Urology and urogenital diseases

Other urology and urogenital experience

  • Worldwide advisory board on a treatment for lower urinary tract symptoms (LUTS)
  • Content validation of a neurogenic detrusor overactivity (NDO) diary in paediatric spina bifida patients
  • Analysis of urology and gynaecology in patient waiting lists
  • Systematic review of lithotripters for ureterolithiasis
  • Presentation of a PRO in urology
  • PRO training in urology

Overactive bladder and urinary incontinence

  • Value dossier for a treatment in stress urinary incontinence
  • HTA review and analysis for urinary incontinence
  • Abstracts, posters and a manuscript on the content validity of a patient bladder diary and the incontinence quality of life questionnaire
  • Further qualitative development of the incontinence quality of life questionnaire
  • Development of a PRO report on quality of life in urinary incontinence
  • Development of a regulatory dossier and claims assistance in idiopathic overactive bladder (OAB) with urinary urge incontinence
  • Recommendations for obtaining EMEA claims on the Incontinence Quality of Life Questionnaire (I-QOL) and the King’s Health Questionnaire (KHQ)
  • Content validation and psychometric validation of the Kings Health Questionnaire in incontinent OAB patients
  • Development of a PRO dossier for the FDA to support the King’s Health Questionnaire on OAB
  • Content validation and psychometric validation of an incontinence questionnaire for patients
  • Content validation of the patient bladder diary for OAB with urinary urge incontinence
  • Health outcomes appendices for phase III neurogenic OAB studies
  • Development and validation of a clinical screening tool for OAB in multiple sclerosis
  • Advisory board for a clinical screening tool for OAB in multiple sclerosis
  • Publications from the tool development and validation projects of OAB in multiple sclerosis
  • Development of health outcomes appendices in idiopathic OAB
  • Preference evaluation to compare treatments for OAB
  • Mode of administration study in an OAB population
  • Economic dossier on an antispasmodic, anticholinergic agent for OAB
  • Review of screening tools in OAB
  • Item pooling for OAB
  • Development of a screener for OAB based on a pragmatic approach and item pooling
  • SAP, analysis, report and manuscript on the OAB-S questionnaire
  • Standalone validation study in treatment-naive OAB patients
  • Development of a tool for ranking the importance of OAB symptoms and the achievement of treatment goals
  • Review of data and promotional claim strategy in OAB
  • Cognitive debriefing of an OAB questionnaire
  • Linguistic validation of a natural remedy for OAB
  • Phase I disease progression study of OAB in Sweden
  • Development of a patient satisfaction questionnaire in OAB
  • Validation of the Overactive Bladder Satisfaction (OAB-S) Questionnaire
  • Support activity on the OAB-S questionnaire
  • Development of a briefing package in relation to the concept of urinary urgency
  • FDA meeting attendance on the development of a briefing package in relation to the concept of urinary urgency
  • Cognitive debriefing of a new PRO assessment for urinary urgency
  • Worldwide advisory board on a treatment for OAB

Nocturia and paediatric enuresis

  • Stand-alone quantitative evaluation of the Impact of Nocturia End of Day Questionnaire
  • Creation of CDFs for the Impact of Nocturia End of Day Questionnaire
  • Consulting in a PRO strategy for use in paediatric enuresis (bed wetting)

Prostatic hyperplasia

  • Early economic model in benign prostatic hyperplasia
  • PRO literature review in benign prostatic hyperplasia

Lower urinary tract symptoms

  • Cognitive debriefing interviews on the symptom assessment goal achievement questionnaire on lower urinary tract symptoms in the UK, Germany and Spain
  • Data analysis and communication activities on Self-Assessment Goal Achievement (SAGA) in lower urinary tract symptoms

Interstitial cystitis

  • Literature review on interstitial cystitis
  • Development of a PRO for interstitial cystitis
  • Identification of cut-points to allow a newly developed interstitial cystitis symptom PRO to be used to screen patients entering a clinical trial and to assess the psychometric properties of the interstitial cystitis
  • Development of a manuscript on the Painful Bladder/Interstitial Cystitis Symptom Score (PBIC-SS) questionnaire
  • Revision of a manuscript on the PBIC-SS questionnaire and submission to a peer-reviewed journal