Method of screening a patient for determining a therapy regimen

Abstract

A method for screening a patient suffering from a urinary dysfunction for determining whether a patient is a viable candidate for therapy through the use of a neurostimulator. The neurostimulator is placed on the patient's skin and is operationally activated to transmit electrical or magnetic signals to a target nerve during therapy sessions held over an assessment time interval. During the therapy sessions, the patient provides therapeutic responses to the electrical or magnetic signals during the therapy sessions. Based upon the patient's therapeutic responses a determination is made to either implant the neurostimulator in the patient's body or to perform an alternative procedure.

What is claimed is: 
     
         1 . A method of screening a patient to determine whether the patient is a viable candidate for therapy by the use of a neurostimulator configured for stimulating at least a first target nerve in the leg of the patient, comprising:
 (a) establishing a neurostimulator for emitting electrical or magnetic stimulation signals, said neurostimulator adapted to transcutaneously transmit said electrical or magnetic stimulation signals to to at least a saphenous nerve in the leg of said patient suffering from overactive bladder;   (b) positioning said neurostimulator on a skin surface during an assessment time interval during at least one set of therapy assessment sessions, said neurostimulator being positioned in proximity to said at least first target nerve;   (c) operationally activating said neurostimulator in accordance with at least a first stimulation protocol during said at least one set of therapy sessions to stimulate said saphenous nerve;   (d) obtaining a therapeutic response of said patient to said neurostimulator activation during said at least one set of therapy sessions;   (e) determining whether said patient therapeutic response is a positive or negative response to said neurostimulator activation during said at least one set of therapy sessions; and,   (f) prescribing either (1) implantation of said neurostimulator in the patient's body in the case of said positive response, or (2) the performance of an alternative step in the case of said negative response.   
     
     
         2 . The method as recited in  claim 1  wherein said positioning said neurostimulator includes placing said neurostimulator on said patient's skin surface of said patient at a location at or below a knee of said patient. 
     
     
         3 . The method as recited in  claim 1  wherein said assessment time interval is a time interval of at least three weeks and includes a plurality of therapy sessions. 
     
     
         4 . The method as recited in  claim 1  wherein said at least one therapy session is for assessing a treatment procedure for a patient suffering from said overactive bladder. 
     
     
         5 . The method as recited in  claim 1  wherein said performance of said alternative step includes providing an extended assessment interval and changing at least one stimulation parameter selected from the group of: a neurostimulator stimulation frequency, a neurostimulator location, a neurostimulation amplitude, a neurostimulator operational time schedule. 
     
     
         6 . The method as recited in  claim 1  wherein said performance of said alternative step includes selecting at least a second target nerve in said at least one therapy assessment session and operationally activating said neurostimulator to stimulate said at least first and second target nerves. 
     
     
         7 . The method as recited in  claim 1  wherein said assessment time interval is extended and encompasses an additional plurality of therapy sessions using a treatment assessment criterion subsequent to adjusting said at least first stimulation protocol. 
     
     
         8 . The method as recited in  claim 7  wherein said treatment assessment criterion is selected from the group of: assessment with respect to a predetermined treatment baseline, a change in a score derived from a patients bladder diary, or a quality of life instrument and combinations thereof. 
     
     
         9 . The method as recited in  claim 7  wherein said treatment assessment criterion is based on said patients ability to increase fluid intake without a worsening of symptoms during said assessment time interval. 
     
     
         10 . The method as recited in  claim 7  wherein said treatment assessment criterion is selected from a measure derived from prior to a first therapy session and selected from the group of: a change in symptom type experienced during or after initiation of said first therapy session, a change in symptom severity during or after initiation of said first therapy session, a change in said patients behavior after initiation of said first therapy session. 
     
     
         11 . The method of  claim 1  wherein a stimulation treatment lasts for 30 to 60 minutes per day. 
     
     
         12 . The method of  claim 1  wherein a stimulation treatment includes a selected number of stimulation treatments per day. 
     
     
         13 . The method of  claim 1  wherein a stimulation treatment includes a selected number of stimulation treatments per week. 
     
     
         14 . The method of  claim 1  wherein the at least a first assessment interval includes both an induction treatment protocol and a maintenance protocol for which stimulation is defined to occur less frequently than in the induction protocol. 
     
     
         15 . The method of  claim 1  wherein the stimulation protocol uses a stimulation frequency selected to be from 1-30 Hz.