Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

Use of Combined Anticholinergic Medication and Sacral Neuromodulation in the Treatment of Refractory Overactive Bladder

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: 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
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UCI Women's Healthcare

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Retrospective chart review

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Retrospective chart review

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Estimate): July 15, 2010
• Last Update Submitted That Met QC Criteria: July 13, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: SNM device; Chart review of patients with surgical placed SNM device
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 2008-6162