Fecal incontinence non-obstructive urinary retention Overactive bladder
Conditions
Interventions
Please reffer to CIP page 16 to 19.
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Overactive Bladder (OAB) Cohort Eligibility Criteria: 1. Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours 2. Subjects 18 years of age or older 3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling 4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol 5. Willing and able to provide signed and dated informed consent Fecal Incontinence (FI) -Cohort Eligibility Criteria: 1. Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe soiling) 2. Subjects 18 years of age or older 3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling 4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol 5. Willing and able to provide signed and dated informed consent Non-Obstructive UrinaryRetention (NOUR) - Cohort Eligibility Criteria: 1. Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations 2. Chronic non-obstructive urinary retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions. 3. Subjects 18 years of age or older 4. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling 5. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol 6. Willing and able to provide signed and dated informed consent
Exclusion criteria
Exclusion criteria: Overactive Bladder (OAB) Exclusion criteria: 1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 3. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 4. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months 5. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy 6. Women who are pregnant or planning to become pregnant 7. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 8. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.* Fecal Incontinence (FI) Exclusion criteria: 1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 2. Uncorrected high grade internal rectal prolapse 3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy 4. Women who are pregnant or planning to become pregnant 5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.* Non-Obstructive Urinary Retention exclusion criteria : 1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy . 4. Women who are pregnant or planning to become pregnant 5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overactive Bladder Cohort primary objective; The primary objective for the overactive bladder cohort of the study is to demonstrate an improvement in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total score at 3 months post-implant compared to baseline. Fecal Incontinence Cohort primary objective; The primary objective for the fecal incontinence cohort of the study is to demonstrate an improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline. Non-Obstructive Urinary Retention Cohort primary objective: The primary objective for the non-obstructive urinary retention cohort of the study is to demonstrate an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months postimplant compared to baseline. All additional objectives per cohort can be found under section 5 of the CIP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overactive Bladder Cohort primary objective; • To characterize change in symptoms at follow-up visits compared to baseline • To characterize the change in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total score and its subscales at follow-up visits compared to baseline • To characterize the change in OAB-q symptom bother score at follow-up visits compared to baseline • To characterize Patient Global Impression of Improvement (PGI-I) and patient satisfaction at follow-up visits Fecal Incontinence Cohort primary objective; • To characterize change in symptoms at follow-up visits compared to baseline • To characterize the change in Cleveland Clinic Incontinence Score (CCIS) at follow-up visits compared to baseline • To characterize change in Fecal Incontinence Quality of Life Questionnaire (FIQoL) at follow-up visits compared to baseline • To characterize Patient Global Impression of Improvement (PGI-I) and patient satisfaction at follow-up visits Non-Obstructive Urinary Retention Cohort primary objective; • To characterize the change in number of clean intermittent self-catheterizations (CISC) and associated symptoms per day at follow-up visits compared to baseline • To characterize the change In the Female Lower Urinary Tract Symptom (FLUTS) Questionnaire and Male Lower Urinary Tract (MLUTS) Questionnaire at follow-up visits compared to baseline • To characterize Patient Global Impression of Improvement (PGI-I) and patient satisfaction at follow-up visits | — |
Countries
Netherlands
Outcome results
None listed