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52 Overactive Bladder Trials
Power is an online platform that helps thousands of Overactive Bladder patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
188 Participants Needed
Sacral Neuromodulation for Overactive Bladder
Hilliard, OhioThis trial collects data on how the body functions throughout the treatment period. It aims to understand the effects of therapy by monitoring physiological signals. The specific patient group is not mentioned, suggesting it may include a wide range of participants.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
300 Participants Needed
Tibial Nerve Stimulation for Urinary Incontinence
Cincinnati, OhioThis trial is testing a small device that sends electrical signals to a nerve in the leg to help people who have sudden, strong urges to urinate. The study focuses on patients who struggle with urgency urinary incontinence and aims to see if this new approach can better manage their condition. Tibial-nerve stimulation has shown promising results in previous studies.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 80
Sex:All
208 Participants Needed
Sacral Neuromodulation for Overactive Bladder
Cleveland, OhioThis will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Neurologic Diseases, Bladder Malignancy, Others
50 Participants Needed
Sacral Neuromodulation for Overactive Bladder
Cleveland, OhioTo assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 75
Sex:Male
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Uncontrolled Diabetes, Others
150 Participants Needed
Revi System for Urge Incontinence
Cleveland, OhioThe Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21+
Sex:All
Key Eligibility Criteria
Disqualifiers:High Surgical Risk, BMI >50, Others
Must Be Taking:Antimuscarinics, Beta-3 Agonists
150 Participants Needed
Home vs Office PNE Lead Removal for Overactive Bladder
Cleveland, OhioFor women undergoing percutaneous nerve evaluation (PNE) for the treatment of overactive bladder the first step is the PNE interstim therapy trial. If the PNE works, patients may opt to have the interstim procedure. The purpose of this study is to see if patients who remove their PNE lead at home have the same satisfaction with the PNE trial as those women who have their lead removed in the office.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, No Consent, Others
30 Participants Needed
Botox + HoLEP for Enlarged Prostate and Overactive Bladder
Cleveland, OhioBenign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life.
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these. A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints.
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart).
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated.
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during HoLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB). The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively.
The investigators hypothesize that administering bladder botox injections during HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP surgery for their obstructive and irritative symptoms.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:40+
Sex:Male
100 Participants Needed
Low-Dose Botox for Urinary Incontinence
Pittsburgh, PennsylvaniaThe purpose of this study is to study the treatment of urgency urinary incontinence (UUI), specifically among women 70 years and older, by comparing reduced versus standard dose of onabotulinumtoxinA (BTX; trade name BOTOX(c)) injection in the bladder.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:70+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Neurologic Disease, Bladder Abnormality, Others
Must Not Be Taking:Anticholinergics, Beta-3 Agonists
376 Participants Needed
PTNS for Urinary Incontinence
Pittsburgh, PennsylvaniaThis study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 99
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Pacemaker, Neurogenic Bladder, Others
50 Participants Needed
EG110A for Neurogenic Detrusor Overactivity
Ann Arbor, MichiganThis is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Tumor, Malignancy, Active Herpes, Others
16 Participants Needed
Emsella Chair Therapy for Overactive Bladder
Royal Oak, MichiganThis trial is testing the Emsella Chair, which uses electromagnetic waves to strengthen pelvic muscles, on patients with overactive bladder. These patients often seek non-surgical treatments due to medication side effects. The chair helps by making the pelvic muscles stronger, similar to doing many Kegel exercises.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pulmonary Insufficiency, Major Metal Implants, Neurogenic Incontinence, Others
Must Be Taking:Antimuscarinics, Beta-3 Agonists
166 Participants Needed
Lidocaine for Overactive Bladder
Louisville, KentuckyThe 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.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:18+
Sex:Female
36 Participants Needed
Sacral Neuromodulation for Urge Incontinence
Chicago, IllinoisSacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998. One of two trial phase techniques are utilized prior to placement of the implantable pulse generator (IPG) to predict a patient's success with the device: a percutaneous nerve evaluation (PNE) or a stage implantation. Patients who experience a \> 50% improvement in UUI symptoms progress to permanent implantation. PNE offers significant advantages compared to a staged implantation including a single anesthetic and operating room trip. Historically, full implantation rates are only 40-50% following PNE versus 70-90% in women who undergo a staged approach. The lower rate of progression to full implantation after PNE may be attributed to lead migration. Newer data suggest up to 90% of PNE trials lead to full implantation. The investigators hypothesize that shortening PNE trial time to 3 days from 7 days will not result in a lower proportion of PNE trials leading to SNM implantation and may offer less time for lead migration. The investigators aim to perform a multi-center, randomized trial to determine if a 3-day PNE trial is not inferior to a 7-day PNE trial with respect to rates of progression to SNM implantation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Neurological Diseases, Bladder Malignancy, Others
193 Participants Needed
eCoin for Urge Urinary Incontinence
Chicago, IllinoisThis trial is testing a small device called eCoin® that is placed under the skin near the ankle. It sends electrical signals to a nerve that helps control the bladder. The study focuses on people who have trouble controlling their bladder and experience sudden urges to urinate. The goal is to see if this device can safely and effectively reduce these symptoms over time. The eCoin is a nickel-sized, battery-powered device implanted in the lower leg to treat overactive bladder, and has been evaluated in previous studies for its safety and effectiveness.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Bladder Obstruction, Stress Incontinence, UTI, Diabetes, Cancer, Others
Must Not Be Taking:Anticholinergics, Β3-adrenoceptor Agonists
200 Participants Needed
Botox for Overactive Bladder
Chicago, IllinoisThis trial is testing if injecting Botox into the bladder during prostate surgery can help men with overactive bladder symptoms. The goal is to see if this treatment can reduce the urgent need to urinate and accidents by relaxing the bladder muscle. Botox has been studied for its effectiveness and safety in treating lower urinary tract symptoms and overactive bladder.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 89
Sex:Male
Key Eligibility Criteria
Disqualifiers:Allergy To OnabotulinumtoxinA, Bladder Cancer, Others
80 Participants Needed
Cranberry Powder for Overactive Bladder
Maywood, IllinoisThe purpose of this study is to learn about how the use of 500 mg of dried cranberry powder extract (NDS-446) changes the bacteria that normal reside in the bladder of women who don't have urinary leakage problems but do have problems with urinary urgency and frequency.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 99
Sex:Female
Key Eligibility Criteria
Disqualifiers:Urinary Incontinence, UTI, Painful Bladder, Others
Must Not Be Taking:Warfarin, Anti-platelet Agents
40 Participants Needed
Nerve Ablation for Overactive Bladder
Knoxville, TennesseeThe 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.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:21 - 80
Sex:Female
32 Participants Needed
RENOVA iStim™ System for Overactive Bladder
Skokie, IllinoisThe OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 80
Sex:Female
200 Participants Needed
Neo-Bladder Augmentation for Neurogenic Bladder
Winston-Salem, North CarolinaThe purpose of this research study is to find out if autologous "neo-bladder" construct for the treatment of fibrotic and/or contracted bladder can improve bladder compliance and be safe long term. The neo-bladder is like a reservoir or pouch that will be surgically attached to the bladder to assist with urine collection.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 60
Sex:All
10 Participants Needed
Antibiotic Prophylaxis for UTIs in Overactive Bladder
Bethesda, MarylandOveractive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance.
The population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC/BPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure.
The patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure.
A urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurogenic Bladder, Recurrent UTI, Others
Must Be Taking:Nitrofurantoin
100 Participants Needed
Vaginal Estrogen vs Oral Mirabegron for Overactive Bladder
Bethesda, MarylandThis trial tests a vaginal estrogen cream and an oral pill called Mirabegron in postmenopausal women with overactive bladder symptoms. The cream helps improve bladder function by adding estrogen, while the pill relaxes the bladder to reduce frequent urination.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Multiple Sclerosis, Parkinson's, Others
Must Not Be Taking:Anticholinergics, Beta-3 Agonists
152 Participants Needed
Electrical Stimulation for Urinary Incontinence
Bethesda, MarylandBackground:
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Urinary Retention, UTI, Obesity, Others
41 Participants Needed
RiSolve App for Overactive Bladder
Washington, District of ColumbiaThe 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).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22+
Sex:Female
596 Participants Needed
Yoga for Overactive Bladder
Durham, North CarolinaThe 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.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 18
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurogenic Bladder, Nerve Damage, Pregnancy, Others
40 Participants Needed
Vibegron for Pediatric Bladder Disorder
Durham, North CarolinaThe purpose of this study is to evaluate the safety, efficacy, and PK of vibegron in pediatric participants with NDO who are regularly using CIC
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:2 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Cerebral Palsy, Uncontrolled Epilepsy, Others
Must Not Be Taking:Digoxin, Lithium, Others
85 Participants Needed
Remote Access Treatment for Urinary Incontinence
Durham, North CarolinaThis study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
286 Participants Needed
Axonics SNM System for Overactive Bladder and Fecal Incontinence
New York, New YorkMulticenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Psychiatric Disorders, SNM Non-responder, Others
130 Participants Needed
Analgesia for Overactive Bladder
Bronx, New YorkThe goal of this clinical trial is to learn more about using phenazopyridine (Pyridium) for pain control during bladder onabotulinumtoxinA ("botox") injections for surgical management of overactive bladder (OAB) for patients at Montefiore Medical Center in The Bronx. It will also learn about if using the phenazopyridine pill affects how satisfied patients are with their experience, how much pain patients feel afterwards, and if doctors think using the Pyridium pill affected how they performed the procedure. The main question it aims to answer is:
- Is oral phenazopyridine at least as good as intravesical lidocaine is for managing pain with bladder botox injections for OAB in Montefiore patients?
Researchers will compare phenazopyridine to intravesical lidocaine, a liquid put into the bladder, to see if phenazopyridine is at least as good at controlling pain with bladder botox injections as intravesical lidocaine is.
Participants will be assigned, by chance, to receive either the oral phenazopyridine pill or the intravesical lidocaine as their pain control for the procedure.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:18+
Sex:Female
120 Participants Needed
Antibiotic Usage for Overactive Bladder
Stony Brook, New YorkIntradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate. A previously published prospective study demonstrated that the rate of post-procedural UTI did not differ amongst patients with neurogenic bladder who did not receive prophylactic antibiotics and were asymptomatic for UTI, regardless of whether they had sterile urine cultures or asymptomatic bacteriuria, suggesting that patients who are not symptomatic for UTI may not require antibiotic prophylaxis prior to intradetrusor onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally evaluate the differences in UTI frequency in subjects who have a negative urinalysis and are not symptomatic for UTI and receive prophylactic antibiotics at the time of intradetrusor onabotulinumtoxinA injection compared to those who do not receive prophylactic antibiotics at the time of injection. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Others
Must Not Be Taking:Antibiotics
200 Participants Needed
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Frequently Asked Questions
How much do Overactive Bladder clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Overactive Bladder clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Overactive Bladder trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Overactive Bladder is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Overactive Bladder medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Overactive Bladder clinical trials ?
Most recently, we added Neo-Bladder Augmentation for Neurogenic Bladder, Reduced Radiation Fluoroscopy for Overactive Bladder and Botox + HoLEP for Enlarged Prostate and Overactive Bladder to the Power online platform.