Device for Bladder Control for Men With SCI
Noninvasive Electrical Stimulation Device to Improve Bladder Control for Men With Spinal Core Injury
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Restoring bladder control is considered a high priority, but remains a critically unmet need requiring further development. The long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder control for individuals with OAB or NDO. Electrical stimulation of the genital nerves inhibits the spinal neural circuits involved in hyper-reflexive bladder spasms.
Genital nerve stimulation (GNS) has been used by multiple groups to inhibit reflexive OAB and neurogenic bladder contractions during acute (1 visit) urodynamic testing and limited chronic take-home testing. The investigators have recently demonstrated that surface GNS inhibits reflexive bladder contractions and reduces incontinence in individuals with SCI during one month of home use using a limited stimulation system. Participant feedback from these studies identified a number of stimulation system issues that created nontrivial inconveniences, which affected activities of daily living and prevented some participants from participating in the study. Required improvements include, but are not limited to better electrode interface, elimination of wired connections, and a smaller device.
The purposes of this proposal are to 1) develop and prototype a device for bladder control for men using GNS and 2) determine the acute effect of GNS on bladder capacity using this new prototype device. This work is building on previous success prototyping a similar device for women with OAB or NDO, which is being developed in other projects. The success of this study will be used to conduct a multi-site study of GNS and lead to clinical implementation.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Dennis Bourbeau, PhD
- Telefonnummer: 4845 (216) 791-3800
- E-mail: Dennis.Bourbeau@va.gov
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106-1702
- Louis Stokes VA Medical Center, Cleveland, OH
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Ledende efterforsker:
- Dennis Bourbeau, PhD
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Kontakt:
- Curtis J Donskey, MD
- Telefonnummer: 4788 (216) 791-3800
- E-mail: curtis.donskey@va.gov
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Suprasacral SCI
- Neurologically stable
- Skeletally mature
- Presence of reflex bladder contractions
- At least 12 months post SCI
Exclusion Criteria:
- Active sepsis
- Open pressure sores on or around pelvis
- Bleeding diathesis
- Significant urethral trauma, erosion, or stricture
- Indwelling catheter for over 1 year AND bladder capacity less than 100 mL
- Significant history of autonomic dysreflexia
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Genital Nerve Stimulation
Study participants will don the device at the beginning of the experiment session.
An initial clinical urodynamics test will be performed to confirm that the participant has neurogenic bladder.
The investigators will select stimulation parameters that effectively inhibit reflexive bladder contractions.
Serial cystometrograms will then be conducted.
Each fill will be conducted either 1) without stimulation (control runs) or 2) with stimulation.
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Genital nerve stimulation (GNS) will be applied using a wearable, transcutaneous neurostimulator and sleeve electrode that targets the genital nerve reflex pathway for the treatment of neurogenic bladder associated with spinal cord injury.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Bladder Capacity
Tidsramme: Day 1
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Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study.
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Day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Usability Metrics
Tidsramme: Day 1
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Study participants will be surveyed regarding device design and usability prior to device usage.
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Day 1
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Electrical Impedance
Tidsramme: Day 1
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The Gravata's electrode to skin contact will be assessed through measuring electrical impedance of the device to confirm adherence to out benchmark (less than 4 kOhms)
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Day 1
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Dennis Bourbeau, PhD, Louis Stokes VA Medical Center, Cleveland, OH
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Neurologiske manifestationer
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Sår og skader
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Traumer, nervesystemet
- Urinblæresygdomme
- Rygmarvssygdomme
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Rygmarvsskader
- Urinblære, neurogen
Andre undersøgelses-id-numre
- RRD5-001-25W
- IU1RD000568-01A2 (Andet bevillings-/finansieringsnummer: VA ORD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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