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Urinary Bladder, Overactive clinical trials

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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: NCT04909255 Recruiting - Sjogren's Syndrome Clinical Trials

Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder

Start date: March 23, 2021
Phase: Phase 4
Study type: Interventional

Overactive bladder is more prevalent among the Sjogren syndrome's population compare to the general population. Both anti-muscarinic agent and beta-3 agonist are recommended as second line treatment for overactive bladder syndrome. However, theoretically, undesirable effect of the anti-muscarinic agent such as dry mouth and constipation would make it less suitable for Sjogren syndrome patient with overactive bladder. Therefore, this study is a randomised control study with the aim to evaluate the therapeutic effect of beta-3 agonist and anti-muscarinic agent on overactive bladder among sjogren's syndrome patient.

NCT ID: NCT04909047 Recruiting - Women Clinical Trials

The Effectiveness of Parassacral Transcutaneous Stimulation Compared to Tibial Transcutaneous Stimulation, Home Protocol and Behavioral Therapy in the Treatment of Female Hyperative Bladder: Randomized Clinical Trial

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Introduction: The overactive bladder is a highly prevalent condition, which negatively impacts the quality of life and daily activities of women. Transcutaneous electrostimulation is currently a therapeutic alternative for urinary urgency symptoms. Although it can be applied to the sacral plexus or tibial nerve, the literature shows the effectiveness of these two modalities, in isolation, but there are few scientific studies that compare them as two therapeutic alternatives. Primary objective: to evaluate the efficacy between parascutaneous electrostimulation, tibial transcutaneous stimulation, and home protocol in the treatment of female overactive bladder. Methodology: This is a clinical trial, which will include women with a clinical complaint of overactive bladder, with or without urgency-incontinence, who will be randomized into 3 groups: transcutaneous parasacral electrostimulation (EETP), transcutaneous tibial electrostimulation (EETT) and a third group, home transcutaneous parasacral electrostimulation (EETPD), will consist of women who have financial difficulties or locomotion to attend the clinic.All groups, in the first session, will be guided to conduct behavioral therapy and will receive an educational booklet with guidelines. The equipment to be used will have a wave frequency of 10 Hz, a pulse width of 700 µs and a 20-minute session, with intensities according to the participant's tolerance. The intervention protocol of the EETP group is 30 sessions, three times a week, with an active electrode in the parasacral region. For EETT, 30 sessions will also be held, three times a week, with the electrode active in the tibial region. Participants will be captured at educational events held by the Pelvic Floor Service Center in Salvador and the metropolitan region. Participants will answer the basic anamnesis questionnaires, ICIQ-OAB, ROMA III criteria, Bristol scale, Hospital Anxiety and Depression Scale, Oswestry scale, Pittsburgh sleep quality index and Female Sexual Function Index. Then, the assessment of the bladder neck and the thickness of the bladder wall will be performed by 2D ultrasonography via suprapubic and intravaginal, following the assessment protocol described for the intervention groups. Primary outcomes: clinical improvement of symptoms, urinary frequency, episodes of urgent urinary incontinence, presence of adverse effects and constipation. Secondary outcomes: quality of life, sexual function, quality of sleep, anxiety and depression, muscle function (PERFECT and electromyography), lumbar-pelvic pain (pain intensity) and ultrasound. Participants will be followed for a minimum of 12 months to verify the long-term response, returning every 3 months. Expected results: The outpatient transcutaneous parasacral electrostimulation is expected to be superior when compared to the tibial transcutaneous electrostimulation in the resolution of the symptoms of the overactive female bladder.

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: NCT04858750 Recruiting - Urolithiasis Clinical Trials

Comparison and Evaluation of USSQ, OABSS, and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J Stents in Patients Who Underwent URL

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire)scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.

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).