Fecal IncontinenceNCT05026970
Validation of a Multimodal Algorithm for the Treatment of Fecal Incontinence
A study testing Biofeedback+Electrostimulation+Kegel, Biofeedback+Tibial Neuromodulation+Kegel and Biofeedback+Kegel in people with Fecal Incontinence, run by Hospital de Mataró at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Biofeedback+Electrostimulation+Kegel, Biofeedback+Tibial Neuromodulation+Kegel and Biofeedback+Kegel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FI episodes at least 6 months before
- FI episodes each month
- No other treatment the year before
- Able to self-administer treatments
Who cannot join
- Pregnancy
- If, to investigators criteria, patient will fail to administer the tratmetns properly, due to physical or psychic conditions
Trial locations and contacts
1 site in 1 country.
Lluís Mundet contact
Spain1 site, 1 recruiting
- Recruiting
Hospital de Mataró
Mataró, Barcelona, 08304
Lluís Mundet, 937417700 ext. 2756
About this study
Official title: 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:
- 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.
- Effect of change in fecal consistency on IF symptoms.
- To evaluate the effect of the combination of treatments on anorectal physiology and neurophysiology (motor and sensory), clinical severity and quality of life.
- Evaluate the persistence of the treatments to the three months of end of the same.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Biofeedback+Electrostimulation+Kegel, Biofeedback+Tibial Neuromodulation+Kegel, Biofeedback+Kegel
- Keywords
- fecal incontinence, anorectal physiology, pragmatic clinical trial
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback+Electrostimulation+KegelCombination product
Also called BF+ES+K
Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+Tibial Neuromodulation+KegelDevice
Also called BF+tNM+K
Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)
Biofeedback+KegelCombination product
Also called BF+K
Biofeedback+Kegel exercises
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback+Electrostimulation+Kegel | Active comparator | Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily) Receives: Device: Biofeedback+Tibial Neuromodulation+Kegel; Combination Product: Biofeedback+Kegel |
| Biofeedback+Tibial Neuromodulation+Kegel | Active comparator | Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily) Receives: Combination Product: Biofeedback+Electrostimulation+Kegel; Combination Product: Biofeedback+Kegel |
| Biofeedback+Kegel | Active comparator | Biofeedback (6 sessions) Kegel exercises (twice daily) Receives: Combination Product: Biofeedback+Electrostimulation+Kegel; Device: Biofeedback+Tibial Neuromodulation+Kegel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 month and 6 month
Anorectal physiology (motor)
Changes in anal mean resting pressure and squeeze (voluntary) pressure after the treatments measured with mmHg
Measured: 3 month and 6 month
Anorectal physiology (sensorial)
Changes in rectal sensory thresholds after the treatments measured in volume (milliliters) of rectal distention
Measured: 3 month and 6 month
Anorectal neurophysiology
Changes in pudendal nerve terminal motor latency (PNTML) measured with milliseconds
Measured: 3 month and 6 month
Quality of Life (QoL) according to FIQL scale
Improvements in Fecal incontinence-related QoL after the treatments
Measured: 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Feb 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lluís Mundet, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026970
- Sponsor's protocol ID
- 16/19
- Status last verified
- Aug 2021
- First submitted
- 13 Apr 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05026970
- Acronym / sponsor ID
- 16/19
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, anorectal physiology, pragmatic clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Effect of change in fecal consistency on IF symptoms.
- To evaluate the effect of the combination of treatments on anorectal physiology and neurophysiology (motor and sensory), clinical severity and quality of life.
- Evaluate the persistence of the treatments to the three months of end of the same.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofeedback+Electrostimulation+Kegel | Active comparator | Device: Biofeedback+Tibial Neuromodulation+Kegel, Combination Product: Biofeedback+KegelBiofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily) |
| Biofeedback+Tibial Neuromodulation+Kegel | Active comparator | Combination Product: Biofeedback+Electrostimulation+Kegel, Combination Product: Biofeedback+KegelBiofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily) |
| Biofeedback+Kegel | Active comparator | Combination Product: Biofeedback+Electrostimulation+Kegel, Device: Biofeedback+Tibial Neuromodulation+KegelBiofeedback (6 sessions) Kegel exercises (twice daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FI episodes at least 6 months before
- FI episodes each month
- No other treatment the year before
- Able to self-administer treatments
Key exclusion criteria (2 listed)
- Pregnancy
- If, to investigators criteria, patient will fail to administer the tratmetns properly, due to physical or psychic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback+Electrostimulation+KegelAlso: BF+ES+KBiofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily) | Combination product | Biofeedback+Kegel, Biofeedback+Tibial Neuromodulation+Kegel |
| Biofeedback+Tibial Neuromodulation+KegelAlso: BF+tNM+KBiofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily) | Device | Biofeedback+Electrostimulation+Kegel, Biofeedback+Kegel |
| Biofeedback+KegelAlso: BF+KBiofeedback+Kegel exercises | Combination product | Biofeedback+Electrostimulation+Kegel, Biofeedback+Tibial Neuromodulation+Kegel |
Primary outcome
Cleveland Severity Score
Time frame: 3 month and 6 month
Changes in clinical severity after the treatments measured with Cleveland score, which ranges from 0 (total continence) to 20 (very severe incontinence)
Anorectal physiology (motor)
Time frame: 3 month and 6 month
Changes in anal mean resting pressure and squeeze (voluntary) pressure after the treatments measured with mmHg
Anorectal physiology (sensorial)
Time frame: 3 month and 6 month
Changes in rectal sensory thresholds after the treatments measured in volume (milliliters) of rectal distention
Anorectal neurophysiology
Time frame: 3 month and 6 month
Changes in pudendal nerve terminal motor latency (PNTML) measured with milliseconds
Quality of Life (QoL) according to FIQL scale
Time frame: 3 month and 6 month
Improvements in Fecal incontinence-related QoL after the treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lluís Mundet contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback+Electrostimulation+Kegel, Biofeedback+Tibial Neuromodulation+Kegel and Biofeedback+Kegel in people with Fecal Incontinence, run by Hospital de Mataró at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alba Raventós, Nurse (937417700 ext. 2748, albar.ravens92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleveland Severity Score (time frame: 3 month and 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.