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Overactive Bladder clinical trials

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NCT ID: NCT04936464 Active, not recruiting - Overactive Bladder Clinical Trials

Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

TTeNS
Start date: September 20, 2021
Phase: N/A
Study type: Interventional

This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.

NCT ID: NCT04917315 Completed - Overactive Bladder Clinical Trials

To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

Start date: May 21, 2020
Phase: Phase 3
Study type: Interventional

Overactive bladder (OAB) is a clinical condition characterized by urgency (i.e., urinary urinary urinary urgency that is difficult to delay and unbearable) with or without urge incontinence, usually associated with frequency and nocturia. The main drug class used is antimuscarinics, and the clinical utility of antimuscarinic drugs is limited due to its mild efficacy and poor tolerability due to side effects of mechanisms such as dry mouth and constipation. In addition to poor tolerability and mild efficacy, recent literature suggests that long-term use of anticholinergics is associated with cognitive impairment and dementia. Therefore, the purpose of this study was to evaluate the treatment effect of overactive bladder symptoms through the change in the average number of urination per day after administration of JLP-2002, a beta 3-adrenergic receptor (β3-AR) agonist with an effective alternative mechanism, for 12 weeks.

NCT ID: NCT04910555 Completed - Clinical trials for Urinary Incontinence

Strong Desire to Void and Balance in Older Women With Overactive Bladder

SURFACE
Start date: May 26, 2021
Phase:
Study type: Observational

Falls have multifactorial etiologies in older people. Lower urinary tract symptoms (LUTS) are one of those, with an increase prevalence over years (30% of people over 75 years old have overactive bladder [OAB]). Previous studies showed that older women with OAB with or without urinary incontinence (UI) are prone to have gait disorders (decrease of gait speed and step width and increase of number of step). Besides UI, it is more likely the strong desire to void (SDV) that seems to impact gait and balance control. In older women with UI, balance on stabilometric parameters have been affected with an increase of the center of pression (COP) sway range, COP area and rambling trajectory. SDV seems to act like an additional cognitive task. A similar and increased reaction time has been observed in comparing with a distracting task in healthy volunteers. In older people who are susceptible to distracting task, SDV may alters balance and gait. The primary objective of this prospective study is to assess the impact of SDV on stabilometric parameters (center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) compared to the "empty bladder" condition. The secondary objectives are to assess the impact of a cognitive task (verbal fluency) on stabilometric parameters in comparison with the "no cognitive task condition" and the "SDV condition"; to assess the impact of "SDV condition" on balance and gait clinical evaluation (Timed up and go test, unipedal stance test, Berg scale, 10m walking speed, 5 chair stand) Thus, showing that SDV may impact balance in geriatric population will lead to the importance to identify and LUTS as potential fall risk factor in order to decrease falls incidence in this population.

NCT ID: NCT04907032 Completed - Overactive Bladder Clinical Trials

Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)

PTNS-M
Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

Abstract Introduction: Urgency Urinary Incontinence (UUI) is a common condition with a prevalence of 9-31% in women in the United States. Despite current treatments, a high number of women have symptoms refractory to first- and second-line treatment approaches. Aims: The primary aim of this randomized controlled trial is to compare the efficacy of percutaneous tibial nerve stimulation (PTNS) and mirabegron treatment versus PTNS with placebo on change in the number of UUI episodes over a 12-week treatment course. Secondary aims include comparing the efficacy of combined treatment of PTNS and mirabegron versus PTNS with placebo on improvement in urinary incontinence symptom specific distress and quality of life related to UUI over a 12-week course of PTNS. Methods: A total of 54 consented participants will be recruited and randomized with 27 patients in the PTNS with mirabegron (daily 50 mg dose for the 12-week course) group and 27 patients in the PTNS with placebo group. Demographics and baseline data will be analyzed by student's t-test and chi-squared test or Fischer's Exact test as appropriate. Hypothesis: We anticipate that combination therapy will prove superior to monotherapy for reducing the number of UUI episodes over a 12-week treatment course.

NCT ID: NCT04873271 Completed - Overactive Bladder Clinical Trials

Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

TITAN 1
Start date: May 11, 2021
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.

NCT ID: NCT04873037 Recruiting - Overactive Bladder Clinical Trials

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

EmsellaOAB
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04865328 Not yet recruiting - Overactive Bladder Clinical Trials

Impact of OAB Symptoms on Quality of Life in Croatia

OAB-CRO
Start date: May 10, 2021
Phase:
Study type: Observational

Overactive bladder (OAB) has a negative impact on the daily activities of affected individuals. OAB affects an estimated 12-17% of adults and has a similar reported prevalence in men and women. It has the potential to impair multiple domains of quality of life, including restriction of social and work life, while also resulting in higher healthcare resource use and costs. The primary objective of the present study was to evaluate, in a Croatian population reporting symptoms of OAB, the effect on work productivity and treatment behaviors (treatment seeking, receiving treatment, treatment dissatisfaction and treatment discontinuation).

NCT ID: NCT04853849 Recruiting - Overactive Bladder Clinical Trials

Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study

MOTIVATION
Start date: August 26, 2021
Phase:
Study type: Observational

This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.

NCT ID: NCT04831801 Terminated - Overactive Bladder Clinical Trials

OAB and the Microbiome

Start date: June 30, 2021
Phase:
Study type: Observational

To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).

NCT ID: NCT04791111 Completed - Overactive Bladder Clinical Trials

AQUA: Anticholinergic Side Effects QUestionnAire

AQUA
Start date: January 1, 2020
Phase:
Study type: Observational

Overactive bladder syndrome (OAB) is very frequent and increase with age. Antimuscarinics allows improvement for OAB symptoms, quality of life and urodynamic parameters. However, antimuscarinics adherence is poor and anticholinergic drugs are often withdrawn few months after their introduction. This low adherence to antimuscarinics can be explained by side effects as dry mouth, blurred vision, constipation or cognitive impairment which are due to systemic anticholinergic effects since specificity and receptor affinity of bladder antimuscarinics are poor with a large distribution of acetylcholine receptors in all the body. Unfortunately, there is no questionnaires which evaluate side effects or constraints. The objective of the study is to develop and validate a new questionnaire to assess side effects of antimuscarinic treatment in a patient with OAB. The study was conducted in a Neuro-urology Department of a University Hospital. To allow a full psychometric validation of the questionnaire, the study protocol included 3 steps: qualitative interviews, feasibility study and validation study. The inclusion criteria were to be aged > 18 years and to have OAB symptoms according to the ICS definition and secondary to a neurogenic dysfunction. First step of the study consisted in a review literature on Pubmed to explore the different side effects secondary to antimuscarinic treatment and do determine which tools were available. In addition, we conducted semi-structured interviews on 30 patients suffering from OAB. For this feasibility study, 30 patients were included. They had to rate each item to evaluate comprehension, acceptation and pertinence with a three-points Likert scale from response "0: not at all or quite" to "2: perfectly". Validation study: 100 patients Content validity was assessed by the panel of experts. Internal consistency reliability was calculated using the α coefficient of Cronbach. Each response has been transformed in a numeric value to perform this test. Alpha coefficient of Cronbach was considered as very good if > 0.7. Test-retest reliability was tested using the intraclass correlation coefficient (ICC) which was significant over 0.7. Objective was to validate this questionnaire with good or very good psychometric properties. Primary outcome was Alpha coefficient of Cronbach and ICC ≥ 0,7.