Incontinence (Urinary/Fecal)

Researchers are evaluating how abdominal massage affects gastrointestinal functions in patients who are mechanically ventilated and receiving enteral nutrition in intensive care units. This study aims to assess abdominal massage's impact on bowel movement frequency, gastric residual volume, and abdominal distension. The trial is designed as a prospective, single-blind randomized controlled trial to provide scientific evidence for abdominal massage use in this patient group. Participants are randomly assigned to either an intervention group receiving abdominal massage or a control group receiving standard care without massage. Abdominal massage is performed twice daily for 15 minutes over three days using specific techniques like effleurage, petrissage, and vibration. The massage is given at the bedside in a semi-Fowler position before enteral feeding, with routine nursing care provided to all patients. Throughout the study, researchers monitor bowel movements, gastric residual volume, abdominal distension, and stool consistency using specialized forms and scales twice daily. Data collection includes clinical assessments such as Glasgow Coma Scale and APACHE II scoring. The study lasts three days for each patient, with detailed recording of gastrointestinal function parameters to evaluate the effects of abdominal massage compared to standard care.

This research aims to evaluate the effectiveness of using a 3D scan to create personalized ostomy appliances for people with an ostomy. The study focuses on whether a 3D scan of the stoma can reduce leakages and improve quality of life compared to standard care. Ostomy appliances collect waste from the stoma but often cause complications such as skin irritation, leaks, and infections, which impact patients' daily lives. Participants will have their stoma scanned with a 3D scanner to create a detailed digital model. This model is then edited and used to produce a personalized ostomy appliance by modifying standard appliances with a laser cutter. The study involves two 2-week periods where participants use their usual ostomy appliance first, then the personalized 3D-printed appliance. The personalized appliances are designed with input from an ostomy nursing team to ensure proper fit based on each patient's body and stoma. During the 4-week study, participants will complete daily symptom diaries and weekly quality of life surveys conducted over the phone. Researchers will track leak incidents, the number of appliances used, and overall patient satisfaction. The study includes ongoing monitoring through electronic surveys requiring internet and device access. Total participation lasts about one month, with safety and quality of life as key measures.

This research aims to assess the long-term safety and effectiveness of the FDA-approved eCoin4 implanted tibial nerve stimulator in people with overactive bladder (OAB) who experience urgency urinary incontinence (UUI). The study is prospective, involves multiple centers, and follows a single group of participants to understand how the device performs in real-world use. Participants will receive an implant of the eCoin device, which provides subcutaneous stimulation to the tibial nerve. This stimulation is intended to help manage urgency urinary incontinence. The treatment involves implanting the device and then monitoring participants over time to evaluate its safety and effectiveness. Throughout the study, participants will complete voiding diaries and quality of life questionnaires during follow-up visits that extend up to 5 years. Researchers will monitor safety by tracking any device- or procedure-related adverse events and measure effectiveness by assessing responder rates at 12 and 24 months. The study includes ongoing evaluations of safety data even after reimplantation when applicable, ensuring comprehensive long-term monitoring.

Researchers are studying surgical preparedness in Latinas undergoing urogynecologic surgery to develop and test a telehealth intervention called TIPPS-Latina. The study aims to understand factors affecting preparedness, design a patient-centered intervention using Human Centered Design and Dissemination & Implementation methods, and pilot test the intervention for feasibility and implementation. This project involves a participatory action framework guiding all study phases. Participants scheduled for urogynecologic surgery will be randomly assigned to receive either routine preoperative counseling alone or routine counseling plus the TIPPS-Latina telehealth intervention. The intervention development follows a three-phase Discover, Design/Build, and Test framework, using mixed methods to refine and evaluate the telehealth support tailored for Latinas. The study includes community patient partners to guide research and intervention design. Participants will complete assessments including the Surgical Preparedness Assessment, health literacy, self-efficacy, trust in provider, decisional conflict, anxiety/depression, and satisfaction with healthcare services. These are measured at preoperative visits, on the day of surgery before the procedure, and 6-8 weeks postoperatively. The study evaluates the intervention's feasibility, acceptability, and appropriateness during preoperative holding on surgery day, with monitoring of implementation outcomes and patient-reported measures over the course of the trial.

Researchers are evaluating the use of abdominal functional electrical stimulation (FES) to improve bowel management time for people living with chronic spinal cord injury (SCI). The study aims to assess whether this stimulation can also enhance bowel-related quality of life, participant-reported bowel function, bowel management strategies, bladder symptoms, and reduce unplanned hospital admissions. Participants' experiences and perspectives about the stimulation sessions and device use will also be explored. All participants in this trial will receive abdominal functional electrical stimulation, where electrodes are applied to the abdomen during bowel routines to assess its effects. The intervention lasts for 10 weeks, with daily monitoring of bowel management time and safety. Stimulation dose is tracked during weeks 3 to 7, and participants complete various questionnaires at weeks 1, 3, 7, and 10 to evaluate quality of life, bowel function, bladder symptoms, and intervention acceptability. Participants will be involved in daily bowel management assessments and safety monitoring over the 10-week period. They will complete several questionnaires about their bowel and bladder symptoms, quality of life, and intervention experience at specific weeks. The study uses video-enabled smart devices and videoconferencing software to support data collection. The primary outcome measured is bowel management time, with multiple secondary outcomes to understand the broader impact of the stimulation.

This research aims to evaluate treatments for adults with fecal incontinence, a condition that significantly affects quality of life. The trial compares whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is more effective than electrical stimulation alone. It is a prospective, randomized, parallel-group, open-label controlled trial enrolling patients with urge, passive, or mixed fecal incontinence. Participants are randomly assigned to one of two groups. The active group uses a NeuroTrac Continence device to deliver electrical stimulation while performing synchronized voluntary anal sphincter contractions during stimulation cycles. The control group receives the same electrical stimulation but remains relaxed without active contractions. Both groups receive standardized education and device training for a 12-week intervention period. Participants will be assessed at the start, after 12 weeks of treatment, and again at 36 weeks for follow-up. Evaluations include the Vaizey/St. Mark's Incontinence Score, quality of life scales, a 14-day bowel diary, anorectal manometry, adherence tracking, and safety monitoring. Optional ultrasound may be performed if clinically indicated. The main measure is change in incontinence score at 12 weeks, with additional outcomes such as episode frequency, manometry parameters, treatment adherence, adverse events, and sustained response over time.

Bowel problems, including fecal incontinence, are common and challenging for people living with spinal cord injury (SCI). This research evaluates the effects of genital nerve stimulation (GNS) using non-invasive electrodes on the function of the anus and rectum in individuals with SCI. The study aims to understand how GNS may influence bowel control by measuring anorectal manometry (ARM) outcomes and collecting detailed medical and bowel function information to predict who might benefit from this approach. Participants will undergo two possible visits. The first visit involves screening, informed consent, and brief GNS to determine nerve responsiveness. Those who respond will be invited for a second visit involving ARM testing with and without GNS using a specific protocol (no stimulation, stimulation, no stimulation repeated). This includes insertion of a catheter and electrode placement to record anorectal reflexes and function. The study randomizes participants to receive either sham or effective stimulation first to balance order effects. During participation, individuals will provide bowel program history, complete surveys about bowel function and quality of life, and undergo neurological and clinical exams. Researchers will measure ARM outcomes such as rectal wall tension, anal sphincter function, and reflex activity up to three weeks after enrollment. Transportation and lodging support are available to reduce barriers. The total time commitment is about 7.5 hours across one or two visits.

Researchers are studying the use of the Victo adjustable artificial sphincter to treat male patients who have urinary incontinence following prostate surgery. This prospective academic study aims to evaluate how well the device works and its safety in managing severe incontinence in this group. This non-interventional study includes adult males who have already undergone implantation of the Victo artificial sphincter. Before surgery, patients receive standard diagnostic tests. After activation of the device, they will have follow-up visits at 3 months and then annually. Patients can also contact the study center at any time if their symptoms worsen or if they face any complications. During the study, participants will complete tests such as the 24-hour pad-weight test to measure incontinence severity and patient questionnaires about their improvement. Researchers will follow patients for up to 5 years to assess treatment outcomes and safety. The total participation time varies based on follow-up but involves regular monitoring and the opportunity to report issues anytime.

Researchers are evaluating the Adjustable Continence Therapy (ACT) device for women with stress urinary incontinence caused by intrinsic sphincter deficiency. This prospective, single arm, non-randomized, multicenter trial aims to assess the safety and effectiveness of ACT in providing meaningful improvement in symptoms for affected women. The study is sponsored by Uromedica and focuses on clinical outcomes related to urinary incontinence. The trial involves implanting two ACT devices in each participant in the paraurethral space near the bladder neck using local, spinal, or general anesthesia. The device includes balloons that are filled with an isotonic solution after implantation via subcutaneous ports placed in the labia majora. This device implantation is the main intervention studied, and participants receive follow-up care to monitor results. Participants will undergo evaluations including provocative pad weight measurement at 12 months to assess urine leakage. Additional assessments include quality of life and urogenital distress questionnaires at 12 months. Researchers will also monitor participants for safety and treatment adherence throughout the study. The trial seeks to gather comprehensive data on symptom improvement and quality of life over the course of a year following device implantation.

This research aims to find out how common anal incontinence is among Hungarian women who have given birth at least once. It also looks at how anal incontinence affects their quality of life and physical activity. Additionally, the study will adapt and test the Hungarian version of the International Consultation on Incontinence Modular Questionnaire - Bowels (ICIQ-B) to check its accuracy and reliability. The study does not involve treatments but observes participants over about three years. During this time, researchers will monitor the impact of anal incontinence on quality of life and physical activity. They will also evaluate the adapted ICIQ-B questionnaire to see how well it works for Hungarian speakers. Participants will be women aged 18 to 50 who speak Hungarian and have given birth before. Researchers will collect information about anal incontinence and other pelvic floor symptoms using questionnaires. They will assess global quality of life as well. The study will last around three years, during which participants' health and activity will be followed to understand the condition's effects better.