Fecal IncontinencePhase 2/3BulkingNCT03052946
Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence
A Phase 2/3 study testing Bulking agent and Endoanal electrostimulation in people with Fecal Incontinence, run by University of Sao Paulo.
Trial summary
Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Bulking agent and Endoanal electrostimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2018to 30 Mar 2020
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate fecal incontinence
Who cannot join
- Severe fecal incontinence
- Pelvic radiotherapy
About this study
Official title: A Prospective Randomized Study Between the Use of Bulking Agent and the Endoanal Electrostimulation Therapy in Patients With Mild or Moderate Anal Incontinence
Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
- Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
- The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
Read the detailed description
- Prospective randomized trial
- Estimated number of 60 patients with mild or moderate anal incontinence with isolated anal sphincter muscle damage or evidence of anal incontinence without verification of anatomical damage to the anorectal sphincter complex with dysfunction or inadequate action of the internal anal sphincter accompanied at the outpatient clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
- Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
- The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
- Conditions
- Fecal Incontinence
- Being tested
- Bulking agent, Endoanal electrostimulation
- Keywords
- fecal incontinence, anorectal manometry, bulking agents
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulking agentProcedure or surgery
Filling bulking agent in the anal canal
Endoanal electrostimulationProcedure or surgery
The technique used will be with a frequency of 30 to 40 Hz with pulse width of 200 ms with maximum intensity of 800mAmp and duration of 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Bulking agent | Active comparator | Bulking agent in fecal incontinence Receives: Procedure: Bulking agent |
| Endoanal electrostimulation | Placebo comparator | Endoanal electrostimulation in fecal incontinence Receives: Procedure: Endoanal electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal incontinence
Score of Fecal Incontinence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start28 Feb 2018 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Mar 2020 (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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bulking agents
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Alfonso Bustamante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052946
- Sponsor's protocol ID
- 09082009
- Acronym
- Bulking
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2017
- Last updated
- 6 Feb 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 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Between the Use of Bulking Agent and the Endoanal Electrostimulation Therapy in Patients With Mild or Moderate Anal Incontinence
- ClinicalTrials.gov ID
- NCT03052946
- Acronym / sponsor ID
- Bulking / 09082009
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, anorectal manometry, bulking agents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 28 Feb 2018 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 14 Feb 2017 (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.
Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
- Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
- The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
Detailed description
- Prospective randomized trial
- Estimated number of 60 patients with mild or moderate anal incontinence with isolated anal sphincter muscle damage or evidence of anal incontinence without verification of anatomical damage to the anorectal sphincter complex with dysfunction or inadequate action of the internal anal sphincter accompanied at the outpatient clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
- Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
- The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Bulking agents
| Arm | Type | Receives |
|---|---|---|
| Bulking agent | Active comparator | Procedure: Bulking agentBulking agent in fecal incontinence |
| Endoanal electrostimulation | Placebo comparator | Procedure: Endoanal electrostimulationEndoanal electrostimulation in fecal incontinence |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate fecal incontinence
Key exclusion criteria (2 listed)
- Severe fecal incontinence
- Pelvic radiotherapy
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 |
|---|---|---|
| Bulking agentFilling bulking agent in the anal canal | Procedure or surgery | Bulking agent |
| Endoanal electrostimulationThe technique used will be with a frequency of 30 to 40 Hz with pulse width of 200 ms with maximum intensity of 800mAmp and duration of 30 minutes | Procedure or surgery | Endoanal electrostimulation |
Primary outcome
Fecal incontinence
Time frame: 6 months
Score of Fecal Incontinence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bulking agent and Endoanal electrostimulation in people with Fecal Incontinence, run by University of Sao Paulo.
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 1 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 6 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Fecal incontinence (time frame: 6 months). 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 6 Feb 2018.