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Overactive Bladder clinical trials

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NCT ID: NCT01764893 Terminated - Overactive Bladder Clinical Trials

Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder

Start date: January 2013
Phase: Phase 4
Study type: Interventional

The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.

NCT ID: NCT01758848 Terminated - Overactive Bladder Clinical Trials

Physical Therapy for Overactive Bladder

Start date: September 2010
Phase: N/A
Study type: Observational

Overactive bladder is a syndrome of symptoms. The core symptom is urgency with/without urge incontinence, frequency, nocturia. The prevalence of overactive bladder increased with age. The elderly is increasing with time, so the people who suffering from overactive bladder is also increasing. Research related to overactive bladder in the field of physical therapy is remained needed. The purposes of this study are to investigate the application of physical therapy to women with overactive bladder, emphasizing on the effect of voluntary muscle contraction for urgency inhibition, including the urodynamic study and clinical study. There are three stages in this study. In the first stage, we are going to develop a specific health-related quality of life questionnaire for urinary incontinence in Taiwan version. One hundred and fifty women with urinary incontinence and fifty healthy women without lower urinary tract symptom will be recruited in the first year to investigate the reliability and validity of the questionnaire. The Short-Form 36, Chinese version, will be used as gold standard for validity. Fifty women with urgency will be recruited in the second stage to test the effect of muscle active contraction strategies to inhibit detrusor pressure and urgency. The three muscle active contraction strategies include pelvic floor muscle strong contraction, pelvic floor muscle tonic contraction, and transversus abdominis tonic contraction. The outcome variables including detrusor pressure of the urodynamic parameter and self-reported urgency score. Simultaneous image record by abdominal ultrasound during the urodynamic examination will be used to ensure the accuracy of muscle action. The predictors of success of strategy from the result of the second year will be used to stratify the patients in the third stage. Eighty women with urgency will be recruited in the final stage to examine the clinical effect of strategy for urgency inhibition.

NCT ID: NCT01605617 Terminated - Overactive Bladder Clinical Trials

Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate

Start date: June 2012
Phase: Phase 4
Study type: Interventional

The investigators are studying two FDA-approved modalities used to treat overactive bladder to determine if they improve overactive bladder with or without urge incontinence when used together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS and fesoterodine fumarate.

NCT ID: NCT01540786 Terminated - Healthy Subjects Clinical Trials

An Exploratory Study to Investigate Bladder Contractions in the Storage Phase and Related Bladder Sensations in Healthy Females and Females With Overactive Bladder (OAB) Using High Resolution and Conventional Urodynamics

Start date: March 2012
Phase: Phase 1
Study type: Interventional

This study aims to identify differences in bladder contractions during the storage phase (non voiding activities) between OAB subjects and healthy subjects, using high resolution urodynamics. The study is divided into two parts: - PART 1: Consists of 5 females with overactive bladder - PART 2: Consists of 25 females with overactive bladder and 15 healthy females Part 1 subjects will be enrolled followed by part 2 subjects. The data from part 1 subjects will be reviewed and analysed by a group of experts before starting the second part (part 2) of the study.

NCT ID: NCT01500382 Terminated - Overactive Bladder Clinical Trials

A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)

Start date: February 27, 2012
Phase: Phase 1
Study type: Interventional

The study is designed to investigate the effects of the investigational drug vibegron (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive bladder. The study will also evaluate the safety and tolerability of multiple oral doses of vibegron in women with overactive bladder. Overactive bladder is best described as urgency and frequency of urination, with or without involuntary urination and/or the need to awaken during the night to urinate. The primary efficacy hypothesis is that vibegron is superior to placebo with respect to change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e., steady state) in participants with overactive bladder. A true mean increase (vibegron/placebo) of 25% in bladder volume is expected. The primary safety hypothesis is that administration of multiple oral doses of vibegron is sufficiently well-tolerated in participants with overactive bladder, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.

NCT ID: NCT01302938 Terminated - Overactive Bladder Clinical Trials

Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder

REMOTE
Start date: March 2011
Phase: Phase 4
Study type: Interventional

To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design

NCT ID: NCT01189071 Terminated - Pain, Postoperative Clinical Trials

Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain

Start date: August 2009
Phase: N/A
Study type: Interventional

This will be a randomized two arm prospective study to evaluate postoperative ureteral stent pain. One arm will be given 3 days of preoperative darifenacin and the control group will have the standard of care which is no preoperative anticholinergic medication. The primary endpoints will be decreased pain scores and less ER visits and hospital admissions for stent difficulty. These will be assessed by a pain diary completed by the participant as well as a questionnaire when the participant returns to clinic for stent removal. Also included in evaluation of the primary end point will be patient phone calls, ER visits and admissions for stent difficulty. Secondary endpoints will be narcotic and postoperative anticholinergic use. This will also be assessed with the pain diary completed by the participant. Participants will be included in the study if they are undergoing a procedure that a stent will likely be required. This will include participants who will have ureteroscopy or extracorporeal shock wave lithotripsy and a stone 1 cm or larger. Also participants with stones smaller than 1 cm who due to anatomy of the ureter or kidney will likely need a stent on preoperative evaluation will also be included in the study. Included as well in the study are participants who will undergo renal or ureteral surgery that a ureteral stent will be utilized. Participants will be randomized after consent is obtained into two groups. One group will receive standard of care which is no preoperative anticholinergic medications. The second group will receive the three day treatment with darifenacin pre procedure. Participants in the second group will be instructed on side effects of darifenacin and given appropriate contact information prior to initiation of the medication. Both groups will be followed postoperatively with a pain diary. Postoperative follow up will continue until the stent is removed 1-2 weeks after the procedure. The exact time of stent removal will depend on the success and nature of the surgery and will be at the discretion of the surgeon. Participants will be able to voluntarily stop the medication for any reason as well as if they have serious side effects from the medication. Data to be collected from each group includes age, gender, race, prior ureteral stents, prior renal or ureteral surgery, past medical history, allergies, current medications and urinary complaints.

NCT ID: NCT01003249 Terminated - Constipation Clinical Trials

Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen

Start date: September 2009
Phase: Phase 4
Study type: Interventional

Dysfunctional voiding is often associated with constipation. The association of constipation with urologic pathologic processes has previously been described since the 1950's, but it was only over the past decade that clinicians have paid more attention to this relationship and recognized it existence with the term dysfunctional elimination syndrome (DES). This term is used to reflect the broad spectrum of functional disturbances that may affect the urinary tract including that of functional bowl disturbances and can be classified as follows: - Functional disorder of filling: overactive bladder, over distention of bladder or insensate bladder, which may be associated with fecal impaction or rectal distention with infrequent bowel movements - Functional disorder of emptying: over-recruitment of pelvic floor activity during voiding causing interrupted and/or incomplete emptying also associated with defecation difficulties due to non- relaxation of the puborectalis muscle, dyssynergic defecation or pain with defecation Several different therapeutic options have been used for patients with dysfunctional voiding mainly to decrease bladder outlet obstruction. These treatments including, alpha adrenergic antagonists, and botulinum toxin are less than optimum. One possible explanation for these drug failures includes the inability of these medications to relax the striated muscles of the pelvic floor necessary for voiding. To date there has been no data to evaluate the role of baclofen on the striated muscle of the external anal sphincter, essential in the defecation process.

NCT ID: NCT00871975 Terminated - Overactive Bladder Clinical Trials

Diagnostic Utility of Tetra-NIRS in Conjunction With Urodynamic Studies

Start date: April 2009
Phase: Phase 4
Study type: Interventional

The purpose of this evaluation is to validate the previous clinical study results using the Tetra-NIRS as compared to the conventional UDS in the voiding procedure. The experiment will use a commercially available Tetra-NIRS device. The hypothesis is that the commercially available Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic procedure).

NCT ID: NCT00852696 Terminated - Overactive Bladder Clinical Trials

Over Active Bladder Patients Having Sling Surgery

Start date: February 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.