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Nocturnal Enuresis clinical trials

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NCT ID: NCT02900495 Completed - Nocturnal Enuresis Clinical Trials

Transcutaneous Electric Nerve Stimulation (TENS) for the Treatment of Nocturnal Enuresis in Children

Start date: August 2016
Phase: N/A
Study type: Interventional

Children referred to the pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail behavioral therapy and who meet inclusion criteria will be offered therapy with a TENS unit. Patients will be randomized into four groups. Group 1 will be the direct bladder stimulation arm with electrodes placed onto the abdomen in the suprapubic region directly over the bladder. Group 2 will be the distal neural loop arm with electrodes placed over the posterior tibial nerve. Group 3 will be the proximal neural loop arm with electrodes placed about 2-3 cm lateral to the midline in the sacral region at the level of S3. Group 4 will be the control arm with electrodes placed on the scapula. We will aim to recruit 32 patients per group for a total of 128 patients. The patients will be provided with a TENS unit (TENS 3000 Analog) and electrode pads and caretakers instructed on how to use the apparatus. The TENS sessions will be performed nightly before bed for 15 minutes. TENS units will be set at a frequency of 10 Hz, and intensity determined by the sensitivity threshold of the patient. 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 prior to starting TENS treatment in order to compare the effect of treatment on QOL. . They will then follow up on these parameters again after another month (one month off of TENS therapy) to assess the durability of treatment effect. The data will be collected at different time points (baseline, 1 month, 2 months) for each group by itself and the groups compared against each other using statistical analysis.

NCT ID: NCT02845648 Completed - Clinical trials for Enuresis, Nocturnal, 2 (Disorder)

Ability to Awaken in Nonmonosymptomatic Enuresis

Start date: July 2010
Phase: N/A
Study type: Observational

To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic enuresis and evaluate the potential implication of improved AA for treatment response prediction.

NCT ID: NCT02747849 Completed - Bedwetting Clinical Trials

Hand & Foot Nocturnal Enuresis TENS Study

Start date: April 2016
Phase: N/A
Study type: Interventional

The investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the TENS device on the hand and foot as a control.

NCT ID: NCT02747810 Withdrawn - Bedwetting Clinical Trials

Pilot Study: Foot Neuromodulation for Nocturnal Enuresis in Children

Start date: March 2016
Phase: N/A
Study type: Interventional

Background: Previous animal model studies at the University of Pittsburgh have shown a significant impact on inhibiting bladder over activity and increasing bladder capacity with neuromodulation techniques, specifically tibial nerve stimulation. This has been translated into adult clinical trials through the department of urology. Through the use of a commercially available subcutaneous nerve stimulator placed on the dorsum of the foot, researchers were able to demonstrate a significant increase in bladder capacity and the delay of voiding sensation for up to 5 hours after stimulation in eight healthy subjects. This prompted the clinical trial approved under IRB PRO13020474 which is currently enrolling patients. The incidence of night-time overactive bladder leading to nocturnal enuresis (bed wetting) is very common in the pediatric and teenage population, particularly in patients without daytime bladder over activity symptoms. When behavioral modification (i.e. refraining from night-time fluid consumption and bladder irritants, and bed wetting alarms for timed voiding) fails which it often does there is a paucity of effective and safe treatment options. Medications can be tried, but generally these are from the tricyclic antidepressant family and carry significant side effects limiting the use. Aim: Researchers aim to utilize the same technology currently being studied under IRB PRO14080250. Electrical stimulation will be applied to the foot via skin surface electrodes for a minimum of 1 hour before bed for 2 weeks to 5 normal subjects. Normal Subjects will be asked to complete a questionnaire about any skin irritation or experiences of toe twitching while wearing the newly designed TENS device, during a return visit with Dr. Stephany. The primary outcomes of this study are safety and functionality of the New TENS unit

NCT ID: NCT02699528 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder

Start date: May 2016
Phase: N/A
Study type: Observational

To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder

NCT ID: NCT02636387 Terminated - Anemia, Sickle Cell Clinical Trials

Desmopressin as a Therapy for Bedwetting in Children With Sickle Cell Disease

Start date: August 26, 2015
Phase:
Study type: Observational

This study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease.

NCT ID: NCT02621736 Completed - Nocturnal Enuresis Clinical Trials

Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).

COMEN
Start date: January 1, 2016
Phase:
Study type: Observational

Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism. The only available medical treatment option is the vasopressin analogum Desmopressin®. However, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension. Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in patients with MEN compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.

NCT ID: NCT02600676 Completed - Clinical trials for Urinary Incontinence

Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis

Start date: September 2015
Phase: N/A
Study type: Interventional

This is a randomized, double blind, placebo controlled study of the effect of Sacral Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic nocturnal enuresis (MNE).

NCT ID: NCT02584231 Completed - Clinical trials for Monosymptomatic Nocturnal Enuresis

Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population

Start date: September 9, 2015
Phase: Phase 4
Study type: Interventional

Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot study performed at our department showed a correlation between weight and plasma concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old. Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary concentration testing will be evaluated

NCT ID: NCT02538302 Completed - Nocturnal Enuresis Clinical Trials

Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

Start date: July 2013
Phase: Phase 3
Study type: Interventional

Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.