Chronic Obstipation Clinical Trial
— 3T-COOfficial title:
Triple Target Treatment (3T) Combining Amplitude Modulated Middle Frequency (AM-MF) Stimulation With Electromyography (EMG)EMG-Biofeedback Versus EMG-Biofeedback in Chronic Obstipation
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.
| Status | Recruiting |
| Enrollment | 140 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | University of Gießen, Dept. of General Surgery | Gießen | Hessen |
| Lead Sponsor | Collaborator |
|---|---|
| dr. schwandner |
Germany,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline. | 3 months | No | |
| Secondary | Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline. | 3 and 12 months | No | |
| Secondary | Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline | 3 and 12 Months | No | |
| Secondary | 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 | No | |
| Secondary | Hinton Test after 3 and 12 months | 3 and 12 months | No | |
| Secondary | Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline | 3 and 12 months | No | |
| Secondary | Adapted Vaizey score after 3 and 12 months compared to baseline | 3 and 12 months | No | |
| Secondary | International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) applied to patients with urine incontinence after 3 and 12 months, compared to baseline. | 3 and 12 months | No |