Validation of a Multimodal Algorithm for the Treatment of Fecal Incontinence

Validation of a Multimodal Algorithm for Treatment of Fecal Incontinence in Women: Study of the Efficacy of the Combination of Treatments on the Impact on Clinical Severity and Quality of Life, and on the Underlying Pathophysiology

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.

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Biofeedback+Tibial Neuromodulation+Kegel; Combination product: Biofeedback+Kegel; Combination product: Biofeedback+Electrostimulation+Kegel

Detailed Description

FI is a very prevalent condition in community dwelling women. We have previously studied the efectivenes of four treatments in women with FI as well as the effect on the anorectal physiology and neurophysiology. All treatments improved clinical symptoms of FI but there were no statistical differences between the treatments, that were Kegel exercises (K), biofeedback (BF)+K, electrostimulation (ES)+K, and transcutaneous neuromodulation (tNM)+K. With this prevoous study we have a clearer idea of the anorectal physiology which should allow to select patients for given treatments.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alba Raventós, Nurse; Phone Number: 2748 937417700; Email: albar.ravens92@gmail.com
• Study Contact Backup: Name: Lluís Mundet; Email: lluismundetp@gmail.com

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Recruiting
      • Hospital de Mataró
      • Contact: Lluís Mundet; Phone Number: 2756 937417700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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); Other Names: BF+tNM+K; Combination product: Biofeedback+Kegel; Biofeedback+Kegel exercises; Other Names: BF+K
Active Comparator: Biofeedback+Tibial Neuromodulation+Kegel; Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)	Combination product: Biofeedback+Kegel; Biofeedback+Kegel exercises; Other Names: BF+K; Combination product: Biofeedback+Electrostimulation+Kegel; Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily); Other Names: BF+ES+K
Active Comparator: Biofeedback+Kegel; Biofeedback (6 sessions) Kegel exercises (twice daily)	Device: Biofeedback+Tibial Neuromodulation+Kegel; Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily); Other Names: BF+tNM+K; Combination product: Biofeedback+Electrostimulation+Kegel; Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily); Other Names: BF+ES+K

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital de Mataró

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pragmatic clinical trial; fecal incontinence; anorectal physiology
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 16/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No