Sleep Enuresis Research
Title: TENS Treatment for Bedwetting
Principal investigator: Adam Howe, MD
Albany Medical College
Children referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail will next be offered therapy with a bedwetting alarm device or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study. The patients will be randomized into three groups of 20 patients each. Group 1 will be the long frequency set at 2 Hz (hertz). Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set at 150 Hz. The patients will be provided with a TENS unit and electrode pads with caretakers instructed on how to use the apparatus.
The child’s TENS unit will be set at a frequency determined by randomization, a pulse width of 260 seconds, and the intensity to be determined in the office based on when the child feels sensitive to the TENS unit. The child will be randomized and will place the electrodes along the posterior tibial nerve on the medial ankle each night before bedtime for 15 minutes for a total of 30 days. Diaries, including nighttime incontinence episodes and a “wet sheet” scale (dry, damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit. Patients will be followed up after one month of TENS with evaluation, including the Pediatric Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in children with bladder dysfunction; this questionnaire will be filled out before starting TENS treatment to compare the effect of treatment on QOL. The data will be collected at different time points (baseline and after 1 month of treatment) for each group by itself, and the groups compared against each other using statistical analysis.
Institutional review board approval was obtained. Children ages 5-18 years old referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Behavioral modification (limiting evening drinking, double voiding before bedtime, bowel habits, and social anxiety factors) will be utilized first. Patients who fail will next be offered therapy with a bedwetting alarm device or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study. Patients who have previously tried pharmacologic treatment for nocturnal enuresis or alternative therapy for urologic disorders within the past 30 days, daytime incontinence symptoms, known “high volume” voiders (determined from history), bedwetting episodes on the average of less than one time per week, medications predisposing to incontinence (e.g., Lithium for bipolar disorder), other known voiding or neurologic disorders (e.g., overactive bladder, myelomeningocele), secondary etiologies for nocturnal enuresis (e.g., cystitis, obstructive sleep apnea, urinary fistulae), prior use of a TENS unit or other neuromodulation for bedwetting, and any contraindications to the usage of a TENS unit such as having a pacemaker will be excluded. Patients who have previously tried the bedwetting alarm will not be excluded from the study.
The patients will be randomized into three groups of 20 patients each. Group 1 will be the long frequency set at 2 Hz. Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set at 150 Hz. There is no sham group in this study as the investigator has previously found posterior tibial TENS to be effective and lasting, and as such, all patients will be treated. The investigator will aim to recruit 20 patients per group for a total of 60 patients. A detailed explanation of the purpose of the study, along with the risks and benefits of TENS will be given to the patient and caretakers by a provider before obtaining informed consent for enrollment into the study. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus.
Parents/patients of enrolled patients will fill out nightly voiding diaries, recording nighttime incontinence episodes and subjective “wet sheets” scale per night (dry, damp, wet, soaked) for 30 days before randomization into the treatment arms. The TENS sessions will be performed at bedtime for 15 minutes for 30 days. TENS units will be set at a frequency of 10Hz, and intensity will be determined in the office by the sensitivity threshold of the patient. Voiding diaries will be kept each night while on TENS therapy. A voiding diary will also be completed 30 days before TENS treatment; patients and families will fill out the Pediatric Urinary Incontinence Questionnaire (PIN-Q), a validated tool for measuring quality of life in children with bladder dysfunction. Patients will follow up on day 30 and as needed (worsening symptoms, adverse reactions, concerns, and questions regarding usage of TENS). Patients who record 2 wet nights per week (a total of 8/30=27% wet nights) will be eligible for the TENS study. Those who record less than 2 wet nights per week will be ineligible for the TENS study but will be offered therapy using a bedwetting alarm device or other treatment.
Title: Investigation of Brain Mechanisms Involved in the Urinary Continence Mechanism Associated With Aging
Principal investigator: Becky Clarkson, PhD
University of Pittsburgh
Urge urinary incontinence (UUI) is a common problem in older people, which vastly reduces quality of life, yet the cause and mechanism of the disease are not well understood. This study will characterize brain control of the bladder in young and old continent individuals and age-matched incontinent counterparts. This will expand the investigators’ current knowledge of how the brain controls the bladder, how that control changes with age and disease, and suggest new targets to guide the development of better treatment.
Current data suggest that bladder control comprises 3 cerebral circuits that maintain continence by suppressing the voiding reflex in the midbrain. In the UUI phenotype that responded to BFB (Biofeedback assisted pelvic floor muscle therapy), the mechanism involved enhancing deactivation of the first brain circuit (medial prefrontal cortex, mPFC), which resulted in less activation of the second circuit (which includes the midcingulate cortex). In the phenotype that was resistant to BFB, no brain changes were observed. Although the investigators have an emerging picture of the brain’s role in UUI, the investigators have only a rudimentary understanding of what is ‘normal,’ i.e., how the brain normally controls the bladder. Moreover, the investigators do not know whether this control mechanism is the same across the lifespan, or whether it changes owing to the impact of aging. Thus, the investigators’ aims are to characterize the brain’s normal role in bladder control in both young and older people, to determine the changes in brain structure and function that lead to bladder control failure (UUI), and to examine how such changes differ between young and old individuals. To address the aims, the investigators will utilize detailed neuroimaging to evaluate 80 asymptomatic women and 80 women with UUI, each group divided into young (18-45) and old (65+ years) individuals. The study will enable the investigators to define the brain’s key structures, functional activity, and mechanisms involved in normal bladder control, and to identify the differences in these elements among those with UUI, both young and old.
By elucidating the mechanisms that mediate the brain’s control (and loss of control) of bladder function, the proposed study should enhance the investigators’ working model, deepen the understanding of the impact of aging, and identify better targets for the treatment of UUI. In addition, it may enable scientists to develop novel and more effective new therapies based on the revolution in neuroscience and more hope for UUI sufferers.
Title: Enuresis Alarm – Is a Manual Trigger System Beneficial?
Principal investigator: Gina Lockwood, MD
University of Iowa
Iowa City, IA
This study aims to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.
Nocturnal enuresis is a common issue in children, and the use of bedwetting alarms has shown the best long-term success. However, using alarms is very time-intensive, often taking months before yielding results. Therefore, researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting.
Children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study.
Participants must first be evaluated by a pediatric urology specialist.