Direct Full-stage Implantation of Sacral Neuromodulation

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Andrea Staack，Loma Linda University

Tracking Information

First Submitted Date ^ICMJE

October 4, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

November 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement in overactive bladder symptoms[ Time Frame: 1 year ]

measured using overactive bladder questionnaire

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Direct Full-stage Implantation of Sacral Neuromodulation

Official Title ^ICMJE

Direct Full-stage Implantation of Sacral Neuromodulation

Brief Summary

The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Device: full stage implantation of sacral neuromodulation
full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence

Study Arms

: overactive bladder patients
Female patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 2019

Estimated Primary Completion Date

November 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Patients >18 years of age - Female gender - Refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents - Willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative) - Willing and able to complete study questionnaires, use Medtronic device programmer, return for scheduled follow-up appointments - Surgical candidate able to hold antiplatelet or anticoagulation prior to surgery - Health insurance provider that will cover full-stage implantation Exclusion Criteria: - Age <18 - Pregnant or planning to become pregnant - Male gender - Unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period - Treatment with botulinum toxin within last 6 months - Recent surgery for stress urinary incontinence or pelvic organ prolapse within last 6 months - Severe pelvic organ prolapse - Post-void residual >150 ml - Symptomatic or recurrent urinary tract infection - Neurologic disorders: cerebrovascular accident with neurologic deficits, Parkinson's, multiple sclerosis, spinal cord injury, significant peripheral neuropathy - Cognitive disorders, e.g. dementia - Interstitial cystitis or chronic pelvic pain syndrome - Poorly controlled diabetes mellitus (HbA1c >10%) - History of bladder malignancy, pelvic radiation, urinary retention requiring catheterization - Anticipated or known need for MRI at the trunk - History of or anticipated surgery at the lower back - Unable to hold antiplatelet or anticoagulation prior to surgery - Life expectancy <1 year

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Andrea Staack，Loma Linda University

Study Sponsor ^ICMJE

Loma Linda University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Loma Linda University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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