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Neuromodulation Implantation Settings Variation for Overactive Bladder

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT02112786
First received: April 9, 2014
Last updated: January 22, 2015
Last verified: January 2015
History of Changes
  Purpose

Participants receiving neuromodulation treatment for overactive bladder symptoms will be routinely fitted with an impulse generator. However, the setting on the impulse generator will be set to either intermittent or continuous stimulation. Participants will complete voiding logs and surveys for a month. Battery life will be interrogated.After a one week period were the device is turned off, the impulse generator will be turned to the opposite setting (intermittent or continuous) and the one month period will be repeated. Again, voiding logs, surveys, and battery life will be collected.

The purpose of this project is to investigate the outcomes of intermittent versus continuous stimulation in patients treated with sacral neuromodulation (SNM) for refractory overactive bladder (OAB) syndrome. In addition, the potential for an improved battery life with intermittent stimulation will be quantified.


Condition Intervention
Overactive Bladder
 Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intermittent Versus Continuous Stimulation in Bilateral Sacral Neuromodulation for Overactive Bladder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Overactive Bladder Symptoms [ Time Frame: Week 0, 2, 12, 13, 15, 25 ] [ Designated as safety issue: No ]
    Symptom improvement with be tracked for overactive bladder symptoms through voiding logs and questionnaires.


Secondary Outcome Measures:
  • Battery Life [ Time Frame: Week 0, 1, 12, 13, 15, 25 ] [ Designated as safety issue: No ]
    Battery life of the implanted device will be interrogated at each follow up visit to measure longevity of battery.
Enrollment: 0
Study Start Date: January 2015
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intermittent then Continuous
This group will be set to intermittent stimulation first, then after the wash out period they will be switched to continuous stimulation.
 Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.
Other Name: RestorePrime Implanted Impulse Generator
Active Comparator: Continuous Then Intermitent
This group will be set to continuous stimulation first, then switch to intermittent after the wash out time period.
 Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.
Other Name: RestorePrime Implanted Impulse Generator

Detailed Description:

The objective of this project is to investigate the outcomes of intermittent versus continuous stimulation in patients treated with sacral neuromodulation (SNM) for refractory overactive bladder (OAB) syndrome. In addition, the potential for an improved battery life with intermittent stimulation will be quantified. Manufacturers recommended settings for newly implanted impulse generators (IPG); however, no standardized recommendations exist for further adjustments. Quality studies examining IPG parameters are lacking, partly due to the numerous setting variables, which can result in a multitude of permutations. When programming an IPG, an option for cycling simulation (16 seconds on, 8 seconds off) is available. It is theorized that because of a "carryover" effect, symptom relief will continue despite the stimulator being off. The potential benefit of the intermittent stimulation is an improved battery life, which may translate into a less frequent need for reimplantation with less morbidity. Participants receiving neuromodulation treatment for overactive bladder symptoms will be routinely fitted with an impulse generator in a pre-study phase. Patients who experience significant symptomatic improvement will receive a full bilateral sacral neuromodulator implantation and will be randomized to either intermittent or continuous stimulation. Participants will fill out voiding logs and surveys over a 12 week period. At that point, a one-week washout period during which the neuromodulator will be turned off. The impulse generator will then be turned to the alternate setting (intermittent or continuous) and the 12 week period will be repeated. Questionnaires and voiding diaries will be collected at each clinic visit. In total, subject participation will last approximately 25 weeks after full implantation of the bilateral leads and pulse generator.

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • patients age 18 to 85 with overactive bladder symptoms refractory to behavioral and anticholinergic therapy, detrusor overactivity on urodynamic study, surgically fit with ability to complete study forms, use patient programmer, and return for follow-up.

Patients must have attempted and failed noninvasive therapy for overactive bladder symptoms for at least 6 months prior to enrollment; previous treatments will be recorded. In addition, patients must be fluent in the English language to complete informed consent paperwork and study questionnaires.

Exclusion criteria:

  • dementia,
  • neurological conditions (spinal cord injury, multiple sclerosis),
  • non-English speaking,
  • acute urinary tract infection,
  • primary pelvic pain,
  • pregnancy or breast-feeding,
  • urinary retention (postvoid residual greater than 100mL),
  • history of bladder cancer in the past 5 years,
  • history of nephrolithiasis or ureterolithiasis,
  • anticoagulant therapy,
  • implanted pacemaker/defibrillator, or
  • anticipated need for future MRI.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112786

Locations
United States, California
Loma Linda University Faculty Medical Offices
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Andrea Staack, MD, Phd Loma LindaUniversity Medical Center
  More Information

Publications:

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT02112786     History of Changes
Other Study ID Numbers: STIM-1, SUFU
Study First Received: April 9, 2014
Last Updated: January 22, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Loma Linda University:
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
 Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on March 03, 2015