Neuromodulation Implantation Settings Variation for Overactive Bladder

NCT ID: NCT02112786

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator

Intervention Type: DEVICE

This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.

Continuous Then Intermitent

This group will be set to continuous stimulation first, then switch to intermittent after the wash out time period.

Group Type: ACTIVE_COMPARATOR

Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator

Intervention Type: DEVICE

This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

RestorePrime Implanted Impulse Generator

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Staack, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Loma LindaUniversity Medical Center

Locations

Loma Linda University Faculty Medical Offices

Loma Linda, California, United States

Countries

United States

References

Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T. Costs of urinary incontinence and overactive bladder in the United States: a comparative study. Urology. 2004 Mar;63(3):461-5. doi: 10.1016/j.urology.2003.10.037.

Reference Type: BACKGROUND

PMID: 15028438 (View on PubMed)

Nitti VW. Clinical impact of overactive bladder. Rev Urol. 2002;4 Suppl 4(Suppl 4):S2-6.

Reference Type: BACKGROUND

PMID: 16986018 (View on PubMed)

Other Identifiers

SUFU

Identifier Type: OTHER

Identifier Source: secondary_id

STIM-1

Identifier Type: -

Identifier Source: org_study_id