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

NCT ID: NCT01672216

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstipation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

EMG-biofeedback alone

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

EMG-biofeedback alone

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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dr. schwandner

OTHER

Sponsor Role lead

Responsible Party

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dr. schwandner

Head of Coloproctology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thilo Schwandner, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Giessen

Locations

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University of Gießen, Dept. of General Surgery

Giessen, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thilo Schwandner, Dr.

Role: CONTACT

Phone: 00496419944701

Email: [email protected]

Facility Contacts

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Thilo Schwandner, Dr.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21383560 (View on PubMed)

Other Identifiers

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101/12 ethics comm. Giessen

Identifier Type: -

Identifier Source: org_study_id