Validation of a Multimodal Algorithm for the Treatment of Fecal Incontinence
NCT ID: NCT05026970
Last Updated: 2021-08-30
Study Results
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-02-01
2023-05-01
Brief Summary
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Secondary:
1. Evaluate the presence of SIBO, gluten-sensitive enteropathy, malabsorption of bile salts or sugars in patients with Bristol stools ≥5 that condition the fecal continuity.
2. Effect of change in fecal consistency on IF symptoms.
3. To evaluate the effect of the combination of treatments on anorectal physiology and neurophysiology (motor and sensory), clinical severity and quality of life.
4. Evaluate the persistence of the treatments to the three months of end of the same.
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Detailed Description
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For the present study we try to validate a multimodal algorithm to treat FI, taking into account the underlying pahtophysiology.
It will have 2 differentiated stages:
Stage 1: Patients with loose stools (Bristol \>5): they will be studied to determine the cause of the diahrrea (mainly food intolerances) and treated accordingly. If FI symptoms remain, patients will pass to:
Stage 2: Patients with Bristol\<6 anf FI symptoms. They will be adressed to 3 combinations of treatments according to the pathophysiology that explain the symptoms, which will be:
BF+ES+K: those patients with direct sphincter damage BF+tNM+K: patients with external anal sphincter dennervation and/or colonic motility disorders.
BF alones: patients with FI mainly explained by a bad control of the pelvic floor function (akinesia/dyssynergia).
All patients will be studied with High Resolution Anorectal Manometry, PNTML, endoanal unltrasonography. Clinical severity and QoL with dedicated intruments or questionnaires.
If after 1sr stage, if so, patients have a clinical severity of Cleveland\<4 they will be followed up at 3 months with K, studued again their clinical severity and QoL.
After 2nd stage, if so, 3-month of targeted treatment will be performed, and reevaluated with HRAM, PNTML and clinical questionnaires. They will be followed up at 3 monts with only K to study the persistance of the treatments.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biofeedback+Electrostimulation+Kegel
Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Tibial Neuromodulation+Kegel
Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Kegel
Biofeedback+Kegel exercises
Biofeedback+Tibial Neuromodulation+Kegel
Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Electrostimulation+Kegel
Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Kegel
Biofeedback+Kegel exercises
Biofeedback+Kegel
Biofeedback (6 sessions) Kegel exercises (twice daily)
Biofeedback+Electrostimulation+Kegel
Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Tibial Neuromodulation+Kegel
Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)
Interventions
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Biofeedback+Electrostimulation+Kegel
Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Tibial Neuromodulation+Kegel
Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Kegel
Biofeedback+Kegel exercises
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FI episodes each month
* No other treatment the year before
* Able to self-administer treatments
Exclusion Criteria
* If, to investigators criteria, patient will fail to administer the tratmetns properly, due to physical or psychic conditions
18 Years
FEMALE
No
Sponsors
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Hospital de Mataró
OTHER
Responsible Party
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Lluís Mundet
Motility Unit Coordinator
Locations
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Hospital de Mataró
Mataró, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Lluís Mundet
Role: primary
Other Identifiers
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16/19
Identifier Type: -
Identifier Source: org_study_id
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