A randomized controlled trial of the effectiveness of osteopathy-based manual physical therapy in treating pediatric dysfunctional voiding
Introduction
Dysfunctional voiding (DV) encompasses a wide spectrum of symptoms that may include urinary urgency, increased voiding frequency (sometimes associated with bladder instability, bladder spasms, small or hypertonic bladder), decreased urination and urine retention (often associated with bladder hypotonia, enlarged bladder, recurrent UTIs or bladder hyposensitivity), daytime urine incontinence (DI), nocturnal enuresis, and dyssynergic voiding (DYS) [1], [2], [3], [4]. Chronic DV may lead to anatomical changes in the bladder wall [5], renal scarring even in the absence of reflux [6], [7] and delayed spontaneous reflux resolution with poorer long-term outcomes following surgery for VUR [1]. The incidence of DV is approximately 10% in children aged 4–6 years and 5% in children aged 6–12 years, and is more commonly seen in girls [4], [8].
The type of DV manifested by DYS is characterized as a non-neuropathic incoordination between the bladder, bladder outlet and pelvic floor during filling and/or emptying phases of micturition, and is particularly problematic because it creates a functional bladder outlet obstruction which may result in increased intravesical pressures, VUR, bladder instability, post-void residuals (PVR) and/or recurrent UTIs.
Standard non-surgical treatment approaches for DV frequently include: medications, e.g. antibiotic prophylaxis, anticholinergics, alpha-blockers and muscle relaxants [9]; the establishment of timed voiding and evacuation schedules [10]; treatment of constipation [4], [11]; and pelvic floor muscle retraining [11], [12]. A multi-modal and multidisciplinary approach is now considered necessary for effective treatment of DV [4], [10].
Existing medical and psychological treatments have demonstrated variable rates of improvement in children with DV using non-surgical treatment approaches ranging from 33% to 100% [4], [13], [14]. Given the potentially serious long-term consequences of ineffective treatment, there is growing interest in finding interventions that can consistently and efficiently improve outcomes for the greatest number of children. Whereas standard treatments rely heavily on child and family compliance with therapeutic routines between clinic visits, certain interventions such as manual physical therapy, osteopathic manipulative techniques and acupuncture approaches are not dependent on compliance for impact [15].
Previous studies of manual treatment (osteopathy, manual physical therapy) have demonstrated some success in treating adult women with DV and/or tension myalgia of the pelvic floor [16], [17], [18]. In addition, there are theoretical, animal and clinical studies supporting the rationale of osteopathy-based treatment and manual physical therapy for upper and lower urinary tract dysfunction [19], [20], [21], [22], [23], [24], [25]. Manual physical therapy based on an osteopathic approach (MPT-OA) involves the palpation and responsive manipulation of body tissues to alleviate restrictions (also referred to as ‘lesions’) that interfere with optimum mobility and health. Specifically, manual physical therapy techniques were employed to mobilize and balance muscular, skeletal and fascial (including cranial, dural, visceral, vascular and lymphatic) structures that are hypothesized to influence elimination processes [16], [17], [19], [20], [24], [26], [27]. Unfortunately, no pediatric studies evaluating the efficacy of MPT-OA in children with dysfunctional voiding have been performed.
The objective of this randomized controlled trial was to evaluate whether manual physical therapy based on an osteopathic approach (MPT-OA) added to standard treatment improves dysfunctional voiding in children with PVR, DI, recurrent UTIs, DYS and VUR more effectively than standard treatment alone.
Section snippets
Patient population
Children aged 4–11 years who were consecutive new referrals to an interdisciplinary pediatric urology clinic, specializing in the treatment of children with recalcitrant voiding dysfunction, between 1999 and 2003 were considered for enrollment in the study. Each of the children enrolled in this study had been treated by a pediatric urologist for at least 6 months prior to study entry. The pediatric urologists had recommended timed voiding, adequate hydration and in some cases medications (e.g.
Study sample
Twenty-one children completed the study. In almost all cases (n = 8) attrition was due to patient's failure to attend the voiding clinic follow-up visits, and therefore study visits were also unachievable. In one case, neurological exclusion criteria were discovered subsequent to enrollment. In another case, surgical re-implantation of the ureters was scheduled prior to study completion. The 11th patient, in retrospect, should not have been enrolled in the study as she did not have either VUR or
Discussion
To our knowledge, this study is the first randomized controlled trial to investigate the effectiveness of MPT-OA for children with DV. The results presented here suggest that MPT-OA can improve outcomes beyond those expected from the current standard-care treatment. This finding is particularly striking given the high proportion of study subjects in the CG who benefited from the standard treatment, and that the children in the TG only received four treatment sessions of MPT-OA. Further, the
Conclusions
Results from the present investigation suggest that MPT-OA, in conjunction with standard-care treatments, provides significant improvements in the short-term outcomes of children with DV, beyond the improvements observed with conventional medical and behavioral treatments alone. The results of this single-center randomized controlled trial provide support for a multi-center randomized controlled trial of MPT-OA in children with DV. Furthermore, this study demonstrates that traditional research
Acknowledgements
This study was supported in part by grants from the National Kidney Foundation of Maryland (DN). Parts of this study were presented at the 2004 Pediatric Academic Societies Conference, San Francisco, California; the 9th European Symposium of Traditional Osteopathy in Germany, 2005; and at the 22nd International Osteopathic Symposium in Montreal, Canada, 2005. Our appreciation to Philippe Druelle, DO, Reuben Bell, DO, and Michael M. Patterson, PhD, for their osteopathic expertise and assistance;
References (33)
- et al.
The relationship among dysfunctional elimination syndromes, primary vesicoureteral reflux and urinary tract infections in children
J Urol
(1998) Vesicoureteral reflux and voiding dysfunction: a prospective study
J Urol
(1989)- et al.
Biofeedback therapy for children with dysfunctional voiding
Urology
(1998) - et al.
Biofeedback methodology: does it matter how we teach children how to relax the pelvic floor during voiding?
J Urol
(2001) - et al.
Improvement of urge-and mixed- type incontinence after acupuncture treatment among elderly women-a pilot study
J Auton Nerv Syst
(2000) Pelvic floor myofascial trigger points: manual therapy for interstitial cystitis and the urgency-frequency syndrome
J Urol
(2001)Interstitial cystitis: a chronic visceral pain syndrome
Urology
(2001)- et al.
Contraction of the pelvic floor during abdominal maneuvers
Arch Phys Med Rehab
(2001) Relationship between dysfunctional voiding and reflux
J Urol
(1992)Nonneurogenic neurogenic bladder (the Hinman syndrome) – 15 years later
J Urol
(1986)