- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02299544
BlueWind Medical System for the Treatment of Patients With OAB (OAB)
Safety and Performance of the BlueWind System for the Treatment of Patients With Overactive Bladder (OAB) Amended to Allow Extended Follow up of the Patients
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Eindhoven, Nederland
- Catharina Ziekenhuis
-
Maastricht, Nederland
- Maastricht UMC
-
Nijmegen, Nederland
- Radboud university medical center Department of Urology
-
-
-
-
-
Bristol, Storbritannia
- Southmead Hosital
-
London, Storbritannia
- College Hospital and National Hospital for Neurology and Neurosurgery
-
London, Storbritannia
- St. Mary's Hospital, Imperial College
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Signed written informed consent.
- Male or female aged 18 - 80.
- Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
- Patients with overactive bladder symptoms:
- Urinary frequency greater than 8 times/24 hours AND/OR Urinary urgency leaks of at least 2 leaks on 3 day voiding diary
- Patient who has failed conservative treatment after at least 6 months of treatment
- Patients with normally functioning upper urinary tract.
- Patients with no clinical evidence of a neurological S2-S4 motor sensory deficit.
- Prior PTNS Group: Patients who have had successful PTNS treatment (successful treatment is defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review).
- De novo Patient Group: Patient who passes the BlueWind compatibility test.
Exclusion Criteria:
- Any metal implant in the area of BlueWind Medical implantation site.
- Patients who have not had stable OAB medications for at least 30 days.
- Patients who have received botulinum toxin injections within the past 6 months.
- Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months.
- Any spinal or genitourinary surgery within the last 6 months. Pelvic pain disorders
- Obvious clinically demonstrated genuine stress incontinence.
- Any neurological disease or disorder including neuropathy or injury resulting in neuropathy.
- Current urinary tract infection, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, vesicourethral reflux, etc.)
- Pelvic radiotherapy and chemotherapy.
- Severe uncontrolled diabetes.
- Patients anticipating magnetic resonance imaging (MRI) exams.
- Presence of cystocele, enterocele or rectocele of grade 3 or 4.
- Prior PTNS Group: Patients who are receiving concomitant nerve stimulation therapies for OAB treatment, except for PTNS maintenance therapy.
- De novo Patient Group: Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including PTNS.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: OAB
Patients with overactive bladder (OAB) with or without urge incontinence. Two patient populations will be enrolled in the study: Patients with no previous treatment with percutaneous tibial nerve stimulation (PTNS) [de novo patient group] and Patients with a documented success on PTNS therapy [prior-PTNS group]. Documented success on PTNS is defined by a ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review. All patients will be treated with BlueWind Medical System. |
The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence of serious adverse events
Tidsramme: 6 months
|
Incidence of serious adverse events system and or procedure related
|
6 months
|
Incidence of serious adverse events (amended)
Tidsramme: 36 months
|
Incidence of serious adverse events system and or procedure related (amended)
|
36 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: John Heesakkers, MD, Principal Investigator
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CP-03-001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på BlueWind Medical system
-
Acutus MedicalFullført
-
Aspire MedicalFullførtSøvnapné, obstruktivBelgia, Tsjekkisk Republikk, Tyskland
-
Cardiovascular and Interventional Radiological...Shockwave Medical, Inc.Har ikke rekruttert ennåKronisk lemmer-truende ischemi
-
Acutus MedicalFullført
-
Aspire MedicalUkjentSøvnapné, obstruktivForente stater
-
Shockwave Medical, Inc.RekrutteringKoronararteriesykdomForente stater, Spania, Frankrike, Tyskland
-
Saluda Medical Pty LtdFullført
-
Carré Technologies Inc.Rekruttering
-
Columbia UniversityRekrutteringVenstre fremre nedadgående koronararteriestenoseForente stater
-
Apnex Medical, Inc.AvsluttetObstruktiv søvnapnéForente stater, Australia