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Completed

NCT Number: NCT00448175

Overactive Bladder Innovative Therapy Trial (OrBIT)

The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Uroplasty, Inc

Minnetonka, Minnesota, 55343, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is at least 18 years of age
  • Experiences OAB with a voiding frequency of at least 8 times per day
  • Is ambulatory and able to use a toilet independently and without difficulty

Exclusion criteria

  • On OAB pharmacotherapy within the previous month
  • Primary complaint is stress urinary incontinence
  • Has pacemaker or implantable defibrillator
  • Has history of heart problems
  • Has nerve damage or neuropathy
  • Has gastric or urinary retention
  • Has uncontrolled narrow-angle glaucoma
  • Has known sensitivity to drug ingredients
  • Is pregnant or planning to become pregnant during the trial

Treatment and study plan

Urgent PC Neuromodulation System

Device

The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

tolterodine

Drug

Primary outcomes

  1. Frequency of Voids at 12 Weeks

    Time frame: Baseline to 12 weeks

    To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.

Secondary outcomes

  1. Urge Incontinence Episodes at 12 Weeks

    Time frame: 12 weeks

  2. Volume Voided at 12 Weeks

    Time frame: 12 weeks

  3. OAB Quality of Life at 12 Weeks

    Time frame: 12 weeks

  4. Known Side Effects Through 12 Weeks

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Uroplasty, Inc

Industry

Registry information

Official study title

Overactive Bladder Innovative Therapy Trial

Acronym: OrBIT

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 16, 2007
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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