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NCT00448175 · ClinicalTrials.gov registry record · Phase 4

Overactive Bladder Innovative Therapy Trial (OrBIT)

A Phase 4 study of Overactive Bladder, sponsored by Uroplasty.

Completed
Registry status
Phase 4
Development phase
100
Enrollment target
1
Study location

NCT00448175: Completed Phase 4 study of Overactive Bladder, sponsored by Uroplasty.

NCT00448175 is a Phase 4 study of Overactive Bladder that has completed, run by Uroplasty. The registered enrollment target is 100 participants, below the 205-participant average among 46 other Overactive Bladder trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00448175, a Phase 4 study of Overactive Bladder, has completed, sponsored by Uroplasty.

COMPLETED
Registry status
Phase 4
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

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).

Primary Outcome

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.

Conditions Studied

Interventions

  • DEVICE Urgent PC Neuromodulation System
  • DRUG Tolterodine

Study Locations (1)

Minnesota

  • Uroplasty, Inc - Minnetonka

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2006-06
Est. Completion 2008-10
Phase Phase 4
Uroplasty

4 total trials

What the finished NCT00448175 record still lists

NCT00448175 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 205-participant average among 46 other Overactive Bladder trials with a reported enrollment target (51% lower).

The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Urgent PC Neuromodulation System is the first listed.

NCT00448175 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT00448175 about?

NCT00448175 is a clinical study titled "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).

What is the current status of trial NCT00448175?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2006-06. Estimated completion is 2008-10.

What conditions does trial NCT00448175 study?

This clinical trial studies the following conditions: Overactive Bladder.

What interventions are being tested in trial NCT00448175?

The interventions under investigation include: Urgent PC Neuromodulation System (DEVICE), Tolterodine (DRUG).

Who is sponsoring clinical trial NCT00448175?

This trial is sponsored by Uroplasty, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00448175 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Overactive Bladder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00448175's enrollment target sits among peer trials

100 23rd of 46 higher than 22 of 46 other Overactive Bladder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Overactive Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00448175, the US trial registry maintained by the National Library of Medicine. NCT00448175 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.