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Combined Anticholinergic Medication and Sacral Neuromodulation to Treat Refractory Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01047046
First received: January 8, 2010
Last updated: July 13, 2010
Last verified: July 2010

January 8, 2010
July 13, 2010
January 2008
December 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: Retrospective chart review ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01047046 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Retrospective chart review ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

Overactive Bladder
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.

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.
Intervention: Other: Retrospective chart review
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01047046
2008-6162
Yes
Karen Noblett, MD, UC Irvine Medical Center
University of California, Irvine
Not Provided
Principal Investigator: Karen Noblett, MD UCI Medical Center
University of California, Irvine
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP