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

NCT01672216 | Unknown Phase 3 DMC

• 1 other identifier: 101/12 ethics comm. Giessen
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstipation

Keywords

Exercise Therapy; Biofeedback (Psychology); Adult; Chronic Obstipation/*therapy; EMG - Biofeedback; EMG - Triggered Stimulation; Augmented biofeedback

Outcome Measures

Primary Outcomes (1)

• Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.

  3 months

Secondary Outcomes (7)

• Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline.

  3 and 12 months

• Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline

  3 and 12 Months

• 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.

  3 and 12 months

• Hinton Test after 3 and 12 months

  3 and 12 months

• Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline

  3 and 12 months

Study Arms (2)

Triple Target Treatment

EXPERIMENTAL

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

EMG-biofeedback alone

ACTIVE COMPARATOR

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

Interventions

Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation DEVICE

Triple Target Treatment

EMG-biofeedback alone DEVICE

EMG-biofeedback alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Patients with chronic obstipation (Rom criteria II)

You may not qualify if:

• 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.

Sponsors & Collaborators

• dr. schwandner: lead

Study Sites (1)

University of Gießen, Dept. of General Surgery

Giessen, Hesse, 35385, Germany

RECRUITING

Related Publications (1)

• Schwandner T, Hecker A, Hirschburger M, Hecker M, Kierer W, Padberg W. Does the STARR procedure change the pelvic floor: a preoperative and postoperative study with dynamic pelvic floor MRI. Dis Colon Rectum. 2011 Apr;54(4):412-7. doi: 10.1007/DCR.0b013e318205ddda.

  PMID: 21383560 BACKGROUND

Study Officials

• Thilo Schwandner, Dr.

  University of Giessen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thilo Schwandner, Dr.

CONTACT

00496419944701; t.schwandner@web.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Coloproctology

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 24, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

DE (1)