Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Faecal incontinence is a devastating condition with huge impact on quality of life. Sacral Nerve Stimulation (SNS) has since 1995 been a treatment option for patients not obtaining satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described.
Standard the neuromodulator (pacemaker) stimulate with Frequency 14 Hz, pulse width 210 mic.sec. and amplitude set at sensory threshold. One study by SM. Koch et all confirms that subsensory stimulation can be effective. At present there is no doubled blinded study's to confirm this theory of effective sub sensory stimulation.
The aim of this study is to determine if subsensory stimulation will be as effective as stimulation with amplitude at sensory threshold. This will be investigated in 20 patients who have had at least a reduction in incontinence episodes or Wexner inc. score of 75 % between preimplantation and latest follow up. The patients will be randomized to three different amplitudes. 1: amplitude set at sensory threshold. 2: 75% of sensory threshold. 3: 50% of sensory threshold. The order of the three settings will be random and in a double blinded manner. The interval between these three pacemaker settings is four weeks. Patients serve as there own controls. Stimulation frequency (14 Hz) and pulse width (210 mic-sec) will remain fixed.
Evaluation will be by means of 4 week bowel habit diary and questionnaires (Wexner inc. score / St. Marks Score / Wexner constipation score / Altomares OD-score / IBS-score/ Rockwood FIQoL -score). All patients will be evaluated with anorectal measurements (sphincter strength and anorectal volume measurements) before any changes of stimulation amplitude.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Aarhus C
-
Aarhus, Aarhus C, Danimarca, 8000
- Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18 years or older
- Informed consent
- Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
- fecal incontinence after primary/secondary sphincter repair
- Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
- Reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(Bowel diary card) or 75% reduction of Wexner Inc. score.
- Willing and competent to fill out diary cards
Exclusion Criteria:
- Colorectal/proctological surgery since IPG-implant
- Pregnancy
- Anorectal Pain
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Sensory threshold - Amplitude
Stimulation amplitude set at sensory threshold.
|
Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
|
|
Sperimentale: 25% below sensory threshold - Amplitude
Stimulation amplitude 75% of sensory threshold.
|
Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
|
|
Sperimentale: 50% below sensory threshold - Amplitude
Stimulation with amplitude set 50% below sensory threshold
|
Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of incontinence episodes Assess number of incontinence episodes.
Lasso di tempo: Will be assessed every four weeks during a twelve-week period
|
Assess number of incontinence episodes, by means of bowel habit diary.
Four week bowel habit diary will be evaluated three times during the twelve-week protocol perioed.
|
Will be assessed every four weeks during a twelve-week period
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assess changes in anorectal volume and pressure with different amplitude.
Lasso di tempo: Will be assessed every four weeks during a twelve-week period
|
Resting and maximal anal sphincter pressure will be measured with different amplitude settings.
In total three evaluations will be made in the twelve week protocol perioed.
|
Will be assessed every four weeks during a twelve-week period
|
|
Assess Quality of life after decrease in stimulation amplitude.
Lasso di tempo: Will be assessed every four weeks during a twelve-week period
|
Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score.
A total of three evaluations will be made every fourth week in the twelve week protocol perioed.
|
Will be assessed every four weeks during a twelve-week period
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 002 (University of CT Health Center)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Sensory Threshold
-
Boston Children's HospitalCompletatoCardiopatia congenita | Ventricolo singoloStati Uniti
-
Clínica BasileaNon ancora reclutamentoModalità di terapia fisica, muscoli respiratori, pressioni respiratorie massime, esercizi di respirazione
-
Hôpital Riviera-Chablais, Vaud-ValaisSconosciutoBroncopneumopatia cronica ostruttiva
-
University of ValenciaCompletatoDebolezza muscolare | Morbilità cardiovascolare | Morbilità respiratoria | Sindrome; IstituzionalizzazioneSpagna
-
Chang Gung Memorial HospitalCompletato
-
University of ValenciaCompletatoDebolezza muscolare | Altre diagnosi, comorbidità e complicanze | Sindrome; IstituzionalizzazioneSpagna
-
NYU Langone HealthReclutamento
-
Centre Hospitalier National d'Ophtalmologie des...ReclutamentoRetinopatia pigmentariaFrancia
-
Mayo ClinicAndersen FoundationCompletato
-
Washington University School of MedicineInternational Headache SocietyReclutamentoEmicraniaStati Uniti