Abstract
The publication ‘United Kingdom Continence Society: Minimum Standards for Urodynamic Studies, 2018’ was commissioned by the UK Continence Society (UKCS), to replace the Joint statement on minimum standards for urodynamic practice in the United Kingdom: Report of the urodynamic training and accreditation steering group (published in April 2009 by the UKCS). The 2009 document has been completely rewritten with the prime aim of providing information, advice and guidance to help with best practice in urodynamic study services. The full version of the 2018 document has been accepted and published in Neurourology and Urodynamics [1]. This work is a shortened version of the document and appears with the permission of NAU under a joint copyright agreement between NAU and UKCS.
12.1 Introduction
The publication ‘United Kingdom Continence Society: Minimum Standards for Urodynamic Studies, 2018’ was commissioned by the UK Continence Society (UKCS), to replace the Joint statement on minimum standards for urodynamic practice in the United Kingdom: Report of the urodynamic training and accreditation steering group (published in April 2009 by the UKCS). The 2009 document has been completely rewritten with the prime aim of providing information, advice and guidance to help with best practice in urodynamic study services. The full version of the 2018 document has been accepted and published in Neurourology and Urodynamics [1]. This work is a shortened version of the document and appears with the permission of NAU under a joint copyright agreement between NAU and UKCS.
Urodynamics have developed in the United Kingdom since the early 1970s, thanks to the scientific efforts of a range of healthcare professionals (HCPs). These include urologists, gynaecologists, clinical scientists, nurses and technicians. As of this writing (2018), UDS are still performed by a range of HCPs, some of whom have received no formal UDS training, largely because they started urodynamic practice before there was any formal urodynamic training. However, today it is expected that all those starting to perform UDS should have received formal training and assessment.
There are uncomfortable deficiencies in the regulation of UD services that undoubtedly harm patients. Indeed, there are currently no statutory requirements for the performance of urodynamic testing and little or no quality assurance, when compared to the essential regulations for treatment modalities from medicinal products to surgical procedures. The UKCS believes that it is unacceptable that UDS, an invasive test and an important part of the patient pathway for many men, women and children, will, if inexpertly performed, lead to some patients being denied necessary treatment, and others being subjected to treatments they cannot, or are unlikely to, benefit from. The UKCS is the major multidisciplinary group of HCPs, in the United Kingdom, dedicated to helping those suffering from lower urinary tract dysfunction (LUTD) such as urinary incontinence, and is determined to improve the care of patients.
It is intended for use by the doctors, nurses and scientists who provide urodynamic services, and as information to those who commission urodynamic services for their patients across the United Kingdom. The document may also help urodynamic services in other countries. However, readers are advised that practices may vary outside the United Kingdom.
The information in this booklet has been compiled from professional sources. While every effort has been made to ensure that the publication provides accurate and expert information and guidance, it is impossible to predict all the circumstances in which it may be used.
The document was developed through a consensus approach predominantly via membership of the UKCS Working Group: clinical scientists, nurses, adult and paediatric urologists, and urogynaecologists, each of who has extensive personal practical experience of performing UDS.
The UKCS is pleased that the following UK organisations have reviewed and endorsed the document: Association for Continence Advice; British Association of Paediatric Urologists; British Association of Urological Nurses; British Association of Urological Surgeons (BAUS); BAUS Section of Female, Neuro Urology, and Urodynamics; British Society of Urogynaecologists; Institute of Physics and Engineering in Medicine; Royal College of Nursing, Continence Forum; Royal College of Obstetricians and Gynaecologists; and the Urogynaecology Nurse Specialist Committee. The document has also been reviewed and endorsed by the International Continence Society.
The aim of the document is to improve the care of patients with LUTD by helping to ensure that the urodynamic studies (UDS) used in their assessment are of the highest possible quality, by providing clear minimum standards for UDS, to the urologists, gynaecologists, clinical scientists, nurses and technicians responsible for carrying out UDS.
The document has the following sections:
Principal indications for UDS in children, women, men and neurological patients
Minimum standards for a urodynamic unit
Urodynamic skill sets
The urodynamic patient pathway
Urodynamic techniques
Guidance for commissioners and providers of urodynamic services
General recommendations
The full report has appendices which can be found on the UKCS website: Urodynamics antibiotics policy; Urodynamics patient leaflets for children, women, men, neurological patients, and patients after urodynamics; Bladder diary and symptom questionnaires (ICIQ-BD – International Consultation on Incontinence Questionnaire Bladder Diary; ICIQ-FLUTS – International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptom; ICIQ-MLUTS – International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms); a template urodynamics report; Skills for health competencies; and Training and CPD details for urodynamics staff.
12.2 Principal Indications for UDS in Children, Women, Men and Neurological Patients
This section does not seek to provide an exhaustive list that includes every possible indication, but to list those indications that include perhaps 90% of those having UDS.
In general, urodynamics are only used if:
Lifestyle changes and drug therapy have not provided adequate improvement in the individual’s quality of life, and further therapy such as surgery is being contemplated after discussion with the patient, and/or carer.
There are factors that might lead to deterioration in lower urinary tract (LUT) function with possible consequences for the upper urinary tract, particularly in children and some patients with neurogenic LUT dysfunction.
Therefore, it follows that UDS are not indicated when:
the patient has not been treated using lifestyle changes and drug therapy, when appropriate;
the patient does not wish to consider surgical management after failed conservative treatment;
UDS is not likely to provide information that will change the management of that patient.
In children, the most frequent indications for UDS are as follows: congenital neurological conditions, including spina bifida and sacral agenesis; congenital structural conditions, including posterior urethral valves, anorectal malformations and bladder exstrophy; dysfunctional voiding; and failed overactive bladder (OAB) treatment prior to Botulinum toxin type A (BTXA) or sacral nerve stimulation.
In women: prior to surgery for bothersome stress incontinence; women with pelvic organ prolapse (POP) and urinary symptoms considering surgery and women with new onset lower urinary tract symptoms (LUTS) post pelvic floor surgery; idiopathic voiding dysfunction/urinary retention; and failed OAB treatment prior to BTXA or sacral nerve stimulation.
In men: prior to possible surgery for suspected prostatic obstruction; post-prostatectomy stress incontinence; in younger men (e.g. <45 years) with voiding symptoms/history of retention; and failed OAB treatment prior to BTXA or sacral nerve stimulation.
In neurological patients, congenital or acquired neurological conditions with a risk of upper tract deterioration (e.g. spinal cord injured patient and spina bifida); and significant LUTS, including incontinence, that have not responded to conservative management.
12.3 Minimum Standards for a Urodynamic Unit
The key features of a urodynamic unit (UDU) include:
Director of the UDU: A director should be appointed who is usually a consultant urologist specialising in functional urology or a consultant urogynaecologist. However, the Director may be a consultant nurse or clinical scientist. The director has many roles primarily aimed at ensuring that the patient has appropriate and safe high-quality UDS.
These roles include: determining the scope of the UDU defined by whether the UDU has a secondary, tertiary or specialist referral pattern; integrating the UDU into the hospital environment; ensuring that the UD staff have the necessary education, training and CPD, to have the necessary skill sets exist to ensure high-quality UDS; to ensure that urodynamic equipment is fit for purpose and maintained; and to lead regular appropriate multi-disciplinary team and audit meetings.
UDU referral patterns: Secondary care units offer a local service with basic UDS for men and/or women without complex problems; tertiary care unit offer a service that also includes video UDS (VUDS), urethral function studies and ambulatory UDS for men and/or women with complex problems, from a wider geographical area; and specialist regional units offer the full range of UD tests to a well-defined population, such as children or spinal cord injury patients.
Integration in the hospital environment: this includes collaboration with the organisation’s Radiology, Information Technology (IT) and Medical Physics departments.
UDU clinical environment: certain features are essential; there must be adequate space for equipment/consumable storage, and consultation, as well as accessibility for wheelchairs/hoists, etc.; patient privacy and dignity is important with proper changing and toilet facilities; a disposal facility for body fluids; and a proper couch for examination.
Administrative support is needed for an effective UDU, including: requirements for service provision, including processing of clinical notes and dictation on patients and establishment and maintenance of a UD database; and making appointments and ensuring that all disposable equipment is available and patient information leaflets in stock.
UDU staffing: UDS are delivered in a variety of models, but all have the same common principles.
Patient safety and well-being necessitate there being two HCPs at each UDS. In general, this allows one to concentrate on the technical aspects of the test whilst the second person talks with the patient and interprets symptoms with urodynamic findings, during the test. In addition, if there is an unexpected event, such as a syncopal attack (fainting), then the patient can be properly cared for. All staff need to be aware of local policies including infection control, manual handling, intimate examination and chaperoning.
The technical aspects of UDS can be provided by a nurse, technologist or a suitably trained doctor.
The clinical aspects of UDS can also be provided by a nurse, clinical scientist or a suitably trained doctor.
During VUDS, it may also be necessary to have radiology staff present.
12.3.1 Training and CPD for UD Staff
The UKCS takes the view that those who have been formally trained best serve patients. Training should be based on indicative minimum numbers of UDS performed, combined with structured competence assessments which document the trainees’ progress until they have acquired the competence needed to work independently. Assessment of competence varies with specialty but may include a log of cases, objective structured assessments of training, direct observations of procedure, mini clinical examination and case-based discussions, including analyses of traces.
Practice levels for consultant staff, or equivalent, working in UDUs is seen as an essential part of CPD and regular sessions in the UDU are essential, and a minimum of 12 sessions per year, once staff are fully trained, is essential to maintaining standards.
Urodynamic papers and books: There are a number of important papers that should be read by all those undertaking UDS, and responsible for either the technical, clinical, or both aspects of UDS. In addition, HCPs intending to perform UDS should read one of the published books on UDS. These papers and books provide the principal information sources for all UDS.
ICS Terminology 2002 [2].
Urodynamic features and artefacts 2012 [3].
ICS Equipment Performance 2014 [4].
International Continence Society: Good Urodynamic Practices and Terms 2016 [5].
Urodynamics Made Easy [6].
Urodynamics [7].
International Children’s Continence Society Standardization Report on Urodynamic Studies of the Lower Urinary Tract in Children [8].
The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children’s Continence Society [9].
Clinical Urodynamics in Childhood and Adolescence [10].
Urodynamic Courses: Urodynamic courses are very valuable and should be chosen by the HCPs according to their experience and the types of patients they deal with or will be investigating. These courses should be led by doctors, nurses and clinical scientists with both practical and academic knowledge of UDS: they should not be industry led. Industry has a very valuable part to play in urodynamic courses by providing equipment for the attendees to see and handle. The organisers should endeavour to make available UD equipment from more than one company.
12.4 Urodynamic Skill Sets
12.4.1 Essential Technical Skills
Essential technical skills refer to the skills needed to run the technical aspects of a UDS. This skill set is used to deliver technical excellence in UDS by a technologist, nurse, clinical scientist or doctor who has been fully trained. The skill set includes:
A relationship with the Medical Physics or Clinical Engineering department/manufacturers with both an annual planned preventative maintenance arrangement, and ability to arrange ad hoc visits, if necessary, in the event of equipment problems.
Maintain the urodynamic equipment (pressure transducers, flow meters, weight transducers and infusion devices) on a day-to-day basis.
Be able to carry out daily/weekly calibration checks of the UD equipment.
Have a sound knowledge of the physiological range for all the main UD measurements: urine flow, and abdominal, urethral, and vesical pressures, as this information is the basis from which high-quality traces result.
Produce a high-quality trace from the technical point of view, with proper quality control according to ICS 2016 (see Section 12.4.2).
Recognise and correct artefacts that occur during UDS, some of which will be physiological, and others mechanical/electrical coming from the equipment, described in a comprehensive paper by Hogan et al. [3].
Be able to annotate traces correctly, so that others who were not present at the UDS can properly understand the recordings.
12.4.2 Essential Clinical Skills
A range of skills and ability is necessary to deliver the clinical aspects of a UDS and to perform an excellent clinical study to each patient. They may be possessed by a nurse, clinical scientist or doctor who has been trained according to UKCS 2018 standards. They include:
Sound knowledge of the anatomy and physiology of the lower urinary tract, and the principle conditions affecting the bladder and urethra (LUTD).
Clinical assessment of patients on the day of the UDS, and, in particular, confirmation of the urodynamic questions to be answered.
Insertion of the urodynamic catheters using the aseptic non-touch technique (bladder) and a clean technique (bowel or vagina).
During insertion of the rectal catheter, ensuring, by digital examination, that the patient does not have a loaded rectum as this is likely to influence the UD findings.
Having a continuous dialogue with the patient in order to assess whether their symptoms are reproduced during the UDS.
Assuring quality control during the UDS.
Altering technique, if need be, during the investigation.
Dealing with patient problems such as fainting: this is an example of a situation that demands that two HCPs are present during all UDS.
Interpreting the UD tracing and reaching one or more urodynamic diagnoses, in light of the urodynamic questions asked.
Stating whether or not the patient’s symptoms have been reproduced during UDS.
Having an outline discussion with the patient at the end of UDS, covering both the diagnosis and a description of possible treatment options (setting a management plan in the light of the question(s) asked).
If the HCP at UDS is the clinician responsible for delivering the treatment, the discussion will be in detail. If not, the detailed discussion will occur at a later date with the responsible consultant who would be expected to be trained in urodynamics, and a member of the local urodynamic MDT.
NOTE: the UKCS considers that the UD diagnosis should be made at the time of the UDS and does not think it is appropriate for the diagnosis to be made at a remote location, by a clinician without access to the patient, perhaps delayed by a considerable period of time.
Being part of, and attending the MDT
Urodynamic equipment
– Recommended equipment: Urodynamics is very dependent upon the appropriate use of good quality equipment. Table 12.1 lists the equipment recommended for different levels of urodynamic service. A guide to the specifications for this equipment can be found in the ICS guidelines for urodynamic equipment performance.
∘ Maintenance routines and regular checks: maintenance of urodynamic equipment and checks of its proper calibration are essential, not just for patient safety but also for a reliable urodynamic measurement. Responsibility for this is equally that of the UD HCPs, as well as the technical support. These checks should be planned and recorded and include:
∘ regular checks of calibration of the flowmeter (checking the accuracy of a known volume)
∘ regular checks of calibration of pressure transducers (checking, e.g., that 0–50 cm H2O is registered correctly)
∘ computer software and hardware updates and maintenance
∘ electrical safety tests, normally every year or two
∘ additional technical support from medical physics or clinical engineering department, or from manufacturer, under contract if necessary
– Detailed technical and operational considerations are outlined in the ‘Buyers’ Guide for Urodynamic Equipment’, published by the Department of Health (www.nhscep.useconnect.co.uk)
Regular audit allows the periodic confirmation of quality in UDUs. The following audits are recommended: the appropriateness of UD referrals; post-UDS urinary traction infection (UTIs); quality control of UD traces (see Table 12.2); outcome of UDS in terms of whether the patient’s symptoms were reproduced, and the defined urodynamic questions answered; effect of UDS on clinical outcome; and patient experience/satisfaction.
| Type of Service | Equipment Required |
|---|---|
| Urine flow recording | Uroflowmeter Commode (female)/stand (male) Ultrasound machine for measurement of post-void residual volume |
| Standard UDS: Filling cystometry and pressure-flow study of voiding | Uroflowmeter Commode (female)/stand (male) Pressure transducer mounting stand Urodynamic equipment with two pressure transducers and infusion pump, and, if required, electromyography (EMG) recording channel |
| VUDS (additional requirements to above) | Imaging apparatus (image intensifier, fixed X-ray unit or ultrasound machine) Urodynamic equipment with video capture included |
| Urethral function studies | Motorised withdrawal unit and pump for urethral pressure profilometry Three pressure channels required if urethral pressure is also measured while filling/voiding |
| Ambulatory UDS | Ambulatory urodynamic equipment (two pressure channels, data logger, linked flowmeter, computer for data download and analysis) |
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