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Urinary Incontinence, Urge clinical trials

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NCT ID: NCT06161506 Recruiting - Clinical trials for Stress Urinary Incontinence

Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Start date: February 15, 2024
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT06091566 Recruiting - Clinical trials for Urinary Incontinence

Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

Start date: January 12, 2024
Phase: N/A
Study type: Interventional

UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient. This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.

NCT ID: NCT06085846 Enrolling by invitation - Clinical trials for Urinary Incontinence

Real-World Registry - The Vivally® System

Start date: July 14, 2023
Phase:
Study type: Observational [Patient Registry]

This is a Real-World Registry Study to collect real-world dosing, utilization, demographic, quality of life, and data from the e-bladder diaries of patients utilizing the Vivally® System. Data points will be drawn from the Avation Medical HIPAA-compliant cloud database including but not limited to: Therapy compliance and stimulation metrics Diary entries provided by patients Various questionnaires Participants have the option to opt out of allowing their data to be part of any publication at any time.

NCT ID: NCT06080217 Active, not recruiting - Clinical trials for Overactive Bladder Syndrome

RF in the Treatment OAB in UUI- a Prospective Randomized Placebo Controlled Study

RFandOAB
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Until now, OAB with or without UUI has been treated mainly in two ways: with behavioral methods and/or patient education or using antimuscarinic drugs and/or beta 3 adrenergic receptor agonists. Unfortunately, the drugs might cause side effects in some women or were insufficiently effective, so the patients abandoned them. Methods In prospective, randomized, placebo controlled study, 80 women were enrolled, using radiofrequency in treating OAB and UUI. Based on ICIQ-OAB, ICIQ-OAB QoL, and ICIQ-FLUTSsex questionnaires, severity of OAB symptoms, QoL and detailed evaluation of female sexual matters associated with their lower urinary tract symptoms. RF was applied 4 times for 20 minutes, once a week. Two week after the completion of the treatment,as well as 3, 6 and 12 months, the level of OAB and UUI was reassessed and processed it statistically and evaluated the treatment effect.

NCT ID: NCT05948397 Not yet recruiting - Quality of Life Clinical Trials

To Use the Combined Version of ICIQ-SF and Quality of Life Scale in Mixed Urinary Incontinence

Start date: August 1, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is detecting the dominant component of mixed urinary incontinence via a combined version of ICIQ-SF and quality of life scale. The main question it aims to answer is: 1. Which component (urgency or stress) urinary incontinence bothers the patient more?

NCT ID: NCT05892575 Not yet recruiting - Aging Clinical Trials

The Effect of Incontinence Program Applied to Obese Elderly on Quality of Life, Coping and Loneliness

Start date: July 2023
Phase: N/A
Study type: Interventional

The goal of this: It was planned in a single-blind randomized controlled pre-test-post-test experimental research design. The aim of this study is to determine the effect of urinary incontinence management program on quality of life, coping with incontinence and loneliness in obese elderly. The main questions it aims to answer are: Does the Urinary Incontinence Management Program prepared for the obese elderly affect the quality of life, coping with incontinence and loneliness levels of the elderly in the experimental and control groups? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the level of coping with incontinence of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there a decrease in the loneliness levels of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life, coping with incontinence and loneliness levels of the elderly in the experimental group after the intervention compared to the pre-intervention?

NCT ID: NCT05882318 Active, not recruiting - Urge Incontinence Clinical Trials

Effectiveness of eCoin at Sensory and Subsensory Amplitudes

ESSENCE
Start date: June 6, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is: - The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy.

NCT ID: NCT05874375 Recruiting - Clinical trials for Urinary Incontinence

UCon Treatment of Overactive Bladder (OAB) in Males

Start date: October 12, 2023
Phase: N/A
Study type: Interventional

UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.

NCT ID: NCT05858125 Recruiting - Clinical trials for Urinary Incontinence

Social Media Navigation Aid Kits for Urinary Incontinence

SNAK
Start date: April 24, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05783219 Recruiting - Overactive Bladder Clinical Trials

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes prior to a percutaneous nerve evaluation (PNE) procedure to a placebo patch in patients already scheduled to undergo a medically indicated percutaneous nerve evaluation (PNE). VAS pain score, The volume of injectable lidocaine used, Patient Satisfaction Score, rate of successful PNE (defined as successful placement of wire in the S3 spinal foramen), and the amplitude of perineal stimulation on a Likert scale will be collected immediately after the procedure. Patients will follow up in 1 week - as is standard of care with the PNE procedure. Adverse events such as pain or change in sensation will be recorded. Number of voids and incontinence episodes per day after the PNE procedure will be recorded. Overall satisfaction score will be recorded at that time. Rate of progression to Sacral nerve stimulator implantation will be collected. The investigators hypothesize that patients in the lidocaine patch group will experience significantly less pain at the time of PNE as measured by a lower change in VAS pain score when compared with the control group.