Efficacy, Tolerability and Safety of Propiverine Hydrochloride in Children and Adolescents with Congenital or Traumatic Neurogenic Detrusor Overactivity—A Retrospective Study

Objectives

Anticholinergic treatment combined with intermittent catheterisation is the cornerstone of the conservative treatment strategy in children with neurogenic detrusor overactivity, which in most cases is due to congenital causes. Efficacy, tolerability and safety of propiverine hydrochloride were evaluated retrospectively in these children.

Methods

At four specialized outpatient clinics, all children's records were scrutinized for first-line propiverine hydrochloride treatment, or second- or third-line treatment after failure of a non-selective alpha-blocker (phenoxybenzamine) and/or other anticholinergics (oxybutynin, trospium chloride). The primary efficacy outcomes were urodynamic parameters, with clinical symptoms as secondary outcomes. Statistical analysis was performed by paired t-tests (significance level p < 0.05).

Results

Altogether 74 children and adolescents (40 boys, 34 girls; age range 11 months–19 years) were treated with propiverine hydrochloride (average duration 2 years and approximately 4 months; individual dose range 5–75 mg). The primary efficacy outcome parameters improved significantly: maximum cystometric capacity 161.2 [standard deviation (SD) 97.3] to 252.2 ml (SD 117.2), p < 0.001; maximum detrusor pressure 43.8 (SD 39.2) to 27.1 cm H₂O (SD 26.4), p = 0.002; bladder compliance 7.6 (SD 6.4) to 17.0 ml/cm H₂O (SD 16.2), p < 0.001. Phasic detrusor overactivity was abolished by 63%; incontinence resolved by 54%. One patient spontaneously reported a typical anticholinergic adverse event, which resolved after dose reduction. No safety concerns were documented.

Conclusions

Propiverine hydrochloride is effective in neurogenic detrusor overactivity in children and adolescents, even in some of those cases unresponsive to other anticholinergics. The low incidence rate (<1.5%) of adverse events evidences a favourable risk-benefit profile of propiverine hydrochloride, considering in particular the total documented treatment and surveillance period of 171 patient years and nine months.     

Anticholinergic Drugs for Adult Neurogenic Detrusor Overactivity: A Systematic Review and Meta-analysis

Context

There is a lack of evidence about the efficacy and safety of anticholinergic drugs and about the optimal anticholinergic drug, if any, for the treatment of adult neurogenic detrusor overactivity (NDO).

Objective

Review the current evidence on the efficacy, safety, and tolerability of anticholinergic drugs in the treatment of adult NDO.

Evidence acquisition

A literature search was conducted from 1966 to May 2011. Meta-analysis of all published randomised controlled trials (RCTs) comparing anticholinergic drugs with placebo and comparing different types, doses, and routes of administration of anticholinergic drugs, in adults with NDO, was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. The primary outcome was patient-reported cure/improvement of overactive bladder symptoms. Secondary outcomes were quality of life (QoL) changes, bladder diary events, urodynamic outcomes, adverse events, and costs to health services.

Evidence synthesis

A total of 960 patients from 16 RCTs with mean follow-up of 3.8 wk were included. Anticholinergic drugs were associated with statistically significantly better patient-reported cure/improvement (risk ratio: 2.80; 95% confidence interval [CI], 1.64 to 4.77), higher maximum cystometric capacity (weighted mean difference [WMD]: 49.49; 95% CI, 15.38 to 84.20), higher volume at first contraction (WMD: 49.92; 95% CI, 20.06 to 79.78), and lower maximum detrusor pressure (WMD: −38.30; 95% CI, −53.17 to −23.43) when compared with placebo. The dry-mouth rates were statistically significantly higher with anticholinergics, with no difference in withdrawals because of adverse events. There was no statistically significant difference in any of the outcomes between oxybutynin and other anticholinergics or among different doses and preparations of anticholinergic drugs. No study reported QoL changes or costs to health services.

Conclusions

Compared with placebo, anticholinergic treatment in patients with NDO is associated with better patient-reported cure/improvement and significant reduction of maximum detrusor pressure; however, there is a higher incidence of adverse events. None of the anticholinergic drugs or different dosages assessed in this review was superior to another.     

Neurogenic Bladder: Past,Present, and Future

Abstract

Summary: The foundation of the management of neuragenie bladder can be attributed to a pioneer in spinal cord injury medicine. Dr. Donald Munro, a neurosurgeon, who also had experience in urologic surgery, established the firstSpinal Cord lnjury Service of 1 0 beds in the Boston Cityhospital in the 1 930s. He later became adviser to the US Army and the Veterans Administration (VA). On his recommendation, paraplegic centers were created in US army hospitals and later in the VA hospitals from 1 943 to 1945. This article reviews the evolution of the management of neuragenie bladder in patients with spinal cord injuries from the past century to the present. The role of urodynamics in defining neurologic lesions is critical to the appropriate management of the voiding dysfunction. Key advances, such as the diagnosis of detrusor sphincter dyssynergia (DSD), recognition of its association with autonomic dysreflexia, and its definitive management, have been emphasized. The role of transrectallinear array sonography using a rectal probe was found useful for defining bladder outlet dysfunction du ring urodynamics. lt also helped to recognize secondary bladder neck obstruction and diagnose false passages in the urethra. Clean technique intermittent catheterization (IC) was evaluated and recommended. ln about 28'7'o patients with DSD that led to secondary bladder neck obstruction, a consequence of IC was reported. Transurethrallaser sphincterotomy (TURS) was first reported by mein 1 991, and later, durable 7 -yearfollow-up results were reported in 78'7'o of the first 99 patients. We reported a surgical technique to lengthen the penis. We also reported the long-term success with semirigid implants in 92'7'o of patients with SCI. This technique helped maintain external condom drainage on a small phallus and improved the sex life of patients, as weil as their quality of life. The author's pertinent areas of interest in the past one-half century were aimed at recognizing specific urologic problems associated with neurologic impairment. Management was aimed at preventive care, early recognition, and timely management to reduce secondary complications and enhance quality of life.     

Use of botulinum toxin in individuals with neurogenic detrusor overactivity: State of the art review

Background

Botulinum neurotoxin (BoNT) injection into the bladder wall has been shown to be an effective alternative to anticholinergic (antimuscarinic) medications and more invasive surgery in those with multiple sclerosis and spinal cord injury with neurogenic detrusor overactivity (NDO) and urinary incontinence who are not tolerating anticholinergic medications. In August 2011, Botox^® (onabotulinumtoxinA) received Food and Drug Administration (FDA) approval for this use. Clinically, intradetrusor injection of BoNT has been found to decrease urinary incontinence and improve quality of life. Its impact on urodynamic parameters is an increase in the maximum cystometric (bladder) capacity and decrease in the maximum detrusor pressures. The most common side effects are urinary tract infections and urinary retention. There have been rare reports and a black box warning of distant spread of BoNT. BoNT has gained popularity because of its effectiveness and long duration of action, relative ease of administration, easy learning curve, reproducibility of results on repeated administration, and low incidence of complications.

Objective

To discuss the structure and function, mechanisms of action, clinical and urodynamic studies, injection technique, potential beneficial and adverse effects, and potential areas of research of BoNT.

Methods

Literature search focused on botulinum toxin in MEDLINE/PubMed. Search terms included botulinum toxin, neurogenic bladder, NDO, botox bladder, botox spinal cord injury, botox, FDA, botox side effects. All papers identified were English language, full-text papers. In addition, English abstracts of non-English papers were noted. The reference list of identified articles was also searched for further papers.

Conclusion

Botulinum toxin is an alternative treatment for individuals with NDO who fail to tolerate anticholinergic medications. Its popularity has increased because of the literature, which has supported its effectiveness, safety, easy use and learning curve, reproducibility of results on repeated use, and recent FDA approval of Botox^® (onabotulinumtoxinA).     

Efficacy and Tolerability of Botulinum Toxin Type A in Patients with Neurogenic Detrusor Overactivity and Without Concomitant Anticholinergic Therapy: Comparison of Two Doses

Background

Botulinum toxin type A (BoNTA) has been reported to be effective for treatment of patients with neurogenic detrusor overactivity (NDO) refractory to anticholinergic agents. However, in most of the studies, the efficacy was associated with concomitant use of anticholinergics.

Objective

To evaluate the efficacy and tolerability of BoNTA and compare two different doses in patients with NDO without concomitant anticholinergics.

Design, setting, and participants

Between 2004 and 2006, adults with NDO refractory to anticholinergics or discontinued anticholinergics due to adverse events or contraindications from four different French clinical centres were included in a prospective, randomised, double-blind, comparative trial. Inclusion criteria were urinary incontinence (UI) resulting from NDO that could not be managed with anticholinergics. Patients with bladder cancer, lithiasis, or urinary infection were excluded.

Intervention

Patients were randomised to receive an intradetrusor injection of 500 U or 750 U of BoNTA.

Measurements

The initial evaluation (ie, clinical and urodynamic variables and quality of life [QoL]) was repeated at days 30, 90, 180, and 360. Primary outcome was complete continence rate at day 30. Secondary outcomes were cumulative incontinence rate, reappearance of leakages, pad usage, urodynamics, and QoL.

Results and limitations

Seventy-seven patients received 500 U (n = 39) or 750 U (n = 38) of BoNTA and were included in the full analysis set for efficacy analysis. Complete continence at day 30 was observed in 22 patients (56.4%) and 28 patients (73.7%) receiving 500 U or 750 U of BoNTA, respectively (p = 0.056; one-sided χ² test to compare to α = 0.025). The median delay in the reappearance of leakages was 168 d. Monotherapy of BoNTA significantly improved UI in patients with NDO. Although there was a trend towards a greater improvement with 750 U of BoNTA, no statistically significant differences in terms of clinical and urodynamic variables and QoL were found between the treatment groups. Tolerability was excellent and equivalent for both doses.

Conclusions

Monotherapy of BoNTA at Dysport (Ipsen, Brisbane, CA, USA) doses of 500 U or 750 U seems to be effective and well tolerated in patients with NDO.     

Reliability Of Cystometrically Obtained Intravesical Pressures In Patients With Neurogenic Bladders

Abstract

Background and Purpose: Urodynamic studies in patients with neurogenic bladder detect and categorize neurourodynamic states, identify the risk for urologic sequelae, and determine the necessity for interventions. Because urodynamic studies serves as a prognostic indicator and guides patient management, pressure measurements during the study must accurately represent bladder function under physiologic conditions. Because nonphysiologic bladder filling used during conventional urodynamic studies may alter the bladder s accommodative properties, we studied how closely the intravesical pressures obtained before filling cystometry resembled those obtained during the filling phase of the cystometrogram.

Methods: Twenty-two patients (21 men, 1 woman) with neurogenic bladders underwent standard urodynamic studies. A 16F triple-lumen catheter was inserted into the bladder, and the intravesical pressures were recorded (physiologic volume-specific pressures, PVSP). After emptying the bladder, an equal volume of normal saline solution was reinfused, and the pressures were recorded again (cystometric volume-specific pressure, CVSP). All patients underwent routine fluoroscopically assisted urodynamic testing. The PVSP and the CVSP were compared using the Wilcoxon signed ranks test. P value of .05 was significant.

Results: The mean PVSP was 14.5 cmH₂O (range, 4-42 cmH₂O) and mean CVSP was 20.6 cmH₂O (range, 6-70 cmH₂O). The CVSP was significantly higher than the PVSP (P = .01).

Conclusion: Filling pressures during cystometry (CVSP) were significantly higher than the pressures measured at rest (PVSP). This study also suggests a strong correlation between PVSP and CVSP.     

Six-Year Follow-Up of Botulinum Toxin A Intradetrusorial Injections in Patients with Refractory Neurogenic Detrusor Overactivity: Clinical and Urodynamic Results

Background

Most reports in the literature on botulinum toxin A (BoNTA) therapy for neurogenic detrusor overactivity (NDO) are based on the results of a single injection. Because most patients may require retreatment, the efficacy and safety of multiple injections must be addressed clearly.

Objective

To investigate the effectiveness and safety of BoNTA intradetrusorial injections in a group of spinal cord–injured (SCI) patients with refractory detrusor overactivity (DO).

Design, setting, and participants

Seventeen SCI patients were prospectively included in the study and followed up to 6 yr.

Intervention

All patients received repeat intradetrusorial injections of BoNTA 300 units (Botox, Allergan, Irvine, CA) under cystoscopic control on an inpatient basis.

Measurements

The preliminary assessment included voiding diary, urodynamics, kidney and bladder ultrasound, and cystourethrography. Patients also completed a standardised quality-of-life (QoL) questionnaire. Clinical evaluation, urodynamics, urinary tract imaging, and QoL assessment were repeated every year throughout the follow-up.

Results and limitations

Before treatment, all patients complained of urinary incontinence and had DO. Bilateral and monolateral renal pelvis dilatation were detected in six and five patients, respectively, and a monolateral and third-grade vesicoureteral reflux was observed in three. At 6-yr follow-up, a significant decrease in the frequency of daily incontinence episodes (p < 0.01), a significant increase in first uninhibited detrusor contraction and in maximum bladder capacity (p < 0.001 for both), and a significant decrease in maximum pressure of these contractions (p < 0.01) were observed. Fifteen patients (88.2%) were completely continent. Renal pelvis dilatation and vesicoureteral reflux resolved in all cases, and the QoL index significantly increased. Limitations of the study are related to the small number of included patients.

Conclusions

In SCI patients with refractory NDO who do not want or are unfit for invasive reconstructive surgery, BoNTA intravesical treatment represents a valid alternative to control DO and urinary incontinence and to preserve upper urinary tract function over a long-term follow-up.     

逼尿肌过度活动对BPH患者膀胱排空的影响及其原因和意义的探讨

目的：研究逼尿肌过度活动（DO）对BPH患者膀胱排空能力的影响,探讨该影响的原因及意义。方法：选取70例BPH病例,按尿流动力学结果有无DO分为两组,运用统计学方法进行回顾性研究。结果：无DO组剩余尿量（PVR）、最大尿流率（Qmax）分别为194．38（±205．830）ml、5．94（±3．692）ml／min;有DO组分别为96．00（±103．120）ml、8．19（±3．704）ml／min,相比差异均有统计学意义（P〈0．05）。两组中并发上尿路积水者共5例,占7．1％,并发上尿路积水者在两组中的分布差异无统计学意义（P〉0．05）。两组中已出现逼尿肌收缩功能受损（DU）者15例,占21．4％,有DO者从下尿路症状（LUTS）出现进展至逼尿肌收缩功能受损的病程明显长于无D0者（P〈0．05）。结论：BPH患者中有DO者与无DO者相比,剩余尿量少、最大尿流率高。DO的存在并不增大上尿路受损风险。推测DO可能是逼尿肌代偿性增厚以外的另一种代偿机制,它增大膀胱排空能力,还可能通过减少排尿时逼尿肌能量消耗来延缓逼尿肌收缩功能受损的发生。     

Adverse Events of Intravesical Botulinum Toxin A Injections for Idiopathic Detrusor Overactivity: Risk Factors and Influence on Treatment Outcome

Background

Intravesical injection of botulinum toxin type A (BoNTA) provides effective treatment for detrusor overactivity and overactive bladder (OAB). However, the high rates of treatment-related adverse events (AEs) prevent its more widespread use.

Objective

To investigate the risk factors of increasing AEs after BoNTA injection for idiopathic detrusor overactivity (IDO).

Design, setting, and participants

This study included a total of 217 patients receiving their first intravesical BoNTA injection for refractory IDO in a tertiary university hospital from 2004 to 2009.

Measurements

AE incidence was analyzed according to gender, age, comorbidities, prostate condition in men, OAB subtype, BoNTA dose, injection site, and baseline urodynamic parameters. Successful outcome was determined based on patient perception of improvement of bladder condition at 3 mo.

Results and limitations

Successful outcomes were reported by 144 (66.3%) patients. By multivariable analysis, male gender (p = 0.013) and baseline postvoid residual (PVR) ≥100 ml (p = 0.003) were independent predictors of acute urinary retention (AUR). Baseline PVR ≥100 ml (p = 0.007) and receiving >100 U BoNTA (p = 0.029) were predictors of straining to void. The incidence of large PVR after treatment was associated with comorbidity (p = 0.011). Urinary tract infection occurred more frequently in women (p = 0.003) and in men with retaining prostate (p = 0.008). No AUR developed after bladder base/trigonal injection. Nevertheless, the occurrence of AUR or large PVR did not affect therapeutic outcome. This study is limited by nonconsecutive enrollment of patients.

Conclusions

Male gender, baseline PVR ≥100 ml, comorbidity, and BoNTA dose >100 U are risk factors for increasing incidence of AEs after intravesical BoNTA injection for IDO.     

Neurotoxin treatments for urinary incontinence in subjects with spinal cord injury or multiple sclerosis: a systematic review of effectiveness and adverse effects

BACKGROUND/OBJECTIVE: The objective was to evaluate the effectiveness of neurotoxin treatments of urinary incontinence (UI) in individuals with spinal cord injury (SCI) or multiple sclerosis (MS). METHODS: Studies were included if published in English, presented randomized adults with SCI or MS, and reported UI outcomes. RESULTS: Ten trials randomizing 288 subjects with SCI (43%), MS (52%), or other spinal conditions (5%) and UI refractory to oral antimuscarinics were included. The overall mean age was 41 years, and 46% were women. Study durations ranged from 1 to 18 months. Treatments included botulinum toxin-A (BTX-A, 2 trials) and 2 vanilloid compounds, capsaicin (6 trials) and resiniferatoxin (4 trials). BTX-A was superior to placebo and resiniferatoxin in reducing daily UI episodes, mainly in individuals with SCI, although significant reductions vs placebo were not evident throughout the study duration. There were 1.1 fewer daily UI episodes in the BTX-A 200 unit group vs 0.1 fewer for the placebo group at the final week 24 assessment. Capsaicin was generally superior to placebo. The weighted difference between capsaicin and placebo in a pooled analysis of 2 trials enrolling subjects with either paraplegia or tetraplegia (n = 32) was -3.8 daily UI episodes [95% Cl -4.7 to -2.9] after 30 days. Capsaicin was comparable to resiniferatoxin. Pelvic pain and facial flushing were associated with capsaicin. CONCLUSION: Neurotoxins may improve refractive UI in adults with SCI or MS, although trial results were inconsistent. Trials were small in size and relatively short in duration. Further studies are needed to determine the efficacy and tolerability of long-term application.     

Electrical Stimulation of the Urethra Evokes Bladder Contractions in a Woman With Spinal Cord Injury

Abstract

Objective: Electrical stimulation of pudendal urethral afferents generates coordinated micturition in animals and bladder contractions in men after spinal cord injury (SCI), but there is no evidence of an analogous excitatory urethra-spinal-bladder reflex in women. The objective of this study was to determine whether electrical stimulation of the urethra could evoke bladder contractions in a woman with SCI.

Case Report: A 38-year-old woman with a C6 ASIA A SCI who managed her bladder with clean intermittent catheterization and oxybutynin demonstrated neurogenic detrusor overactivity on urodynamics. Oxybutynin was discontinued 2 days prior to urodynamic testing with a custom 12F balloon catheter mounted with ring-shaped electrodes located in the bladder neck, mid urethra, and distal urethra. The inflated balloon was placed against the bladder neck to stabilize the catheter electrodes in place along the urethra. However, the balloon limited emptying during contractions. Urodynamics were performed at a filling rate of 25 mL/minute until a distention-evoked bladder contraction was observed. The urethra was stimulated over a range of bladder volumes and stimulus parameters to determine whether electrical stimulation could evoke a bladder contraction.

Findings: Electrical stimulation via urethral electrodes evoked bladder contractions that were dependent on bladder volume (>70% capacity) and the intensity of stimulation.

Conclusions: This is the first report of an excitatory urethra-spinal-bladder reflex in a woman with SCI. Future studies will determine whether this reflex can produce bladder emptying.     

Electrical Stimulation of the Urethra Evokes Bladder Contractions in a Woman With Spinal Cord Injury

Objective:

Electrical stimulation of pudendal urethral afferents generates coordinated micturition in animals and bladder contractions in men after spinal cord injury (SCI), but there is no evidence of an analogous excitatory urethra-spinal-bladder reflex in women. The objective of this study was to determine whether electrical stimulation of the urethra could evoke bladder contractions in a woman with SCI.

Case Report:

A 38-year-old woman with a C6 ASIA A SCI who managed her bladder with clean intermittent catheterization and oxybutynin demonstrated neurogenic detrusor overactivity on urodynamics. Oxybutynin was discontinued 2 days prior to urodynamic testing with a custom 12F balloon catheter mounted with ring-shaped electrodes located in the bladder neck, mid urethra, and distal urethra. The inflated balloon was placed against the bladder neck to stabilize the catheter electrodes in place along the urethra. However, the balloon limited emptying during contractions. Urodynamics were performed at a filling rate of 25 mL/minute until a distention-evoked bladder contraction was observed. The urethra was stimulated over a range of bladder volumes and stimulus parameters to determine whether electrical stimulation could evoke a bladder contraction.

Findings:

Electrical stimulation via urethral electrodes evoked bladder contractions that were dependent on bladder volume (>70% capacity) and the intensity of stimulation.

Conclusions:

This is the first report of an excitatory urethra-spinal-bladder reflex in a woman with SCI. Future studies will determine whether this reflex can produce bladder emptying.     

Clinical Efficacy and Safety of Tolterodine Compared to Oxybutynin and Placebo in Patients with Overactive Bladder

This study compared the clinical efficacy (determined from micturition diaries) and safety of 12 weeks’ treatment with either tolterodine 2 mg twice daily, oxybutynin 5 mg three times daily or placebo in patients with an overactive bladder. A total of 277 patients were randomized and treated at 25 centers. Both tolterodine and oxybutynin significantly increased volume voided/micturition compared to placebo. Both treatment groups evoked greater decreases in micturitions per 24 hours and incontinence episodes per 24 hours compared to placebo; however, only tolterodine was significantly better than placebo in reducing micturition frequency. Tolterodine and oxybutynin were equivalent in their effectiveness. Tolterodine was significantly better tolerated than oxybutynin when adverse events (particularly frequency and intensity of dry mouth), dose reduction and patient withdrawals were considered. Oxybutynin is an effective drug whose frequent adverse effects limit its clinical usefulness. Tolterodine has equivalent efficacy to oxybutynin, but with less severe adverse effects. This will allow patients to receive more effective treatment for their condition, with better compliance.     

Autonomie Dysreflexia in a Man With Multiple Sclerosis

Background/Objective: To report manifestation of autonomic dysreflexia (AD) in a man with multiple sclerosis (MS).

Design: Case report.

Findings: A young man presented with a history of several admissions to the emergency department with complaints of hypertensive attacks, palpitations, difficulty in breathing, headaches, and flushing. The attacks were attributed to a previously diagnosed anxiety disorder. Onset of numbness of the left leg numbness prompted a more thorough study, which showed evidence of MS. AD was suspected as the cause of his recurrent attacks of hypertension. Bladder distension was identified as the cause of AD, and his hypertensive attacks were controlled by management of neurogenic bladder.

Conclusions: This report emphasizes that AD can occur in MS. Somatic symptoms warrant thorough investigation before attributing them to psychosomatic causes.     

Autonomic Dysreflexia in a Man With Multiple Sclerosis

Background/Objective:

To report manifestation of autonomic dysreflexia (AD) in a man with multiple sclerosis (MS).

Design:

Case report.

Findings:

A young man presented with a history of several admissions to the emergency department with complaints of hypertensive attacks, palpitations, difficulty in breathing, headaches, and flushing. The attacks were attributed to a previously diagnosed anxiety disorder. Onset of numbness of the left leg numbness prompted a more thorough study, which showed evidence of MS. AD was suspected as the cause of his recurrent attacks of hypertension. Bladder distension was identified as the cause of AD, and his hypertensive attacks were controlled by management of neurogenic bladder.

Conclusions:

This report emphasizes that AD can occur in MS. Somatic symptoms warrant thorough investigation before attributing them to psychosomatic causes.     

Efficacy of botulinum-A toxin bladder injections for the treatment of neurogenic detrusor overactivity in multiple sclerosis patients: an objective and subjective analysis

AIMS: We studied the use of botulinum-a toxin (BTX-A) injections into the bladder as an alternative approach in patients with neurogenic detrusor overactivity due to multiple sclerosis (MS) with drug-refractory overactive bladder (OAB) symptoms. METHODS: Sixteen MS patients--11 women, 5 men; mean age 48.6 years--with refractory OAB symptoms were included in a one-center prospective study. For outcome analysis, we used a bladder diary, a complete urodynamic study, and validated questionnaires for subjective assessment. We injected 300 U of BTX-A (Botox) into the bladder and into the external sphincter muscle to reduce the probability of posttreatment urine retention. RESULTS: There was an increase in residual volume from 81.3 +/- 23.8 to 126.3 +/- 32.9 ml after 4 weeks. In one woman, transient self-catheterization was unavoidable. Four weeks and 3 and 6 months after BTX-A injection, the significant results were as follows: daytime frequency was reduced by 29%, 44%, and 30%, respectively. Nocturia diminished by 33%, 72%, and 40%. Use of pads was be reduced by 38% after 4 weeks and by 64% after 3 months. Urodynamically, reflex volume and maximal cystometric bladder capacity increased by 73%, 77%, and 58% (at 6 months, the increase was not significant) and by 36%, 27%, and 36% (not significant). Maximal detrusor pressure decreased by 35%, 22%, and 57%. Subjective outcome indicated significant improvement of symptoms at 4 weeks and 3 months, but not at 6 months. Patient satisfaction with the therapy was very high. CONCLUSIONS: BTX-A detrusor injections are very effective in the treatment of drug-resistant OAB symptoms in MS patients as reflected in urodynamic measurements and in patient satisfaction. Build up of residual urine remains a problem of which patients must be informed.     

Improving the Efficiency of Screening for Major Depression in People With Spinal Cord Injury

Abstract

Background/Objective: To investigate the metric properties, relative efficiency, sensitivity and specificity, and positive predictive value of a short form of the Patient Health Questionnaire-9 (PHQ-9) that may be used as a screening test for depression.

Methods: Data from the National Spinal Cord Injury Statistical Center Database containing 3,652 records with complete data for the PHQ-9 were analyzed using Confirmatory Factor Analysis, Item Response Theory Graded Response Model analysis, and sensitivity and specificity analysis of classification.

Results: A scale comprised of items 1, 2, and 6 from the PHQ-9 has a relative efficiency of 0.66 compared to the 9-item scale. Using this 3-item scale and a cutoff score of 3 or more provides specificity of 0.93 and sensitivity of 0.87; a cutoff of 4 provides specificity of 0.95 and sensitivity of 0.82. The shorter version of the scale reduces the effect of response bias caused by gender. The relative efficiency of the 9-item scale is 0.88 for women compared to men; the 3-item scale increases the relative efficiency to 0.93.

Conclusion: A 3-item scale provides adequate information for clinical screening purposes. Cutoff scores of either 3 or 4 are acceptable and present options for decision making within a particular clinical setting. Additionally, the 3-item scale reduces the effect of gender of the respondent on the score obtained.