Efficacy of Acupuncture as a Treatment for Faecal Incontinence
1 other identifier
interventional
100
1 country
1
Brief Summary
Overall Aim: To improve the long-term management outcomes for faecal incontinence (FI); through the implementation of new alternative treatment to complement existing treatment options, and enable better utilization of limited healthcare resources. Primary Specific Aim: To evaluate the effectiveness of Traditional Chinese Medicine (TCM) acupuncture in the treatment of faecal incontinence. Secondary Aims:
- To evaluate the safety profile of TCM acupuncture.
- To explore the patient satisfaction and uptake of TCM acupuncture as an alternative management strategy for FI.
- To evaluate improvements in health-related quality of life with TCM-acupuncture.
- To explore the cost-effectiveness of TCM acupuncture. Hypothesis: Traditional Chinese Medicine therapy, in the form of acupuncture, is an effective treatment for faecal incontinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2018
CompletedFirst Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedMarch 19, 2020
March 1, 2020
2.8 years
February 18, 2020
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who showed improvement in weekly number of incontinence episodes (baseline compare to subjects' week 10)
Assessed for superiority of intervention arm compared to the control arm
10 weeks
Secondary Outcomes (2)
Mean change in St Mark's incontinence score
10 weeks
Mean change in Faecal Incontinence Quality of Life (FIQL) score
10 weeks
Other Outcomes (1)
Mean change in anorectal manometry scores
10 weeks
Study Arms (2)
Acupuncture
EXPERIMENTALAcupuncture Regime: 2-3 sessions per week, each lasting an hour, over a period of 10 weeks (with deviation of 2 weeks for scheduling), total of 30 sessions
Best medical therapy
ACTIVE COMPARATORBest Medical Therapy Regime: 3 sessions to be completed over a period of 10 weeks (with deviation of 2 weeks for scheduling), with subjects learning and practicing biofeedback exercises daily
Interventions
Acupuncture sessions - 2-3 times/week, each session lasting 1 hour, over a period of 10 weeks (with allowed deviation up to 2 weeks due to scheduling)
Best Medical Therapy - 3 biofeedback sessions over a period of 10 weeks (with allowed deviation up to 2 weeks due to scheduling), where subjects learn and practice the exercises daily
Eligibility Criteria
You may qualify if:
- Patients presenting with faecal incontinence
- At least 2 episodes of faecal incontinence per week, St Mark's incontinence score of 5 or greater
- Patients aged 21 years or older
- Prior colonoscopy done to exclude underlying colonic pathology
- Written informed consent obtained
You may not qualify if:
- Active inflammation of the bowel, including inflammatory bowel disease, infection or perianal sepsis
- Pregnant women
- Current or previous diagnosis of the gastrointestinal tract, genitourinary, or pelvic cancers
- Presence of congenital or acquired neurological deficits (including spinal disorders)
- Previous history of complex major pelvic, anal or rectal surgery
- Previous history of multi-focal or major sphincter injuries or deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore General Hospital
Singapore, Singapore
Related Publications (1)
Ng YY, Tan KY, Zhao Y, Seow-En I, Chok AY, Chuang J, Loy MS, Tan EK. Efficacy of Traditional Acupuncture Compared to Biofeedback Therapy in Fecal Incontinence: A Randomized Controlled Trial. Dis Colon Rectum. 2024 Oct 1;67(10):1313-1321. doi: 10.1097/DCR.0000000000003357. Epub 2024 Jul 2.
PMID: 38954475DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emile Kwong Wei Tan
Singapore General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 19, 2020
Study Start
February 7, 2018
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
March 19, 2020
Record last verified: 2020-03