Overactive Bladder Clinical Trial
Official title:
Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)
The purposes of this study are:
1. To provide evidence from a randomized controlled trial that InterStim Therapy provides
better relief of symptoms of OAB than standard medical treatments in current use.
2. To fulfill the requirements of the FDA-mandated post-approval study of the safety of the
tined lead using a minimally invasive approach.
Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary
voiding dysfunction symptoms impose a significant physical and psychosocial impact on
individuals, including loss of self-esteem and a decrease in the ability to maintain an
independent lifestyle. These symptoms can substantially affect a subject's daily activities.
Patients with OAB are managed with diet modification, bladder training or retraining, pelvic
muscle rehabilitation, medication and biofeedback. Medications are used as the first-line
therapy for urgency frequency and urinary urge incontinence.
InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the
treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence
and significant symptoms of urgency-frequency alone or in combination, in subjects who have
failed or could not tolerate more conservative treatments.
InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of
the trail and Phase II the non-randomized portion.
Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects
randomized to SMT.
Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297
enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and
Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of
OAB.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04578899 -
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|
N/A | |
| Active, not recruiting |
NCT03556891 -
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
|
N/A | |
| Not yet recruiting |
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Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
|
N/A | |
| Completed |
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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 |
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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 |
NCT02835846 -
Investigation of the Effect of the Female Urinary Microbiome on Incontinence
|
Phase 4 | |
| Completed |
NCT02857816 -
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
|
N/A | |
| Completed |
NCT02202031 -
Controlling Urgency Through Relaxation Exercises
|
N/A | |
| Withdrawn |
NCT02320201 -
Foot Neuromodulation for Overactive Bladder in Children
|
N/A | |
| Completed |
NCT01437670 -
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
|
N/A | |
| Not yet recruiting |
NCT01423838 -
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
|
Phase 4 | |
| Not yet recruiting |
NCT01409512 -
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
|
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 | |
| 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 |
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A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment
|
N/A |