An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00080470
• Collaborator: (none)
• Enrollment: 148
• Locations: 11
• Arms: 2
• Duration (Months): 114
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Device: bion	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.	Device: bion; battery powered microstimulator
Sham Comparator: 2 No Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.	Device: bion; battery powered microstimulator

Outcome Measures

Primary Outcome Measures

1. Number of Leaks Per Day [12 months]

2. Freedom From Major Complications [5 years]

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

1. Age 18 years and above.

2. Diagnosed with urinary urge incontinence.

3. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.

4. Have normal upper urinary tract function.

5. Be capable of giving informed consent.

6. Be capable and willing to follow all study related procedures.

Key Exclusion Criteria:

1. Have any active implantable device regardless of whether stimulation status is ON or OFF.

2. Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period.

3. Less than one year post partum and/or are breast-feeding.

4. Have any passive implant that contains metal or electrically conductive materials.

5. Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.

6. Have conditions requiring diathermy procedures.

7. Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.

8. Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.

9. Have history of coagulopathy or bleeding disorder.

10. Have a history of pelvic pain as primary diagnosis.

11. Have anatomical restrictions such that the study device placement is not possible.

12. Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.

13. Have a life expectancy of less than 1 year.

14. Cannot independently comprehend and complete the QoL questionnaires.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Health Sciences Center (University of Arizona)	Tucson	Arizona	United States	85724
2	The Department of Urology, Stanford University Medical Center	Stanford	California	United States	94305-5118
3	Milestone Medical Research	Englewood	Colorado	United States	80112
4	Bladder Control Center of Norwalk	Norwalk	Connecticut	United States	06850
5	Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery	Washington	District of Columbia	United States	20307-5001
6	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
7	Cornerstone Medical Specialty Center	Woodbury	Minnesota	United States	55125
8	The Pelvic and Sexual Health Institute (affiliated with Graduate Hospital)	Philadelphia	Pennsylvania	United States	19146
9	Dallas Center for Pelvic Medicine	Dallas	Texas	United States	75231
10	Baylor College of Medicine	Houston	Texas	United States	77030
11	Sound Urological Associates	Edmonds	Washington	United States	98026

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Tamara Baynham, PhD, Boston Scientific, Neuromodulation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00080470
• Other Study ID Numbers: CR-B-001
• First Posted: Apr 5, 2004
• Last Update Posted: Nov 19, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Boston Scientific Corporation: Incontinence; Refractory; Urinary; Urge; Stimulation; Nerve; Microstimulator; Neuromodulation
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Incontinence, Urge

Study Results

Participant Flow

Pre-assignment Detail	Although enrollment numbers totaled 148 subjects, the total number of implanted subjects were used for the analysis. Total number of implanted subjects is 87.

Arm/Group Title	Treatment	Control
Arm/Group Description	Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.	No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
Period Title: Overall Study
STARTED	45	42
COMPLETED	11	14
NOT COMPLETED	34	28

Baseline Characteristics

Arm/Group Title	Control	Treatment	Total
Arm/Group Description	No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.	Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.	Total of all reporting groups
Overall Participants	42	45	87
Age, Customized (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	59.26 (12.66)	54.82 (16.73)	56.97 (14.99)
Sex: Female, Male (Count of Participants)
Female	41 97.6%	40 88.9%	81 93.1%
Male	1 2.4%	5 11.1%	6 6.9%

Outcome Measures

1. Primary Outcome

Title	Number of Leaks Per Day
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Control
Arm/Group Description	Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.	No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
Measure Participants	45	42
Mean (Standard Deviation) [Number of Leaks Per Day]	NA (NA)	NA (NA)

2. Primary Outcome

Title	Freedom From Major Complications
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Control
Arm/Group Description	Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.	No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
Measure Participants	45	42
Number [Number of Adverse Events]	0 (NA)	0 (NA)

Adverse Events

Time Frame	5 years
Arm/Group Title	Control		Treatment
Arm/Group Description	No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.		Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
All Cause Mortality
	Control		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Control		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/42 (83.3%)		32/45 (71.1%)
Gastrointestinal disorders
Abdominal pain lower	1/42 (2.4%)	1	0/45 (0%)	0
Abdominal Pain Upper	1/42 (2.4%)	1	0/45 (0%)	0
Anal Discomfort	1/42 (2.4%)	1	1/45 (2.2%)	1
Constipation	0/42 (0%)	0	1/45 (2.2%)	1
Diarrhoea	2/42 (4.8%)	2	1/45 (2.2%)	1
Proctalgia	2/42 (4.8%)	3	0/45 (0%)	0
General disorders
Adhesion	1/42 (2.4%)	1	0/45 (0%)	0
Implant Site Pain	2/42 (4.8%)	2	3/45 (6.7%)	3
Implant Site Paresthesia	0/42 (0%)	0	1/45 (2.2%)	1
Therapeutic Product Ineffective	17/42 (40.5%)	18	13/45 (28.9%)	16
Therapeutic Response Decreased	5/42 (11.9%)	5	4/45 (8.9%)	5
Infections and infestations
Cystitis	0/42 (0%)	0	1/45 (2.2%)	1
Urinary Tract Infection	2/42 (4.8%)	2	2/45 (4.4%)	2
Vaginal Infection	1/42 (2.4%)	1	0/45 (0%)	0
Injury, poisoning and procedural complications
Device Breakage	3/42 (7.1%)	3	1/45 (2.2%)	1
Device electrical Finding	3/42 (7.1%)	3	0/45 (0%)	0
Device Failure	1/42 (2.4%)	1	0/45 (0%)	0
Device Migration	4/42 (9.5%)	4	2/45 (4.4%)	3
Failure of Implant	1/42 (2.4%)	1	1/45 (2.2%)	1
Inappropriate Device Stimulation of Tissue	1/42 (2.4%)	1	6/45 (13.3%)	6
Incision Site Pain	1/42 (2.4%)	1	0/45 (0%)	0
Procedural Pain	0/42 (0%)	0	1/45 (2.2%)	1
Suture Related Complication	1/42 (2.4%)	1	0/45 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/42 (0%)	0	1/45 (2.2%)	1
Back Pain	1/42 (2.4%)	1	1/45 (2.2%)	1
Limb Discomfort	1/42 (2.4%)	1	0/45 (0%)	0
Muscle Spasm	0/42 (0%)	0	1/45 (2.2%)	1
Musculuskeletal Pain	2/42 (4.8%)	2	0/45 (0%)	0
Myalgia	0/42 (0%)	0	1/45 (2.2%)	1
Pain in Extremity	3/42 (7.1%)	3	3/45 (6.7%)	3
Nervous system disorders
Dysaesthesia	0/42 (0%)	0	1/45 (2.2%)	1
Hypoaesthesia	1/42 (2.4%)	1	0/45 (0%)	0
Muscle Contractions involuntary	3/42 (7.1%)	3	7/45 (15.6%)	8
Nerve Compression	1/42 (2.4%)	1	1/45 (2.2%)	1
Neurological symptom	1/42 (2.4%)	2	0/45 (0%)	0
Renal and urinary disorders
Dysuria	1/42 (2.4%)	1	0/45 (0%)	0
Micturition urgency	1/42 (2.4%)	1	0/45 (0%)	0
Pollakiuria	0/42 (0%)	0	1/45 (2.2%)	1
Urge Incontinence	1/42 (2.4%)	1	3/45 (6.7%)	3
Reproductive system and breast disorders
Genital Pain	0/42 (0%)	0	1/45 (2.2%)	1
Pelvic Discomfort	0/42 (0%)	0	1/45 (2.2%)	1
Pelvic Pain	3/42 (7.1%)	3	3/45 (6.7%)	3
Perineal Pain	2/42 (4.8%)	2	0/45 (0%)	0
Vaginal Pain	1/42 (2.4%)	1	3/45 (6.7%)	3
Vulval disorder	1/42 (2.4%)	1	0/45 (0%)	0
Skin and subcutaneous tissue disorders
Scar Pain	1/42 (2.4%)	1	0/45 (0%)	0

Limitations/Caveats

This study was limited by poor adherence to the clinical protocol and by incomplete data recovery. Analysis of efficacy-related endpoints was not possible.

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.