Multicenter Randomized Controlled Trial to Compare the Outcome of Conservative Triple Target Treatment With EMG-Biofeedback in Chronic Obstipation (3T-CO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Giessen
Sponsor:
Information provided by (Responsible Party):
dr. schwandner, University of Giessen
ClinicalTrials.gov Identifier:
NCT01672216
First received: August 7, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

Previous studies revealed only a low evidence for the various biofeedback methods and pelvic floor exercises for treatment of chronic obstipation. The number of randomized controlled trials is low with in part significant systemic deficiencies. However, the results from the previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so promising that a further randomized controlled trial appears useful to demonstrate a higher degree of evidence. The purpose of this study is to determine whether triple target treatment (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if the duration of treatment (3, 6 or 9 months) influence the efficacy.


Condition Intervention Phase
Chronic Obstipation
Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation
Device: EMG-biofeedback alone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Triple Target Treatment (3T) Combining Amplitude Modulated Middle Frequency (AM-MF) Stimulation With Electromyography (EMG)EMG-Biofeedback Versus EMG-Biofeedback in Chronic Obstipation

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline. [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline [ Time Frame: 3 and 12 Months ] [ Designated as safety issue: No ]
  • Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) after 3 and 12 months compared to baseline, as well as between the two treatment groups over the course of time as compared to baseline. [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Hinton Test after 3 and 12 months [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Adapted Vaizey score after 3 and 12 months compared to baseline [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) applied to patients with urine incontinence after 3 and 12 months, compared to baseline. [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple Target Treatment
In the 3T arm, patients were stimulated with a carrier wave of 25 KHz and biphasic modulations of the pulse train of 40 Hz. Anxious patients trained at first only in the biofeedback mode. The stimulation was introduced after four weeks for these patients. Patients were instructed to carry out the training at home, with an alternating combination in the morning and with EMG-triggered stimulation in the evening, each for 20-minute periods. Apart from this, the protocol of the active treatment group was identical to that of the control group.
Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation
Active Comparator: EMG-biofeedback alone
In the biofeedback arm, patients were instructed to carry out EMG-biofeedback training at home, standing, mornings and evenings, for 20-minute periods. The core of the task was to pull the plug-electrode upward inside the anal channel, like a lift, and to hold it there during varying periods of tension. This can only be done successfully if the perineum rises and at the same time the puborectal muscle is activated. Just squeezing the sphincter muscles does not produce this lifting effect.
Device: EMG-biofeedback alone

Detailed Description:

Methods in this parallel-group randomized multicenter study with blinded observer we enroll 140 patients with chronic obstipation. The study is divided into two trials. After three months the first trial is completed and can be extended directly into the second trial (completed after 12 months) after an interim analysis. Primary endpoints are changes from baseline to three and twelve months in the Altomare ODS Score.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Patients with chronic obstipation (Rom criteria II)

Exclusion Criteria:

  • Chronic inflammatory bowel disease, systemic peripheral neuropathy (MS, diabetes), disorders of enteric nervous system (Hirschsprung disease, chagas, IND, myopathy desmosis coli), idiopathic megacolon/megarectum, patients with mental or intellectual deficits.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672216

Contacts
Contact: Thilo Schwandner, Dr. 00496419944701 t.schwandner@web.de

Locations
Germany
University of Gießen, Dept. of General Surgery Recruiting
Gießen, Hessen, Germany, 35385
Contact: Thilo Schwandner, Dr.    00496419944701    t.schwandner@web.de   
Sponsors and Collaborators
dr. schwandner
Investigators
Principal Investigator: Thilo Schwandner, Dr. University of Giessen
  More Information

Publications:
Responsible Party: dr. schwandner, Head of Coloproctology, University of Giessen
ClinicalTrials.gov Identifier: NCT01672216     History of Changes
Other Study ID Numbers: 101/12 ethics comm. Giessen
Study First Received: August 7, 2012
Last Updated: September 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
Exercise Therapy
Biofeedback (Psychology)
Adult
Chronic Obstipation/*therapy
EMG - Biofeedback
EMG - Triggered Stimulation
Augmented biofeedback

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014