Clinical Research Directory

Noninvasive Ultrasound Assessment of Detrusor Dysfunction

The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.

Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics

Pelvic health physical therapy (PHPT) is an evidence-based intervention for bladder dysfunction (BD) and pelvic floor disorders (PFD) in men postprostatectomy, and postpartum women. However, there is a dearth of objective outcome measures - in particular, those that can capture changes remotely, between clinic visits. In other domains, such as physical activity, wearable digital devices have started to fill this gap. The investigators aim to evaluate if commercially available wearables for the bladder (WeB) can provide valid, objective outcomes to evaluate, monitor and treat people with BD and PFD. The WeB toolkit, comprising a wearable bladder ultrasound device and an intravaginal exerciser (women only), eventually aims to provide real-world, actionable data to both users and healthcare providers, thereby improving patient outcomes through closed-loop interventions. Preliminary studies in women with multiple sclerosis have shown strong associations with gold-standard clinical measures, suggesting that WeB tools could revolutionize care for these patients. However, the effectiveness of these tools in a wider range of patient demographics, especially postpartum women, and men, has yet to be established. The investigators seeks to extend the promising pilot findings to these additional 'special' populations seen in the PHPT clinic. The investigators hypothesize that the WeB tools will retain their accuracy and utility across these diverse groups. The investigators plan to i) validate WeB in these special populations against gold-standard clinical measures for BD, ii) evaluate the responsiveness of WeB tools to changes in outcomes before and after PHPT and iii) assess user experience in these populations. By ensuring the WeB tools' broad applicability, this research seeks to close the gap in continuous care and enable objective, personalized treatment strategies. The outcomes will have significant implications for the management of BD and PFD, potentially offering a more inclusive and empowering approach to patient care in women postpartum and men post-prostatectomy.

Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).

Understanding the Coloplast Intermittent Catheter Selection Study: This study aims to understand how adults who need to use catheters to empty their bladder by themselves decide which Coloplast catheter works best for them. The two types of catheters studied are called SpeediCath and Luja. Why is this study being done? The study wants to find out which catheter type helps people feel most satisfied when they start to use it on their own. It also looks at why people choose their catheter at the beginning, how happy they are with it over the first six months, and what problems they might face using it. Who can join the study? * Adults aged 18 or older who have bladder problems and need to empty their bladder using a catheter. * People who have been trained on how to use a catheter. * People who have chosen to use either SpeediCath or Luja catheters from Coloplast. * People who can perform the catheterization themselves at least two times per day. Certain people cannot join, such as pregnant women, anyone who cannot give consent, or those who have trouble filling out questionnaires. What will happen in the study? Participants will visit the study center three times: * At the start (to select their catheter and answer questions about the reasons for the specific catheter selection) * After 3 to 12 weeks (to share their perception on the impact of the used catheter) * After 6 months (to measure final satisfaction and any difficulties) If a participant changes to a different catheter type or catheter brand during the study, this will be recorded, and they will continue in the study. How will this study help? The information gathered will help healthcare providers understand what matters most to people when selecting a catheter. This can improve how catheters are recommended and support patients better during self-catheterization and improve treatment adherence and compliance.

Vascularized Composite Bladder Allograft Transplantation

This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients with terminal bladder pathology. A vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to standard urinary diversion, which employs bowel. A robotic surgical approach will be employed.

Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children

The over-arching aim of this study is to evaluate the effects of two specific anti-cancer chemotherapies, vincristine and doxorubicin, on bladder function and urine composition.

Concomitant Renal and Urinary Bladder Allograft Transplantation

The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

NESA Neuromodulation Versus Transcutaneous Posterior Tibial Stimulation

Introduction: Overactive bladder (OAB) is a common condition characterized by urinary urgency, frequency, and, in some cases, urge incontinence. Non-invasive neuromodulation has emerged as an effective therapeutic option by modulating the neural pathways involved in bladder control. This approach offers a promising alternative for patients who do not respond to conventional treatments. Objectives: To evaluate the effect of non-invasive NESA neuromodulation compared to posterior tibial stimulation in patients with overactive bladder. compared to posterior tibial stimulation, with same-day exercises and patient education on quality of life, symptoms, discomfort and sleep. day of the session and patient education on quality of life, symptoms, discomfort and sleep. Methods: Twenty-four patients (24 women), aged 38-85 years with overactive bladder will be included in this experimental clinical trial study. Each patient will attend ten sessions two days a week. Patient life quality will be measured using SF-36, sleep quality with the Pittsburgh questionnaire, perception of urinari incontinence (UI) symptoms and patient quality of life with the ICIQ-SF questionnaire. All these variables will be measured before, immediately after the ten sessions and at two months after the end of treatment. Ethic: The study was approved by the ethics committee of the University of Valencia, and all participants will be given an informed consent form.

Study of the Quality of Life in School Aged-children With Posterior Urethral Valves

Posterior urethral valves (PUV) are the most common congenital obstructive lesion of the urethra, affecting from 1 per 3000 to 1 per 8000 live births. Valve ablation usually resolves the obstruction in PUV but patients still may suffer of deterioration in renal and urinary functions. Renal insufficiency is the most feared long-term complication. Up to 50 % of the patients will develop chronic kidney disease (CKD), and up to 20 % will develop end-stage renal disease (ESRD) and ultimately will require kidney transplantation. PUV is the first urological cause of ESRD. Progression towards CKD depends on febrile urinary tract infections (UTIs), severity of a vesicoureteral reflux and bladder dysfunction. Bladder dysfunction is due to an overactive and small poorly compliant bladder during infancy. Detrusor overactivity usually decreases in childhood and bladder capacity increases. The most common symptom of this bladder dysfunction is urinary incontinence. 60 % of children are continent at the age of 5 years old and 90 % at 10 years old. In case of persistent bladder dysfunction, medical treatment (anticholinergics, alpha-blockers) may be introduced, or even intermittent catheterizations. Current scientific literature has very few studies on quality of life (QoL) in patients with PUV, mostly in adult patients and very small cohorts. Men treated for PUV in childhood had a good quality of life compared to the normative population, except for sleeping, eating and sexual activity. It seemed that the more severe the urological and nephrological functions were, the lower the QoL was. Children were only asked about intermittent urinary catheterization, and family point of view has never been collected. However, QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling, or after diagnosis in an infant with PUV. Hence, the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life, as measured by the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).

Bowel And Bladder Function in Infant Toilet Training

The overall purpose is to assess whether assisted infant toilet training during the first year of life can prevent functional gastrointestinal and urinary tract disorders up to 4 year of age. Healthy Swedish children will be randomized to start assisted infant toilet training at 0-2 months of age or at 10-11 months of age. The toilet training process will be described including mother-to-infant attachment and parental stress.

The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group

Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra. Clean intermittent catheterization (CIC) is one of the main tools for neurogenic lower urinary tract dysfunction management, as it provides adequate bladder emptying and protects the upper urinary tract from high pressures, hence preventing progressive renal damage. Despite its important role, CIC is difficult to perform in various situations: lack of manual dexterity, female wheelchair patients, body habitus, anatomical morbidity due to extensive surgery or psychological problems. For such patients, continent urinary diversion (CUD) is a viable option for bladder emptying optimization. Various techniques have been described to create an anti-reflux appendicovesical anastomosis in pediatric lower urinary tract reconstruction, whether performed via an extravesical or an intravesical route, all share a common denominator of creating a submucosal tunnel in an attempt to replicate the physiological anti-reflux mechanism.