NCT02112786

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

Same day

First QC Date

April 9, 2014

Last Update Submit

January 22, 2015

Conditions

Overactive Bladder

Keywords

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Overactive Bladder Symptoms

    Symptom improvement with be tracked for overactive bladder symptoms through voiding logs and questionnaires.

    Week 0, 2, 12, 13, 15, 25

Secondary Outcomes (1)

  • Battery Life

    Week 0, 1, 12, 13, 15, 25

Study Arms (2)

Intermittent then Continuous

ACTIVE COMPARATOR

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

Continuous Then Intermitent

ACTIVE COMPARATOR

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

Interventions

Intermittent or Continuous Setting RestorePrime Implanted Impulse GeneratorDEVICE

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

Also known as: RestorePrime Implanted Impulse Generator
Continuous Then IntermitentIntermittent then Continuous

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Faculty Medical Offices

Loma Linda, California, 92354, United States

Location

Related Publications (2)

  • 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.

    PMID: 15028438BACKGROUND

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

    PMID: 16986018BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea Staack, MD, Phd

    Loma LindaUniversity Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 14, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

US(1)