Non-invasive method to treat urological and gastrointestinal disorders
View Patent ↗Provided herein are methods and devices useful for inhibiting or treating urological conditions, such as overactive bladder (OAB) symptoms including bladder overactivity, urinary frequency, urinary urgency, urinary incontinence, interstitial cystitis (IC), urinary retention, and pelvic pain; gastrointestinal conditions, such as fecal incontinence, irritable bowel syndrome (IBS), and constipation; and sexual conditions, such as premature ejaculation, erectile disorder, and female sexual arousal disorder by non-invasive transcutaneous electrical stimulation of the foot.
1. A method of reducing a frequency of urination in a patient, comprising:
transcutaneously delivering pulsed electrical energy directly to a foot of the patient through a device comprising a plurality of electrodes placed on the skin of the patient's foot, the pulsed electrical energy comprising electrical pulses having a frequency ranging from 1 Hz to 500 Hz and a voltage ranging from 1 V to 50 V, the electrical pulses configured to inhibit bladder contractions in the patient and to increase a micturition volume threshold in the patient's bladder, wherein the electrodes are arranged such that:
two or more electrodes are in contact with the skin on a dorsal surface of the patient's foot, and at least two of the electrodes have opposite polarities;
two or more electrodes are in contact with the skin on a plantar surface of the patient's foot, and at least two of the electrodes have opposite polarities; or
at least one electrode is in contact with the skin on the dorsal surface of the patient's foot and at least one electrode is in contact with the skin on the plantar surface of the patient's foot, and at least one electrode in contact with the skin on the dorsal surface of the patient's foot has an opposite polarity from at least one electrode in contact with the skin on the plantar surface of the patient's foot.
2. The method of claim 1 , wherein the electrical pulses are applied by one or more surface electrodes on skin of the dorsal side of the foot about one or more metatarsal bones and one or more surface electrodes of opposite polarity on skin of the plantar side of the foot about one or more metatarsal bones.
3. The method of claim 1 , wherein the electrical pulses are applied by one or more surface electrodes on skin of the dorsal side of the foot about one or more metatarsal bones and one or more surface electrodes of opposite polarity on skin of the dorsal side of the foot about one or more of the talus, cuboid, intermediate cuneiform, lateral cuneiform or navicular bones.
4. The method of claim 1 , wherein the electrical pulses are applied by one or more surface electrodes on skin of the plantar side of the foot about one or more metatarsal bones and one or more surface electrodes of opposite polarity on skin of the plantar side of the foot about the calcaneous bone.
5. The method of claim 1 , in which the pulses are biphasic.
6. The method of claim 5 , in which the pulses are symmetrical.
7. The method of claim 5 , in which the pulses are square or rectangular.
8. The method of claim 5 , in which the pulses are charge balanced.
9. The method of claim 1 , wherein the pulses are applied in two or more stimulation intervals of from 0.5 to 200 seconds with a rest period of no electrical stimulation able to inhibit bladder or rectal contractions between stimulation intervals.
10. The method of claim 1 , in which the pulses are applied at a voltage less than an intensity threshold to induce toe movement (T) in a patient.
11. The method of claim 1 , in which the electrical pulses are applied by electrodes in a garment electrode.
12. The method of claim 1 , in which the pulse frequency ranges from 1 to 50 Hz.
13. The method of claim 1 , in which the pulse frequency ranges from 5 to 20 Hz.
14. The method of claim 1 , in which the pulse frequency is approximately 5 Hz.
15. The method of claim 1 , in which the voltage ranges from 3V to 12V.
16. The method of claim 1 , in which the voltage ranges from 0.5 T to 4 T, where T is a toe-twitch threshold of the patient.
17. The method of claim 1 , in which the duration of pulses ranges from 0.1 to 3 ms.
18. The method of claim 1 , in which the duration of pulses ranges from 0.2 to 1 ms.
19. The method of claim 1 , in which the duration of pulses is approximately 1 ms.
20. The method of claim 1 , wherein the electrical pulses are configured to increase the micturition volume threshold by at least about 35%.
21. The method of claim 20 , wherein the electrical pulses are configured to increase the micturition volume threshold by at least about 53.2%.
22. The method of claim 1 , wherein the electrical pulses are configured to increase the micturition volume threshold by at least about 23%.
23. The method of claim 22 wherein the electrical pulses are configured to increase the micturition volume threshold by at least about 37%.
24. The method of claim 1 , wherein the electrical pulses have a frequency of about 20 hz.
25. The method of claim 1 , wherein the electrical pulses are configured to inhibit large amplitude rhythmic bladder contractions.
26. The method of claim 25 , wherein the electrical pulses are configured to inhibit the large amplitude rhythmic bladder contractions for a period greater than zero minutes and up to about ten minutes.
27. The method of claim 26 , wherein the electrical pulses have a frequency of about 5 hz.
28. A method of reducing a frequency of urination in a patient, comprising:
transcutaneously delivering pulsed electrical energy directly to a foot of the patient through a device, the device comprising:
an electrode assembly comprising a plurality of inward facing electrodes, the assembly configured such that one or more of the electrodes contacts the skin of the patient on a plantar surface of the patient's foot and/or one or more of the electrodes contacts the skin of the patient on the dorsal surface of the patient's foot, wherein at least one of the electrodes has a first polarity and another of the electrodes has an opposite polarity,
wherein the pulsed electrical energy comprises electrical pulses having a frequency ranging from 1 Hz to 500 Hz and a voltage ranging from 1 V to 50 V, the electrical pulses configured to inhibit bladder contractions in the patient and to increase a micturition volume threshold in the patient's bladder.