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Completed

NCT Number: NCT04478799

Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Al Qalyubia Governorate, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Transcutanous Posterior Tibial Nerve Stimulation

Device

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 Stimulation

Device

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.

Primary outcomes

  1. Number of incontinence episodes

    Time frame: 24 months

    Change in the number of incontinence episodes

  2. Incontinence Score using Vaizey incontinence score

    Time frame: 24 months

    Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).

Secondary outcomes

  1. Fecal Incontinence Quality of life Score

    Time frame: 24 months

    Change in quality of life score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected

  2. Resting pressure (mm hg)

    Time frame: 3 months

    Pressure during relaxation of the anal sphincter

  3. Squeeze pressure (mm hg)

    Time frame: 3 months

    Pressure during contraction of the anal sphincter

  4. First sensation (volume of the balloon by cm water)

    Time frame: 3 months

    First sensation of the stool in the rectum

  5. First Urge (volume of the balloon by cm water)

    Time frame: 3 months

    The patient is trying to hold defecation and he can

Sponsors and collaborators

Lead sponsor

Batterjee Medical College

Other

Collaborators

  • Benha University

Registry information

Official study title

Long Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in Treatment of Functional Non-Retentive Fecal Incontinence

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2020
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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