Describing monotherapy and combination use in male and female patients with treatment for Lower Urinary Tract Symptoms. A retrospective, observational study using the UK CPRD

Date of ISAC Approval: 
12/07/2018
Lay Summary: 
Lower Urinary Tract Symptoms (LUTS) is a term used to describe a number of urinary symptoms in men and women. Under the umbrella of LUTS, Overactive Bladder (OAB) is a common condition in both men and women causing urinary urgency (sometimes with leakage of urine), increased use of the toilet during the day, and sometimes during the night. Benign Prostatic Hyperplasia/LUTS (BPH/LUTS) is a common cause of LUTS in men and occurs when the prostate becomes enlarged, and interferes with the normal passage of urine. Stress Urinary Incontinence (SUI) is one of the most common causes of accidental urine leakage in women, often during activities such as laughing, running and lifting. Combinations of medicines that work in different ways have been used to produce better outcomes with patients in areas of healthcare such as managing blood-pressure and diabetes. In LUTS too, several clinical studies have shown this to be the case. This study aims to complement these clinical studies by exploring which LUTS medicines are used alone and in combination with others in real-life practice, how long patients take their medicines for, and how much resource use such as GP appointments and hospital admissions is associated with different treatments.
Technical Summary: 
Background and Objectives: Drug combinations have successfully been used in many areas of healthcare to achieve better outcomes than by monotherapy alone. There is currently a lack of understanding of the Real-World landscape of combination therapy employed in the area of lower urinary tract symptoms (LUTS) in UK clinical practice. The proposed study aims to deliver key insights into this landscape in terms of therapies prescribed, and the patients who receive them. Methods: This is a retrospective database analysis using the Clinical Practice Research Datalink (CPRD) GOLD to retrieve anonymised primary care data on LUTS patients over a three-year selection period (Jan2014-Dec2016). Male and female cohorts will be further divided by type of LUTS experienced. The extent of monotherapy and combination treatments will be described alongside persistence with each treatment. Patient demographics (age, comorbidities, polypharmacy, treatment experience and socio-economic status) will also be described. Healthcare resource use will be explored using CPRD data linkage with the secondary care, Hospital Episodes Statistics (HES) database. Treatment switching, and the presence of a read code diagnosis of LUTS will also be assessed for all patients. Analysis: No a priori hypothesis will be tested. Aggregated summary statistics will be provided on the observations described above.
Health Outcomes to be Measured: 
- Description of the overall extent of monotherapy and combination therapy for the treatment of lower urinary tract symptoms (LUTS) - Description of number and proportion of patients prescribed individual monotherapies and combinations for the treatment of LUTS - Description of baseline socio-demographic characteristics of patients prescribed individual monotherapies and combinations for the treatment of LUTS - Description of healthcare resource use associated with patients on individual monotherapies and combinations in both the 12-month pre-index and 12-month post-index periods in terms of frequency of; GP consultations, specialist referrals, urological investigations/tests, hospital admissions, surgical interventions and prescription of incontinence supplies - Description of patient persistence with individual monotherapies and combinations during 12-months post-index in terms of time to discontinuation - Description of number and proportion of patients to have a recorded Read-code diagnosis for a LUTS in medical records - Description of number and proportion of patients who switched from monotherapy to combination and vice-versa in the 12-month pre-index and 12-month post-index period
Collaborators: 

Jameel Nazir - Chief Investigator - Astellas Pharmaceuticals
Margarita Landeira - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Dr Amit Kiran - Collaborator - Astellas Pharma Europe Ltd. - UK
Celine Quelen - Collaborator - Creativ-Ceutical
Francis Fatoye - Collaborator - Manchester Metropolitan University
Mahmood Ali - Corresponding Applicant - Astellas Pharmaceuticals
Mr Ramzi Argoubi - Collaborator - Creativ-Ceutical
Sameh Ferchichi - Collaborator - Creativ-Ceutical
Xinyi Tu - Collaborator - Creativ-Ceutical

Linkages: 
HES Admitted;HES Outpatient;Practice IMD (Standard)