Primary care management of lower urinary tract symptoms in men: Development and validation of a diagnostic and decision-making aid

Cardiff University0 个研究点目标入组 880 人开始时间: 2017年10月9日最近更新: 2021年11月1日

适应症

试验速览

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32606065/ protocol (added 02/07/2020)

•2. Aged 16 years and over
•3. Present to their GP with a main complaint of one or more lower urinary tract symptoms
•4. Able and willing to give informed consent for participation in study
•5. Able and willing to undergo all index tests and reference test, and complete study documentation

•Current exclusion criteria as of 12/03/2018
•1. Neurological disease or injury affecting lower urinary tract function
•2. LUTS considered secondary to current or past invasive treatment or radiotherapy for pelvic disease
•3. Contraindications to urodynamics e.g. heart valve or joint replacement surgery within the last 3 months, immunocompromised/immunosuppressed.
•4. Indwelling urinary catheter or intermittent self-catheterisation
•5. Initial assessment suggests that clinical findings are suggestive of possible:
•5.1. prostate or bladder cancer*
•5.2. recurrent or persistent symptomatic UTI**
•5.3. retention, e.g. palpable bladder after voiding renal impairment
•6. Unable to consent in English or Welsh where a suitable translator is not available
•Original exclusion criteria
•1. Neurological disease or injury affecting lower urinary tract function
•2. Past or current invasive treatment for LUT malignancy
•3. Initial assessment suggests that clinical findings are suggestive of possible:
•3.1. Prostate or bladder cancer*
•3.2. Recurrent or persistent symptomatic UTI**
•4. Unable to consent in English or Welsh where a suitable translator is not available
•*According to standard NHS cancer pathways. If deemed unlikely, then eligible for study participation.
•**If UTI successfully treated but LUTS remain, then eligible for study.

发起方