InSite - OAB: InSite for Over Active Bladder
Sponsor
MedtronicNeuro (Industry)
Overall Status
Completed
CT.gov ID
NCT00547378
Collaborator
(none)
571
2
106
Study Details
Study Description
Brief Summary
The purposes of this study are:
-
To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use.
-
To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary voiding dysfunction symptoms impose a significant physical and psychosocial impact on individuals, including loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. These symptoms can substantially affect a subject's daily activities.
Patients with OAB are managed with diet modification, bladder training or retraining, pelvic muscle rehabilitation, medication and biofeedback. Medications are used as the first-line therapy for urgency frequency and urinary urge incontinence.
InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.
InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of the trail and Phase II the non-randomized portion.
Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects randomized to SMT.
Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297 enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of OAB.
Study Design
Study Type:
Interventional
Actual Enrollment
:
571 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Aug 1, 2016
Actual Study Completion Date
:
Aug 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 1 InterStim Therapy |
Device: InterStim
|
| Active Comparator: 2 Standard Medical Therapy |
Drug: Standard Medical Therapy
Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg
|
Outcome Measures
Primary Outcome Measures
- Randomized Cohort: OAB Therapeutic Response [6 months]
To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as: at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (<8 voids/day) for subjects with urgency-frequency at baseline.
- All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery [5 years]
To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33. Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest.
Secondary Outcome Measures
- All Implanted Cohort: Tined Lead Migration Rate [5 years]
To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint.
- All Implanted Cohort: Infection Rate Associated With the Tined Lead [5 years]
To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have a diagnosis of OAB including urinary urge incontinence or urgency-frequency
-
Be male or female at least 18 years of age or older
-
Be able to consent to participate by signing the Informed Consent
-
Be willing and able to attend visits and comply with the study protocol including adequate operation of equipment
-
Have failed or are not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification)
-
Have failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) at least one anticholinergic or antimuscarinic medication AND have at least one anticholinergic or antimuscarinic medication not yet attempted
-
Have been on current regiment of OAB medications or have not been on any OAB medications, for at least 4 weeks prior to beginning the baseline voiding diary
Exclusion Criteria:
-
Have severe or uncontrolled diabetes or diabetes with peripheral nerve involvement
-
Have concomitant medical conditions which would limit the success of the study procedure
-
Have skin, orthopedic or neurologic anatomical limitations that could prevent successful placement of an electrode
-
Have neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
-
Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
-
Have urinary tract mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
-
Have symptomatic urinary tract infection (UTI)
-
Have implantable neurostimulators, pacemakers, or defibrillators
-
Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
-
Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
-
Be a woman who is pregnant or planning to become pregnant or are a woman of child-bearing potential who is not using a medically-acceptable method of birth control
-
Have a life expectancy of less than one year
-
Have plans to enroll in another investigation device or drug trial during their participation in this trial, or currently enrolled in an investigational device or drug trial
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- MedtronicNeuro
Investigators
- Study Chair: Steven Siegel, MD, Metro Urology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00547378
Other Study ID Numbers:
- Protocol 1634
- NCT00549094
First Posted:
Oct 22, 2007
Last Update Posted:
Dec 12, 2017
Last Verified:
Nov 1, 2017
Keywords provided by MedtronicNeuro
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Thirty-eight centers were activated to enroll subjects. In total, 571 subjects were enrolled: 243 randomized cohort (96 excluded due to eligibility failure); 328 non-randomized cohort (102 excluded due to declined to participate; did not meet inclusion criteria and other). Subjects were enrolled between November 2007 and March 10, 2011. |
|---|---|
| Pre-assignment Detail | The study has 2 cohorts. The randomized cohort included subjects who were randomized 1:1 to either InterStim Therapy (IST) or Standard Medical Therapy (SMT) and were followed for 6 months. The all implanted cohort include implanted subjects from the randomized cohort plus additional subjects enrolled after randomized cohort enrollment completion. |
| Arm/Group Title | InterStim Therapy | Standard Medical Therapy | All Implanted/Non-Randomized Cohort |
|---|---|---|---|
| Arm/Group Description | Randomized Cohort - InterStim Therapy. This includes those subjects who were randomized to InterStim Therapy. | Randomized Cohort - Standard Medical Therapy. This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant. | These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. |
| Period Title: Randomized Cohort | |||
| STARTED | 70 | 77 | 0 |
| Month 3 | 62 | 72 | 0 |
| Month 6 | 59 | 71 | 0 |
| COMPLETED | 59 | 71 | 0 |
| NOT COMPLETED | 11 | 6 | 0 |
| Period Title: Randomized Cohort | |||
| STARTED | 51 | 40 | 181 |
| Month 3 | 51 | 39 | 178 |
| Month 6 | 50 | 36 | 178 |
| Month 12 | 48 | 32 | 175 |
| Month 24 | 42 | 30 | 161 |
| Month 36 | 42 | 29 | 146 |
| Month 48 | 38 | 27 | 136 |
| Month 60 | 36 | 23 | 114 |
| COMPLETED | 36 | 22 | 111 |
| NOT COMPLETED | 15 | 18 | 70 |
Baseline Characteristics
| Arm/Group Title | Randomized Cohort: InterStim Therapy | Randomized Cohort: Standard Medical Therapy | All Implanted Cohort: Non-randomized Subjects | Total |
|---|---|---|---|---|
| Arm/Group Description | This includes those subjects who were randomized to InterStim Therapy. | This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant. | These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. | Total of all reporting groups |
| Overall Participants | 70 | 77 | 181 | 328 |
| Age, Customized (years) [Mean (Standard Deviation) ] | ||||
| Age, years |
60.4
(14.4)
|
57.1
(15.3)
|
57.2
(14.1)
|
57.9
(14.5)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
66
94.3%
|
71
92.2%
|
165
91.2%
|
302
92.1%
|
| Male |
4
5.7%
|
6
7.8%
|
16
8.8%
|
26
7.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
3
4.3%
|
0
0%
|
8
4.4%
|
11
3.4%
|
| Not Hispanic or Latino |
67
95.7%
|
77
100%
|
173
95.6%
|
317
96.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
61
87.1%
|
70
90.9%
|
161
89%
|
292
89%
|
| Black |
7
10%
|
7
9.1%
|
12
6.6%
|
26
7.9%
|
| Asian/White |
1
1.4%
|
0
0%
|
0
0%
|
1
0.3%
|
| American Indian or Alaska Native/White |
0
0%
|
0
0%
|
2
1.1%
|
2
0.6%
|
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
0.6%
|
1
0.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
1
0.6%
|
1
0.3%
|
| Other |
1
1.4%
|
0
0%
|
4
2.2%
|
5
1.5%
|
| Baseline Leaks/Day (Leaks/Day) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Leaks/Day] |
2.4
(1.7)
|
2.7
(1.9)
|
3.4
(3.0)
|
3.0
(2.6)
|
| Baseline Voids/Day (Voids/Day) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Voids/Day] |
11.2
(2.9)
|
11.9
(4.3)
|
13.1
(4.8)
|
12.5
(4.5)
|
Outcome Measures
| Title | Randomized Cohort: OAB Therapeutic Response |
|---|---|
| Description | To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as: at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (<8 voids/day) for subjects with urgency-frequency at baseline. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT): an analysis that includes all randomized subjects. This was analysis in the randomized cohort. |
| Arm/Group Title | InterStim Therapy | Standard Medical Therapy |
|---|---|---|
| Arm/Group Description | Subjects who were randomized to InterStim Therapy group | Subjects who were randomized to Standard Medical Therapy group |
| Measure Participants | 70 | 77 |
| Number [percentage of participants with response] |
61
87.1%
|
42
54.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | InterStim Therapy, Standard Medical Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | The two-sided Cochran-Mantel-Haenszel (CMH) test, stratified for center, was used to test the difference in responder rates between the 2 groups | |
| Title | All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery |
|---|---|
| Description | To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33. Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This objective was analyzed in the all implanted cohort. |
| Arm/Group Title | All Implanted Cohort |
|---|---|
| Arm/Group Description | The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years. |
| Measure Participants | 272 |
| Number (95% Confidence Interval) [Cumulative probability at 5 years] |
0.224
|
| Title | All Implanted Cohort: Tined Lead Migration Rate |
|---|---|
| Description | To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This objective was analyzed in the all implanted cohort. |
| Arm/Group Title | All Implanted Cohort |
|---|---|
| Arm/Group Description | The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years. |
| Measure Participants | 272 |
| Number (95% Confidence Interval) [Cumulative probability at 5 years] |
0.059
|
| Title | All Implanted Cohort: Infection Rate Associated With the Tined Lead |
|---|---|
| Description | To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant. |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This objective was analyzed in the all implanted cohort. |
| Arm/Group Title | All Implanted Cohort |
|---|---|
| Arm/Group Description | The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years. |
| Measure Participants | 272 |
| Number (95% Confidence Interval) [Cumulative probability at 5 years] |
0.012
|
Adverse Events
| Time Frame | Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort. | |||||
| Arm/Group Title | Randomized Cohort: InterStim Therapy Group | Randomized Cohort: Standard Medical Therapy Group | All Implanted Cohort | |||
| Arm/Group Description | Adverse events are summarized for those subjects randomized to the InterStim Therapy group and received full system implant (n=51). Out of 70 subjects, there are 11 subjects who were not implanted with any device component, and 8 subjects who were implanted with lead only, but no neurostimulator. These subjects were not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy. | Adverse events are summarized for those Subjects randomized are compliant to Standard Medical Therapy group (n=75). Out of 77 subjects, 2 subjects crossovered to InterStim Therapy group and received implant. These subjects are not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy. | The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years. | |||
All Cause Mortality |
||||||
| Randomized Cohort: InterStim Therapy Group | Randomized Cohort: Standard Medical Therapy Group | All Implanted Cohort | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/51 (0%) | 1/75 (1.3%) | 8/272 (2.9%) | |||
Serious Adverse Events |
||||||
| Randomized Cohort: InterStim Therapy Group | Randomized Cohort: Standard Medical Therapy Group | All Implanted Cohort | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/51 (9.8%) | 4/75 (5.3%) | 107/272 (39.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Cardiac disorders | ||||||
| Sick sinus syndrome | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cardiac failure congestive | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 5 |
| Myocardial infarction | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 3 |
| Acute myocardial infarction | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Arrhythmia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Atrial fibrillation | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Cardiac failure | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Coronary artery disease | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Angina pectoris | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Aortic valve incompetence | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 2 |
| Atrioventricular block first degree | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Bradycardia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 3 |
| Cardiac arrest | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cardiac failure chronic | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cardio-respiratory arrest | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Coronary artery stenosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Ventricular tachycardia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Congenital, familial and genetic disorders | ||||||
| Adenomatous polyposis coli | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Hereditary spastic paraplegia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Spondylolisthesis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Vertigo positional | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Endocrine disorders | ||||||
| Adrenal mass | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Inappropriate antidiuretic hormone secretion | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 2 |
| Gastrointestinal disorders | ||||||
| Abdominal hernia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 3 |
| Constipation | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Ileus | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Abdominal pain | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Diarrhoea | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Diverticulitis intestinal haemorrhagic | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Dysphagia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Gastrooesophageal reflux disease | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Hiatus hernia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Ileus paralytic | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Impaired gastric emptying | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Intestinal perforation | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Oesophageal stenosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pancreatitis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pneumoperitoneum | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Rectocele | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Retroperitoneal haematoma | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Gastrointestinal haemorrhage | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| General disorders | ||||||
| Pain | 0/51 (0%) | 0 | 1/75 (1.3%) | 1 | 2/272 (0.7%) | 2 |
| Chest pain | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 5/272 (1.8%) | 6 |
| Asthenia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Hernia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Implant site erosion | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Non-cardiac chest pain | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Infections and infestations | ||||||
| Pyelonephritis | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 3/272 (1.1%) | 4 |
| Vaginal cellulitis | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pneumonia | 1/51 (2%) | 1 | 1/75 (1.3%) | 1 | 1/272 (0.4%) | 1 |
| Urinary tract infection | 0/51 (0%) | 0 | 1/75 (1.3%) | 1 | 4/272 (1.5%) | 5 |
| Pneumonia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 7/272 (2.6%) | 8 |
| Cellulitis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 5/272 (1.8%) | 12 |
| Clostridial infection | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Enterocolitis infectious | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Gastroenteritis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Infection | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Lobar pneumonia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Wound infection | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Appendicitis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Catheter bacteraemia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cystitis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Escherichia sepsis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Listeria encephalitis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Meningitis viral | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pharyngitis streptococcal | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Sepsis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Skin infection | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Staphylococcal abscess | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Staphylococcal | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Staphylococcal infection | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Humerus fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 3 |
| Clavicle fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Femur fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Intentional misuse | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Joint injury | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Accidental overdose | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Anastomotic stenosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Ankle fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cardiac valve replacement complication | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Device malfunction | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Extrusion of device | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Fibula fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Head injury | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Multiple drug overdose | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pelvic fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Postoperative ileus | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Procedural complication | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Renal injury | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Thoracic vertebral fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Upper limb fracture | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Investigations | ||||||
| Hepatic enzyme abnormal | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 0/272 (0%) | 0 |
| Electrocardiogram change | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Electroencephalogram abnormal | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 3 |
| Diabetes mellitus non-insulin-dependent | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Hypercalcaemia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Hypoglycaemia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Malnutrition | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Obesity | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Toe deformity | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Osteoarthritis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 12/272 (4.4%) | 13 |
| Arthritis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Exostosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Intervertebral disc degeneration | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Intervertebral disc protrusion | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Myalgia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Shoulder pain | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Spinal column stenosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Synovial cyst | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Breast cancer | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Lung neoplasm malignant | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Multiple myeloma | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pancreatic carcinoma | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Nervous system disorders | ||||||
| Syncope | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 3/272 (1.1%) | 3 |
| Transient ischaemic attack | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 3 |
| Carotid artery stenosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Arachnoid cyst | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Carpal tunnel syndrome | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cerebellar haemorrhage | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cerebrovascular accident | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cubital tunnel syndrome | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Dementia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Dizziness | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Encephalopathy | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 2 |
| Global amnesia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Haemorrhage intracranial | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Headache | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Migraine | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Mononeuropathy multiplex | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Normal pressure hydrocephalus | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Psychiatric disorders | ||||||
| Affective disorder | 0/51 (0%) | 0 | 1/75 (1.3%) | 1 | 0/272 (0%) | 0 |
| Bipolar disorder | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Conversion disorder | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Depression | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Major depression | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Mental status changes | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Psychotic disorder | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Suicidal ideation | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 2 |
| Renal and urinary disorders | ||||||
| Renal failure acute | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 4/272 (1.5%) | 5 |
| Calculus ureteric | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cystitis interstitial | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Cystocele | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Nephrolithiasis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Renal failure | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Renal tubular necrosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pregnancy | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Reproductive system and breast disorders | ||||||
| Pelvic prolapse | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Uterine enlargement | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Uterine prolapse | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary embolism | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 5/272 (1.8%) | 5 |
| Chronic obstructive airways disease exacerbated | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 5 |
| Respiratory failure | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 3 |
| Respiratory distress | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 2/272 (0.7%) | 2 |
| Acute respiratory failure | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Asthma | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 2 |
| Chronic obstructive pulmonary disease | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Hypoxia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Pneumothorax | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Sleep apnoea syndrome | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Decubitus ulcer | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Surgical and medical procedures | ||||||
| Intestinal adhesion lysis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Surgery | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Vascular disorders | ||||||
| Aneurysm | 0/51 (0%) | 0 | 1/75 (1.3%) | 1 | 0/272 (0%) | 0 |
| Deep vein thrombosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 3/272 (1.1%) | 5 |
| Aortic disorder | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Aortic stenosis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
| Venous insufficiency | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 1/272 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Randomized Cohort: InterStim Therapy Group | Randomized Cohort: Standard Medical Therapy Group | All Implanted Cohort | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 29/51 (56.9%) | 22/75 (29.3%) | 217/272 (79.8%) | |||
| Gastrointestinal disorders | ||||||
| Dry mouth | 0/51 (0%) | 0 | 4/75 (5.3%) | 4 | 5/272 (1.8%) | 5 |
| Constipation | 1/51 (2%) | 1 | 7/75 (9.3%) | 7 | 19/272 (7%) | 25 |
| General disorders | ||||||
| Undesirable change in stimulation | 6/51 (11.8%) | 8 | 0/75 (0%) | 0 | 60/272 (22.1%) | 75 |
| Implant site pain | 3/51 (5.9%) | 3 | 0/75 (0%) | 0 | 40/272 (14.7%) | 55 |
| Therapeutic product ineffective | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 37/272 (13.6%) | 42 |
| Lead migration/dislodgment | 2/51 (3.9%) | 2 | 0/75 (0%) | 0 | 14/272 (5.1%) | 17 |
| Infections and infestations | ||||||
| Urinary tract infection | 11/51 (21.6%) | 14 | 3/75 (4%) | 3 | 74/272 (27.2%) | 123 |
| Nasopharyngitis | 4/51 (7.8%) | 4 | 2/75 (2.7%) | 2 | 15/272 (5.5%) | 18 |
| Sinusitis | 4/51 (7.8%) | 4 | 2/75 (2.7%) | 2 | 21/272 (7.7%) | 28 |
| Upper respiratory tract infection | 3/51 (5.9%) | 3 | 2/75 (2.7%) | 2 | 26/272 (9.6%) | 34 |
| Fungal infection | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 19/272 (7%) | 25 |
| Bronchitis | 0/51 (0%) | 0 | 1/75 (1.3%) | 1 | 17/272 (6.3%) | 19 |
| Injury, poisoning and procedural complications | ||||||
| Drug toxicity | 0/51 (0%) | 0 | 7/75 (9.3%) | 7 | 13/272 (4.8%) | 18 |
| Fall | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 25/272 (9.2%) | 27 |
| Contusion | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 19/272 (7%) | 22 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 3/51 (5.9%) | 3 | 1/75 (1.3%) | 1 | 33/272 (12.1%) | 39 |
| Osteoarthritis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 27/272 (9.9%) | 31 |
| Arthralgia | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 22/272 (8.1%) | 25 |
| Pain in extremity | 2/51 (3.9%) | 2 | 0/75 (0%) | 0 | 21/272 (7.7%) | 28 |
| Arthritis | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 17/272 (6.3%) | 17 |
| Nervous system disorders | ||||||
| Paraesthesia | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 19/272 (7%) | 19 |
| Restless legs syndrome | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 15/272 (5.5%) | 15 |
| Psychiatric disorders | ||||||
| Depression | 2/51 (3.9%) | 2 | 1/75 (1.3%) | 1 | 27/272 (9.9%) | 30 |
| Renal and urinary disorders | ||||||
| Cystitis interstitial | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 16/272 (5.9%) | 23 |
| Stress incontinence | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 16/272 (5.9%) | 17 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Sleep apnoea syndrome | 0/51 (0%) | 0 | 0/75 (0%) | 0 | 18/272 (6.6%) | 19 |
| Vascular disorders | ||||||
| Hypertension | 1/51 (2%) | 1 | 0/75 (0%) | 0 | 15/272 (5.5%) | 19 |
Limitations/Caveats
Predominantly female and Caucasian subjects could detract from generalizability. Centers followed individual protocols for peri-op antibiotics, lead choice, and procedure techniques. Lack of standardization may have impacted overall study results.
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.
Results Point of Contact
| Name/Title | Shenita Bolstrom |
|---|---|
| Organization | Pelvic Health & Gastric Therapies |
| Phone | 763-526-8254 |
| shenita.bolstrom@medtronic.com |
Responsible Party:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00547378
Other Study ID Numbers:
- Protocol 1634
- NCT00549094
First Posted:
Oct 22, 2007
Last Update Posted:
Dec 12, 2017
Last Verified:
Nov 1, 2017