Efficacy of Acupuncture as a Treatment for Faecal Incontinence

NCT04276350 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-19

No results posted yet for this study

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.

Conditions

  • Faecal Incontinence

Interventions

PROCEDURE

Acupuncture

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)

PROCEDURE

Best Medical Therapy

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

Sponsors & Collaborators

  • Singapore College of Traditional Chinese Medicine

    collaborator UNKNOWN
  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Emile Kwong Wei Tan · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-07
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276350 on ClinicalTrials.gov