Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

Completed

• Conditions: Overactive Bladder
• Interventions: Other: Retrospective chart review

• Registration Number: NCT01047046
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-13
• Last Update Posted: 2010-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SNM device placement	Retrospective chart review	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UCI Women's Healthcare; 🇺🇸 Orange, California, United States