Monday, November 10, 2008

Development and validation of the fecal incontinence and constipation quality of life measure in children with spina bifida

Nanigian DK, Nguyen T, Tanaka ST, Cambio A, DiGrande A, Kurzrock EA. Development and validation of the fecal incontinence and constipation quality of life measure in children with spina bifida. Journal of Urology. 2008 Oct;180(4 Suppl):1770-3; discussion 1773.

Department of Urology, University of California-Davis, Davis Children's Hospital, California, USA.

PURPOSE: Fecal incontinence and constipation in children with spina bifida are recognized to impact quality of life. Most disease specific quality of life instruments on fecal incontinence target adults and/or children without neuropathic bowel. We developed an instrument to evaluate bowel function and its impact on quality of life in children with spina bifida and their caregivers. MATERIALS AND METHODS: A 51-item questionnaire termed the FIC QOL (Fecal Incontinence and Constipation Quality of Life) survey was developed from expert opinion, patient interviews, and modification of previously published adult and pediatric studies for nonneuropathic bowel dysfunction. The items are divided into 7 quality of life factor groupings, including bowel program, dietary management, symptoms, travel and socialization, family relationships, caregiver emotional impact and financial impact. The questionnaire was given to caregivers of children with and without spina bifida. Discriminant validity was evaluated by comparing the spina bifida and control groups. Test-retest reliability was evaluated by having 41 patients complete 2 surveys within 4 to 6 weeks. RESULTS: Comparing questionnaires from 92 index patients and 52 controls showed a statistically significant difference for all 7 quality of life factor groupings. The FIC QOL instrument objectively demonstrated the negative impact of fecal incontinence and constipation on quality of life in these families. Comparing 82 questionnaires at 2 time points demonstrated the reliability of all FIC QOL questions. CONCLUSIONS: The FIC QOL instrument provides a valid and reliable measure of the effect of fecal incontinence and constipation on the quality of life of caregivers and their children with spina bifida.

PMID: 18721959

Evaluating Outcomes of Enterocystoplasty in Patients With Spina Bifida: A Review of the Literature

Scales CD Jr, Wiener JS. Evaluating Outcomes of Enterocystoplasty in Patients With Spina Bifida: A Review of the Literature. Journal of Urology. 2008 Oct 16.

Duke University Medical Center, Durham, North Carolina.

PURPOSE: The urological complications of spina bifida impose a significant burden of disability and disease. Therapy is focused on the bladder to achieve the primary goals of maintaining normal renal function and attaining urinary continence. When medical management fails, surgical intervention, including enterocystoplasty, is frequently performed. However, practice patterns for enterocystoplasty show significant variation. Given this context, we examined outcome measures for enterocystoplasty in patients with spina bifida.

MATERIALS AND METHODS: A MEDLINE(R) search was performed for articles on enterocystoplasty in patients with spina bifida. A total of 226 articles were identified and manually reviewed for relevant studies. Additional articles were selected based on a cited reference search. RESULTS: Almost all studies are retrospective, single institution case series of a relatively small number of patients. Few uniform or validated outcome measures for enterocystoplasty exist but reported measures typically include urodynamic, continence and satisfaction parameters. Interinstitutional variability in urodynamic measurements and in definitions of continence makes a comparison of outcomes difficult. The complication rate following enterocystoplasty is significant, well described and primarily related to the use of gastrointestinal segments for urine storage.

CONCLUSIONS: Medical management is the mainstay of neurogenic bladder therapy in the spina bifida population. Enterocystoplasty remains an important option to prevent or reverse upper tract deterioration, and/or improve or cure socially unacceptable incontinence despite poorly defined outcome measures. The development of appropriate and validated outcomes measures may enable more uniform, effective and safe urological care of patients with spina bifida.

PMID: 18930285

Endourethral injection of bulking agents for urinary incontinence in children

Godbole P, Bryant R, MacKinnon AE, Roberts JP. Endourethral injection of bulking agents for urinary incontinence in children. BJU International (Journal of the British Association of Urological Surgeons). 2003 Apr;91(6):536-9.

Department of Paediatric Surgery, Sheffield Children's Hospital, Sheffield, UK. prasadgodbole@btinternet.com

OBJECTIVE: To assess the early and late outcome of endourethral injection with bulking agents in children with urinary incontinence (a neuropathic bladder or exstrophy-epispadias complex), by reviewing our experience over a 5-year period.

PATIENTS AND METHODS: The records of 15 children (10 boys) were reviewed retrospectively; 10 had spina bifida and a neurogenic bladder, four had a neurogenic bladder from other causes and one had epispadias. All children had a stable low-pressure detrusor and a compliant bladder with sphincteric weakness on preoperative urodynamic testing. Four children had undergone previous enterocystoplasty with a Mitrofanoff stoma, with concomitant urethral lengthening in two and a Goretex trade mark bladder neck sling in two. Three children voided spontaneously while 12 depended on intermittent catheterization. The agent was injected under general anaesthesia in all patients but one, with an endourethral submucosal injection of the bulking agent into four or more points at the junction of the bladder neck and proximal urethra, aiming to obtain visual occlusion of the urethra. The median (range) number of injections was 2 (1-3); five children had one injection, seven had two and three had three. There were no procedure-related complications and most were day-case procedures. Initially PTFE paste was used as the bulking agent, being replaced by bovine collagen or polydimethylsiloxane in the latter half of the series.

RESULTS: At a median (range) follow-up of 28 (11-65) months three children were completely dry after a single injection; there was no change in four and a short-term improvement (median 25 months, range 4 days to 37 months) in eight. After this period all children deteriorated to their original incontinence grade; hence the overall cure rate was three of 15.

CONCLUSION: This experience with a long-term follow-up differs from previously reported high success rates for the endourethral injection of bulking agents for urinary incontinence in children. Despite a short-term benefit, in the long-term this technique was unreliable and often ineffective. Patients and their carers should be given a realistic and guarded prognosis.

PMID: 12656911

The management of the failed bladder neck procedure in patients with spina bifida

Walker RD. The management of the failed bladder neck procedure in patients with spina bifida. BJU International (Journal of the British Association of Urological Surgeons).. 2003 Oct;92 Suppl 1:35-7. Review.

Urinary incontinence secondary to decreased outlet resistance is common in patients with spina bifida. Most often these patients require both augmentation cystoplasty and a procedure to increase resistance at the bladder neck. The choices for operations to increase bladder neck resistance include the artificial urinary sphincter (AUS), the Kropp and Leadbetter procedures (and variations) and bladder neck wraps or slings. Bladder neck injection with bulking agents has also been used but the long-term results are unknown and most authors do not address what to do when the procedure fails. While the short-term success with each of the open procedures has been good, the longer-term success has been less satisfactory. The purpose of this study is twofold; to review the author's experience with those patients in whom a rectus fascial wrap has failed and in the discussion, to review how others have
managed the failures in procedures that they have advocated.

PMID: 12969007

Epanded PTFE bladder neck slings for incontinence in children: the long-term outcome

Godbole P, Mackinnon AE. Epanded PTFE bladder neck slings for incontinence in children: the long-term outcome. BJU International (Journal of the British Association of Urological Surgeons). 2004 Jan;93(1):139-41.

Department of Paediatric Urology, Sheffield Children's NHS Trust, Sheffield, UK. prasadgodbole@btinternet.com

OBJECTIVE: To assess the long-term outcome of circumferential expanded PTFE (Gore-tex, WL Gore Associates, Scotland) bladder neck slings for achieving urethral continence in children with a neuropathic bladder.

PATIENTS AND METHODS: The records were reviewed of 19 children undergoing bladder reconstruction (most with a neuropathic bladder) who had a Gore-tex sling placed circumferentially at the bladder neck, over a 5-year period. Of these, seven had spina bifida; two each spinal dysraphism, surgery for anorectal anomalies and an idiopathic neuropathic bladder; five who developed a neuropathic bladder from other causes, and one born with bladder exstrophy. All children had an uncompliant bladder with a low urethral leak-point pressure on preoperative urodynamics. In all children conventional clean intermittent catheterization and pharmacotherapy had failed. Four had had previous augmentation surgery while 15 had concomitant bladder augmentation and formation of a Mitrofanoff stoma. The main outcome measure was achieving dryness. The original intention of the procedure was also to maintain urethral catheterization.

RESULTS: Full details of the follow-up were available in 17 patients. Despite initial good short-term results, at a median follow up of 7 years, in 14 patients the sling had to be removed because of erosion, often with transient urethral leakage before the bladder neck subsequently closed. A bladder calculus was associated with each case of erosion except one.

CONCLUSION: Although in the short term this technique had favourable results, it was not a useful technique in the long term.

PMID: 14678386

Intravesical oxybutynin for children with poorly compliant neurogenic bladder: a systematic review.

Guerra LA, Moher D, Sampson M, Barrowman N, Pike J, Leonard M. Intravesical oxybutynin for children with poorly compliant neurogenic bladder: a systematic review. Journal of Urology. 2008 Sep;180(3):1091-7. Review.

Division of Pediatric Urology, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada. lguerra@uottawa.ca

PURPOSE: Children with neurogenic bladder and poor bladder compliance are usually treated with bladder catheterization and oral anticholinergic medication. They may become nonresponders to the drug or present with severe side effects. We evaluated the effectiveness and tolerability of intravesical oxybutynin in children with poorly compliant neurogenic bladder.

MATERIALS AND METHODS: We conducted a search of MEDLINE, EMBASE, CINAHL, SciELO, dissertations/theses in ProQuest, LILACS, the Cochrane Library, protocol registries and the gray literature. Two reviewers independently assessed study quality and extracted data.

RESULTS: Eight studies (2 prospective, 6 retrospective) assessed the effectiveness and side effects of intravesical oxybutynin in children with neurogenic bladder. A total of 297 children started treatment, of whom 22% (66 patients) discontinued therapy, with 9% (28) quitting due to systemic side effects. Mean change in bladder compliance (primary outcome) was reported in only 2 studies (+7.4 and +7.5 ml/cm H(2)O). The pooled mean change in pressure at maximum bladder capacity was -16.4 cm H(2)O (95% CI -22.8 to -10.0). Incontinence improved significantly in most studies, with "dry and improved" rates ranging from 61% to 83%. The funnel plot of pressure at maximum bladder capacity suggested no publication bias.

CONCLUSIONS: Adjunctive intravesical oxybutynin therapy increased mean maximum bladder capacity and decreased bladder pressure in children with neurogenic bladder. However, identified studies offered a low level of evidence, with most being poorly reported retrospective case series with potential biases. Although the incidence of side effects was lower with the intravesical route, side effects are still possible and should be discussed with patients and families. The evidence available is insufficient to recommend this therapy. Research of more sound study design such as a randomized controlled trial should be conducted to assess the efficacy and side effects of intravesical oxybutynin in children.

PMID: 18639290

Dosage escalation of intravesical oxybutynin in the treatment of neurogenic bladder patients

Haferkamp A, Staehler G, Gerner HJ, Dörsam J. Dosage escalation of intravesical oxybutynin in the treatment of neurogenic bladder patients. Spinal Cord. 2000 Apr;38(4):250-4.

Department of Urology, University of Heidelberg, Germany.

OBJECTIVE: We prospectively analyzed the dose dependent outcome and side effects of neurogenic bladder patients with intravesical application of oxybutynin at our centre.

MATERIALS AND METHODS: We examined the data of 32 patients with neurogenic bladders and detrusor hyperreflexia. We registered clinical outcome, continence situation, side effects and urodynamic data of patients with (A) standard dosages of intravesical oxybutynin (0.3 mg/kg bodyweight per day) and (B) with increasing dosages in steps of 0.2 mg/kg bodyweight per day up to 0.9 mg/kg bodyweight per day.

RESULTS: We examined 32 patients aged 1 to 34 years, mean age 12 years. 21/32 patients became totally continent with the dosage (A). They showed a significant (P<0.01) decrease in the median max detrusor pressure (MDP) and a significant (P<0.01) increase in the median compliance and the median age adjusted bladder capacity (AABC). Eleven out of 32 patients remained incontinent under this dosage (A). Their median MDP, their median compliance and their median AABC remained nearly unchanged. Seven out of 11 incontinent patients under dosage (A) were treated efficiently with the higher dosages (B). Their median necessary dosage escalation to achieve treatment success was 0.7 mg/kg bodyweight per day (range 0.5 to 0.9 mg/kg bodyweight per day). Their median MDP was significantly (P<0.05) decreased and their median compliance and median AABC were significantly (P<0.05) increased. Four out of 11 patients remained incontinent and showed only little improvement in urodynamic data. Two out of 11 patients with the dosage escalation (B) showed side effects at a dosage of 0. 9 mg/kg bodyweight per day.

CONCLUSIONS: The intravesical application of oxybutynin was a well tolerated and efficacious therapy. The topical oxybutynin therapy dosage (A) was efficient in 66% of our selected patients, the escalating dosage titration (B) could increase the efficiency to 87%.

PMID: 10822396

Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida

Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E. Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida. BJU International (Journal of the British Association of Urological Surgeons). 2001 May;87(7):674-8.

Department of Paediatrics, Catholic University, Rome, and Bassini Hospital, Milan-Bicocca University, Cinisello Balsamo, Milan, Italy. pietro.ferrara@mailcity.com

OBJECTIVE: To evaluate the incidence of side-effects of oral and intravesical oxybutynin chloride in children with meningomyelocele (MMC) and a neurogenic bladder.

PATIENTS AND METHODS: The study comprised 225 children with a neurogenic bladder from MMC who were evaluated with urodynamic testing and voiding cysto-urethrography to identify those at high risk of upper tract damage. In all, 101 children (mean age 4.2 years, range 0.25-10) had unco-ordinated detrusor-sphincter function and low compliance; they were treated with either oral or intravesical oxybutynin and clean intermittent catheterization.

RESULTS: Of the 101 patients, 67 were treated with oral oxybutynin; in 11 the treatment was discontinued because of the side-effects. The other 34 patients used both clean intermittent catheterization and intravesical oxybutynin. In this group there were side-effects in six patients, including drowsiness, hallucinations and cognitive changes.

CONCLUSIONS: Oral and intravesical oxybutynin is effective for managing neurogenic bladder dysfunction, but intravesical administration is safer and better tolerated than oral oxybutynin in the treatment of children with MMC. However, adverse effects such as cognitive impairment can also occur in children treated with intravesical oxybutynin and these patients must be closely monitored because these effects may differ from those with oral administration.


PMID: 11350411