Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

Neurogenic Bladder Clinical Trial

— TTNS-RCT  

Official title:

Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074616
• Other study ID #: HSC-MS-19-0518
• Secondary ID: KL2TR003168
• Status: Completed
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: April 20, 2023

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Traumatic and non-traumatic SCI performing IC
• Up to 2 anticholinergic overactive bladder (OAB) medications
• No changes in OAB medications
• Neurologic level of injury above T10
• English and Spanish speaking

Exclusion Criteria:

• Past history of genitourinary diagnoses or surgeries
• History of central nervous system (CNS) disorders and/or peripheral neuropathy
• Pregnancy
• Lower motor neuron bladder
• Concern for tibial nerve pathway injury
• Absence of toe flexion or AD with electric stimulation
• Bladder chemodenervation in past 6 months
• Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis

Related Conditions & MeSH terms

• Chronic Spinal Cord Injury
• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

Device:
• High Dose
Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks,with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
• Low dose
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (27)

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Canbaz Kabay S, Kabay S, Mestan E, Cetiner M, Ayas S, Sevim M, Ozden H, Karaman HO. Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results. Neurourol Urodyn. 2017 Jan;36(1):104-110. doi: 10.1002/nau.22868. Epub 2015 Sep 9. — View Citation

Chaabane W, Guillotreau J, Castel-Lacanal E, Abu-Anz S, De Boissezon X, Malavaud B, Marque P, Sarramon JP, Rischmann P, Game X. Sacral neuromodulation for treating neurogenic bladder dysfunction: clinical and urodynamic study. Neurourol Urodyn. 2011 Apr;30(4):547-50. doi: 10.1002/nau.21009. — View Citation

Chen G, Liao L, Li Y. The possible role of percutaneous tibial nerve stimulation using adhesive skin surface electrodes in patients with neurogenic detrusor overactivity secondary to spinal cord injury. Int Urol Nephrol. 2015 Mar;47(3):451-5. doi: 10.1007/s11255-015-0911-6. Epub 2015 Jan 22. — View Citation

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Sirls ER, Killinger KA, Boura JA, Peters KM. Percutaneous Tibial Nerve Stimulation in the Office Setting: Real-world Experience of Over 100 Patients. Urology. 2018 Mar;113:34-39. doi: 10.1016/j.urology.2017.11.026. Epub 2017 Nov 28. — View Citation

Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019. — View Citation

Stampas A, Korupolu R, Zhu L, Smith CP, Gustafson K. Safety, Feasibility, and Efficacy of Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury Neurogenic Bladder: A Randomized Control Pilot Trial. Neuromodulation. 2019 Aug;22(6):716-722. doi: 10.1111/ner.12855. Epub 2018 Oct 3. — View Citation

Stampas A, Tansey KE. Spinal cord injury medicine and rehabilitation. Semin Neurol. 2014 Nov;34(5):524-33. doi: 10.1055/s-0034-1396006. Epub 2014 Dec 17. — View Citation

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Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21. — View Citation

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Welk B, Carlson K, Baverstock R. A pilot study of the responsiveness of the Neurogenic Bladder Symptom Score (NBSS). Can Urol Assoc J. 2017 Dec;11(12):376-378. doi: 10.5489/cuaj.4833. Epub 2017 Nov 1. No abstract available. — View Citation

Welk B, Lenherr S, Elliott S, Stoffel J, Presson AP, Zhang C, Myers JB. The Neurogenic Bladder Symptom Score (NBSS): a secondary assessment of its validity, reliability among people with a spinal cord injury. Spinal Cord. 2018 Mar;56(3):259-264. doi: 10.1038/s41393-017-0028-0. Epub 2017 Nov 29. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with reduction in bladder medication		3 months after subject enrollment
Primary	Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the neurogenic bladder symptom score (NBSS)scale.	The NBSS scale consists of 24 questions each with a score ranging form 0-4.Higher the score indicates a worse outcome.	3 months after subject enrollment
Primary	Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the voiding dairy		3 months after subject enrollment
Secondary	Number of participants with improved quality of life as assessed by the I-QOL questionnaire		3 months after subject enrollment
Secondary	Number of participants with decreased anticholinergic side effects as measured by the anticholinergic side effects survey		3 months after subject enrollment
Secondary	Number of participants with stable or improved bladder capacity as assessed by the urodynamic study	urodynamic study	At baseline and 3 month after subject enrollment