Overactive Bladder (OAB)

This Phase 2b study is a prospective, multicenter, double blind, randomized, placebo and sham controlled trial to assess the safety, efficacy and dose response of NT 201 delivered by the Vibe System in participants with idiopathic overactive bladder (OAB).

Overactive bladder (OAB) is associated with systemic chronic inflammation. Indices derived from complete blood count (such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)) have shown associations with OAB presence. However, whether baseline inflammatory status predicts response to beta-3 adrenergic agonist therapy remains untested. This prospective observational cohort study evaluates the predictive ability of baseline NLR, PLR, and SII for 3-month treatment response to mirabegron 50 mg in women with OAB.

The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. The primary outcome measure will be urinary tract infection (UTI) rates within 30 days from the BOTOX-A procedure. Secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.

Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).

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.

This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke. Primary Hypothesis: PTNS therapy will significantly improve OAB symptoms in post-stroke patients compared to standard care/sham stimulation. Primary Outcome Measure: Change from baseline in Overactive Bladder Symptom Score (OABSS) and/or frequency of urgency episodes as assessed after 12 weeks of treatment."

Overactive bladder (OAB) is a common condition that causes a sudden, strong need to urinate, often with frequent daytime and night-time trips to the toilet, and sometimes leaking. It can have a substantial impact on everyday quality of life. Two of the most common medicines used to treat OAB work in different ways: one type (antimuscarinics, such as solifenacin) blocks a nerve signal in the bladder, while another type (beta-3 agonists, such as mirabegron) helps the bladder muscle relax. Many people with OAB are already taking other medicines - for example, for mood, sleep, or allergies - that, without being intended for the bladder, also block that same nerve signal. The combined effect of all these medicines is called the "anticholinergic burden." Researchers want to understand whether a person's existing anticholinergic burden changes how well each OAB treatment works. The idea is that if this nerve pathway is already heavily blocked by other medicines, an antimuscarinic might be less helpful, and a treatment that works in a different way (mirabegron) might be a better choice. In this study, adults with newly diagnosed OAB who have not yet been treated will be randomly assigned to take either solifenacin or mirabegron once a day. Before starting, each participant's anticholinergic burden will be measured using a validated tool called the Drug Burden Index (DBI) and ACB. Bladder symptoms will be assessed with a standard questionnaire (ICIQ-FLUTS) and a bladder diary at the start of treatment and again after 1 and 2 months. By comparing how participants respond depending on their baseline anticholinergic burden, the study aims to learn whether measuring this burden can help doctors choose the most effective first-line treatment for each patient.

Overactive bladder is a common condition that causes a frequent, urgent need to urinate and can significantly reduce quality of life. When other treatments do not work well enough, doctors can inject a medication called onabotulinumtoxinA (a form of botulinum toxin) into the bladder wall. This procedure is often done in the office and is effective, but it can cause pain and anxiety during the injection. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, drug-free method that uses mild electrical pulses delivered through pads placed on the skin. It is thought to reduce the sensation of pain and is already used to help with discomfort during some office procedures. The purpose of this study is to find out whether applying TENS to the front of the lower legs (the pretibial area) reduces pain and anxiety in patients undergoing an intravesical onabotulinumtoxinA injection. Participants will be randomly assigned to one of two groups. In one group, the TENS device will be turned on (active). In the other group, the pads will be placed in the same location but the device will not be turned on (placebo). Neither the patient nor the doctor performing the assessment will know which group the patient is in. Pain will be measured during the procedure using a visual analog scale. Anxiety will be measured before the procedure using a standard questionnaire, and patient satisfaction will be measured afterward. The study aims to enroll 68 participants in total.

A study to evaluate the safety and effectiveness of FemPulse System

This randomized, double-blind, placebo-controlled trial evaluates whether oral zinc plus phytase supplementation modifies clinical response to intradetrusor botulinum toxin injection in patients with overactive bladder. Participants will receive either zinc plus phytase supplementation or matching placebo for five days prior to intradetrusor botulinum toxin injection. Participants will be followed for six months after treatment to assess need for repeat botulinum toxin injection, urinary symptoms, and patient-reported outcomes related to overactive bladder.

Overactive bladder (OAB) is a syndrome with urgency as the main symptom, usually accompanied by frequent urination, nocturia, and sometimes urge urinary incontinence. Globally, the prevalence of OAB in the general population has been reported to be about 20%. Nocturia was defined as the patient waking up at least once during the night to urinate. Among lower urinary tract symptoms, nocturia can significantly affect daily life and quality of life. Reported causes of nocturia include nocturnal polyuria, sleep disorders, circadian rhythm disruption (e.g., circadian rhythm sleep disorders), and reduced bladder capacity. Because overactive bladder (OAB) may be associated with reduced bladder capacity, anticholinergic agents are used as standard therapy in the management of nocturia associated with OAB. However, anticholinergic medications are associated with poor adherence, such as inadequate efficacy and adverse effects (e.g., dry mouth, constipation, and cognitive impairment). Therefore, it is imperative to find alternative therapies for anticholinergic drugs. Previous studies have shown that transcutaneous tibial nerve stimulation (TNS) can also significantly improve lower urinary tract symptoms, such as frequency, urgency, incontinence, and nocturia, and is also one of the options for the treatment of OAB. A previous study also demonstrated its improvement in sleep quality in women with nocturia. However, the efficacy of tibial nerve stimulation in the treatment of active bladder with nocturia is still a blank, and further studies are needed.

The goal of this clinical trial is to learn if probiotics can help improve symptoms in adults with overactive bladder (OAB) and anxiety. The main questions it aims to answer are: 1. Does taking probiotics lower the number of times participants need to urinate in a 24-hour period? 2. Does taking probiotics lower participants' anxiety levels? Researchers will compare probiotics to a placebo (a look-alike powder that contains no active bacteria) to see if the probiotics work better to treat OAB and anxiety when both groups also use standard behavioral therapy (like bladder training). Participants will: 1. Take probiotics or a placebo twice a day for 12 weeks. 2. Learn and practice bladder training using a manual and educational videos. 3. Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study. 4. Answer survey questions about their anxiety and quality of life during clinic visits. 5. Provide urine samples for routine checkups to ensure they do not have infections.

The goal of this clinical trial is to learn whether a new sacral neuromodulation (SNM) system (INO-SNM-01) can safely and effectively sense bladder nerve activity and provide stimulation to help manage symptoms of refractory overactive bladder in adult women aged 18-70 who have not responded to standard treatments. The main questions it aims to answer are: * Is there a clear relationship between bladder nerve activity and patient-reported urgency sensations? * Can targeted stimulation based on bladder nerve activity reduce overactive bladder symptoms? * Is the INO-SNM-01 System safe to use? Researchers will not use a comparison group in this study. Instead, all participants will receive the investigational device to see if it works as intended. Participants will undergo surgery to have a temporary trial lead implanted near the sacral nerve and spend up to 2 days in hospital for monitoring and testing to assess the device sensing and stimulation capabilities. Up to 10 participants will take part in this first-in-human feasibility study at a single site in Australia.

The main goal is to understand what it is truly like to live with OAB from the patient's perspective, including how it affects: daily activities, emotional wellbeing and mental health, social life and relationships, work and overall quality of life.

The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.

This is a pilot study to assess using validated outcome measures how ingesting pumpkin seed oil extract supports patient bladder function in a United States population.

The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are: * Does using TENS at home during daily activities reduce the number of urgency episodes? * Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment? Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation): * Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions. * Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period. Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width). Participants will: * Complete bladder symptom questionnaires before and after the study * Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage * Answer quality of life questions at the start and at 4 weeks

The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women. The main questions this study aims to answer are whether Li-SWT improves overactive bladder symptoms and quality of life, and whether these improvements are sustained over a 12-month follow-up period, compared with standard medical therapy. Researchers will compare Li-SWT with oral solifenacin succinate, a commonly used antimuscarinic medication for OAB. Participants will be randomly assigned to receive either Li-SWT once weekly for 8 weeks or solifenacin 5 mg taken orally once daily for 12 months. All participants will complete symptom questionnaires and three-day voiding diaries and will undergo uroflowmetry, post-void residual measurement, and filling cystometry at specified time points during follow-up.

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.

This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.

The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.

Overactive bladder (OAB) is one of the most common health problems in the adult population. The goal of this project is to improve the awareness of the problem and to correctly refer the targeted persons to a specialist or a doctor. This will be provided by an online screening tool, designed as web platform and mobile application, where the data will be stored in respect to GDPR. People with a positive result from the online screening tool will be offered an examination by a specialist (gynaecologist, urogynaecologist, urologist) involved in the project. The specialist will have access to the results from the online screening tool - he/she will log into the web platform with a view of the participants profile. He/she will perform the diagnosis, confirm or refute the diagnosis and complement it with any further diagnostic tests and set the standard treatment.

The investigator hypothesizes that controlled delivery of low heat (45-50 Centigrade) to the sub-detrusor and detrusor muscle can ablate the autonomic nerve endings and control overactive bladder symptoms without causing significant damage to the surrounding structures. Low heat in such a manner is below urethral sensation and enables office treatment. The transvaginal approach is non-invasive and improves overactive bladder (OAB) symptoms and patients' quality of life. The investigator believes that the RF administration results could be equal or better for first-line treated patients compared to pharmacological refractory patients.

The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment. Before inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.

The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).