None listed
Conditions
Brief summary
Faecal incontinence (FI) is a chronic, debilitating condition with enormous consequences for patients and the community. Numerous studies have documented the tremendous negative impact of FI on quality of life. FI has also been shown to be associated with substantial economic costs for the local health system. Since FI is believed to be a heterogeneous disorder, initial management is symptom based. Addressing the underlying abnormal bowel habits, if present, is the first step. Additional conservative therapies include dietary, medical and psychological modifications, and are estimated to benefit a quarter of patients. When a conservative approach fails, treatment with biofeedback (BF) is often recommended. A multitude of perspective and randomized trials have persistently shown short and long-term improvement in around 60% to 70% of patients treated with BF. Neuromodulation is an established therapeutic modality in the treatment of patients suffering from different pelvic floor disorders. For patients with FI failing BF, the only well-established option at present is neuromodulation by an implantable sacral nerve stimulator. This treatment is invasive and costly, has potential significant complications and is associated with significant financial burden for the local health system. Therefore, there is a need for a less invasive and costly method of performing neuromodulation. Percutaneous tibial nerve stimulation (PTNS) has the potential to address these disadvantages. With this method, neuromodulation is delivered through the posterior tibial nerve using a disposable needle electrode. Although PTNS is a well-proven and recognized treatment for urge urinary incontinence, in the last decade its role in treating patients with FI is slowly being elucidated. A recent systemic review included 6 prospective studies of PTNS for treating FI, and showed that PTNS results in significant improvements in some outcome measures of these patients. In all of these studies, patients were required to fail conservative management, but not specifically biofeedback, and in none of the studies was PTNS evaluated in combination with BF. We thus hypothesize that the combination of PTNS and BF for treating patients with FI, especially patients with urge incontinence, who are at high risk for BF failure, will be more effective than the current standard of care of BF treatment only. The impact of this combined efficacy will translate into improving the care of our patients, reducing the negative impact on the patients and their families’ quality of life, and reducing the costs for our local health system. Our main study objective is to determine the feasibility of combining PTNS with BF for the treatment of patients with faecal incontinence. Our secondary objectives are (1) To determine the physiological effect of combination therapy of PTNS and BF on anorectal dysfunction and (2) To assess the efficacy of combination therapy of PTNS and BF for FI.
Interventions
All patients with faecal incontinence (FI) referred to the Neurogastroenterology Unit at Royal North Shore for biofeedback treatment will be screened using physiological testing and symptom based questionnaires as routinely used in the Unit. These include on initial evaluation a general symptom questionnaire (Anorectal Manometry Questionnaire), the Rome III Integrative Questionnaire, and the Hospital Anxiety and Depression (HAD) scale. After digital rectal examination, patients undergo comprehen
All patients with faecal incontinence (FI) referred to the Neurogastroenterology Unit at Royal North Shore for biofeedback treatment will be screened using physiological testing and symptom based questionnaires as routinely used in the Unit. These include on initial evaluation a general symptom questionnaire (Anorectal Manometry Questionnaire), the Rome III Integrative Questionnaire, and the Hospital Anxiety and Depression (HAD) scale. After digital rectal examination, patients undergo comprehensive anorectal function studies, which include using a 7-lumen water-perfused manometry catheter with 0.5 cm spaced sideholes and a compliant balloon attached to the end (Dentsleeve International, Canada). The catheter is connected to calibrated pressure transducers and data from the pressure transducers is displayed in digital form on a computer using data conversion software (Neomedix, Sydney Australia). Each individual study comprises assessments of the following parameters: (i) resting anal sphincter pressure, (ii) maximum anal sphincter squeeze pressure and duration of maximum anal squeeze pressure, (iii) straining rectal pressure and concomitant anal relaxation or paradoxical contraction, (iv) rectal sensitivity thresholds using a latex balloon and/or barostat studies and (v) balloon expulsion test (time taken to expel a rectal balloon inflated with 50 ml of warm water whilst the patient is seated on a private toilet). If clinically indicated, further testing including anorectal ultrasound, defacting proctogram and/or colonoscopy will be performed to rule out a structural/ organic cause for the patients’ symptoms. For the current study, patients will be screened for eligibility criteria as detailed below. Patients who satisfy these criteria will be given oral and written explanation detailing the PTNS procedure and trial, and offered participation in the study. All patients will go on to receive standard of care anorectal BF training. This consists of 30-60 minute sessions, every week for six weeks, with a gastroenterologist and/or nurse specialist. The protocol consists of (1) education regarding the anatomy of normal defecation, (2) advice on correct toilet positioning, (3) anal squeeze pressure exercises, aimed at improving strength and duration of squeeze, (4) diaphragmatic breathing, with manometric feedback, to achieve adequate rectal pressure, (5) manometry-based biofeedback to allow anal relaxation to be synchronized with strain, (6) balloon expulsion retraining, and (7) rectal sensory retraining when appropriate. A disease specific questionnaire (Faecal Incontinence Questionnaire) is filled out before BF. Both before and after BF treatment all patients fill out the Faecal Incontinence Severity Index (FISI), the quality of life questionnaire (SF36) and a 10 cm visual analogue scale (VAS) for (i) global bowel satisfaction (score anchors: 0 = completely unsatisfied; 10 = completely satisfied), (ii) impact of bowel dysfunction on quality of life (score anchors: 0 = no impact; 10 = most impact) and (iii) willingness to participate in the therapeutic course (score anchors: 0 = not willing; 10 = very willing). In addition to this standard of care BF treatment, patients consenting to participate in the study will undergo five sessions of BF and PTNS at the same time. The patients will undergo these combined sessions once weekly for 5 weeks, and then will go on to receive 7 additional weekly sessions of PTNS only. Another combined BF and PTNS session will be performed at 3 months, for a total of 13 PTNS sessions. Thus, all patients included in the study will be given the benefit of both BF treatment and PTNS neurostimulation. A combined session of PTNS and BF includes 30 minutes of PTNS and afterwards performing BF exercises. PTNS involves a needle electrode being inserted adjunct to the posterior tibial nerve at the medial malleolus of the ankle. It is inserted about 3–4 centimetres. The electrode is then connected to a hand held nerve stimulator which sends an electrical impulse to the nerve. This nerve impulse is transmitted to the sacral plexus which regulates the control of bladder and pelvic floor muscles. The maximum treatment intensity is determined in the following way: the stimulus intensity is increased slowly until the patient's great toe begins to curl. The level at which the patient's toe curls is determined to be the maximum intensity for treatment. Each treatment session lasts 30 minutes of continuous stimulation. PTNS therapy will be delivered using the incontinence-control electrical stimulation system, non-implantable (Endotherapeutics Pty Ltd). This device is listed on the ARTG and will be used for the indication approved under this listing. PTNS will be delivered by a qualified nurse who has undergone specific training in PTNS treatment and follow-up.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who are referred to biofeedback treatment for faecal incontinence and satisfy the following will be offered participation: 1. Females 2. Age >=18 and =<80 3. Faecal incontinence: defined as an uncontrolled passage of faecal material occurring at least 2-4 times a month, in the last 6 months. 4. Urge symptoms: defined as having an urge sensation before the uncontrolled passage in at least part of the FI episodes. 5. Failure of a trial of diet and bulking or laxative therapy in an effort to restore normal bowel movements. 6. Severity of FI: a minimal score of 8 on the FIS. 7. Willingness to give written informed consent and willingness to comply with the study.
Exclusion criteria
1. Presence of overt organic anorectal disorder - based on standard testing including physician assessment and imaging (anorectal ultrasound and/or colonoscopy). 2. Any general medical condition or medication that may compromise PTNS/BF treatment including: a. Hypercoagulability state or anti-coagulation medication. b. Latex allergy. c. Implanted stimulator, pacemaker or defibrillator d. Sciatica symptoms e. Peripheral neuropathy f. Peripheral vascular disease 3. Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study. 4. Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study 5. Previous anorectal biofeedback training.
Outcome results
None listed