Comparison of the Efficacy between Biofeedback plus Laxatives Therapy Group and Laxatives Therapy Group in Dyssynergic Defecation Associated with Spinal Cord Disease: A Prospective Randomized Controlled Trial

Biofeedback Therapy in Dyssynergic Defecation Associated with Spinal Cord Disease: A Prospective Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000337

Enrollment

Registered

2012-02-02

Start date

2012-02-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Behavioral : Enrolled pateints will be randomly assigned to "Biofeedback+laxative group(experimental group)" or "Laxative group(control group). The therapeutic efficacy of the biofeedback in the const

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients between 20 years and 65 years old at age and with previous history of spinal cord injury or disease ? Patients whose spinal cord disease were comfirmed by the physicians who were major in the rehabilitation medicine, neurology,or neurosurgery. ? Patients with minimal or no neurologic sequalae and able to walk independently or by depending on the cane ? Constipation with the definite chronological relationship to the spinal cord diseases ? At least two studies suggests dyssyngergic defecation by the physiologic studies such as anorectal manometry, balloon expulsion test, colonic transit time study, and defecography ? Constipation which is not responded to dietery intervention and one kind of laxative

Exclusion criteria

Exclusion criteria: ? Patients who were unable to walk independently because of the neurologic deficit of spinal cord diseases ? Patients who had constipation before the development of spinal cord injury ? Patients with mild constipation which was responded to dietery intervention and one kind of osmotic laxative. ? Patients with organic lesions except spinal cord diseases which may develop constipation ? Patients who underwent gastric or bowel resection surgery ? Patients with untreated intraabdominal or intrapelvic malignancies ? Patients with uncontrolled hypothyroidism ? Patients with sequalae caused by neurologic disorders except spinal cord disease, such as stroke, parkinsonism, brain tumor, and so on ? Patients with uncompensated cardipulmonary disease ? Patients who did not agree with the participation to this study

Design outcomes

Primary

Measure	Time frame
Global defecatory satisfaction score	—

Secondary

Measure	Time frame
Anorectal manometry results	—

Countries

Korea, Republic of

Contacts

Public ContactDong-Hoon Yang

Asan Medical Center

gi.dr.yang@gmail.com+82-2-3010-5809

Outcome results