Fecal IncontinenceNCT04478799
Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience
A study testing Transcutanous Posterior Tibial Nerve Stimulation in people with Fecal Incontinence, run by Batterjee Medical College at 1 site in Egypt.
Trial summary
Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of FI, with a short term reduction in… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Transcutanous Posterior Tibial Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 15 Jul 2020
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranged from (6-14 years) with FNRFI with normal bowel habits
- Children with normal defecation frequency and normal stool consistency
- Children with incontinence score ranging from 8-22 according to Vaizey score
Who cannot join
- Children who have traumatic sphincter injury.
- Children who have Fecal impaction
- Children who have Spinal diseases causing incontinence
- Children who have Anorectal malformation
- Children who were not cooperative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in Treatment of Functional Non-Retentive Fecal Incontinence
Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS) showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the presence of the stimulating electrode very close to the posterior tibial nerve. However, TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a needle may result in stimulation that is sufficient to produce a neuromodulatory effect.
Read the detailed description
Treatment of FNRFI is often difficult and requires prolonged therapies with unexpected responses and frequent relapses. The corner-stones in treatment of FNRFI are education, positive motivation, and toilet training. Preparation of children and their parents for a long-lasting treatment is mandatory with the expectation of many ups and downs. The main goal is to have regular bowel movements and normal continence and this can be achieved by teaching the child the importance of regular toilet use and avoid urges.
Many previous studies, reported the short term effect of TPTNS in treatment of FNRFI. However, there are sufficient studies evaluating the long term effect of TPNS and this has motivated the authors to conduct of this study The aim of this study is to evaluate the Long term outcome and quality of life in children with Functional non-retentive fecal incontinence and received Bilateral Transcutaneous posterior tibial nerve stimulation therapy.
- Conditions
- Fecal Incontinence
- Being tested
- Transcutanous Posterior Tibial Nerve Stimulation, Sham Transcutanous Posterior Tibial Nerve Stimulation
- Keywords
- Posterior Tibial Nerve Stimulation, Fecal Incontinence, Long Term Effect
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutanous Posterior Tibial Nerve StimulationDevice
children were managed by bilateral TPTNS following the procedure described in 2006 by Queralto et al(11). A positive auto-adhesive electrode was applied 1.5 inch above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Electrical stimulation device (EMS physio Ltd, OX129 F, England) was connected to both electrodes. This device delivers a low frequency current (10 Hz), and the intensity was gradually increased till flexion of the big toe or spread out of the other toes in a fan shape occurred. Then the intensity was lowered to (10 Hz) again to avoid the motor response of the toes. Intensity was determined by the child's sensitivity. The procedure was done for 20-30 minutes and repeated2 times per week for 3 months
Sham Transcutanous Posterior Tibial Nerve StimulationDevice
Sham transcutaneous stimulation Patients also had twice-weekly 20-30-min sessions for 3 months. The same self-adhesive electrodes as used for group A were employed, placed in a similar position. The stimulator was briefly switched on for 30 s to induce only a minor electrical sensation in the skin, and was then turned off for the rest of the treatment. This short duration was given for only for a few seconds to avoid lower limb stimulation. Patients in all TWO groups were told that they may or may not have any perception of the electrical stimulation. Without prior knowledge of what to expect from treatment, this enabled the sham group to act as a control. In order to improve on the blinding effect of the study, the electronic display window of the stimulators was shielded from the patients in the TWO groups. All patients underwent therapy in individual screened cubicles to prevent comparison between patients of the treatment being administered.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Transcutanous Posterior Tibial Nerve Stimulation) | Experimental | Patients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises Receives: Device: Transcutanous Posterior Tibial Nerve Stimulation |
| Group B (Sham Control) | Sham comparator | Patients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises Receives: Device: Sham Transcutanous Posterior Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incontinence episodes
Change in the number of incontinence episodes
Measured: 24 months
Incontinence Score using Vaizey incontinence score
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
Measured: 24 months
Secondary outcomes (5)
Fecal Incontinence Quality of life Score
Change in quality of life score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected
Measured: 24 months
Resting pressure (mm hg)
Pressure during relaxation of the anal sphincter
Measured: 3 months
Squeeze pressure (mm hg)
Pressure during contraction of the anal sphincter
Measured: 3 months
First sensation (volume of the balloon by cm water)
First sensation of the stool in the rectum
Measured: 3 months
First Urge (volume of the balloon by cm water)
The patient is trying to hold defecation and he can
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Sep 2017
- Primary completion1 May 2020
- Study completion15 Jul 2020
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
- Model description
- The current single-blind randomized controlled study included 102 children with FNRF who were randomly allocated into two groups. Group 1, Bilateral transcutaneous posterior tibial nerve stimulation and group B, Sham TPTNS. Inclusion criteria included those with FI and normal defecation frequency, normal bowel habits and stool consistency. Children younger than 4 years or those who are not cooperative, or those with traumatic sphincter injury, fecal impaction, spinal diseases causing incontinence, anorectal malformation, were excluded from the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
- Investigators
- Mohamed S Kharoub, MD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478799
- Sponsor's protocol ID
- Banha University
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After Publication, investigators would like to share the data with other researchers who interested in this topic
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in Treatment of Functional Non-Retentive Fecal Incontinence
- ClinicalTrials.gov ID
- NCT04478799
- Acronym / sponsor ID
- Banha University
- Conditions
- Fecal Incontinence
- Keywords
- Posterior Tibial Nerve Stimulation, Fecal Incontinence, Long Term Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 21 Jul 2020 (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.
Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS) showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the presence of the stimulating electrode very close to the posterior tibial nerve. However, TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a needle may result in stimulation that is sufficient to produce a neuromodulatory effect.
Detailed description
Treatment of FNRFI is often difficult and requires prolonged therapies with unexpected responses and frequent relapses. The corner-stones in treatment of FNRFI are education, positive motivation, and toilet training. Preparation of children and their parents for a long-lasting treatment is mandatory with the expectation of many ups and downs. The main goal is to have regular bowel movements and normal continence and this can be achieved by teaching the child the importance of regular toilet use and avoid urges.
Many previous studies, reported the short term effect of TPTNS in treatment of FNRFI. However, there are sufficient studies evaluating the long term effect of TPNS and this has motivated the authors to conduct of this study The aim of this study is to evaluate the Long term outcome and quality of life in children with Functional non-retentive fecal incontinence and received Bilateral Transcutaneous posterior tibial nerve stimulation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The current single-blind randomized controlled study included 102 children with FNRF who were randomly allocated into two groups. Group 1, Bilateral transcutaneous posterior tibial nerve stimulation and group B, Sham TPTNS. Inclusion criteria included those with FI and normal defecation frequency, normal bowel habits and stool consistency. Children younger than 4 years or those who are not cooperative, or those with traumatic sphincter injury, fecal impaction, spinal diseases causing incontinence, anorectal malformation, were excluded from the study.
| Arm | Type | Receives |
|---|---|---|
| Group A (Transcutanous Posterior Tibial Nerve Stimulation) | Experimental | Device: Transcutanous Posterior Tibial Nerve StimulationPatients belonging to the group A received Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises |
| Group B (Sham Control) | Sham comparator | Device: Sham Transcutanous Posterior Tibial Nerve StimulationPatients belonging to the group B received Sham Transcautanoues posterior tibial nerve stimulation plus diet and Kegel exercises |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ranged from (6-14 years) with FNRFI with normal bowel habits
- Children with normal defecation frequency and normal stool consistency
- Children with incontinence score ranging from 8-22 according to Vaizey score
Key exclusion criteria (5 listed)
- Children who have traumatic sphincter injury.
- Children who have Fecal impaction
- Children who have Spinal diseases causing incontinence
- Children who have Anorectal malformation
- Children who were not cooperative
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 |
|---|---|---|
| Transcutanous Posterior Tibial Nerve Stimulationchildren were managed by bilateral TPTNS following the procedure described in 2006 by Queralto et al(11). A positive auto-adhesive electrode was applied 1.5 inch above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Electrical stimulation device (EMS physio Ltd, OX129 F, England) was connected to both electrodes. This device delivers a low frequency current (10 Hz), and the intensity was gradually increased till flexion of the big toe or spread out of the other toes in a fan shape occurred. Then the intensity was lowered to (10 Hz) again to avoid the motor response of the toes. Intensity was determined by the child's sensitivity. The procedure was done for 20-30 minutes and repeated2 times per week for 3 months | Device | Group A (Transcutanous Posterior Tibial Nerve Stimulation) |
| Sham Transcutanous Posterior Tibial Nerve StimulationSham transcutaneous stimulation Patients also had twice-weekly 20-30-min sessions for 3 months. The same self-adhesive electrodes as used for group A were employed, placed in a similar position. The stimulator was briefly switched on for 30 s to induce only a minor electrical sensation in the skin, and was then turned off for the rest of the treatment. This short duration was given for only for a few seconds to avoid lower limb stimulation. Patients in all TWO groups were told that they may or may not have any perception of the electrical stimulation. Without prior knowledge of what to expect from treatment, this enabled the sham group to act as a control. In order to improve on the blinding effect of the study, the electronic display window of the stimulators was shielded from the patients in the TWO groups. All patients underwent therapy in individual screened cubicles to prevent comparison between patients of the treatment being administered. | Device | Group B (Sham Control) |
Primary outcome
Number of incontinence episodes
Time frame: 24 months
Change in the number of incontinence episodes
Incontinence Score using Vaizey incontinence score
Time frame: 24 months
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
5 secondary outcomes
Fecal Incontinence Quality of life Score
Time frame: 24 months
Resting pressure (mm hg)
Time frame: 3 months
Squeeze pressure (mm hg)
Time frame: 3 months
First sensation (volume of the balloon by cm water)
Time frame: 3 months
First Urge (volume of the balloon by cm water)
Time frame: 3 months
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 22 Jul 2020.
- Individual participant dataSharing planned: Yes. After Publication, investigators would like to share the data with other researchers who interested in this topic
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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.
Mohamed S Kharoub, MD study director
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutanous Posterior Tibial Nerve Stimulation in people with Fecal Incontinence, run by Batterjee Medical College at 1 site in Egypt.
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 3 inclusion and 5 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 22 Jul 2020. 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 Egypt. 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. 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.
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?
Number of incontinence episodes (time frame: 24 months). The study lists 2 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 22 Jul 2020.