.0001), and between low maximum urethral closure pressure and positive posterior vaginal wall pull down maneuver (P < 0.0001). Regarding the intrinsic sphincter deficiency diagnosis, the posterior vaginal wall pull down maneuver positive predictive value was 94.67% and the negative predictive value was 95.4%, with a specificity of 97.6% and sensitivity of 90%. CONCLUSION: Posterior vaginal wall pull down maneuver is a reliable clinical test, easy to carry out, inexpensive and without significant risk. This test allows the diagnosis of intrinsic sphincter deficiency in women suffering from stress urinary incontinence, thus avoiding further invasive urodynamic testing (urethral pressure profile, Valsalva Leak Point Pressure measurement) in women with genuine stress urinary incontinence. Furthermore, it is helpful when choosing the type of sling procedure (retropubic vs transobturator) when a surgery is planned.