Neuromodulation Implantation Settings Variation for Overactive Bladder

January 22, 2015 updated by: Loma Linda University

Intermittent Versus Continuous Stimulation in Bilateral Sacral Neuromodulation for Overactive Bladder

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Faculty Medical Offices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • RestorePrime Implanted Impulse Generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Symptoms
Time Frame: Week 0, 2, 12, 13, 15, 25
Symptom improvement with be tracked for overactive bladder symptoms through voiding logs and questionnaires.
Week 0, 2, 12, 13, 15, 25

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Battery Life
Time Frame: Week 0, 1, 12, 13, 15, 25
Battery life of the implanted device will be interrogated at each follow up visit to measure longevity of battery.
Week 0, 1, 12, 13, 15, 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Andrea Staack, MD, Phd, Loma LindaUniversity Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STIM-1
  • SUFU (Other Identifier: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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