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Showing 1-20 of 739 trials
NCT07668128
Pregnancy involves significant physiological changes, such as hormone fluctuations, weight gain, and fetal growth, which can affect multiple organ systems. These changes often lead to symptoms like stress urinary incontinence (SUI) and may worsen existing conditions. SUI affects about one-third of pregnant women and can decrease quality of life. Pelvic floor muscle exercise (PFME) is a recommended treatment to manage urinary incontinence during pregnancy and postpartum. This study aims to compare the effectiveness of three interventions: routine health education, traditional PFME, and tactile feedback PFME, on reducing SUI symptoms, shortening the second stage of labor, and improving quality of life. Participants will be enrolled in their third trimester and randomly assigned to one of the three groups, with each intervention lasting 8 weeks. Outcome measures include urinary symptoms (via bladder diary, UDI-6, and IIQ-7), quality of life (via KHQ and WHOQOL-BREF), and labor outcomes (duration of the second stage).
NCT07604025
The goal of this clinical trial is to learn which treatment is more effective for children with functional constipation (FC) and fecal incontinence (FI), also called retentive encopresis. Functional constipation is common in children and can cause pain, embarrassment, social stress, and repeated medical visits. One of the hardest symptoms to treat is fecal incontinence. Two common treatments are polyethylene glycol 3350 (PEG), an osmotic laxative, and Senna, a plant-based stimulant laxative. PEG is often used as standard maintenance therapy, while Senna is increasingly used, especially in children with difficult or refractory constipation. However, there is not enough high-quality evidence comparing these two treatments directly in children with fecal incontinence. The main question this study aims to answer is: Does Senna reduce the number of fecal incontinence episodes more than PEG after 3 months of treatment? The study will also assess safety, tolerability, abdominal pain or cramping, use of rescue enemas, treatment satisfaction, and treatment compliance. This is a prospective, randomized, double-blinded clinical trial. Children will be randomly assigned to receive either daily Senna or daily PEG for 3 months. Neither the families nor the treating medical team will know which treatment the child is receiving. Both medications will be prepared as identical-looking white powder in identical packages. Participants will be children aged 4 to 18 years who have functional constipation according to Rome IV criteria and have fecal incontinence at least 4 times per week. Children with an organic disease that may cause fecal incontinence, such as Hirschsprung disease, spinal cord abnormalities, or anorectal malformations, will not be included. Before starting the study medication, all participants will complete a 3-day bowel clean-out using high-dose PEG, with Pico-Salax added on the third day. After this clean-out, children will start their assigned daily treatment, either Senna or PEG. The dose will be based on age and may be adjusted by the physician according to stool consistency, stool frequency, cramping, and the child's clinical response. All families will also receive behavioral advice, including regular toilet sitting twice daily, correct toilet position using a footstool, and going to the toilet when the child feels the need. Participants will: * Take daily Senna or daily PEG for 3 months * Visit the clinic at baseline, 1 month, 2 months, and 3 months * Complete a 7-day stool and fecal incontinence diary before each visit * Report abdominal pain, cramping, diarrhea, perianal irritation, or any other adverse events * Return medication containers so compliance can be checked by weighing the remaining medication * Complete satisfaction and improvement questionnaires at the 3-month visit Outcome Measurements: The primary outcome is the mean number of fecal incontinence episodes per week after 3 months of treatment. This will be measured using a prospective 7-day diary completed by the family before the 3-month clinic visit. The secondary outcomes, assessed at 3 months, include: * Change in patient-initiated toilet sitting, meaning times when the child independently says they need to defecate * The proportion of children who reach 0-1 fecal incontinence episodes per week * The proportion of children with any improvement, defined as at least 1 fewer fecal incontinence episode per week * Number of rescue enemas used during the 3-month study period * Frequency and severity of abdominal pain or cramping * Parent-reported satisfaction with treatment using a 5-point Likert scale * Family impression of overall improvement using a 5-point Likert scale * The proportion of children still meeting Rome IV criteria for functional constipation * Treatment compliance, defined as good compliance if more than 80% of doses were taken The study plans to enroll 80 children total, with 40 children in the Senna group and 40 children in the PEG group.
NCT05438849
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.
NCT05878951
The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.
NCT07599189
The goal of this clinical trial is to learn if essential oil aromatherapy works to improve urinary symptoms in adults with multiple sclerosis. It will also learn about the safety of essential oil use in this population. The main questions it aims to answer are: * Does essential oil aromatherapy reduce urinary urgency, frequency, and incontinence episodes in participants with multiple sclerosis? * What medical problems do participants have when using essential oil aromatherapy? Researchers will compare essential oil aromatherapy to a placebo (a look-alike neutral oil with no therapeutic properties) to see if essential oil aromatherapy works to improve urinary symptoms in multiple sclerosis patients. Participants will: * Use essential oil aromatherapy or a placebo oil every day for 6 weeks * Complete a urinary symptom scales to record the frequency, urgency, and any leakage episodes each day * Fill out quality of life questionnaires at the beginning and end of the study
NCT06885931
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
NCT05773742
The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).
NCT04193709
This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.
NCT05952258
The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.
NCT06758219
The primary aim of the study was to determine the Turkish version of the "Validity and Reliability of the Knowledge Assessment Scales for Dementia and Urinary Incontinence in Community Older People". The secondary aim of the study was to measure the knowledge level of dementia and urinary incontinence in the community-living elderly population.
NCT05989646
The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.
NCT07335484
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
NCT07530484
This study aims to evaluate the effect of sling insertion angle on surgical outcomes and quality of life in women with stress urinary incontinence (SUI) undergoing single-incision midurethral sling surgery. Women diagnosed with urodynamic stress urinary incontinence who underwent surgery using a single-incision sling system were included. Patients were categorized into two groups based on sling insertion angle: an acute-angle group (\<45°, resembling a retropubic trajectory) and a standard-angle group (approximately 45°, toward the obturator foramen). The primary outcome was objective cure at 6 months, defined as a negative cough stress test without the need for additional anti-incontinence treatment. Secondary outcomes included objective cure at 1 and 3 months, postoperative voiding difficulty, persistent SUI symptoms, and quality of life assessed using the Incontinence Quality of Life (I-QOL) questionnaire. This study provides clinical evidence on whether sling insertion angle influences early and mid-term outcomes following single-incision midurethral sling surgery.
NCT06789406
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
NCT06798311
The study is designed to address the disparity in available conservative/behavioral treatments for UI/LUTS. The program was developed by experts from urogynecology, psychology, and physical therapy then modified based on focus group feedback from racially minoritized women. The study team created a patient-centered, culturally adapted, self-directed, 8-week, home-based module for women with LUTS/UI. The SUPPORT program combines multiple evidence-based conservative treatments for LUTS/UI including cognitive behavioral therapy, behavioral modifications, and home physical therapy exercise. Progression through the home-based program is supported by research staff. This prospective interventional study aims to evaluate the feasibility and acceptability of the SUPPORT program and its impact on patient-centered treatment outcomes, while enabling comparisons across race and ethnicity. This approach will provide a comprehensive understanding of how to effectively deliver self-management strategies for pelvic floor disorders. At the start of the 8 week SUPPORT course participants will also be given access to a custom programmed GPT trained on the SUPPORT workbook and given instructions on empathetic communication techniques and assisting patients in performing the SUPPORT exercises as outlined in the program. At the end of 8 weeks patients will fill out a survey assessing the frequency of use and interactions with the LLM.
NCT07108062
Objective: To evaluate the effectiveness of telerehabilitation (via lifestyle and dietary advice) in managing primary nocturnal enuresis (bedwetting) in children aged 5-10 years. Background: Nocturnal enuresis is common in children and can be influenced by genetic, hormonal, and bladder-related factors. Treatment includes behavioral, pharmacological, and psychological approaches. Telerehabilitation-remote delivery of care-emerged during the COVID-19 pandemic as a promising tool for maintaining continuity of care. Methodology: Design: Randomized Controlled Trial Participants: Children aged 5-10 with primary NE (wetting ≥4 nights/week), recruited online. Exclusion: Children with secondary NE due to medical conditions or those on medication. Groups: Study group: Received telerehabilitation (lifestyle + dietary guidance). Control group: No telerehabilitation. Duration: 3 weeks (1 week baseline, 1 week intervention, 1 week follow-up) Assessment: Number of wet nights per week (using ICCS classification: responders, partial responders, non-responders) Pediatric quality of life Intervention Details: Telerehabilitation involved dietary recommendations (e.g., reducing evening fluid intake, avoiding caffeine/chocolate), lifestyle tips, and motivational counseling delivered remotely to caregivers. Data Analysis: Pre- and post-intervention outcomes compared using paired t-tests. Demographics and clinical characteristics recorded.
NCT05547672
Prospective multicenter study designed to test the feasibility of the UroMems Artificial Urinary Sphincter.
NCT07489794
This study aims to investigate the relationship between urinary incontinence severity and surface electromyography (EMG) findings in women with multiple sclerosis. It will also examine the association of urinary incontinence with disability, quality of life, physical activity, and fatigue.
NCT06198439
Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and limitation of social interactions and physical activities, which significantly affects quality of life. Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations. Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.
NCT06416982
Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I.