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Completed

NCT Number: NCT01047046

Combined Anticholinergic Medication and Sacral Neuromodulation to Treat 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UCI Women's Healthcare

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 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.

    Time frame: Retrospective chart review

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2010
Registry last updated
Jul 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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