How to define failure of intradetrusor injections of botulinum toxin A for neurogenic detrusor overactivity.

INTRODUCTION: Neurogenic detrusor overactivity (NDO) has a major impact on patients' quality of life and can lead to upper urinary tract complications. Intradetrusor botulinum toxin type A injections are administered as second-line treatment to these patients following the failure of anticholinergic agents. The aim of the DETOX 2 study is to propose a consensus definition of the failure of intradetrusor botulinum toxin injections for NDO in patients presenting spinal cord injury, spina bifida, or multiple sclerosis (MS) with self-catheterization. METHOD: This study followed the method adopted by the French National Authority for Health for recommendations by consensus. Based on a review of the literature and a preliminary survey, a steering committee compiled a questionnaire and selected a rating group comprising 16 experts from the Neuro-Urology Committee of the French Urology Association (cnuAFU) and Genulf. The experts were asked to complete the online questionnaire. At the end of the first round, all participants came together to discuss any disagreements and a second-round online questionnaire was completed to reach a consensus. RESULTS: Thirteen of the 16 experts approached completed both rounds of questionnaires. A strong consensus was reached for two proposals (median score = 9/10) which were therefore included in the definition from the first round: at least one repeat injection of the same botulinum toxin at the same dose must be given to rule out failure on technical grounds and a duration of efficacy <3 months must be considered a failure. At the end of round 2, a relative consensus was reached regarding the clinical criterion defining failure (median score = 7/10) and the urodynamic criterion of failure (median score = 8/10). An additional proposal was selected during this second round on the need for a voiding diary (median score = 8/10). CONCLUSION: The first consensus definition of failure of an intradetrusor injection of TB-A for NDO has been achieved with this study: persistence of detrusor overactivity with maximum detrusor pressures >40 cm H2O and/or a compliance issue and/or persistence of urinary incontinence and/or urgency and/or a number of daily self-catheterizations >8/day and/or efficacy <3 months. This study will help to standardize research on the failure of the intradetrusor botulinum toxin for NDO in clinical practice and clinical research.

Botulinum Toxin Type A Injection After Failure of Augmentation Enterocystoplasty Performed for Neurogenic Detrusor Overactivity: Preliminary Results of a Salvage Strategy. The ENTEROTOX Study.

OBJECTIVE: To evaluate the clinical efficacy, urodynamic effect and safety of Botulinum Toxin A (BTXA) injections after failure of augmentation enterocystoplasty (AE) performed for neurogenic detrusor overactivity. PATIENTS AND METHODS: We performed a multicenter retrospective study that included patients who had AE and at least one injection of BTXA after AE in 15 GENULF (French Speaking Neuro-Urology Study Group) centers. Clinical and urodynamic data were collected from medical files according to a standardized questionnaire and colligated in an anonymous database. RESULTS: Thirty-three patients with an injection of BTXA after AC in 9 out of 15 centers were included. Mean age at the time of AE was 24 ± 15 years. Overall efficacy (defined by clinical efficacy associated with a request by the patient for reinjection) was observed in 58% of the patients. Mean maximum cystomanometric capacity increased by 28% (333 ± 145 vs 426 ± 131 mL; P = .007) and maximum detrusor pressure (Pdet max) decreased by 43% (44 ± 37 vs 25 ± 18 cm H2O; P = .02) after BTXA. Only one side effect was recorded out of the 152 procedures (transient generalized muscle weakness without respiratory distress). CONCLUSION: In patients with failure after AE performed for neurogenic detrusor overactivity, injection of BTXA in the enlarged bladder was effective in over half of the cases with low morbidity. If this therapeutic approach were confirmed, it could be proposed as an alternative to AE surgical revision.

User perception of a new hydrophilic-coated male urinary catheter for intermittent use.

AIMS: This study investigated user perception and adherence related to a hydrophilic-coated urinary catheter (LoFric® Origo™), available for male patients who practice intermittent catheterization. DESIGN: The study had a prospective observational design, including patients from 19 European hospitals. METHODS: A total of 416 patients were eligible for the study; 179 experienced catheter users and 237 de novo. Two questionnaires were filled out, one describing background data and a second, 8 weeks later, evaluating catheter features. RESULTS: The response rate for the second questionnaire was 88% (365 patients). Patients evaluating the new catheter showed a general satisfaction rate of 81% and 72% kept using it. The hygienic grip of the catheter was appreciated by 85% and the foldable feature by 67%. The results show that convenience, ease of use, and hygienic factors are patient-preferred features for a urinary catheter. These factors were confirmed for the evaluated hydrophilic-coated catheter.

Intradetrusor Injections of Botulinum Toxin A in Adults with Spinal Dysraphism.

PURPOSE: The aim of the current study was to determine the outcomes of botulinum toxin A intradetrusor injections in adult patients with spina bifida. MATERIALS AND METHODS: All patients with spinal dysraphism who underwent intradetrusor injections of botulinum toxin A from 2002 to 2016 at a total of 14 centers were retrospectively included in analysis. The primary end point was the global success of injections, defined subjectively as the combination of urgency, urinary incontinence and detrusor overactivity/low bladder compliance resolution. Univariate and multivariate analysis was performed to seek predictors of global success. RESULTS: A total of 125 patients were included in study. The global success rate of the first injection was 62.3% with resolution of urinary incontinence in 73.5% of patients. All urodynamic parameters had improved significantly by 6 to 8 weeks compared to baseline, including maximum detrusor pressure (-12 cm H2O, p <0.001), maximum cystometric capacity (86.6 ml, p <0.001) and compliance (8.9 ml/cm H2O, p = 0.002). A total of 20 complications (3.6%) were recorded for the 561 intradetrusor botulinum toxin A injections, including 3 muscular weakness complications. The global success rate of the first injection was significantly lower in patients with poor compliance (34.4% vs 86.9%, OR 0.08, p <0.001). On multivariate analysis poor compliance was associated with a lower global success rate (OR 0.13, p <0.001). Female gender (OR 3.53, p = 0.01) and patient age (OR 39.9, p <0.001) were predictors of global success. CONCLUSIONS: Intradetrusor botulinum toxin A injections were effective in adult patients with spina bifida who had detrusor overactivity. In contrast, effectiveness was much lower in adult patients with spina bifida who had poor bladder compliance. The other predictors of global success were female gender and older age.

Sacral neuromodulation and pregnancy: Results of a national survey carried out for the neuro-urology committee of the French Association of Urology (AFU).

AIMS: To assess the impact of sacral neuromodulation (SNM) on pregnancy and vice-versa, by identifying women who had received SNM for lower-urinary tract symptoms (LUTS) and had become pregnant. METHODS: A cross-sectional descriptive study was carried out based on responses to an on-line questionnaire sent to practitioners listed on the InterStim enCaptureTM National Registry. Questions were related to pre-pregnancy health and SNM efficacy, deactivation of the device, its impact on LUTS, childbirth, the infant, its reactivation and postpartum effectiveness. RESULTS: Twenty-seven pregnancies were recorded among 21 women. Six women had had a pregnancy prior to implantation, two of whom had had a c-section. A total of 18.5% of women had the device disabled prior to conception. The others had their device disabled during the first trimester and did not reactivate it before delivery. Complications were reported in 25.9% of pregnancies: six women had urinary infections, including three of the four treated for chronic retention of urine (CRU), and 1 woman had pain at the stimulation site. There were 24 live births (including one premature birth and four c-sections), one spontaneous miscarriage and two voluntary interruptions of pregnancy. No neonatal disorders have been reported. Effectiveness of sacral neuromodulation decreased in 20% in postpartum. CONCLUSIONS: In 27 pregnancies established during SNM for LUTS, 18.5% of patients deactivated their case before pregnancy and the others switched it off during the first trimester. Three-quarters of women with CRU had urinary infection. No adverse effects on fetuses were found. SNM effectiveness deteriorated in 20% cases after childbirth.

Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial.

OBJECTIVE: Our aim was to assess the usefulness of cranberry extract in multiple sclerosis (MS) patients suffering from urinary disorders. METHODS: In total, 171 adult MS outpatients with urinary disorders presenting at eight centers were randomized (stratification according to center and use of clean intermittent self-catheterization) to cranberry versus placebo in a 1-year, prospective, double-blind study that was analyzed using a sequential method on an intent-to-treat basis. An independent monitoring board analyzed the results of the analyses each time 40 patients were assessed on the main endpoint. Cranberry extract (36 mg proanthocyanidins per day) or a matching placebo was taken by participants twice daily for 1 year. The primary endpoint was the time to first symptomatic urinary tract infection (UTI), subject to validation by a validation committee. RESULTS: The second sequential analyses allowed us to accept the null hypothesis (no difference between cranberry and placebo). There was no difference in time to first symptomatic UTI distribution across 1 year, with an estimated hazard ratio of 0.99, 95% CI [0.61, 1.60] (p = 0.97). Secondary endpoints and tolerance did not differ between groups. CONCLUSION: Taking cranberry extract versus placebo twice a day did not prevent UTI occurrence in MS patients with urinary disorders. Trial Registration NCT00280592.

First-line urological evaluation in multiple sclerosis: validation of a specific decision-making algorithm.

BACKGROUND: Urinary disorders that lead to urological complications are frequent in multiple sclerosis, resulting in diminished quality of life. Urinary management guidelines are scarce and targeted to neuro-urology specialists. OBJECTIVE: This study aimed to construct and validate an algorithm dedicated to neurologists and general practitioners to facilitate first-line evaluation and treatment of urinary disorders associated with multiple sclerosis. METHODS: 49 items concerning urological symptom evaluation and therapeutic strategies were derived from literature analysis and evaluated by an expert panel. The Delphi method established consensus between the experts and allowed development of the First-Line Urological Evaluation in Multiple Sclerosis (FLUE-MS) algorithm. Two questions from the Urinary Bothersome Questionnaire in Multiple Sclerosis were included and their validation to verify comprehensiveness and acceptability was also conducted. RESULTS: Three rounds of expert review obtained consensus of all 49 items and allowed finalisation of the algorithm. Comprehension and acceptability of two Urinary Bothersome Questionnaire in Multiple Sclerosis questions were verified (mean comprehensiveness score: 1.99/2 [99.7% total comprehensiveness], mean acceptability score: 1.99/2 [99.1% complete acceptability]). CONCLUSION: The FLUE-MS algorithm was designed for neurologists and general practitioners, enabling identification of 'red flags', timely patient referral to specialist neuro-urology units, and appropriate first-line therapy.

Neurogenic lower urinary tract dysfunction.

The two roles of the lower urinary tract are storage of urine and emptying at appropriate times. Optimal and coordinated activity of the bladder and urethra is subject to complex neural control which involves all levels of the nervous system, from cortex to peripheral nerve. This explains the high prevalence of urinary disturbances in neurological disease. Information obtained from history taking and supplemented by use of a bladder diary forms the cornerstone of evaluation. Ultrasonography is used to assess the degree of incomplete bladder emptying, and for assessing the upper tracts. Urodynamic tests, with or without simultaneous fluoroscopic monitoring, assess detrusor and bladder outlet function and give fundamental information about detrusor pressure and thus the risk of upper tract damage. Impaired emptying is most often managed by clean-intermittent self-catheterization, which should be initiated if the postvoid residual urine exceeds one-third of bladder capacity or is greater than 100mL, or rarely if spontaneous voiding is dangerous due to high detrusor pressure. Storage symptoms are most often managed using antimuscarinic medications. Intradetrusor injection of botulinum toxin type A is emerging as an effective treatment for managing detrusor overactivity. Understanding of the underlying mechanism of lower urinary tract dysfunction is crucial for effective management.

Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study.

AIMS: Electrostimulation is an established therapeutic option for neurogenic urinary disorders. The aim of this study was to investigate the efficacy of the noninvasive technique of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with multiple sclerosis (MS) and troublesome symptoms of an overactive bladder (OAB). METHODS: A multicentric study enrolled 70 MS patients, suffering from OAB for a 3-month study period. INTERVENTION: Daily sessions of 20 min of TPTNS were provided. No change of associated treatments during the study period. The primary outcome measurement was Urgency and Frequency reported by bladder diary and symptom score performed before the treatment (Day 0, D0) and at D30 and D90. The secondary outcomes measurements were continence, symptom score, quality of life, psychosocial burden at DO, D30, and D90 and cystometry at baseline, with and without TPTNS and at D90. RESULTS: Clinical improvement of OAB was shown in 82.6% and 83.3% of the patients on D30 and D90, respectively, with significant improvement of primary and secondary outcomes compared to baseline. The initial acute cystometric response to TPTNS was positive in 51.2% of the patients (increase of >30% of cystometric capacity and/or reflex volume), without correlation with TPTNS clinical efficiency. The procedure was well tolerated. CONCLUSIONS: Chronic TPTNS appears to be effective in the management of severe OAB in MS, without compromising bladder emptying or inducing side effect. Treatment may be effective even in the absence of an acute cystometric effect. Additional works are required to demonstrate long-term efficacy of TPTNS.

Rehabilitation in practice: neurogenic lower urinary tract dysfunction and its management.

This series of articles for rehabilitation in practice aims to cover a knowledge element of the rehabilitation medicine curriculum. Nevertheless they are intended to be of interest to a multidisciplinary audience. The competency addressed in this article is 'the trainee consistent demonstrates a knowledge of the pathophysiology of various specific impairments including bladder dysfunction' and 'management approaches for specific impairments including bladder dysfunction'. The lower urinary tract (bladder and urethra) has two roles: storage of urine and emptying at appropriate times. The optimal and coordinated activity of the lower urinary tract is subject to a complex neural control which involves all levels of the nervous system, from cortex to peripheral innervation. The complexity of the neural control of lower urinary tract explains the high prevalence of urinary disturbances in neurologic disease. Information obtained from history taking and supplemented by use of a bladder diary forms the cornerstone of evaluation. Ultrasonography is used to assess the degree of incomplete bladder emptying, and for assessing the upper tracts. Urodynamic tests, with or without simultaneous fluoroscopic monitoring, assess detrusor and bladder outlet function and give fundamental information about detrusor pressure and thus the risk factor for upper tract damage. Impaired emptying is most often managed by clean intermittent self-catheterization and this should be initiated if the post-void residual urine is greater than 100 mL or exceeds one third of bladder capacity, or rarely if spontaneous voiding is dangerous due to high detrusor pressure. Storage symptoms are most often managed using antimuscarinic medications. Other options include desmopressin to reduce urine output or intra-detrusor injection of botulinum toxin type A to reduce detrusor overactivity. Understanding of the underlying mechanism of lower urinary tract dysfunction is crucial for effective management.

Botulinum toxin-A (Botox) intradetrusor injections in children with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review.

OBJECTIVES: Describe and discuss the efficacy and safety of botulinum toxin type A (BTX-A) intradetrusor injections in children with neurogenic detrusor overactivity (NDO) and urinary incontinence or overactive bladder symptoms of neurogenic origin (NOAB). METHODS: A MEDLINE and EMBASE search for clinical studies involving BTX-A injected into the detrusor of children with NDO or NOAB was performed, prior to data analysis. RESULTS: A total of six articles evaluating the efficacy and safety of Botox in patients with NDO and incontinence/NOAB were selected. The underlying neurological disease was myelomeningocele in 93% of patients. Most were over 2 years of age. The most common amount of Botox injected was 10-12 U/kg with a maximal dose of 300 U, usually as 30 injections of 10 U/ml in the bladder (excluding the trigone) under cystoscopic guidance and general anaesthesia. Most of the studies reported a significant improvement in clinical (65-87% became completely dry) as well as urodynamic (in most studies mean maximum detrusor pressure was reduced to <40 cm H(2)O and compliance was increased >20 ml/cm H(2)O) variables, without major adverse events. CONCLUSIONS: Botox injections into the detrusor provide a clinically significant improvement and seem to be very well tolerated in children with NDO and incontinence/NOAB refractory to antimuscarinics.

An orthosis and physiotherapy programme for camptocormia: a prospective case study.

OBJECTIVE: Camptocormia, or bent spine syndrome, is an acquired postural disease leading to lumbar kyphosis observed when the patient stands up. Classic orthoses and physiotherapy programmes provide little correction and are often poorly tolerated. The aim of this study was to evaluate the effectiveness and tolerance of a new orthosis combined with physiotherapy for treating camptocormia. METHODS: Fifteen patients (5 men and 10 women, 71.4 (standard deviation (SD) 7.3) years old) consulting for camptocormia were consecutively included in the study. Patients who had pain when they straightened up were excluded. Patients equipped with the orthosis were hospitalized for 5 days in order to learn a self-rehabilitation programme. They were evaluated before and after hospitalization, then at 30 and 90 days. RESULTS: In comparison with day 0 (without orthosis), the mean increase in lumbar lordosis with the orthosis was 10.1 degrees (SD 9.9) at day 30 (p < 0.05) and 12.5 degrees (SD 9.7) at day 90 (p < 0.001). Average pain values showed a reduction of 69% (SD 36) and 70% (SD 35) in the initial pain at days 30 and 90, respectively. The average increase in quality of life was 87% and 92% at days 30 and 90, respectively. CONCLUSION: This new orthosis, relying on the principle of thoraco-pelvic anterior distraction, gives excellent results in the treatment of camptocormia.

Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review.

OBJECTIVES: This systematic literature review discusses the efficacy and safety of botulinum toxin type A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity (NDO) and urinary incontinence or overactive bladder symptoms of neurogenic origin (NOAB). METHODS: A MEDLINE and EMBASE search for clinical studies with botulinum toxin A injected into the detrusor of adults with NDO was performed. For several efficacy and safety variables data were extracted by one person and independently quality-controlled by another person. Extracted data were reviewed to propose recommendations for use in clinical practice based on level of evidence and expert opinion. RESULTS: A total of 18 articles evaluating the efficacy or safety of Botox in patients with NDO and incontinence/NOAB resistant to antimuscarinic therapy, with or without clean intermittent self-catheterisation (CIC), were selected. The amount of Botox injected was mostly 300 U, usually as 30 injections of 10 U/ml in the bladder (excluding the trigone) under cystoscopic guidance and with different types of anaesthesia. Most of the studies reported a significant improvement in clinical (approximately 40-80% of patients became completely dry between CICs) as well as urodynamic (in most studies mean maximum detrusor pressure was reduced to < or =40 cm H(2)O) variables and in the patients' quality of life, without major adverse events. CONCLUSIONS: Botox injections into the detrusor provide a clinically significant improvement in adults with NDO and incontinence/NOAB refractory to antimuscarinics. It seems to be very well tolerated. However, more adequately powered, well-designed, randomised, controlled studies evaluating the optimal dose, number and location of injections, impact on antimuscarinic regimen and CIC use, duration of effect, and when to perform repeat injections are warranted.

The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines.

Vesicourethral dysfunction is very frequent in multiple sclerosis (MS) and has functional consequences for patients' quality of life and also an organic impact following complications of the neurogenic bladder on the upper urinary tract. While the functional impact and its management are well documented in the literature, the organic impact remains underestimated and there are no consensual practical guidelines for the screening and prevention of MS neurogenic bladder complications. The aim of this review of the literature, focused on identifying the risk factors of urinary tract complications in MS, is to put forward well informed considerations to help in the definition of practical guidelines for the follow-up of the neurogenic bladder in MS in order to improve its prevention and patient management. Four main risk factors have been identified for upper urinary tract damage: the duration of MS, the presence of an indwelling catheter, high-amplitude neurogenic detrusor contractions and permanent high detrusor pressure. Detrusor-sphincter dyssynergia, age over 50 and male sex may form three additional risk factors. Recommendations for long-term urological follow-up, taking into account these specific risks are constructed according to the procedures recommended by the French Health Authorities.

Intravesical glucidic capsaicin versus glucidic solvent in neurogenic detrusor overactivity: a double blind controlled randomized study.

AIMS: Many studies report the use of alcoholic capsaicin instillation to treat neurogenic detrusor overactivity (NDO) in spinal cord injured (SCI) and multiple sclerosis (MS) patients. However, poor tolerability due to the irritative effect of the ethanol solvent limits its use. Our study aimed to evaluate the efficacy and tolerability of a new formulation of capsaicin in a glucidic solution in a multicenter clinical trial. MATERIALS AND METHODS: Thirty-three patients (26MS/7SCI) suffering from urinary incontinence due to refractory NDO were prospectively enrolled in a double-blind placebo controlled study and randomized to capsaicin group (CG, N = 17) or solvent group (SG, N = 16). They respectively received an intravesical instillation of 100 ml capsaicin diluted in glucidic solvent (CG) or glucidic solvent alone (SG). Efficacy (voiding chart, maximum cystometric capacity (MCC)) and tolerability were evaluated on days 0 (D0), 30 and 90. RESULTS: On D0, groups were homogeneous. On D30, significant improvement of overactive bladder syndrome and an increase in MCC were shown in CG, whereas there were no improvement in SG. No significant improvement was shown on D90 in both groups. There were no significant differences between groups regarding prevalence, duration, or intensity of side effects, except for short duration pubic pain during instillation more often reported in CG (58.8%) than in SG (12.5%) (P < 0.01). CONCLUSION: This placebo controlled study using glucidic capsaicin confirms its short-term efficacy in NDO patients. Global tolerance of glucidic capsaicin appeared satisfactory. Long-term efficacy and tolerance of repeated glucidic capsaicin instillations need to be evaluated.

Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study.

PURPOSE: We determined the safety and efficacy of each of 2 doses of botulinum toxin type A (BTX-A) (200 or 300 U BOTOX) injected into the detrusor for urinary incontinence caused by neurogenic detrusor overactivity of predominantly spinal cord origin. MATERIALS AND METHODS: A total of 59 patients with urinary incontinence caused by neurogenic detrusor overactivity (due to spinal cord injury in 53 and multiple sclerosis in 6) requiring clean intermittent self-catheterization were randomized to receive a single dose into the detrusor of BTX-A (200 U or 300 U) or placebo. Changes in daily frequency of urinary incontinence episodes were monitored via a patient bladder diary during 24 weeks. Key urodynamic assessments (maximum cystometric capacity, reflex detrusor volume and maximum detrusor pressure during bladder contraction) were used to provide objective measures of the treatment effect on bladder function. The impact of treatment on quality of life was assessed using the Incontinence Quality of Life questionnaire. RESULTS: There were significant posttreatment decreases in incontinence episodes from baseline in the 2 BTX-A groups (p

Intravesical capsaicin versus resiniferatoxin for the treatment of detrusor hyperreflexia in spinal cord injured patients: a double-blind, randomized, controlled study.

PURPOSE: Chemical defunctionalization of C-fiber bladder afferents with intravesical vanilloids such as capsaicin (CAP) or resiniferatoxin (RTX) improves detrusor hyperreflexia in humans and animals. The little existing data comparing the efficacy and tolerance of these 2 vanilloid agents seem to favor RTX in 10% alcohol over CAP, which is usually diluted in 30% alcohol. We compared the efficacy and tolerability of the 2 vanilloid agonists in what to our knowledge is the first randomized, controlled study comparing nonalcohol CAP vs RTX in 10% alcohol in neurogenic patients with detrusor hyperreflexia. MATERIALS AND METHODS: This single center, randomized, double-blind, parallel groups study included 39 spinal cord injured adults with detrusor hyperreflexia. On day 0 patients were randomized to receive 1, 100 ml intravesical instillation of 100 nMol/l RTX diluted in 10% ethanol or 1 mmol/l CAP diluted in glucidic solvent. Efficacy (voiding chart and cystomanometry) and tolerability were evaluated during a 3-month followup. RESULTS: On day 30 clinical and urodynamical improvement was found in 78% and 83% of patients with CAP vs 80% and 60% with RTX, respectively, without a significant difference between the 2 treated groups. The benefit remained in two-thirds of the 2 groups on day 90. There were no significant differences in regard to the incidence, nature or duration of side effects in CAP vs RTX treated patients. CONCLUSIONS: Our results strongly argue for the importance of accounting for the role of vanilloid solute when interpreting the efficacy and tolerance of vesical vanilloid instillation in detrusor hyperreflexia cases. They suggest that a glucidic solute is a valuable solvent for vanilloid instillation.

Botulinum a toxin and detrusor sphincter dyssynergia: a double-blind lidocaine-controlled study in 13 patients with spinal cord disease.

OBJECTIVE: To compare the efficacy and tolerance of botulinum A toxin (BTx) versus lidocaine (L), applied in the external urethral sphincter with a single transperineal injection in order to treat detrusor sphincter dyssynergia (DSD) in spinal cord injured patients. METHODS: Thirteen patients (1F, 12 M) suffering from chronic urinary retention due to DSD were randomised to receive one transperineal injection of 100 IU BTx Botox degrees in 4 ml of 9% saline (botulinum group, (BG)) or 4 ml of 0.5% L (lidocaine group, (LG)). The main criteria of efficacy was post-voiding residual urine volume (PRUV), assessed three times daily on day one (D1), D7 and D30 after each injection. Other criteria were micturition diary, satisfaction score (SS), maximal urethral pressure (MUP), maximum detrusor pressure (DP) and type of DSD, recorded on D0 and D30. RESULTS: In the BG, there was a significant decrease in PRUV (D7: -141.4 ml (p<0.03); D30: -159.4 ml (p<0.01)), in MUP (D30: -32 cm H(2)O, p<0.04) whereas no significant improvement was shown in the LG. SS was higher in BG than LG (p<0.02). DSD improved in BG whereas it remained unchanged in LG. All LG patients also received one injection of BTx on D30. They still presented improvement in PRUV and MUP 1 month later (D30'). Tolerance appeared satisfactory in both groups. CONCLUSIONS: The preliminary results of this initial randomised double-blind study clearly demonstrated the superiority of BTx compared to L in improving clinical symptoms and urethral hypertonia associated with DSD in spinal cord injured patients.