Plain English Summary
Background and study aims
Men diagnosed with prostate cancer understandably often choose treatments that are most likely to get rid of the cancer. Surgical removal of the prostate can lead to changes in the frequency of passing urine and the amount of urine passed. These long-term changes can be bothersome and can lead to changes in lifestyle such as when and how much liquid is drunk. There is little information provided to men before surgery on how prostate removal might affect their urinary frequency and flow rate.
This study aims to measure the effects of prostate removal on urine flow and frequency. It will also interview men who have had prostate removal to find out about their symptoms, any changes to their lifestyle they have made and the information that was available to them before surgery. In addition, there will be interviews of men who are considering whether to have prostate removal to understand the information that would be most helpful. The results will help to guide creation of a leaflet to provide information at the point where a man is deciding about treatment for prostate cancer.
Who can participate?
Men who are about to have surgical prostate removal will participate in the part of the study that involves measuring their urinary function. Men who have already had their prostate removed and those who are considering it will participate in the interview part of the study.
What does the study involve?
In the urine function measurement part of the study, men will be given a Flowtaker device to measure their urine flow, amount and frequency. The device looks like a jug that stands on a sensor. For one week before surgery and 3 and 12 months after the surgery, participants will pass urine into the device when they are at home. They will also keep a diary of their liquid intake during the week and will fill out questionnaires on symptoms that might be affected by prostate removal and their quality of life.
For the interview part, the participants will be interviewed for up to 30 minutes on their urinary symptoms and the information they received before their surgery.
What are the possible benefits and risks of participating?
There is no personal benefit from participating. Travel expenses associated with the study will be refunded. There are also no risks expected, though it might be inconvenient at times for men to pass urine into the Flowtaker device rather than a toilet.
Where is the study run from?
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
December 2017 to August 2020
Who is funding the study?
The Urology Foundation (UK)
Who is the main contact?
Dr Alison Bray, firstname.lastname@example.org
Home Assessment of urinary voiding and storage function before and After Radical Prostatectomy for prostate cancer: setting patient expectations (The HAARP study)
The aim is to quantify the effect of radical prostatectomy on urinary function, including flow rates, voided volumes, and daytime and night-time frequency. This information will be used to develop patient literature to inform patients of changes following surgery.
Approved 05/04/2018, South West - Cornwall & Plymouth Research Ethics Committee (Level 3, Block B,
Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0)207 104 8241; email@example.com), ref:18/SW/0086
Observational qualitative study
Primary study design
Secondary study design
Quality of life
Patient information sheet
See additional files.
Urinary function following radical prostatectomy for prostate cancer
40 men will complete a fluid intake diary and perform home uroflowmetry for 1 week using the Flowtaker device before surgery and at 3 and 12 months after radical prostatectomy for prostate cancer. They will also complete symptoms questionnaires that ask about their urinary function, bowel habits, sexual function, hormones, and general quality of life.
The researchers will also interview a small number of men to inform the development of a leaflet that can be given to patients who are thinking about having a radical prostatectomy in order to help them make an informed decision. The interview will ask about urinary symptoms before and after surgery, expectations of urinary symptoms following surgery, information received and changes to lifestyle.
Primary outcome measure
1. Number of voids per 24-h period assessed using the Flowtaker device at baseline and 3 and 12 months after radical prostatectomy
2. Number of voids per night assessed using the Flowtaker device at baseline and 3 and 12 months after radical prostatectomy
3. Urinary flow rate assessed using the Flowtaker device at baseline and 3 and 12 months after radical prostatectomy
4. Voided volume assessed using using the Flowtaker device at baseline and 3 and 12 months after radical prostatectomy
Secondary outcome measures
1. Urinary symptoms measured by the ICIQ-MLUTS questionnaire at baseline and 3 and 12 months after radical prostatectomy
2. General well-being measured by the FACT-P questionnaire at baseline and 3 and 12 months after radical prostatectomy
3. Qualitative analysis of interviews
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Men undergoing radical prostatectomy for prostate cancer
Target number of participants
Participant exclusion criteria
1. Men with an indwelling urinary catheter
2. Men who carry out intermittent self-catheterisation
3. Men unable or unwilling to void in a standing position
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The Newcastle upon Tyne Hospitals NHS Foundation Trust Freeman Road High Heaton
Newcastle upon Tyne
Trial participating centre
North Bristol NHS Trust Southmead Road Westbury-on-Trym
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Joint Research Office
1st Floor Regent Point
Regent Farm Road
Newcastle upon Tyne
+44 (0)191 282 5959
The Urology Foundation
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. A report of quantitative results.
2. A report of qualitative results.
3. An information leaflet informing patients of the effect of radical prostatectomy on urinary function.
4. Publications, abstracts and conference submissions.
IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Basic results (scientific)