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Validation of a Multimodal Algorithm for the Treatment of Fecal Incontinence

NCT05026970 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-08-30

No results posted yet for this study

Summary

Thisi is a pragmatical clinical trial with the main aim of main aim of evaluating the effectiveness of the combination of treatments for the management of fecal incontinence (FI), on profiles of patients with IF based on pathophysiological criteria, measuring physiological, clinical and quality of life outputs.

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.

Conditions

  • Fecal Incontinence

Interventions

COMBINATION_PRODUCT

Biofeedback+Electrostimulation+Kegel

Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)

DEVICE

Biofeedback+Tibial Neuromodulation+Kegel

Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)

COMBINATION_PRODUCT

Biofeedback+Kegel

Biofeedback+Kegel exercises

Sponsors & Collaborators

  • Hospital de Mataró

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-12-01
Completion
2023-05-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026970 on ClinicalTrials.gov