Chronic Obstipation
Conditions
Keywords
Exercise Therapy, Biofeedback (Psychology), Adult, Chronic Obstipation/*therapy, EMG - Biofeedback, EMG - Triggered Stimulation, Augmented biofeedback
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.
Interventions
Sponsors
dr. schwandner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline. | 3 and 12 months |
| Adapted Vaizey score after 3 and 12 months compared to baseline | 3 and 12 months |
| 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 |
| Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline | 3 and 12 months |
Countries
Germany
Contacts
Primary ContactThilo Schwandner, Dr.
Outcome results
None listed