Primary care management of lower urinary tract symptoms in me

Not Applicable

Completed

• Conditions: ower urinary tract symptoms; Urological and Genital Diseases; Renal and Urogenital

• Registration Number: ISRCTN10327305
• Lead Sponsor: Cardiff University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-09
• Study Completion: 2021-04-30
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 880

Inclusion Criteria

1. Men
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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the diagnoses of detrusor overactivity, bladder outlet obstruction and detrusor underactivity estimated by the decision aid (using invasive urodynamics as the gold standard reference test).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Construction of a patient management algorithm to guide initial treatment for men with LUTS<br> 2. Construction of a prototype online decision aid for use in primary care<br> 3. Qualitative analysis of patients and clinicians views on the use of a LUTS decision aid in the primary care setting<br> 4. Percentage change in referral rates to secondary care for men with LUTS<br> 5. Estimation of costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective<br>