Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

NCT ID: NCT01047046

Last Updated: 2010-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Retrospective chart review

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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UC Irvine Medical Center

Principal Investigators

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Karen Noblett, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Medical Center

Locations

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UCI Women's Healthcare

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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2008-6162

Identifier Type: -

Identifier Source: org_study_id

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