Radiation ExposureNCT03147729
Radiofrequency in Anal Incontinence: Randomized Clinical Trials
A study testing Radiofrequency non ablation in people with Radiation Exposure, run by Escola Bahiana de Medicina e Saude Publica at 1 site in Brazil.
Trial summary
Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and gases, which can help to improve quality of life. Based on these experiences objectives were drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life of patients with anal incontinence, to… Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Radiofrequency non ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2015to 30 Dec 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 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals between 18 and 66 years of age with a clinical complaint of Anal Incontinence and who agree to participate voluntarily in the research.
Who cannot join
- Individuals with cognitive impairment, use of pacemakers, women who use the Intra-Uterine Device (IUD) of copper, pregnant women, individuals who are taking vasodilators or anticoagulants and hemophiliacs, patients with cognitive deficits or psychiatric illness, patients with chronic neurological degenerative diseases and individuals with hemorrhoid metallic clamp.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola bahiana de Medicina e Saúde Pública
Salvador, Estado de Bahia, 40290-000
About this study
Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and gases, which can help to improve quality of life. Based on these experiences objectives were drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life of patients with anal incontinence, to correlate the anal incontinence severity and to evaluate a sexual function and to verify an influence with radiofrequency treatment. It is a blind randomized clinical trial. For the collection of data it was used a fecal quality of life questionnaire (FIQL). The questionnaire assess the severity of Anal Incontinence (FISI), the degree of patient's satisfaction using a five-point scale (Likert) and a visual analogue EVA scale). It was divided in two groups, in one group it was used radiofrequency and pelvic exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises. It was accomplished in eight sections. As a result, it is expected the efficiency of the treatment of radiofrequency in the quality of life, in sexual function and in it's severity.
- Conditions
- Radiation Exposure
- Being tested
- Radiofrequency non ablation
- Keywords
- Radiofrequency, Anal incontinence, Fecal incontinence, Women sexual function, Sexuality
- Medical subject headings
- Encopresis, Fecal Incontinence, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency non ablationRadiation
Use of radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency in anal incontinence: a pilot study | Other | It will be a single arm study with a group of anal incontinence with 10 women with anal incontinence Receives: Radiation: Radiofrequency non ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of radiofrequency in anal incontinence
The radiofrequency application protocol will be used in the form of a capacitive electric transfer, bipolar configuration, with the Tonderm brand, Spectra G2 model, which has two electrodes: one active, in the anal region, with liquid glycerin and another, dispersive, coupled to the patient's hip. The temperature will be measured through a digital thermometer with infra-red until it reaches 41°C and will be maintained for 2 minutes. It will use Consent form, questionnaire of socio-demographic data and basic anamnesis. Then Fecal Incontinence Quality of Life, Fecal Incontinence Severity Index and Female Sexual Function Index. After, a perineal physical evaluation will be performed by an experienced Physical Therapist. The professional will perform a perineal muscle strength test, reflex and sensitivity test. For the sensitivity evaluation will be used a digital osiometer. The patients will be divided into two groups.
Measured: 8 radiofrequency sessions will be performed, with a 7 day interval between them. The session will be 20 minutes.Participants will be followed up for a minimum of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jun 2015
- Primary completion3 May 2017
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Bahiana de Medicina e Saude Publica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Barros Ferreira, Escola Bahiana de Medicina e Saude Publica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147729
- Sponsor's protocol ID
- CAAE: 43462915.8.0000.554 4
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in scientific articles.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency in Anal Incontinence: Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT03147729
- Acronym / sponsor ID
- CAAE: 43462915.8.0000.554 4
- Conditions
- Radiation Exposure
- Keywords
- Radiofrequency, Anal incontinence, Fecal incontinence, Women sexual function, Sexuality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Escola Bahiana de Medicina e Saude PublicaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 10 May 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.
Anal incontinence (AI) is used to englobe the involuntary loss of both fecal material and gases, which can help to improve quality of life. Based on these experiences objectives were drawn: to evaluate the effectiveness of radiofrequency and it's influence on quality of life of patients with anal incontinence, to correlate the anal incontinence severity and to evaluate a sexual function and to verify an influence with radiofrequency treatment. It is a blind randomized clinical trial. For the collection of data it was used a fecal quality of life questionnaire (FIQL). The questionnaire assess the severity of Anal Incontinence (FISI), the degree of patient's satisfaction using a five-point scale (Likert) and a visual analogue EVA scale). It was divided in two groups, in one group it was used radiofrequency and pelvic exercises and in the other turned off radiofrequency (heated glycerin) and pelvic exercises. It was accomplished in eight sections. As a result, it is expected the efficiency of the treatment of radiofrequency in the quality of life, in sexual function and in it's severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency in anal incontinence: a pilot study | Other | Radiation: Radiofrequency non ablationIt will be a single arm study with a group of anal incontinence with 10 women with anal incontinence |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals between 18 and 66 years of age with a clinical complaint of Anal Incontinence and who agree to participate voluntarily in the research.
Key exclusion criteria (1 listed)
- Individuals with cognitive impairment, use of pacemakers, women who use the Intra-Uterine Device (IUD) of copper, pregnant women, individuals who are taking vasodilators or anticoagulants and hemophiliacs, patients with cognitive deficits or psychiatric illness, patients with chronic neurological degenerative diseases and individuals with hemorrhoid metallic clamp.
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 |
|---|---|---|
| Radiofrequency non ablationUse of radiofrequency | Radiation | Radiofrequency in anal incontinence: a pilot study |
Primary outcome
The effectiveness of radiofrequency in anal incontinence
Time frame: 8 radiofrequency sessions will be performed, with a 7 day interval between them. The session will be 20 minutes.Participants will be followed up for a minimum of 12 months.
The radiofrequency application protocol will be used in the form of a capacitive electric transfer, bipolar configuration, with the Tonderm brand, Spectra G2 model, which has two electrodes: one active, in the anal region, with liquid glycerin and another, dispersive, coupled to the patient's hip. The temperature will be measured through a digital thermometer with infra-red until it reaches 41°C and will be maintained for 2 minutes. It will use Consent form, questionnaire of socio-demographic data and basic anamnesis. Then Fecal Incontinence Quality of Life, Fecal Incontinence Severity Index and Female Sexual Function Index. After, a perineal physical evaluation will be performed by an experienced Physical Therapist. The professional will perform a perineal muscle strength test, reflex and sensitivity test. For the sensitivity evaluation will be used a digital osiometer. The patients will be divided into two groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Yes. Publication in scientific articles.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency non ablation in people with Radiation Exposure, run by Escola Bahiana de Medicina e Saude Publica at 1 site in Brazil.
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 1 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 10 May 2017. 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 Brazil. 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?
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?
The effectiveness of radiofrequency in anal incontinence (time frame: 8 radiofrequency sessions will be performed, with a 7 day interval between them. The session will be 20 minutes.Participants will be followed up for a minimum of 12 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 10 May 2017.