Treating resistant constipation in children :laxatives and transcutaneous electrical stimulation (TES) Bridget R Southwell – Research Scientist, Fellow Julie Jordan-Ely - Continence Nurse Specialist 1. Murdoch Children’s Research Institute, Melbourne, Australia 2. Department of Paediatrics, University of Melbourne, Victoria, Australia

Home-based transcutaneous electrical stimulation (TES) YI Yik 1,2,3,4, KA Ismail 1,2, JM Hutson 1,2,3, BR Southwell 1,2. 1. Murdoch Children’s Research Institute, Melbourne, Australia 2. Department of Paediatrics, University of Melbourne, Victoria, Australia 3. Department of Urology, Royal Children’s Hospital, Melbourne, Australia 4. Department of General Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia

Introduction Slow-transit constipation motility is reduced in the whole colon resistant to laxatives Transcutaneous electrical stimulation (TES) using interferential current (IFC) delivered across the skin with sticky electrodes. used by physiotherapists to treat musculoskeletal pain and bladder incontinence. We have previously trialled TES-IFC to treat chronic constipation in children

TES trials for constipation Location Stim Frequency # of Pts Clinician Pilot 2003 Hospital 20 mins x3 /wk 1 mth- physio 8 P Chase 2005 RCT 2006-2008 Clinic 46 P RCT 23 stim Chase Clarke 2009 Manometry Clarke 2012 1st home Home 1 h/ day - 1 mth 11 P Ismail 2009 2nd home 1 h/ day - 6 mths 68 P Yik 2012 Suburban Clinic – Disimpaction, Educaton, Laxatives, Diet (DELD) 1 hr/ day- 2-3 mths 60 A&P Jordan-Ely (2011) Hospital Clinic DELD 1 hr/ day - 2-3 mths 33 P Dobson 2013 Total 214 P STC Adult 1 hr/ day - 2 mths 20 A Lynn 2011 IBS adult clinic 15 min x 12 67 A RCT 33 stim Coban 2012 home 1 hr/ day - 3 mths 11A Queralto 2013 98 A Child Adult

Aim: Determine if TES administered daily at home can improve defecation, soiling, abdominal pain and laxative use in STC children. Added onto existing treatment Clinician naive to electrical therapy

Patients STC was determined by radionuclear colonic transit study 62 patients (34 female, mean 7 yrs, 2-16 yrs) Patient/parent trained to give stimulation at home

Methods 4 electrodes- 2 on front, 2 on back- at belly button

Stimulation parameters- beating current Currents crossed, 4000 Hz, 4080-4150 Hz- beat 1 hour daily for 3- 6 months- battery operated stimulator Bowel diary: defecation, soiling, laxative use Quality of life (PedsQL), colonic transit time (nuclear transit scintigraphy)

Results

Laxative use decreased or stopped GENDER OUT

Urge to Defecate Increased GENDER OUT

Summary TES-IFC is non-invasive using removable sticky pad electrodes and can be given at home by the patient or parent. When added onto existing treatment in children with STC, increased defecation into the normal range in ½ stopped soiling laxative use stopped in ¼, reduced in ½ Increased urge to defecate Clinician training was needed and took 6 patients. SUMMARIZE TO 3 LINES ON HOME TES

Disimpaction with PEG and SP Polyethylene glycol (PEG 3345 + electrolytes) and sodium picosulphate (SP) are well-established treatments for constipation. PEG - disimpaction in 92% of children Candy DC, et al. J.Pediatric Gastroenterology Nutr. 2006 43:65-70 SP -treatment response in 83% of adults with chronic constipation Wulkow R, et al. Int J Clin Pract. 2007 61:944-50 This study investigated the effect of combined PEG/SP to achieve bowel disimpaction in treatment-resistant pediatric patients presenting to a surgeon in a tertiary children’s hospital.

D.E.L.D. Disimpaction Education Laxatives Diet – nurse-led treatment Disimpaction PEG+E and Sodium Picosulphate (SP) Education – Bristol Stool Scale (BSS), toilet timing, toilet posture, stress effects. Laxatives - low level PEG+E & SP Diet – food and water

METHODS Retrospective audit - 44 pts -4 month period Poor response to medical treatment by clinicians (GPs, paediatricians, gastroenterologists) before referral to surgeon Radionuclear colonic transit studies. PEG + electrolytes (13.7g/ sachet), SP (0.5mg/drop) Dosage: - Day 1 6-10 sachets PEG+E /15-20 drops SP - Day 2 6-8 sachets PEG+E /20 drops SP - Day 3 4-6 sachets PEG+E /10 drops SP Instructions to administer at home over 3 days. PEG+E dissolved in 125 ml water/sachet and mixed with an equal volume of juice, drunk at 125 ml/60 min during the morning. SP added to any drink in evening.

Dose of laxatives Polyethylene Glycol +Electrolytes (PEG+E) Sodium Picosulphate (SP) Each sachet contains 13.7g PEG+E Each drop contains 0.5mg per drop SP

Stool output increased over 3 days 2 - 15 cups of stool during day 2-3 mean +/- SEM : 6.7+ 0.3 (1 cup = 250ml)

Stool consistency targeted to BSS Type 4 Stool consistency improved Hard Soft Hard Soft Stool consistency targeted to BSS Type 4

Stool volume increased 0.9+ 0.2/wk to 6.6 + 0.3 p/w

Soiling episodes decreased 4.5 ±0.5 to 1.1 ±0.3/week

Disimpaction also works in adults Adults and children Suburban clinic Emergency Department- Elderly Aged-Care facility Extreme Cases Duchenes muscular dystrophy, palliative, faecaloma 12 cups Hard faecaloma-

Summary- disimpaction High-dose PEG+E / SP was effective in disimpaction for children with treatment-resistant chronic constipation presenting to a tertiary surgical clinic. The combination of PEG+E and SP produced disimpaction in all patients without complication. This method could be useful for all patients with chronic constipation.

JA Jordan-Ely, KM Dobson, BR Southwell, JM Hutson Transcutaneous electrical stimulation combined with disimpaction, education, laxatives, and diet JA Jordan-Ely, KM Dobson, BR Southwell, JM Hutson

To determine if TES plus DELD is more effective than TES alone Aim To determine if TES plus DELD is more effective than TES alone

Methods 33 patients (17 males, 4-16 yrs) with STC DELD Daily diary Start TES 1 hour/daily after DELD 2-3 months TES

DELD + TES is more effective than TES alone

DELD + TES increased BA more than TES alone High-dose oral medication for disimpaction was well tolerated. All patients had successful disimpaction over 3 days (mean 6 cups of stool in total) and then continued with low dose of medication and TES therapy. All patients started with < 3 bowel actions/week. After 8-12 weeks of TES, 32/33(97%) increased to >3 BA/wk with 29 /33(88%) having 7 BA/wk. Median stool consistency improved from BSS score of 2 (range:1-7) to 4 (4-5) (p<0.0001). Median stool output improved from 1(0-2) to 7(2-10) cups/wk (p<0.0001). Soiling episodes decreased from 5 (0-7) to 0 (0-4) episodes/wk (p<0.0001). Patients were weaned off laxatives during TES, and off TES after 3 months and continued with daily defecation.

DELD +TES Soiling stopped completely Stool consistency changed to BSS 4-5

DELD + TES 97% patients increased defecation to >3 BA /week 88% had daily BA stool volume increased from 1 to 7 cups/pw BSS shifted from Hard (type 2) to Soft (type 4) (p<0.0001) Soiling episodes decreased from 5 to 0 per week

Advantages of DELD+ TES Improvement in higher % patients (97 % vs. 50%) More rapid response Patients/families empowered Significant improvement in QOL

Conclusion TES alone: improved 50% of patients (6 months). DELD alone: improves BA but impaction recurs after 2-3 months. TES + DELD improves more patients faster Combined DELD/TES most effective.

TES trials for constipation Location Stim Frequency # of Pts Clinician Pilot 2003 Hospital 20 mins x3 /wk 1 mth- physio 8 P Chase 2005 RCT 2006-2008 Clinic 46 P RCT 23 stim Chase Clarke 2009 Manometry Clarke 2012 1st home Home 1 h/ day - 1 mth 11 P Ismail 2009 2nd home 1 h/ day - 6 mths 68 P Yik 2012 Suburban Clinic – Disimpaction, Educaton, Laxatives, Diet (DELD) 1 hr/ day- 2-3 mths 60 A&P Jordan-Ely (2011) Hospital Clinic DELD 1 hr/ day - 2-3 mths 33 P Dobson 2013 Total 214 P STC Adult 1 hr/ day - 2 mths 20 A Lynn 2011 IBS adult clinic 15 min x 12 67 A RCT 33 stim Coban 2012 home 1 hr/ day - 3 mths 11A Queralto 2013 98 A Child Adult

Conclusion Disimpaction with PEG + sodium picosulphate is effective in most children and adults with CC TES is a non-invasive technique Can be delivered at home Increases defecation in treatment-resistant patients Better with DELD Promising for use in children and adults.

Bridget.southwell@mcri.edu.au