Trial Outcomes & Findings for An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome (NCT NCT00131573)
NCT ID: NCT00131573
Last Updated: 2013-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
12 months
Results posted on
2013-11-19
Participant Flow
Although enrollment numbers totaled 118 subjects, the total number of implanted subjects were used for the analysis. Total number of implanted subjects is 85.
Participant milestones
| Measure |
Control
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
Treatment
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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
39
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
33
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
Baseline characteristics by cohort
| Measure |
Control
n=46 Participants
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
Treatment
n=39 Participants
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
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
47.96 Years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
46.64 Years
STANDARD_DEVIATION 15.55 • n=7 Participants
|
47.35 Years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
39 participants
n=5 Participants
|
33 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Treatment
n=39 Participants
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.
|
Control
n=46 Participants
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
|---|---|---|
|
Average Number of Voids Per Day
|
NA Average Number of Voids
Standard Deviation NA
This study was limited by poor adherence to the clinical protocol and by incomplete data recovery. Analysis of efficacy-related endpoints was not possible.
|
NA Average Number of Voids
Standard Deviation NA
This study was limited by poor adherence to the clinical protocol and by incomplete data recovery. Analysis of efficacy-related endpoints was not possible.
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Treatment
n=39 Participants
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.
|
Control
n=46 Participants
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
|---|---|---|
|
Freedom From Major Complications
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Treatment
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=46 participants at risk
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
Treatment
n=39 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Inappropriate Device Stimulation of Tissue
|
2.2%
1/46 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Incision site Pain
|
2.2%
1/46 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/46 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Defaecation Urgency
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
|
Gastrointestinal disorders
Faecal Incontinence
|
2.2%
1/46 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/46 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Pelvi Floor Dyssynergia
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Adhesion
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
General disorders
Implant Site Haematoma
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Implant site Pain
|
8.7%
4/46 • Number of events 4 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
|
General disorders
Implant site Swelling
|
0.00%
0/46 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
General disorders
No therapeutic response
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Pain
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
General disorders
Therapeutic Product Ineffective
|
21.7%
10/46 • Number of events 10 • 5 years
|
12.8%
5/39 • Number of events 5 • 5 years
|
|
General disorders
Therapeutic Response Decreased
|
13.0%
6/46 • Number of events 9 • 5 years
|
12.8%
5/39 • Number of events 6 • 5 years
|
|
Infections and infestations
Cystitis
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Infections and infestations
Implant Site Infection
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Infections and infestations
Incision Site Infection
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Infections and infestations
Post procedural infection
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/46 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Device Breakage
|
4.3%
2/46 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
|
Injury, poisoning and procedural complications
Device electrical Finding
|
2.2%
1/46 • Number of events 1 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Device failure
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Injury, poisoning and procedural complications
Device Migration
|
10.9%
5/46 • Number of events 6 • 5 years
|
0.00%
0/39 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.2%
1/46 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Muscle Contractions involuntary
|
4.3%
2/46 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neurological Symptom
|
0.00%
0/46 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Bladder Discomfort
|
2.2%
1/46 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Bladder Pain
|
2.2%
1/46 • Number of events 1 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Cystitis Interstitial
|
4.3%
2/46 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Micturition Urgency
|
4.3%
2/46 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/46 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Urinary Retention
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
6.5%
3/46 • Number of events 3 • 5 years
|
10.3%
4/39 • Number of events 4 • 5 years
|
|
Reproductive system and breast disorders
Perineal Pain
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
|
Vascular disorders
Haematoma
|
0.00%
0/46 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place