Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

NCT01047046 | Completed DMC

• 1 other identifier: 2008-6162
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

SNM device; Chart review of patients with surgical placed SNM device

Outcome Measures

Primary Outcomes (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.

  Retrospective chart review

Secondary Outcomes (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.

  Retrospective chart review

Study Arms (1)

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

Interventions

Retrospective chart review 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.

SNM device placement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Women's Healthcare

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Noblett, MD

  UCI Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 15, 2010

Record last verified: 2010-07

Locations

US (1)