Clinical Trials Logo

Clinical Trial Summary

The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study.


Clinical Trial Description

Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment of the obstruction (transurethral resection of the prostate). These patients are usually started empirically on alpha-blockers or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and latter, to treat overactive bladder. We hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as long acting Fesoterodine or Toviaz.

Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on symptoms of patients with bladder outlet obstruction and overactive bladder. In addition, anticholinergic drug Toviaz is not associated with increased incidence of complication like acute urinary retention, a state where patient is unable to empty the bladder as an adverse effect of the drug.

A large proportion of our patients that are undergoing treatment for bladder outlet obstruction also have overactive bladder. We propose an open label trial to evaluate the efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. Toviaz is an antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with overactive bladder on urodynamic test preoperatively will be considered. If these patients continue to have symptoms at the one-month post-operative visit, they will be enrolled into the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, we will see if there is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7 months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and complications. An FDA approved flexible dosing regimen will be allowed for the duration of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00605319
Study type Interventional
Source Weill Medical College of Cornell University
Contact
Status Completed
Phase Phase 4
Start date January 2010
Completion date January 2013

See also
  Status Clinical Trial Phase
Recruiting NCT03457805 - Prostatic Artery Embolization in Advanced Prostate Cancer N/A
Completed NCT00507455 - Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction Phase 2
Recruiting NCT04626167 - Concomitant Renal and Urinary Bladder Allograft Transplantation Early Phase 1
Not yet recruiting NCT06422312 - A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients. N/A
Suspended NCT01779349 - Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" N/A
Not yet recruiting NCT01388348 - Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study N/A
Completed NCT00710749 - The Value of Multiple Urine Flow Rate Measurements in Male Benign Prostatic Hyperplasia (BPH) Subjects N/A
Recruiting NCT03486639 - Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity
Enrolling by invitation NCT02869061 - Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture Phase 1/Phase 2
Active, not recruiting NCT05631080 - Transurethral Prostate Enucleation in Surveillance Protocol for Low Risk Prostate Cancer Phase 4
Completed NCT02031653 - Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
Recruiting NCT03503721 - Bipolar Transurethral Enucleation (BipolEP) vs Bipolar Transurethral Resection of the Prostate N/A
Not yet recruiting NCT05910983 - Prostate Enucleation With Intravesical Botox Injections in Treating BPH and Bladder Overactivity N/A
Recruiting NCT03281798 - Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction N/A
Completed NCT05470751 - GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
Completed NCT04981080 - DU and BOO in Women With and Without Symptoms of VD
Completed NCT00410514 - A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO) Phase 2
Recruiting NCT06152666 - Day-case Endourology; Enablers, Barriers, Unexpected Outcomes
Not yet recruiting NCT04514718 - Low Energy HoLEP on IPSS N/A
Completed NCT01661621 - Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1 Phase 4