Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047046
• Other study ID #: 2008-6162
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: July 13, 2010
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
United States	UCI Women's Healthcare	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No