Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Direct Full-stage Implantation of Sacral Neuromodulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697954
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Staack, Loma Linda University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Direct Full-stage Implantation of Sacral Neuromodulation
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Improvement in overactive bladder symptoms [ Time Frame: 1 year ]
    measured using overactive bladder questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, California
Loma Linda University Faculty Medical Offices
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Layout table for additonal information
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: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence, Urge
Urinary Bladder, Overactive
Urinary Incontinence
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases