Active clinical trials for "Urinary Bladder, Overactive"

Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing conditions, and to investigate whether additional educational information affects satisfaction with treatment as perceived by the patient.

Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine). OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold. This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases. Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day. The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A

OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a small proportion of this group turns to seek medical help. Once treated, evaluation of treatment outcome is problematic since outcome measures for success vary widely (i.e. improvement in number of incontinence episodes, number of urge episodes, change in frequency and nocturia etc) but do not include measures of patient reported outcomes. The OAB Assessment Tool is a self-administered questionnaire (8-question self-filled survey) primarily intended to identify patients with symptoms of OAB. The same comparable information could be obtained after a certain treatment period, thus providing accurate and precise measures of success. It could also offer insight to the changes of the different parameters that make up the problem. Due to its ease of administration and its high specificity in assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.

The aim of the original study was to compare Incobot/A versus Onabot/A in order to evaluate if the differences in the pharmacologic formulations between the two drugs could affect their efficacy and safety in the treatment of neurogenic overactive bladder (OAB). In the original study protocol two different dosages for either Incobot/A and Onabot/A (200 U and 100 U) were considered, to treat patients with neurogenic detrusor overactivity incontinence performing intermittent catheterization (IC) with higher dosages and those able to void spontaneously with lower dosage, with the resulting four treatment groups. For such a study, a very large sample of participants should have been treated and followed up, to have adequate power to demonstrate the hypothesis. At the end of last February 2020, we had to temporarily stop all the clinical activities related to the study and patients' recruitment, due to the occurrence of Sars-Cov-2 pandemic in our Country. At that point, a non-inferiority study seemed to be possible and adequate, and we adapted the protocol accordingly. In addition, on the basis of previously published information, we could hypothesize that the new drug (Incobot/A) would have had at least a roughly similar effect to the control drug (Onabot/A). In order to perform a non-inferiority study, the power and sample size analysis have been re-planned. Thus, we perform a not planned interim analysis to show the preliminary results of an ongoing, non-inferiority trial in which patients' recruitment temporarily stopped due to incontrollable external factors. The present study will be aimed to assess the non-inferiority of Incobot/A compared to Onabot/A on the efficacy and safety parameters, in the treatment of patients with refractory NDOI performing IC, who are randomized to receive 200 U of Incobot/A or Onabot/A intradetrusor injections and who are followed up to 12 wks after treatment

Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women. Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.

The aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder

Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.

Approximately 20 Study Sites will participate over total 24 months. Study population will consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3 months. Primary Study Objectives: To assess efficacy of the StimRouter stimulation in improving OAB symptoms of urgency and frequency as measured by Patient Voiding Diary when targeting the posterior tibial nerve To assess safety of the StimRouter therapy for the indication of OAB Secondary Study Objective: To evaluate efficacy of the StimRouter therapy in addressing urinary urge incontinence as measured by the Patient Voiding Diary Study Design is prospective, multi-center, randomized, double-blinded Primary Endpoint: The primary efficacy endpoint will be the difference between the investigational and control groups in proportion of responders, where Responder is defined as having ≥50% improvement in average voiding frequency above the normal value of 8 (those returning to normal voiding based on 7-day average voids/leak episodes < 9, will be categorized as achieving half or more reduction) AND having ≥50% improvement in average number of moderate to severe urgency episodes, at approximately three months after programming. Secondary Endpoint: Secondary endpoint will be the difference between the investigational and control groups in proportion of patients with reduction by half or more in urinary urge incontinence as measured by the average number of urge incontinence episodes per day.

The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.

Overactive Bladder (OAB) is a chronic condition caused by instability of the detrusor or bladder muscle, which gives rise to symptoms of urinary urgency and often urinary incontinence. Idiopathic Detrusor Overactivity (IDO) is a subset of OAB where the cause for the bladder muscle instability is unknown. OAB is usually treated by conservative measures or with oral medications eg. anticholinergics. Injection of onabotulinum toxin A (onaBoNT-A) into the bladder wall is licenced in the treatment of refractory IDO where oral medications fail. The injected toxin paralyses the bladder by blocking the ability of certain (motor) nerves to communicate with the bladder muscle. As these nerves are mainly concentrated in what is known as the "body" of the bladder this is traditionally where the injections are given. In addition to its action on motor nerves, onaBoNT-A also affects sensory nerve pathways. Recent studies show that IDO is caused by both motor and sensory nerve dysfunction, therefore injecting the "trigone", a part of the bladder where sensory nerves are particularly dense, may be of clinical benefit. Three studies comparing trigone versus trigone-sparing injection of botulinum toxin in the treatment of IDO have been carried out. One of these indicated a significant benefit in targeting the trigone and the other two did not show any difference. Our study aims to examine if injection of onaBoNT-A into the trigone alone will provide symptom and functional improvement in patients with IDO by comparing peritrigonal injection of onaBoNT-A with the traditional method of injection which spares the trigone.