Overactive Bladder Clinical Trial
Official title:
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.
Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9% in the United States and has been found to increase with age. OAB has a negative impact on health related quality of life (QoL), Per American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global response assessments (GRA) compared to 20.9% of sham subjects (p <0.001). PTNS subjects also had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is also early data from an implanted chronic tibial nerve stimulation lead study that shows a minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in incontinence episodes per day at one week. Our study will test the concept of whether the PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical improvement after a one week induction course. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04578899 -
"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
|
N/A | |
| Active, not recruiting |
NCT03556891 -
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
|
N/A | |
| Not yet recruiting |
NCT05977634 -
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
|
N/A | |
| Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
| Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
| Recruiting |
NCT03727711 -
TPTNS: Home vs Hospital Treatment for Overactive Bladder
|
N/A | |
| Completed |
NCT00768521 -
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
|
Phase 1 | |
| Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
| Completed |
NCT02211846 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
|
Phase 1 | |
| Completed |
NCT02857816 -
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
|
N/A | |
| Completed |
NCT02835846 -
Investigation of the Effect of the Female Urinary Microbiome on Incontinence
|
Phase 4 | |
| Completed |
NCT02202031 -
Controlling Urgency Through Relaxation Exercises
|
N/A | |
| Withdrawn |
NCT02320201 -
Foot Neuromodulation for Overactive Bladder in Children
|
N/A | |
| Completed |
NCT01458197 -
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
|
Phase 2 | |
| Not yet recruiting |
NCT01409512 -
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
|
N/A | |
| Not yet recruiting |
NCT01423838 -
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
|
Phase 4 | |
| Completed |
NCT01437670 -
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
|
N/A | |
| Withdrawn |
NCT01210859 -
Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents
|
N/A | |
| Terminated |
NCT01758848 -
Physical Therapy for Overactive Bladder
|
N/A | |
| Completed |
NCT01122550 -
Reproducibility Study of Overactive Bladder Symptom Score [OABSS]
|
N/A |