Enuresis (Bedwetting)

This research aims to explore brain activity in children with Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to healthy children of similar age and gender. It also investigates whether sacral transcutaneous electric nerve stimulation (TENS) influences brain areas controlling the bladder. The study focuses on children aged 6 to 14 years, as brain activity related to bladder control has not yet been studied in this group, though adult studies suggest increased brain activity may be a factor in OAB and DUI. Participants include children with OAB and DUI who will receive sacral TENS treatment applied for two hours daily over 10 weeks. The study involves two main parts: a cross-sectional comparison between affected and healthy children and an interventional cohort study where children with symptoms undergo sacral TENS. Imaging sessions include structural MRI and functional MRI scans with both full and empty bladder states, performed before and after the treatment. Healthy children will have only baseline imaging. During the study, children and/or their parents complete various assessments including frequency and volume charts, screening tools for attention deficit hyperactivity disorder and autism spectrum disorders, and quality of life questionnaires. Researchers will measure brain activity changes, structural brain differences, and quality of life changes before and after treatment. The primary outcomes focus on brain activity at baseline and after TENS, with secondary outcomes assessing quality of life and urinary symptoms. The study is conducted under careful monitoring to ensure safety and data quality.

Researchers are investigating the effects of Structured Pelvic Floor Muscle Rehabilitation (SPFMR) combined with desmopressin acetate (DDAVP) treatment in children aged 7 to 13 with Primary Monosymptomatic Nocturnal Enuresis (PMNE), a condition characterized by bedwetting without daytime urinary symptoms. This randomized controlled trial aims to determine if adding SPFMR can reduce the frequency and severity of bedwetting episodes and lower relapse rates during both short- and long-term follow-ups compared to DDAVP treatment alone. The study has two groups: one receiving only DDAVP and urotherapy training as prescribed by a pediatric urologist, and the other receiving DDAVP plus 10 weeks of structured pelvic floor muscle rehabilitation sessions led by a physiotherapist. The rehabilitation includes diaphragmatic breathing, biofeedback-assisted pelvic floor training, core stabilization and squat exercises, strengthening of specific muscles, balance training, and home exercises. Each rehabilitation session lasts about 60 minutes, with home exercises performed three times weekly. Participants will keep diaries documenting bedwetting frequency and severity and undergo assessments such as uroflowmetry, post-void residual measurement, bladder diaries, and pelvic floor muscle activation evaluations at baseline and several follow-up points. Researchers will monitor treatment responses and relapse rates over time. The study follows ethical guidelines, requires parental consent, and expects to conclude in 2027.

Researchers are studying the treatment of daytime urinary incontinence in children aged 5 to 14 years who do not fully respond to low doses of either solifenacin or mirabegron alone. The goal is to see if combining low doses of both medications works better than using a high dose of either drug by itself. This is a phase 3 clinical trial designed as a multicenter, randomized, single-blinded study involving 236 children diagnosed with this condition. Participants are randomly assigned to one of four groups. Two groups start with solifenacin 5 mg daily and two groups start with mirabegron 25 mg daily for the first 6 weeks. If children do not respond completely after 6 weeks, they receive an add-on treatment for 12 more weeks: either an additional dose of the same drug or the other drug, depending on their initial group. The total treatment period lasts 18 weeks. During the study, researchers assess treatment response by tracking the number of wet days per week from week 6 through the end of the study. Additional evaluations include measuring incontinence severity, urge severity, urine volume, frequency of urination, and quality of life using questionnaires. Safety, side effects, and tolerability are also monitored. Participation involves regular visits and assessments over the full 18-week treatment period.

Researchers are investigating the development of lower limb lymphoedema and urinary issues such as nocturia and nocturnal polyuria in patients treated for urogenital cancers like prostate and bladder cancer. This prospective observational study aims to determine how often these conditions occur after pelvic lymph node dissection surgery and to identify factors that may predict their development. The study also seeks to find the best clinical methods to detect early lymphoedema in the legs after treatment. The study involves 150 patients scheduled for transperitoneal pelvic lymph node dissection for urogenital cancer. Participants will be followed from before surgery until one year after surgery. All receive standard care including education about lymphoedema prevention, skincare routines, and supervised exercises to improve circulation, with frequency of therapy sessions decreasing over time. If lymphoedema develops, compression stockings will be provided. Evaluations occur at baseline, 6 weeks, 6 months, and 12 months post-surgery. During the study, participants will undergo clinical assessments for lymphoedema and urinary symptoms at scheduled visits. Researchers will track the incidence and prevalence of lymphoedema, as well as its detection methods, validity, and reliability. They will also study prognostic factors for lymphoedema and urinary conditions, monitoring changes over time. The study lasts up to two years, with participants enrolled during the first year and followed for one year after their surgery.

Researchers are evaluating the effects of melatonin supplementation on sleep and daytime functioning in adolescents aged 13 to 17 who have short or disrupted sleep due to behavioral causes, such as difficulty falling asleep, staying asleep, or waking too early. This study uses a randomized, double-blind, crossover design to compare melatonin with a placebo. The goal is to understand how melatonin influences sleep duration and emotional regulation in typically developing adolescents without organic sleep disorders. Participants will receive 3 mg of melatonin or a placebo one hour before bedtime for 12 consecutive nights during each treatment period. The study uses a crossover method, meaning each adolescent will experience both melatonin and placebo treatments at different times, allowing direct comparison within the same individual. This design helps researchers assess the impact of melatonin more accurately by controlling for individual differences. During the study, participants will be monitored for changes in objective sleep duration and emotional regulation using specific tools over two-week periods for each treatment. Researchers will collect data on sleep patterns and daytime functioning to determine the effects of melatonin versus placebo. Participants will be followed through these treatment periods to measure changes and ensure safety, contributing valuable information on melatonin's impact on adolescent sleep and daily performance.

Lower urinary tract dysfunction (LUTD) in children involves problems with urine storage and voiding, often linked to abnormal reflexes formed in the central nervous system. Relaxation has been shown to help improve these functions. This trial evaluates a new Micturition Desire-Relaxation Training Device designed to help children with LUTD by training them to link the sensation of needing to urinate with a relaxed state. The study is a randomized controlled trial conducted over six months to assess the device's clinical effects. Participants are randomly assigned to either the intervention group using the active Micturition Desire-Relaxation Training Device or a sham group using an inactive device. In the intervention group, children will do supervised training sessions followed by home use of the device, performing 5 to 10 daily sessions lasting about 10 minutes each over eight weeks. The sham group follows the same training schedule but uses a non-functioning device for four weeks. Both groups maintain fluid intake and voiding diaries with monthly records, and caregivers receive remote support from study physicians. Throughout the study, participants complete voiding diaries and enuresis questionnaires at baseline, during treatment, and at 3 and 6 months post-intervention to monitor symptom changes and recurrence. Daily training adherence and any adverse events are recorded and reviewed by physicians through a secure cloud platform. The trial measures outcomes such as improvement rates in enuresis, daytime urinary incontinence frequency, total voiding episodes, and various bladder function and behavioral assessments, tracking progress over the full six-month period.

Researchers are evaluating the role of sulbutiamine in treating monosymptomatic nocturnal enuresis in children aged 6 to 18 years. The study compares the effects of sulbutiamine alone, imipramine alone, and a combination of both drugs to understand their impact on reducing the number of wet nights in affected children. Participants are randomly assigned to one of three groups: one receiving 25 mg of imipramine daily, another receiving 100 mg of sulbutiamine daily, and a third group receiving both medications combined. Each treatment is taken orally for one month, with follow-up visits occurring monthly for a total of three months to monitor progress and side effects. During the study, children and their parents will record the number of wet nights each month using a calendar. Researchers will assess this data alongside any side effects reported during outpatient follow-ups. The primary measurement is the reduction in wet nights over three months, while safety is evaluated through monthly clinic visits. Participants can expect regular monitoring and support throughout the study period.

Researchers are evaluating the safety and effectiveness of combining Solifenacin and Mirabegron compared to Desmopressin in treating children aged 6 to 18 years who have primary mono-symptomatic nocturnal enuresis (bedwetting without other urinary symptoms). This condition affects many children and involves involuntary nighttime urination. The study aims to find out if the combination therapy reduces the number of wet nights better than Desmopressin alone and to learn about any medical problems that may occur while taking the treatments. Participants will be randomly assigned to receive either the combination of Solifenacin and Mirabegron or Desmopressin daily for three months. They will visit the clinic once a month for checkups and tests during this period. The treatments involve daily medication taken by mouth, and researchers will track symptoms and side effects over the 90-day treatment period. Throughout the study, participants will keep a diary recording the number of wet nights and any symptoms they experience. Researchers will monitor safety by checking for side effects and will measure the percentage of improvement in wet nights per week after 90 days. The total study duration includes these 3 months of treatment with monthly clinic visits to assess progress and safety.

This research investigates the use of Transcutaneous Electrical Nerve Stimulation (TENS) therapy to treat primary nocturnal enuresis (bedwetting) in children aged 5 to 17 years. Children referred to a pediatric urology clinic who have not improved after behavioral modifications will be offered either a bedwetting alarm or TENS therapy. The study aims to compare two different pulse widths of TENS to understand their effects on nighttime wetting episodes and bladder symptoms. Participants will be randomly assigned to one of two groups: one receiving TENS with a high pulse width of 260 microseconds and the other with a low pulse width of 50 microseconds. Each child will use the TENS unit with electrodes placed on the medial ankle along the posterior tibial nerve for 30 minutes at bedtime every night for 30 days. Intensity will be set based on the child's sensitivity, and families will be instructed on device use. There is no placebo group; all participants receive active treatment. During the study, parents and children will keep nightly diaries tracking the frequency and severity of bedwetting using a wet sheet scale. Before and after treatment, they will complete the Bowel & Bladder Questionnaire to assess bladder symptoms. Follow-up visits will occur after one month to evaluate progress and any side effects. The main outcome measured is the percentage of wet nights over 30 days, alongside severity and symptom questionnaire results. Participation includes daily monitoring and a month of treatment.

Researchers are evaluating the UCon medical device with a Bar Electrode for treating symptoms of overactive bladder (OAB) and bowel dysfunction (BD) in female patients. This early feasibility clinical investigation aims to assess both the initial safety and performance of the device in a group of 40 women over 12 weeks. The UCon device electrically stimulates the dorsal genital nerve (DGN) through the skin to help manage bladder and bowel muscle activity and relieve symptoms. The study includes two main periods: screening and intervention. During the screening phase, participants use the UCon device with a Patch Electrode at home for 4 weeks to determine eligibility for the next phase. In the intervention period, the Bar Electrode is inserted into the clitoral hood, followed by a recovery time of 4 to 8 weeks. After recovery, participants self-administer electrical stimulation using the Bar Electrode at home for either 4 or 12 weeks. Participants will be closely monitored throughout the study with assessments of device safety, proper electrode insertion, and symptom changes at 4 and 12 weeks. Researchers will evaluate treatment effects on OAB and BD symptoms, quality of life, and user acceptance of the device. Safety monitoring includes tracking adverse events, and participants will provide feedback during the study. The total study duration for each participant includes screening, recovery, and intervention phases.