Fecal IncontinenceNCT03394794
Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women
A study testing Pelvic floor rehabilitation in people with Fecal Incontinence, run by Hospital de Mataró.
Trial summary
This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Pelvic floor rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to 1 Mar 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age higher than 18
- To be woman
- Have had incontinence episiodes at least from 6 month since the beginning of the study
- Have had incontinence episodes during the last month prior the beginning of the study
- The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.
Who cannot join
- Not meeting inclusion criteria
- Have very mild condition (Wexner <4)
- To be unable to perform / understand the treatments properly
- Being pregnant
- To have used treatmets for fecal incontinence within the last six months prior to the start of the study
- If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.
About this study
Official title: Study of the Efficacy of Treatment of Fecal Incontinence in Community-dwelling Women: Assessment of Individual Efficacy on Anorectal Physiology and Cortical Plasticity, Its Impact on Clinical Severity and on Quality of Life.
This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life.
Read the detailed description
Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak.
The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL.
This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.
- Conditions
- Fecal Incontinence
- Being tested
- Pelvic floor rehabilitation
- Keywords
- anorectal physiology, therapies, quality fo life
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor rehabilitationDevice
The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.
| Study group | Role | What they receive |
|---|---|---|
| Kegel exercises | Active comparator | Pelvic floor exercises designed in the 1950s' by Arnold Kegel. Receives: Device: Pelvic floor rehabilitation |
| biofeedback | Experimental | Biofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility. Receives: Device: Pelvic floor rehabilitation |
| electrostimulation | Experimental | Administration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility. Receives: Device: Pelvic floor rehabilitation |
| transcutaneous neuromodulation | Experimental | Stimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes Receives: Device: Pelvic floor rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical severity
severity of the symptoms measured with Cleveland score
Measured: Changes of severity after 3 month-treatment
maximum anal resting pressure
pressure of the anal canal measured with mmHg
Measured: Changes maximum anal resting pressure after 3 month-treatment
maximum squeeze pressure
pressure on the anal canal when squeezing measured with mmHg
Measured: Changes maximum squeeze pressure after 3 month-treatment
rectal sensitivity
patient's rectal perception, measured with cm3 of distention of a rectal balloon
Measured: changes in rectal balloon filling after 3 month-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Feb 2013
- Primary completion1 Dec 2016
- Study completion1 Mar 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
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
- NCT03394794
- Sponsor's protocol ID
- IF02-11/2012
- Status last verified
- Jan 2018
- First submitted
- 29 Nov 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Treatment of Fecal Incontinence in Community-dwelling Women: Assessment of Individual Efficacy on Anorectal Physiology and Cortical Plasticity, Its Impact on Clinical Severity and on Quality of Life.
- ClinicalTrials.gov ID
- NCT03394794
- Acronym / sponsor ID
- IF02-11/2012
- Conditions
- Fecal Incontinence
- Keywords
- anorectal physiology, therapies, quality fo life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 9 Jan 2018 (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.
This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life.
Detailed description
Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak.
The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL.
This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kegel exercises | Active comparator | Device: Pelvic floor rehabilitationPelvic floor exercises designed in the 1950s' by Arnold Kegel. |
| biofeedback | Experimental | Device: Pelvic floor rehabilitationBiofeeback therapy to improve neuromuscular coordination and strengthen sphincter contractility. |
| electrostimulation | Experimental | Device: Pelvic floor rehabilitationAdministration of electric current with a specific device (stimulator) and through a vaginal prove, in order to improve pelvic floor contractility. |
| transcutaneous neuromodulation | Experimental | Device: Pelvic floor rehabilitationStimulation of tibial nerve with a specific electric current through a stimulator and surface electrodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age higher than 18
- To be woman
- Have had incontinence episiodes at least from 6 month since the beginning of the study
- Have had incontinence episodes during the last month prior the beginning of the study
- The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.
Key exclusion criteria (6 listed)
- Not meeting inclusion criteria
- Have very mild condition (Wexner <4)
- To be unable to perform / understand the treatments properly
- Being pregnant
- To have used treatmets for fecal incontinence within the last six months prior to the start of the study
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 |
|---|---|---|
| Pelvic floor rehabilitationThe aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel. | Device | Kegel exercises, biofeedback, electrostimulation, transcutaneous neuromodulation |
Primary outcome
clinical severity
Time frame: Changes of severity after 3 month-treatment
severity of the symptoms measured with Cleveland score
maximum anal resting pressure
Time frame: Changes maximum anal resting pressure after 3 month-treatment
pressure of the anal canal measured with mmHg
maximum squeeze pressure
Time frame: Changes maximum squeeze pressure after 3 month-treatment
pressure on the anal canal when squeezing measured with mmHg
rectal sensitivity
Time frame: changes in rectal balloon filling after 3 month-treatment
patient's rectal perception, measured with cm3 of distention of a rectal balloon
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor rehabilitation in people with Fecal Incontinence, run by Hospital de Mataró.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical severity (time frame: Changes of severity after 3 month-treatment). The study lists 4 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 9 Jan 2018.