Direct Full-stage Implantation of Sacral Neuromodulation

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.

Study Overview

• Status: Withdrawn
• Conditions: Urinary Bladder, Overactive; Urge Incontinence
• Intervention / Treatment: Device: full stage implantation of sacral neuromodulation

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
overactive bladder patients; Female patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation	Device: full stage implantation of sacral neuromodulation; full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in overactive bladder symptoms	measured using overactive bladder questionnaire	1 year

Collaborators and Investigators

• Sponsor: Loma Linda University

Publications and helpful links

General Publications

• Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.
• Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.079. Epub 2012 Oct 24.
• Ganz ML, Smalarz AM, Krupski TL, Anger JT, Hu JC, Wittrup-Jensen KU, Pashos CL. Economic costs of overactive bladder in the United States. Urology. 2010 Mar;75(3):526-32, 532.e1-18. doi: 10.1016/j.urology.2009.06.096. Epub 2009 Dec 29.
• Coyne KS, Sexton CC, Irwin DE, Kopp ZS, Kelleher CJ, Milsom I. The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well-being in men and women: results from the EPIC study. BJU Int. 2008 Jun;101(11):1388-95. doi: 10.1111/j.1464-410X.2008.07601.x.
• Latini JM, Alipour M, Kreder KJ Jr. Efficacy of sacral neuromodulation for symptomatic treatment of refractory urinary urge incontinence. Urology. 2006 Mar;67(3):550-3; discussion 553-4. doi: 10.1016/j.urology.2005.09.066.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: 5180114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes