Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749316
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2021-02-02
Brief Title:
Acs-Tens Treatment for Faecal Incontinence a RCT With Sham-controls
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Transcutaneous Electric Nerve Stimulation on Acupoints Acu-TENS for the Treatment of Faecal Incontinence a Prospective Randomised Sham-controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
Detailed Description:
Faecal incontinence FI is the involuntary loss of flatus liquid or solid stool per rectum Owing to the emotional stress and the psychosocial stigma surrounding this problem it is under-reported by patients
Conservative management of FI involves lifestyle medical adjustments and pelvic floor sphincter training If conservative treatment fails surgical options such as sphincter repair sacral nerve stimulation SNM and percutaneous tibial nerve stimulation PTNS can be reformed SNM and PTNS involve application of nervous electrical stimulation neuromodulation with significant improvement of symptoms The positions of electrical stimuli are also very similar to acupuncture sites acupoints used in Traditional Chinese Medicine for the treatment of faecal incontinence However disadvantage of these methods are 1 they are invasive and may cause complications such as pain infection and bleeding and 2 the devices for each SNM device can be costly
Transcutaneous Electrical Nerve Stimulation TENS is non-invasive which is commonly used for the management of pain It works via the application of electrical stimuli using adhesive gel pads They are cheap to run and are widely accepted by patients Hence application of TENS over acupoints Acu-TENS may provide a novel non-invasive treatment
A randomised controlled trial will be carried out on patients with FI Demographic data past medical history in particular any structural or neurological causes of FI will be recorded Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment Acu-TENS machine will be applied to standardised acupuncture points Assessment of FI via Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the validated questionnaires Short Form 36 SF-36 and the Fecal Incontinence Quality of Life Scale FIQL Chinese version questionnaires will be carried out at baseline and followup intervals
Conservative management of FI involves lifestyle medical adjustments and pelvic floor sphincter training If conservative treatment fails surgical options such as sphincter repair sacral nerve stimulation SNM and percutaneous tibial nerve stimulation PTNS can be reformed SNM and PTNS involve application of nervous electrical stimulation neuromodulation with significant improvement of symptoms The positions of electrical stimuli are also very similar to acupuncture sites acupoints used in Traditional Chinese Medicine for the treatment of faecal incontinence However disadvantage of these methods are 1 they are invasive and may cause complications such as pain infection and bleeding and 2 the devices for each SNM device can be costly
Transcutaneous Electrical Nerve Stimulation TENS is non-invasive which is commonly used for the management of pain It works via the application of electrical stimuli using adhesive gel pads They are cheap to run and are widely accepted by patients Hence application of TENS over acupoints Acu-TENS may provide a novel non-invasive treatment
A randomised controlled trial will be carried out on patients with FI Demographic data past medical history in particular any structural or neurological causes of FI will be recorded Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment Acu-TENS machine will be applied to standardised acupuncture points Assessment of FI via Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the validated questionnaires Short Form 36 SF-36 and the Fecal Incontinence Quality of Life Scale FIQL Chinese version questionnaires will be carried out at baseline and followup intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None