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Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

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ClinicalTrials.gov Identifier: NCT01047046
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : July 15, 2010
Sponsor:
Information provided by:
University of California, Irvine

Brief Summary:
This study is a retrospective chart review including all patients who received surgical placement of a SNM device with Dr. Noblett from 2001 to the present.

Condition or disease Intervention/treatment
Overactive Bladder Other: Retrospective chart review

Detailed Description:
The following data will be collected from patient charts: age at time of surgery, gravidity/parity, body mass index, pre-existing medical conditions/surgical history, current medications, menopausal status, form and severity of OAB symptoms, other previously or currently used interventions, method of SNM device placement, observed motor/sensory response, percent improvement of symptoms, follow-up OAB symptoms, frequency of InterStim settings adjustments, adverse events, significant changes in health, and incidence/reason for drop out.

Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Combined Anticholinergic Medication and Sacral Neuromodulation in the Treatment of Refractory Overactive Bladder
Study Start Date : January 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

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U.S. FDA Resources

Group/Cohort Intervention/treatment
SNM device placement
Patients who have undergone a placement of a SNM device to treat refractory OAB. A retrospective chart review will be performed on all patients who underwent a one or two-stage placement of an SNM device, which includes an implantable pulse generator (IPG), for refractory urge incontinence and urgency frequency symptoms. The patients will be those of Dr. Karen Noblett, having their device placed after 2001.
Other: Retrospective chart review

This study is a retrospective chart review including all patients who received surgical placement of a SNM device with Dr. Noblett from 2001 to the present.

The following data will be collected from patient charts: age at time of surgery, gravidity/parity, body mass index, pre-existing medical conditions/surgical history, current medications, menopausal status, form and severity of OAB symptoms, other previously or currently used interventions, method of SNM device placement, observed motor/sensory response, percent improvement of symptoms, follow-up OAB symptoms, frequency of InterStim settings adjustments, adverse events, significant changes in health, and incidence/reason for drop out.




Primary Outcome Measures :
  1. Prevalence of combined therapy - determine the nmbr of pts on anticholinergic medication to treat symptoms of OAB after placement of SNM device, examine outcomes and defining characteristics of these pts compared to those not receiving anticholinergics. [ Time Frame: Retrospective chart review ]

Secondary Outcome Measures :
  1. Predictors of SNM therapy success - collect data factors; previously trialed conservative therapies, age, and severity of urinary symptoms, and examine for a correlation with urinary symptom resolution with either SNM therapy or combined therapy. [ Time Frame: Retrospective chart review ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone a placement of a SNM device to treat refractory OAB. A retrospective chart review will be performed on all patients who underwent a one or two-stage placement of an SNM device, which includes an implantable pulse generator (IPG), for refractory urge incontinence and urgency frequency symptoms. The patients will be those of Dr. Karen Noblett, having their device placed after 2001.
Criteria

Inclusion Criteria:

  • Female patients with symptoms of OAB, namely urge incontinence and urgency-frequency.
  • Ages 18 and older.

Exclusion Criteria:

  • Any patient who received surgical placement of an SNM device to treat non-obstructive urinary retention, or the symptoms of an underlying neurologic pathology, such as Parkinson's or Multiple Sclerosis.

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): NCT01047046


Locations
United States, California
UCI Women's Healthcare
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen Noblett, MD UCI Medical Center

Responsible Party: Karen Noblett, MD, UC Irvine Medical Center
ClinicalTrials.gov Identifier: NCT01047046     History of Changes
Other Study ID Numbers: 2008-6162
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: July 2010

Keywords provided by University of California, Irvine:
SNM device
Chart review of patients with surgical placed SNM device

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs