Clinical Research Directory

Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder

This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on symptoms of overactive bladder in women with idiopathic overactive bladder

Moving Beyond p-Values: MCID for OAB-V8 8 and ICIQ-SF in Patients With OAB

The goal of this study was to determine the Minimal Clinically Important Difference (MCID) for the Overactive Bladder Questionnaire-Version 8 (OAB-V8) and the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) in people with Overactive Bladder Syndrome (OAB).

Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study

Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage. Women who join the study will be randomly placed into one of two groups: One group will take tadalafil (5 mg), a medicine taken once a day. The other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day. The study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits. The main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects. Women aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.

Yoga for Treatment of Overactive Bladder in Pediatric Patients

The goal of this pilot study is to assess the impact of yoga as a treatment modality in pediatric patients age 8-18 diagnosed with idiopathic overactive bladder as measured by validated questionnaires and urinary biomarkers. The main question it aims to answer is: Does yoga help improve overactive bladder symptoms in this patient population? Participants will take part in a weekly yoga session for a total of 6 weeks with validated questionnaires and urinary samples for biomarkers to be completed at the beginning, middle and end of the study. This study will follow a cross-over study design and patients will receive standard of care while not in the active treatment arm.

Oxybutynin for Post-surgical Bladder Pain and Urgency

Bladder pain and urgency are common after bladder surgery. The objective is to determine if transdermal administration is superior to oral administration in alleviating pain and urgency.

Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

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.

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Improving Overactive Bladder Treatment Access and Adherence

Overactive bladder (OAB) and urinary incontinence (UI) are chronic debilitating and embarrassing conditions that affect 33 million Americans. Yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. OAB syndrome is characterized by urinary urgency, with and without urinary incontinence, urinary frequency, and nocturia. Evidence-based treatments are available, including behavioral therapy, pharmacotherapy, and minimally invasive procedures. Diagnosis and treatment are also associated with improvement in urinary symptoms and overall quality of life (QOL).3 However, 70-80% of treated patients will discontinue use of therapy in the first year due to one of several factors (e.g., cost, tolerability, inadequate effect). In addition, only 4.7% progress to advanced therapies suggesting undertreatment for those that need it most. Vulnerable populations are especially at risk, as therapy utilization are lowest among older, lower income, and/or minority groups. Poor access, insufficient patient education regarding disease chronicity, expected outcomes, costs, and potential side effects lead to unrealistic patient perceptions about therapy. This leads to suboptimal therapy duration, poor treatment efficacy, adherence, and undertreatment. The study aims to evaluate a tailored patient-centered tool to begin the treatment process.

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial

Background: Overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence. Overactive bladder affects approximately 13% of older women and thus represents a condition with high prevalence. Affected women report significant limitations in daily life, as well as social isolation. Despite the high occurrence of this condition, therapeutic options are limited, partly because the etiology of this condition is not fully understood. Increasingly, studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition. Therefore, the aim of this study is to test, whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms. Design: Randomized controlled study Methods: Intake of OMNi BiOTiC® 41167 or placebo twice daily for 6 months; swabs (vaginal and urethral) and urine samples from a single-use catheter for microbiome determination at 0, 3, and 7 months. Outcome: Reduction of subjective symptoms (yes/no) after 3 and 7 months; reduction of Overactive Bladder Symptom Score after 3 and 7 months; change in the urogenital microbiome after 3 and 7 months (comparison of intervention vs. placebo).

Platelet-Rich Plasma Versus Botulinum Toxin for Refractory Overactive Bladder: A Randomized Trial

Overactive bladder is a common condition that causes sudden urges to urinate, frequent urination, night-time urination, and sometimes leakage of urine. Many people with overactive bladder improve with lifestyle changes and medicines. However, some patients do not respond to these standard treatments and continue to suffer from bothersome symptoms. This study is designed to help patients who have not improved with available medical therapy. Two treatments will be compared in this research. The first treatment uses platelet-rich plasma. Platelet-rich plasma is made from a patient's own blood and contains growth factors that may help repair the lining of the bladder and improve bladder function. The second treatment uses botulinum toxin. Botulinum toxin is a protein that can reduce unwanted bladder contractions and is already approved for use in patients with overactive bladder who did not respond to other treatments. The purpose of this study is to evaluate whether platelet-rich plasma injection into the bladder wall is safe, effective, and durable when compared with botulinum toxin injection into the bladder muscle. We believe that platelet-rich plasma may improve bladder health by encouraging tissue repair and reducing inflammation, while botulinum toxin may reduce bladder overactivity by blocking chemical signals that cause muscle contractions. This study will take place at Benha University Hospital in Egypt. About 48 adult participants with overactive bladder that has not improved after at least six months of medical therapy will be enrolled. Participants will be randomly assigned to one of two groups. One group will receive platelet-rich plasma injections into the bladder lining, and the other group will receive botulinum toxin injections into the bladder muscle. The procedures will be performed under anesthesia using a cystoscope, which is a thin instrument inserted into the bladder. Participants will be followed for one year. At several time points during follow-up, they will complete bladder symptom questionnaires, keep a voiding diary, and undergo urodynamic studies to measure bladder capacity and function. Researchers will also monitor safety by recording any side effects, such as urinary tract infections or temporary difficulty emptying the bladder. The main goal of this study is to determine whether platelet-rich plasma can reduce symptoms of overactive bladder as effectively as botulinum toxin, with fewer side effects and longer-lasting results. If successful, platelet-rich plasma could offer a new treatment option for patients who continue to struggle with overactive bladder despite standard medical therapy.

Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

To record the T-PTNS device (SmartUric) treatment performed by the patient at home via a mobile application in a remotely monitorable, secure and interactive manner with registration notes and a sham control group.

Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children

The purpose of this study is to find out if overactive bladder (OAB) can be safely treated by stimulating a nerve near the ankle. This procedure is called percutaneous tibial nerve stimulation (PTNS). It will be done by a device called the Urgent PC. The Urgent PC works by sending weak electrical signals through a thin needle to the nerve near the ankle. Stimulating this nerve may change bladder control.

Cyclic Versus Continuous Sacral Neuromodulation for LUTS

This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.

Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome

The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women 50 years and older who have the metabolic syndrome. The main questions it aims to answer are: * Is the study design feasible and acceptable to participants? * Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo (a look-alike substance that contains no drug)? Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.)

Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder The main questions it aims to answer are: •Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\] Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis. Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.

Overactive Bladder Syndrome and Hypopressive Exercise

Overactive Bladder Syndrome (OAB) is a condition characterized by a sudden and urgent need to urinate, with or without urge incontinence, accompanied by increased urinary frequency. This syndrome significantly impacts individuals' social and economic lives, psychological well-being, work productivity, daily activities, and overall quality of life. The Abdominal Hypopressive Technique (AHT) was suggested by Caufriez for the treatment of pelvic floor disorders in women. It has been utilized in the treatment of pelvic floor dysfunctions, such as Urinary Incontinence (UI), particularly in postpartum women. A review of the existing literature reveals a lack of studies examining the relationship between overactive bladder syndrome and hypopressive exercises. Current research predominantly focuses on the effects of hypopressive exercises on pelvic organ prolapse, pelvic floor muscle tone, urinary incontinence, and stress urinary incontinence. Although AHT was initially developed for the treatment of pelvic floor disorders, it is now recommended for all women, regardless of the presence of UI. However, studies on AHT remain limited, which poses challenges for its broader scientific application. This highlights the need for robust scientific studies to strengthen the evidence base. The present study aims to evaluate the impact of an online hypopressive exercise training program on overactive bladder syndrome symptoms and quality of life. The main questions it aims to answer are: * Does online hypopressive exercise training effectively reduce the symptoms of overactive bladder syndrome? * Does online hypopressive exercise training effective in improving the quality of life among women with overactive bladder syndrome?

Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections

The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women

The goal of this clinical trial is to learn if surface tibial electrical stimulation (mild electrical signals on the inside of the ankle) helps women 60 years or older with urine leakage that happens on the way to the bathroom or at night time. The main questions it aims to answer are: 1). How many treatments per week over a 12-week period improve a person\'s bladder symptoms?; 2). Is a person more confident that they will not fall and / or leak urine on the way to the bathroom after the treatment with the electrical stimulation treatments; 3). Does the way a person walks when they need to go to the bathroom change after they have had the electrical stimulation? They will visit the clinic 3 times to complete several questionnaires and walk with a full bladder and empty bladder. On the first visit, the participant will be taught how to use the electrical stimulation device. Participants will either receive the treatment 2 or 4 times per week for 12 weeks or no treatment with the option to receive treatment following the 12 weeks. Participants will be given a bladder diary to complete at the start of treatment, at 6 weeks, then at 12 weeks and will be instructed in completion. They will drink water until they have a strong urge to urinate, then will walk along an electronic pathway and will go empty their bladder. After emptying, they will walk back along the electronic pathway again. They will also complete a Timed Up and Go test - stand up from a chair, walk 3 meters, then turn around, walk back, then sit down. At the 6th week follow up and the 12th week follow up, they will complete each questionnaire again and complete the walking tasks again.

Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome

A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.