Direct Full-stage Implantation of Sacral Neuromodulation

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ClinicalTrials.gov Identifier: NCT03697954

Recruitment Status : Withdrawn (Work has already been published by other groups)

First Posted : October 5, 2018

Last Update Posted : October 14, 2020

Sponsor:

Information provided by (Responsible Party):

Andrea Staack, Loma Linda University

Study Description

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.

Condition or disease	Intervention/treatment
Urinary Bladder, Overactive Urge Incontinence	Device: full stage implantation of sacral neuromodulation

Study Design

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Study Type :	Observational
Actual Enrollment :	0 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Direct Full-stage Implantation of Sacral Neuromodulation
Estimated Study Start Date :	May 2021
Estimated Primary Completion Date :	December 2022
Estimated Study Completion Date :	December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Overactive Bladder

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697954

Locations

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

Sponsors and Collaborators

Loma Linda University

More Information

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.

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.

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.

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Responsible Party:	Andrea Staack, MD PhD, Loma Linda University
ClinicalTrials.gov Identifier:	NCT03697954
Other Study ID Numbers:	5180114
First Posted:	October 5, 2018 Key Record Dates
Last Update Posted:	October 14, 2020
Last Verified:	October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Additional relevant MeSH terms:

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Urinary Incontinence, Urge Urinary Bladder, Overactive Urinary Incontinence Urination Disorders	Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Urinary Bladder Diseases

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