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Introduction

The International Continence Society-‘Benign Prostatic Hyperplasia’ (ICS-‘BPH’) study was initiated following the First World Health Organization (WHO) Consultation on benign prostatic hyperplasia (BPH) in 2014. At this meeting, there was no formal acknowledgement of the role of urodynamics in the assessment of men presenting with lower urinary tract symptoms (LUTS), which were then typically described as ‘prostatism’ or ‘clinical BPH’, and the seven-item American Urological Association (AUA) symptom score was adopted as the International Prostate Symptom Score (IPSS).

There were concerns that such a short symptom score did not cover the range of problematic symptoms experienced by patients, and that many urologists relied upon symptom ascertainment alone to select patients for invasive therapies, despite evidence that LUTS had poor diagnostic specificity.

In addition, there were suggestions that urodynamic studies could be used to identify patients with obstruction who might be more suitable for invasive treatments, thus leading to better patient selection and outcome, particularly in the context of increasing diversification of technologies for the treatment of LUTS.

In this context, the ICS-‘BPH’ study was established. A number of things have now changed. In particular, there is general consensus that the IPSS is not diagnostic, and acceptance that urodynamic studies have a role in the evaluation of men with LUTS. There has also been a marked change in the use of terminology in this area. In particular, the term ‘prostatism’ has been rejected and there is considerable care now in the use of ‘BPH’.

BPH tends now to be reserved for histological diagnosis, with LUTS used to describe lower urinary tract symptoms, BPE (benign prostatic enlargement) an enlarged prostate found on digital or ultrasound examination, and BPO (benign prostatic obstruction) the diagnosis of obstruction confirmed by urodynamic studies.

The title of the ICS-‘BPH’ study was thus soon outdated, and so inverted commas were used to denote the difficulties surrounding the term ‘BPH’! In the sections that follow, the methods and major findings from the ICS-‘BPH’ study are presented and their contribution evaluated.

Methods of the ICS-‘BPH’ study

The main aims of the ICS-‘BPH’ study were:

(1) To investigate the relationships between the results of urodynamic studies and a wide range of urinary symptoms;
(2) To produce a valid and reliable symptom, sexual function and quality of life questionnaire, including, if possible, a scored short form for use in clinical practice and research;
(3) To undertake an observational study of outcome of treatments according to current clinical practice around the world;
(4) To compare methods of pressure-flow analysis to establish the ‘optimum’ method of diagnosing bladder outlet obstruction.

These aims were addressed in three phases:

Phase I International, multicenter observational study collecting baseline data on LUTS and their impact on quality of life, sexual function, uroflowmetry and urodynamic studies;

Phase II International, multicenter observational study of outcome approximately 12 months following treatment;

Phase III Evaluation of treatments in randomized trials, e.g. CLasP study. Urologists from around the world were invited to recruit consecutive patients over 45 years of age with LUTS presumed to be of benign origin who could complete a frequency-volume chart and questionnaire and undergo uroflowmetry and urodynamics.

Men with significant urological disease, unfit for treatment or taking medication active on the lower urinary tract were excluded.

The ICS-‘BPH’ study questionnaire was designed to be self-completed. It was developed in English and then professionally translated into 15 other languages (Danish, Dutch, Finnish, French, French Canadian, German, Israeli, Italian, Japanese, Norwegian, Portuguese, Spanish, Swedish, Taiwanese, Turkish). Each translation was re-translated and checked by a lay advisor or national coordinator prior to use.

In the ICSmale questionnaire, men are asked to record each urinary symptom according to one of five grades from ‘never’ through ‘occasionally’, ‘sometimes’ and ‘most of the time’ to ‘all of the time’. Immediately beneath each question concerning the prevalence of the symptom follows a question referring to the degree of problem or bother caused by each of the symptoms graded from ‘not a problem’ through ‘a bit of a problem’ or ‘quite a problem’ to ‘a serious problem’.

The majority of symptoms are presented in this format, with the exception of the more specific items of frequency, nocturia and acute retention which are couched in terms of numbers. In addition, there are seven specific questions concerning quality of life (ICSQoL), including three fixed format questions, two global quality of life questions and two open-ended questions.

Patients in the UK also completed the generic health status instruments: Short Form 36 (SF-36) and EuroQol. Sexual function was explored using four questions (ICSsex). Each patient was also asked to keep a 7-day frequency-volume chart recording times of micturitions and incontinent episodes. An assessment was made of the patient’s prostate size by digital rectal examination (in grams) or by transrectal ultrasound (in cubic centimeters).

Three flow rate measurements were requested for each patient, with the assessment of residual urine by ultrasound after each void. Urodynamic studies were recorded at the time of investigation by the clinician on the ICS-‘BPH’ study patient information record, and the urodynamic trace was photocopied to be analyzed centrally.

The investigator was asked to judge whether the patient was unobstructed, had classical obstruction, questionable obstruction or another diagnosis. All data forms were returned centrally for processing and analysis using Statistical Analysis System (SAS) and Stata software.