The primary objective in the study is to explore the effect of three different amplitude settings (50% of sensory threshold, 80% of sensory threshold and sensory threshold) on number of UUI episodes per day.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective in the study is to explore the effect of three different a
mplitude settings (50% of
sensory threshold, 80% of sensory threshold and sensory threshold) on number of
UUI episodes per day
Secondary outcome
Secondary objective of this study is quality of life (ICIQ*
OABqol) for the three different amplitude settings.
Additional measures include: *
Safety *
Patient Global Impression of Improvement (PGI*I) *
Urinary Frequency
Background summary
One of the most common patient complaints about sacral neuromodulation (SNM) for
overactive bladder (OAB) is unwanted or uncomfortable stimulation. It is often
assumed that higher amplitude
stimulation will provide better efficacy, but there is a lack of clinical eviden
ce regarding amplitude effects of SNM for OAB. However, there is some evidence t
hat SNM for fecal incontinence is effective at sub-sensory threshold/
amplitude.This study will explore whether lower amplitude stimulation can
provide improved symptom control when compared to baseline. Potential effects
of lower amplitude
may include changes in or sustained efficacy, or reduced patient complaints due
to uncomfortable stimulation.
More information can be found under Section 4; Background CIP page 17 of the
protocol
Study objective
The primary objective in the study is to explore the effect of three different a
mplitude settings (50% of sensory threshold, 80% of sensory threshold and sensor
y threshold) on number of UUI episodes per day.
Study design
This is a prospective, randomized, multicenter, single*blinded study to
explore the efficacy and quality of life (QoL) of 3 different amplitude
settings. The study will be conducted at approximately 20 centers in
the United States, Canada and Europe.
Enrolled subjects who meet all eligibility criteria, have successful
therapy evaluation (50% improvement in UUI or UF voiding symptoms,
or return to normal voiding of < 8 voids per day for UF subjects) and
qualify for a neurostimulator device implant in the study will be
randomized to one of the 3 amplitude settings. Subjects will complete
enrollment/baseline visits, lead implant, therapy evaluation,
neurostimulator device implant, randomization, 1*week follow*up visit, 6*
week follow*up visit and 12*week follow*up visit.
The total study duration for a subject is approximately 16 weeks.
Intervention
1. Enrollment / Baseline
2. Tined Lead or temporary Test Stimulation Lead Implant
3. Therapy Evaluation
4. Neurostimulator Device Implant (randomization procedures)
5. One Week Follow*up Visit
6. Six Week Follow*up Visit
7. Twelve Week Follow*up Visit
See Protocol pages 22 until 28 .
Study burden and risks
Participation in this study will not expose the subject to greater risks than if
he/she were receiving
InterStim Therapy outside of the study. There might be other discomforts and ris
ks related to InterStim Therapy and/
or this study that are not foreseen at this time. In addition, based on the amp
litude
settings, subjects may experience less than desired improvements in OAB symptoms
.
The risks associated with InterStim II System are minimized in this study by sel
ecting only qualified
Investigators experienced in InterStim Therapy, selecting an appropriate patient
population via
inclusion/exclusion screening, and monitoring subject progress and events report
ed 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.
Endepolsdomein 5
Maastricht 6229GW
NL
Endepolsdomein 5
Maastricht 6229GW
NL
Listed location countries
Age
Inclusion criteria
1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
2. Female subjects 18 years of age or older
3. Candidate for InterStim Lead Placement
4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)
5. Willing and able to provide signed and dated informed consent
6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication
Exclusion criteria
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. History of diabetes unless the diabetes is well-controlled through diet and/or medications
3. Symptomatic urinary tract infection (UTI)
4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
6. Implanted with a neurostimulator, pacemaker, or defibrillator
7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy
8. Women who are pregnant or planning to become pregnant
9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements
10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee)
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 |
|---|---|
| ClinicalTrials.gov | NCT03335761 |
| CCMO | NL63881.078.17 |