How is urination flow rate, volume and frequency affected in men who have had complete surgical removal of the prostate to treat prostate cancer?
| ISRCTN | ISRCTN18295405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18295405 |
| IRAS number | 242020 |
| Secondary identifying numbers | IRAS 242020 |
- Submission date
- 14/02/2020
- Registration date
- 28/04/2020
- Last edited
- 28/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Contact information
Scientific
Medical Physics
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
 ORCID ID |
0000-0003-1402-804X |
|---|---|
| Phone | +44 (0)191 233 6161 |
| abray3@nhs.net |
Study information
| Study design | Observational qualitative study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | ISRCTN18295405_PIS_v2.0_03Apr2018.pdf |
| Scientific title | Home Assessment of urinary voiding and storage function before and After Radical Prostatectomy for prostate cancer: setting patient expectations (The HAARP study) |
| 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(s) | 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 |
| 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 |
| 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 study start date | 18/12/2017 |
| Overall study end date | 31/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 40 |
| Participant inclusion criteria | Men undergoing radical prostatectomy for prostate cancer |
| 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
- England
- United Kingdom
Study participating centres
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
Newcastle Joint Research Office
1st Floor Regent Point
Regent Farm Road
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)191 282 5959 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | https://newcastlejro.com |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2.0 | 03/04/2018 | 28/04/2020 | No | Yes |
| Participant information sheet | version v1 | 02/05/2019 | 28/04/2020 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN18295405_PIS_v2.0_03Apr2018.pdf
- uploaded 28/04/2020
- ISRCTN18295405_PIS (interview)_v1_02May2019.pdf
- uploaded 28/04/2020
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.
