Clinical trial NCT01672216: Multicenter Randomized Controlled Trial to Compare the Outcome of Conservative Triple Target Treatment With EMG-Biofeedback in Chronic Obstipation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstipation
Keywords: Exercise Therapy
Biofeedback (Psychology)
Adult
Chronic Obstipation/*therapy
EMG - Biofeedback
EMG - Triggered Stimulation
Augmented biofeedback
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.
timeFrame: 3 months
Secondary outcomes:
measure: Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline.
timeFrame: 3 and 12 months
measure: Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline
timeFrame: 3 and 12 Months
measure: 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.
timeFrame: 3 and 12 months
measure: Hinton Test after 3 and 12 months
timeFrame: 3 and 12 months
measure: Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline
timeFrame: 3 and 12 months
measure: Adapted Vaizey score after 3 and 12 months compared to baseline
timeFrame: 3 and 12 months
measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) applied to patients with urine incontinence after 3 and 12 months, compared to baseline.
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University of Gießen, Dept. of General Surgery
state: Hessen
Study officials:
affiliation: University of Giessen
name: Thilo Schwandner, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.