Overactive Bladder Innovative Therapy Trial (OrBIT)

• Sponsor: Uroplasty, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00448175
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 28
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Device: Urgent PC Neuromodulation System; Drug: Tolterodine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Overactive Bladder Innovative Therapy Trial
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Urgent PC treatment arm	Device: Urgent PC Neuromodulation System; 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).; Drug: Tolterodine

Outcome Measures

Primary Outcome Measures

1. Frequency of Voids at 12 Weeks [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 Outcome Measures

1. Urge Incontinence Episodes at 12 Weeks [12 weeks]

2. Volume Voided at 12 Weeks [12 weeks]

3. OAB Quality of Life at 12 Weeks [12 weeks]

4. Known Side Effects Through 12 Weeks [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uroplasty, Inc	Minnetonka	Minnesota	United States	55343

Sponsors and Collaborators

• Uroplasty, Inc

Investigators

• Study Director: Megan O'Toole, Uroplasty, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Uroplasty, Inc
• ClinicalTrials.gov Identifier: NCT00448175
• Other Study ID Numbers: UPC032006
• First Posted: Mar 16, 2007
• Last Update Posted: May 16, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Uroplasty, Inc: OAB symptoms of urgency, frequency, and urge incontinence
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Tolterodine Tartrate

Study Results

Participant Flow

Recruitment Details	Subjects were recruited by investigator sites with limited advertising
Pre-assignment Detail	After 12 weekly PTNS treatments, 35 patients were considered responders (reporting of "Moderately" or "Markedly" improved on the Global Response Assessment (GRA))and allowed to continue in the trial through 12 months.

Arm/Group Title	Urgent PC Treatment Arm	4mg Daily Tolterodine
Arm/Group Description	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).	90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
Period Title: 12 Weeks PTNS vs. Drug
STARTED	50	50
COMPLETED	41	43
NOT COMPLETED	9	7
Period Title: 12 Weeks PTNS vs. Drug
STARTED	35	0
COMPLETED	25	0
NOT COMPLETED	10	0

Baseline Characteristics

Arm/Group Title	Urgent PC Treatment Arm	4mg Daily Tolterodine	Total
Arm/Group Description	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).	90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)	Total of all reporting groups
Overall Participants	50	50	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	33 66%	35 70%	68 68%
>=65 years	17 34%	15 30%	32 32%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.5 (15.2)	58.2 (11.3)	57.85 (13.25)
Sex: Female, Male (Count of Participants)
Female	48 96%	46 92%	94 94%
Male	2 4%	4 8%	6 6%
Region of Enrollment (participants) [Number]
United States	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Frequency of Voids at 12 Weeks
Description	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.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Urgent PC Treatment Arm	4mg Daily Tolterodine
Arm/Group Description	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).	90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
Measure Participants	41	43
Mean (Standard Deviation) [Voids/day]	-2.4 (4)	-2.5 (3.9)

2. Secondary Outcome

Title	Urge Incontinence Episodes at 12 Weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Volume Voided at 12 Weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	OAB Quality of Life at 12 Weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Known Side Effects Through 12 Weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Urgent PC Treatment Arm		4mg Daily Tolterodine
Arm/Group Description	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).		90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
All Cause Mortality
	Urgent PC Treatment Arm		4mg Daily Tolterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Urgent PC Treatment Arm		4mg Daily Tolterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Urgent PC Treatment Arm		4mg Daily Tolterodine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/50 (12%)		4/50 (8%)
Surgical and medical procedures
Bruising	1/50 (2%)	3	0/50 (0%)	0
Leg cramp	2/50 (4%)	2	0/50 (0%)	0
Redness/Inflammation at needle site	1/50 (2%)	2	0/50 (0%)	0
Pressure/discomfort at needle site	3/50 (6%)	3	0/50 (0%)	0
Vasovagal response to needle placement	1/50 (2%)	1	0/50 (0%)	0
Jolt felt in leg during treatment	1/50 (2%)	1	0/50 (0%)	0
Blurred Vision	0/50 (0%)	0	1/50 (2%)	2
Headache	0/50 (0%)	0	1/50 (2%)	1
Constipation	0/50 (0%)	0	1/50 (2%)	1
Increase urgency/frequency	0/50 (0%)	0	1/50 (2%)	1
Severe Dizziness	0/50 (0%)	0	1/50 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.