Condition category
Urological and Genital Diseases
Date applied
14/02/2020
Date assigned
28/04/2020
Last edited
28/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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, abray3@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alison Bray

ORCID ID

http://orcid.org/0000-0003-1402-804X

Contact details

Medical Physics
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 233 6161
abray3@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 242020

Study information

Scientific title

Home Assessment of urinary voiding and storage function before and After Radical Prostatectomy for prostate cancer: setting patient expectations (The HAARP study)

Acronym

HAARP

Study hypothesis

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.

Ethics approval

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; nrescommittee.southwest-cornwall-plymouth@nhs.net), ref:18/SW/0086

Study design

Observational qualitative study

Primary study design

Observational

Secondary study design

Qualitative

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See additional files.

Condition

Urinary function following radical prostatectomy for prostate cancer

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Drug names

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

18/12/2017

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Men undergoing radical prostatectomy for prostate cancer

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

40

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

10/05/2018

Recruitment end date

31/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Freeman Hospital
The Newcastle upon Tyne Hospitals NHS Foundation Trust Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Southmead Hospital
North Bristol NHS Trust Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Newcastle Joint Research Office
1st Floor Regent Point
Regent Farm Road
Newcastle upon Tyne
NE3 3HD
United Kingdom
+44 (0)191 282 5959
nuth.nuthsponsorship@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://newcastlejro.com

Funders

Funder type

Charity

Funder name

The Urology Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned outputs:
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

31/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

28/04/2020: The participant information sheets were uploaded as additional files. 05/03/2020: Trial's existence confirmed by the South West - Cornwall & Plymouth Research Ethics Committee.