- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01933074
Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19102
- Pelvic and Sexual Health Insitute
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion criteria: Age > 18, urinary urgency (at least mild bother on a single item Urgency Scale), and negative urine dipstick on clean catch.
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Exclusion Criteria:: Urinary incontinence (greater than mild on the Incontinence Severity Index), recent (<6week) urinary tract infection, active or recent(<3month) nephrolithiasis, prior diagnosis of congenital urinary tract abnormality, known neurological disorder (multiple sclerosis, Parkinson's, spina bifid, spinal cord injury), recent pregnancy < 3 months, prior sacral nerve stimulation or Botox injection.
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Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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To determine the association between the severity of neuropathic pain and the severity of urinary symptoms in women with urinary urgency.
Tidsram: 1 year
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We propose a prospective cross-sectional study.
We will recruit 137 women with urinary urgency and without incontinence or infection.
All women will complete validated symptom questionnaires to measure neuropathic pain, urinary, bowel, sexual symptoms and quality of life.
All patients will bring a first morning clean catch urine void to the office on ice within one week of completing the questionnaires.
The specimen will be transported to the lab within 24 hours and stored at -80 degrees.
Enzyme-linked immunosorbent assays (ELISA) will be used to determine expression of urinary creatinine and neuropeptides.
The primary outcome will be the severity of urinary symptoms as measured by the Interstitial Cystitis Symptom Index.
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1 year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The association between neuropathic pain and the expression of potential neural biomarkers in the urine of women with urinary urgency.
Tidsram: 1 year
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To determine the association between the severity of neuropathic pain and expression of urinary neurotrophic peptides in women with urgency.
We hypothesize that in women with urinary urgency, increasing severity of neuropathic pain will be associated with increasing levels of urinary neurotrophic peptides NGF and BDNF.
Nerve growth factor (NGF) and Brain-Derived Neurotrophic factor (BDNF) - NGF and BDNF are neurotrophic growth factors that are released in urine from different cell types in the bladder wall making urine a convenient sample for measurement of their levels.
Activation of the myelinated A fiber and unmyelinated C fibers in the bladder wall can lead to an elevation in NGF and BDNF levels, sensitization of bladder afferent pathways and development of neurogenic inflammation in the urinary bladder [2,3].
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1 year
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Uduak Umoh-Andy, MD, University of Pennsylvania
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 817047
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