NCT05026970

Brief 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. 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. 2.Effect of change in fecal consistency on IF symptoms.
  3. 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. 4.Evaluate the persistence of the treatments to the three months of end of the same.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

April 13, 2020

Last Update Submit

August 24, 2021

Conditions

Fecal Incontinence

Keywords

fecal incontinenceanorectal physiologypragmatic clinical trial

Outcome Measures

Primary Outcomes (5)

  • Cleveland Severity Score

    Changes in clinical severity after the treatments measured with Cleveland score, which ranges from 0 (total continence) to 20 (very severe incontinence)

    3 month and 6 month

  • Anorectal physiology (motor)

    Changes in anal mean resting pressure and squeeze (voluntary) pressure after the treatments measured with mmHg

    3 month and 6 month

  • Anorectal physiology (sensorial)

    Changes in rectal sensory thresholds after the treatments measured in volume (milliliters) of rectal distention

    3 month and 6 month

  • Anorectal neurophysiology

    Changes in pudendal nerve terminal motor latency (PNTML) measured with milliseconds

    3 month and 6 month

  • Quality of Life (QoL) according to FIQL scale

    Improvements in Fecal incontinence-related QoL after the treatments

    3 month and 6 month

Study Arms (3)

Biofeedback+Electrostimulation+Kegel

ACTIVE COMPARATOR

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

Device: Biofeedback+Tibial Neuromodulation+KegelCombination Product: Biofeedback+Kegel

Biofeedback+Tibial Neuromodulation+Kegel

ACTIVE COMPARATOR

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

Combination Product: Biofeedback+Electrostimulation+KegelCombination Product: Biofeedback+Kegel

Biofeedback+Kegel

ACTIVE COMPARATOR

Biofeedback (6 sessions) Kegel exercises (twice daily)

Combination Product: Biofeedback+Electrostimulation+KegelDevice: Biofeedback+Tibial Neuromodulation+Kegel

Interventions

Biofeedback+Electrostimulation+KegelCOMBINATION_PRODUCT

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

Also known as: BF+ES+K
Biofeedback+KegelBiofeedback+Tibial Neuromodulation+Kegel
Biofeedback+Tibial Neuromodulation+KegelDEVICE

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

Also known as: BF+tNM+K
Biofeedback+Electrostimulation+KegelBiofeedback+Kegel
Biofeedback+KegelCOMBINATION_PRODUCT

Biofeedback+Kegel exercises

Also known as: BF+K
Biofeedback+Electrostimulation+KegelBiofeedback+Tibial Neuromodulation+Kegel

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FI episodes at least 6 months before
  • FI episodes each month
  • No other treatment the year before
  • Able to self-administer treatments

You may not qualify if:

  • Pregnancy
  • If, to investigators criteria, patient will fail to administer the tratmetns properly, due to physical or psychic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Alba Raventós, Nurse

CONTACT

937417700albar.ravens92@gmail.com

Lluís Mundet

CONTACT

lluismundetp@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Motility Unit Coordinator

Study Record Dates

First Submitted

April 13, 2020

First Posted

August 30, 2021

Study Start

February 1, 2019

Primary Completion

December 1, 2022

Study Completion

May 1, 2023

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)