The purpose of this investigation is to confirm long-term clinical performance and safety of the InterStim Micro System. The primary objectives of the study will evaluate data at 3 months post-implant; however, subjects will be followed for 2 years…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Sacral Neuromodulation (SNM) is a treatment for bladder and bowel control
symptoms through the modulation of sacral nerves. SNM is delivered by sending
electrical pulses to the sacral nerve to modulate the neural activity that
influences the behavior of the pelvic floor, lower urinary tract, urinary and
anal sphincters, and colon. SNM delivered by the Medtronic InterStim System is
an advanced therapy option for the treatment of the indications specified in
the clinical investigational plan.1-4 Safety and performance have been
established with long-term follow-up reported in the literature.5-7 This
prospective clinical study will fulfill post-market clinical follow-up
obligations for the InterStim Micro System and is an active mechanism to assess
performance and safety in patients SNM therapy in an organized, systematic
manner based on the intended use
Study objective
The purpose of this investigation is to confirm long-term clinical performance
and safety of the InterStim Micro System.
The primary objectives of the study will evaluate data at 3 months
post-implant; however, subjects will be followed for 2 years for the additional
measures and safety assessments.
Study design
A minimum of 50 subjects who complete the Three-month Follow-up Visit is
required for the overactive bladder and fecal incontinence cohorts. A minimum
of 30 subjects who complete the Three-month Follow-up Visit is required for the
non-obstructive urinary retention cohort. Each subject will only be qualified
for one of the study cohorts.
The study is intended to be conducted at approximately 40 centers in Europe,
Canada, Australia and the United States (and United States Territories). This
is an on-label, post-market study of an approved system. All subjects implanted
in the study will
qualify under the approved indications for sacral neuromodulation.
Intervention
Please reffer to CIP page 16 to 19.
Study burden and risks
Participation in this study will not expose the subject to greater risks than
if he/she were receiving an InterStim Micro System implant and sacral
neuromodulation therapy with the InterStim Micro System outside of the study.
The risks associated with an InterStim Micro System implant and sacral
neuromodulation therapy with the InterStim Micro System are minimized in this
study by selecting only qualified Investigators experienced in sacral
neuromodulation, selecting an appropriate patient population via
inclusion/exclusion screening, and monitoring subject progress and events
reported for this study. The review and minimization of the potential risks to
the patient and the potential benefits to the patient support the conduct of
this study.
See CIP section 10 for more information
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72035.091.20 |