472 Clinical Trials for Various Conditions
The goal of this clinical trial is to evaluate the effectiveness of nightly timed awakening in the treatment of nocturnal enuresis in children aged 6-17. The main questions it aims to: * Determine feasibility of nightly timed awakenings * Determine the role, if any, of comorbidities on resolution of enuresis * Determine incidence of daytime accidents * Obtain patient and parental satisfaction scores Researchers will compare a control group to treatment groups to see if there is any impact on nocturnal enuresis. Participants will be woken up by parents in the middle of the night to use the restroom. In addition, participants will receive 30 minute psychotherapy sessions using telehealth.
Nocturnal Enuresis, Voiding Dysfunction
Children referred to 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 two groups of 35 patients each.Group 1 will be the high pulse width set at 260us. Group 2 will be the low pulse width set at 50us. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus. The child's TENS unit will be set at a pulse width determined by randomization, frequency of 10Hz, and an intensity to be determined in the office based upon 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 bed time for 30 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 Bowel \& Bladder Questionnaire (BBQ), a validated tool for measuring symptoms in children with voiding dysfunction \[6\]; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment. 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.
Nocturnal Enuresis, Bedwetting
Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm.
Bedwetting, Nocturnal Enuresis, Urinary Incontinence
Children referred to 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 30 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 150 Hz. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus. The child's TENS unit will be set at a frequency determined by randomization, pulse width of 260 seconds, and an intensity to be determined in the office based upon 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 bed time 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 prior to starting TENS treatment in order 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.
Nocturnal Enuresis, Bed Wetting
This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.
Nocturnal Enuresis
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.
Nocturnal Enuresis, Bedwetting
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.
Bedwetting
To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Bedwetting
The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years. The main questions this study aims to answer are: 1. Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage. 2. Is the device safe and effective compared to the sham group? Participants will: 1. Be randomly assigned to an active or sham control group in a blinded, multicenter study. 2. Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals. 3. Enter a 3-month, treatment-free follow-up phase, with SUI assessment. 4. Proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit. The total study duration will last approximately 18 months, with each individual's participation lasting approximately 6-8 months. This study aims to provide robust data on the effectiveness, safety, and durability of the SUI-100 device for treating female Stress Urinary Incontinence.
Stress Urinary Incontinence (SUI)
The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.
Stress Urinary Incontinence, Vaginal Prolapse
This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).
Stress Urinary Incontinence, Urinary Incontinence, Mixed Urinary Incontinence
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.
Stress Incontinence Female, Urinary Incontinence, Urinary Incontinence,Stress, Pain, Pain Acute
Holmium laser enucleation of the prostate (HoLEP) is a surgical procedure used to treat benign prostatic hyperplasia (BPH). HoLEP involves the removal of obstructive prostatic tissue via an endoscopic approach to relieve bothersome urinary symptoms. HoLEP is recommended by the American Urological Association (AUA) as a size-independent treatment for BPH. While the surgery is highly durable and versatile, post-operative stress urinary incontinence (SUI) has been reported following HoLEP, up to 44%. Pelvic floor physical therapy (PFPT) is a therapeutic strategy with low cost and risk to patients used to treat SUI following prostate surgery. However, data on the efficacy of conducting PFPT prior to HoLEP in minimizing or eliminating post-operative urinary incontinence is limited. The investigators will recruit patients who have already agreed to undergo HoLEP for this study. Participants will be randomized into two groups: The intervention group will begin standardized PFPT before surgery and will continue PFPT after surgery, and the second group will begin PFPT after surgery only (current practice). Both groups will continue with PFPT following surgery until urinary continence is regained. Investigators will compare the time required to regain urinary continence and patient-reported outcomes between the two groups.
Prostatic Hyperplasia, Stress Urinary Incontinence
The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention, Lower Urinary Tract Symptoms
Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.
Urinary Urge Incontinence, Stress Urinary Incontinence, Prostatic Hyperplasia
The goal of this clinical trial is to compare the efficacy of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence to treatment with pelvic floor physical therapy. The main questions it aims to answer are: Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy? Does treatment with the device under study combined with pelvic floor physical therapy improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy alone and treatment with the device alone? Participants will be given one of three treatments: 1. The devices under study alone 2. The device under study plus 4 weekly visits with a pelvic floor physical therapist 3. Four weekly visits with a physical therapist alone Participants will perform a standardized pelvic floor muscle training program 10 minutes a day, four times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).
Stress Urinary Incontinence, Pelvic Floor Disorders
The burden of urinary incontinence (UI) on American women is immense in both human and financial terms, and continues to rise with the aging US population. Although numerous non-surgical management strategies have proven efficacy for both stress and urge urinary incontinence, there remains a lack of appropriate UI management in the primary care setting. The goal of this multi-site cluster randomized comparative effectiveness trial is to compare the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced practice provider (APP) co-management. These two evidence-based, practice-changing strategies are designed to improve the quality of care for an ethnically diverse population of women with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both arms of the study will include basic physician education (academic detailing) and electronic clinical decision support. In Arm 1, the investigators will implement an electronic referral system (electronic referral), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management).
Urinary Incontinence
This study aims to compare the effectiveness of a Urogynecology Social Media Navigation Aid Kit (SNAK) and routine counseling in the treatment of women with newly diagnosed urinary incontinence. The study will conduct a randomized controlled trial on treatment-naïve patients seeking care for urinary incontinence. The research will have five aims: 1. evaluate the impact of SNAK on patients' self-efficacy in managing urinary incontinence symptoms 2. compare patient satisfaction with urinary incontinence treatment between SNAK and routine counseling groups 3. assess the impact of SNAK on urinary incontinence severity 4. evaluate the impact of SNAK on patients' quality of life 5. examine if there is an impact of SNAK on patients' treatment decision. Participants will be randomized to routine counseling alone versus routine counseling plus a SNAK. They will be given a baseline survey at their initial enrollment to the study. The investigators will follow up at a 3-month interval where they will be given a post-intervention survey.
Urinary Incontinence, Stress Incontinence, Female, Urge Incontinence
The goal of this pilot study is to report the safety and efficacy of a suture-suspended mesh-reduced sling for treating stress urinary incontinence (SUI) in women. The main question\[s\] it aims to answer are: * investigate the efficacy of this mesh-reduced suture-based surgical technique for improving SUI symptoms * investigate the efficacy of this mesh-reduced suture-based surgical technique on key urethral support defects observed with 3D ultrasound Participants will consent to participate following which they will complete pre-operative assessments according to our routine clinical pathway. The participant will then undergo surgery and will be followed up to 12 months post-operatively via symptom assessment and pelvic exam.
Stress Urinary Incontinence
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity.
Urgency Urinary Incontinence
Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies. The purpose of this study is to 1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system 2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy 3. To assess the cost-effectiveness of home biofeedback therapy.
Fecal Incontinence, Dyssynergic Defecation, Urinary Incontinence
A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
The goal of this clinical trial is to assess the efficacy and usability of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence. The main questions it aims to answer are: Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ? Participants will be given one of the devices under study, in addition to educational materials on use of the device, and a treatment schedule. Participants will perform a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, five times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).
Stress Urinary Incontinence, Urinary Incontinence, Pelvic Floor Disorders
The main goal of this clinical trial is to improve the care for urinary incontinence (UI) provided to adult women by primary care providers. The main questions it aims to answer are: * Can a practice-based intervention involving primary care providers lead to improved quality of incontinence care? * Will this intervention reduce the utilization of specialist care for urinary incontinence? * What effect will this intervention have on patient outcomes, including disease-specific outcomes, symptom severity, quality of life, and patient knowledge? * Does our intervention reduce disparities in care? Provider participants will be randomized at the office level to either an intervention group or a delayed intervention (control) group. The intervention group will receive an intervention consisting of academic detailing, clinical decision support tools, electronic referral, and the ability to refer to an advanced practice provider for co-management. The delayed intervention group will provide usual care until the crossover phase of the study, at which point they will receive the same intervention as the intervention group. Patient participants will bring up urinary incontinence with their primary care provider and complete three electronic surveys. Researchers will compare the intervention group to the delayed intervention (control) group to see if the intervention results in increased adherence to evidence-based quality indicators.
Urinary Incontinence
The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.
Urinary Incontinence
The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.
Urinary Incontinence
The purpose of this study is to investigate how a support group with other individuals who share the condition urinary incontinence (UI) impacts patients experience with management of urinary incontinence.
Urinary Incontinence
The aim of this randomized controlled trial study is to evaluate the efficacy and safety of platelet-rich plasma (PRP) in the treatment of female stress urinary incontinence (SUI), compared to placebo. Subjects will undergo an injection of PRP (or injectable saline placebo) into the anterior vaginal wall in the office. Primary outcomes will include a negative urinary stress test plus improvement with the Patient Global Impression of Improvement (PGI-I) at 6-months. Secondary outcomes will include the Female Sexual Function Index (FSFI), the Incontinence Quality of life (I-QOL), Questionnaire for Urinary Incontinence Diagnosis (QUID), and the visual analog scale for pain.
Urinary Incontinence,Stress, Urinary Incontinence
A prospective, two-arm randomized clinical trial utilizing a multidimensional intervention to reduce falls in older women with Urinary Urge Incontinence. The intervention consist of general balance and strength training, bladder training and urge suppression, and home hazard assessments. The control group will receive informational booklets on fall prevention and behavioral treatment for urinary urge incontinence.
Urinary Incontinence, Urge
The objective of this trial is to evaluate the safety and efficacy of the combined FormaV and VTone Applicators for Symptoms of Mixed Urinary Incontinence. Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol. The subject will return for 3 follow-up visits: 4 weeks (1M FU), 3 months follow up (3M FU), 6 months follow up (6M FU) after the treatment.
Urinary Incontinence