Trial Outcomes & Findings for An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence (NCT NCT00080470)
NCT ID: NCT00080470
Last Updated: 2013-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
148 participants
Primary outcome timeframe
12 months
Results posted on
2013-11-19
Participant Flow
Although enrollment numbers totaled 148 subjects, the total number of implanted subjects were used for the analysis. Total number of implanted subjects is 87.
Participant milestones
| Measure |
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.
|
Control
No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
42
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
34
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Baseline characteristics by cohort
| Measure |
Control
n=42 Participants
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
Treatment
n=45 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=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
59.26 Years
STANDARD_DEVIATION 12.66 • n=5 Participants
|
54.82 Years
STANDARD_DEVIATION 16.73 • n=7 Participants
|
56.97 Years
STANDARD_DEVIATION 14.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Treatment
n=45 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=42 Participants
No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
|---|---|---|
|
Number of Leaks Per Day
|
NA Number of Leaks Per Day
Standard Deviation NA
This study was limited by poor adherence to the clinical protocol and by incomplete data recovery. Data related to clinical effectiveness was not recoverable. Analysis of efficacy-related endpoints was not possible.
|
NA Number of Leaks Per Day
Standard Deviation NA
This study was limited by poor adherence to the clinical protocol and by incomplete data recovery. Data related to clinical effectiveness was not recoverable. Analysis of efficacy-related endpoints was not possible.
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Treatment
n=45 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=42 Participants
No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
|---|---|---|
|
Freedom From Major Complications
|
0 Number of Adverse Events
NA
|
0 Number of Adverse Events
NA
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Treatment
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=42 participants at risk
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
|
Treatment
n=45 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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Gastrointestinal disorders
Anal Discomfort
|
2.4%
1/42 • Number of events 1 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
2/42 • Number of events 2 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Proctalgia
|
4.8%
2/42 • Number of events 3 • 5 years
|
0.00%
0/45 • 5 years
|
|
General disorders
Adhesion
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
General disorders
Implant Site Pain
|
4.8%
2/42 • Number of events 2 • 5 years
|
6.7%
3/45 • Number of events 3 • 5 years
|
|
General disorders
Implant Site Paresthesia
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
General disorders
Therapeutic Product Ineffective
|
40.5%
17/42 • Number of events 18 • 5 years
|
28.9%
13/45 • Number of events 16 • 5 years
|
|
General disorders
Therapeutic Response Decreased
|
11.9%
5/42 • Number of events 5 • 5 years
|
8.9%
4/45 • Number of events 5 • 5 years
|
|
Infections and infestations
Cystitis
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Infections and infestations
Urinary Tract Infection
|
4.8%
2/42 • Number of events 2 • 5 years
|
4.4%
2/45 • Number of events 2 • 5 years
|
|
Infections and infestations
Vaginal Infection
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Injury, poisoning and procedural complications
Device Breakage
|
7.1%
3/42 • Number of events 3 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Device electrical Finding
|
7.1%
3/42 • Number of events 3 • 5 years
|
0.00%
0/45 • 5 years
|
|
Injury, poisoning and procedural complications
Device Failure
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Injury, poisoning and procedural complications
Device Migration
|
9.5%
4/42 • Number of events 4 • 5 years
|
4.4%
2/45 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Failure of Implant
|
2.4%
1/42 • Number of events 1 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Inappropriate Device Stimulation of Tissue
|
2.4%
1/42 • Number of events 1 • 5 years
|
13.3%
6/45 • Number of events 6 • 5 years
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculuskeletal Pain
|
4.8%
2/42 • Number of events 2 • 5 years
|
0.00%
0/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.1%
3/42 • Number of events 3 • 5 years
|
6.7%
3/45 • Number of events 3 • 5 years
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Nervous system disorders
Muscle Contractions involuntary
|
7.1%
3/42 • Number of events 3 • 5 years
|
15.6%
7/45 • Number of events 8 • 5 years
|
|
Nervous system disorders
Nerve Compression
|
2.4%
1/42 • Number of events 1 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neurological symptom
|
2.4%
1/42 • Number of events 2 • 5 years
|
0.00%
0/45 • 5 years
|
|
Renal and urinary disorders
Dysuria
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Renal and urinary disorders
Micturition urgency
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urge Incontinence
|
2.4%
1/42 • Number of events 1 • 5 years
|
6.7%
3/45 • Number of events 3 • 5 years
|
|
Reproductive system and breast disorders
Genital Pain
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Pelvic Discomfort
|
0.00%
0/42 • 5 years
|
2.2%
1/45 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.1%
3/42 • Number of events 3 • 5 years
|
6.7%
3/45 • Number of events 3 • 5 years
|
|
Reproductive system and breast disorders
Perineal Pain
|
4.8%
2/42 • Number of events 2 • 5 years
|
0.00%
0/45 • 5 years
|
|
Reproductive system and breast disorders
Vaginal Pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
6.7%
3/45 • Number of events 3 • 5 years
|
|
Reproductive system and breast disorders
Vulval disorder
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Scar Pain
|
2.4%
1/42 • Number of events 1 • 5 years
|
0.00%
0/45 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place