Can bladder health predict kidney transplant success?

ISRCTN	ISRCTN31508938
DOI	https://doi.org/10.1186/ISRCTN31508938
Integrated Research Application System (IRAS)	367244
Sponsor	NHS Greater Glasgow and Clyde
Funder	NHS Greater Glasgow and Clyde

Submission date: 06/01/2026
Registration date: 22/01/2026
Last edited: 22/01/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Many patients with kidney failure need a kidney transplant. Some of these patients will have problems relating to the storage or passage of urine. In many cases, this is unrecognized before transplant, especially if the patient no longer passes urine. This can lead to problems after the transplant, resulting in infections, complications and poor kidney function. There are very few studies which have looked at how issues with the patient’s urinary tract and bladder affect the outcome of a kidney transplant. However, it’s well-recognized amongst kidney transplant surgeons to be a significant problem. This study aims to determine the number of patients who have undiagnosed waterworks issues before transplant and investigate if these issues make it more likely for the patient to have urinary tract infections, poor kidney transplant function or other complications in the year following transplant.

Who can participate?
Patients having a kidney transplant in Glasgow, UK.

What does the study involve?
Everyone will be approached within two years: both when they join the transplant waiting list and when they receive a transplant. Patients will be followed up at 6 weeks and 1 year after transplant, taking measures of bladder function from history, questionnaires and simple studies of urine flow/ bladder function.

What are the possible benefits and risks of participating?
Currently, there is no standardized suggested work-up of the bladder and urinary tract prior to a kidney transplant. Different transplant centers do different things and there is no agreed-upon best approach. The results from this study might better inform how and why a patient’s lower urinary tract should be assessed before transplant. This information will hopefully reduce complications and improve outcomes after transplant. If the study identifies problems pre-transplant that predict complications after transplant, it is hoped that the results of this study could inform a larger study in the future that could intervene on these issues pre-transplant to see if it prevents complications in the future. However, at the moment, what to measure or how best to intervene is not known. It’s hoped that this study will help us better understand these issues.

If a catheter insertion is needed to fill the bladder, there may be some mild discomfort on catheter insertion. There is a very small risk of introducing infection.

Where is the study run from?
Glasgow Renal Transplant Unit, Queen Elizabeth University Hospital, UK.

When is the study starting and how long is it expected to run for?
March 2026 to March 2031.

Who is funding the study?
NHS Greater Glasgow and Clyde, UK.

Who is the main contact?
Prof David Kingmore, david.kingmore@ggc.scot.nhs.uk

Contact information

Prof David Kingsmore
Principal investigator

Glasgow Renal Transplant Unit
Queen Elizabeth University Hospital
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom

Phone	+44 0141 451 6209
Email	david.kingmore@ggc.scot.nhs.uk

Miss Emma Aitken
Scientific

Glasgow Renal Transplant Unit
Queen Elizabeth University Hospital
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom

Phone	+44 0141 451 6209
Email	emma.aitken@ggc.scot.nhs.uk

Mr Dhruv Satya Sahni
Public

Glasgow Renal Transplant Unit
Queen Elizabeth University Hospital
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom

Phone	+44 0141 451 6209
Email	Dhruv.Sahni@glasgow.ac.uk

Study information

Primary study design	Observational
Observational study design	Longitudinal study
Participant information sheet	48778_PIS_Phase I_V1.1_08Dec2025.pdf
Scientific title	A longitudinal cohort study of urological complications predictable by pre-transplant lower urinary tract symptoms
Study acronym	SCOPE
Study objectives	1. Primary objectives: - To evaluate the association between pre-transplant Lower urinary tract symptoms (LUTS) with post-transplant urological complications. These will include Acute urinary retention, recurrent UTIs, ureteric strictures and leaks, urosepsis, and need for surgical/radiological intervention for urological causes. 2. Secondary objectives: - To evaluate how the presence of moderate-severe LUTS impacts graft outcomes in the immediate 12 months following transplantation - To determine if duration of time on the transplant waiting list and/ or anuria predict objective change in LUTS or adverse urological outcomes post-transplant - To determine the change in LUTS post-renal transplantation. - Decline in kidney function (transient/ permanent) due to urological causes
Ethics approval(s)	Not yet submitted
Health condition(s) or problem(s) studied	Kidney transplant, lower urinary tract symptoms, urological complications
Intervention	Patients will be recruited over two years and followed up until they are one year post-transplant, removed from the transplant waiting list or have died. All patients at the time of transplant and at the time of transplant wait-listing will be approached to offer participation. History, examination and all perioperative follow-up will be conducted as would be standard of care. Patients will be recruited in two phases: - PHASE 1 (enrolled at transplantation): Evaluation of patients beginning on the day of transplant, prospectively at 6 weeks and 1 year - PHASE 2 (enrolled at waitlisting): Evaluation of patients at time of waitlisting, prospectively 1-year post-waitlisting (if not yet transplanted), on day of transplant and at 6 weeks and 1-year post-transplant All patients will undergo baseline assessment with history, examination, questionnaires (IPSS for males and ICIQ-FLUTS for females), along with Uroflowmetry and post-void residual assessment. For patients who do not produce enough urine for conclusive results (≥130 ml), a small filling catheter will be used to instil saline, and repeat assessment will be conducted. This will be limited to 300ml, without pressure testing and does not constitute/imply invasive urodynamic testing. These assessments, along with review of medical notes, will be performed at the time of transplant listing (Phase 2), after 1 year on the transplant waiting list (Phase 1), on the day of transplant, 6 weeks and 12 months after transplantation.
Intervention type	Other
Primary outcome measure(s)	Urological complications measured using a medical notes review for (acute urinary retention, recurrent UTIs, urine leak, ureteric strictures, urinary sepsis episodes, need of surgical/ radiological intervention for urological cause) at one year post renal-transplant
Key secondary outcome measure(s)	Association between time on transplant waiting list, anuria status, and post-transplant LUTS and urological outcomes measured using a medical notes review at one year post renal-transplant Lower urinary tract symptoms measured using the International Prostate Symptom Score (IPSS) for males, and the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) for females at one year post renal-transplant Graft survival measured using a medical notes review at one year post renal-transplant Decline in Renal function due to urological cause measured using a medical notes review (eGFR, creatinine) at one year post renal-transplant
Completion date	10/03/2031

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Adult patients (18 years of age or older) scheduled to undergo first-time renal transplantation (both deceased and living donor candidates) 2. Able to give informed written consent to participate
Key exclusion criteria	1. Unable or unwilling to provide consent 2. Patients undergoing re-transplant 3. Patients undergoing simultaneous urological reconstructive procedures 4. Patients with previously reconstructed bladders (includes Augmentation cystoplasty, ileal conduit, neobladder etc.) 5. Significant cognitive impairment, which would limit their capacity to accurately report symptoms
Date of first enrolment	04/03/2026
Date of final enrolment	04/03/2030

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

NHS Greater Glasgow and Clyde

J B Russell House
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
Scotland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files	version 1.1	08/12/2025	07/01/2026	No	No
Participant information sheet	version 1.1	08/12/2025	07/01/2026	No	Yes
Participant information sheet	version 1.1	08/12/2025	07/01/2026	No	Yes
Protocol file	version 1.4	09/12/2025	07/01/2026	No	No

Additional files

48778_Protocol_v1.4_09Dec2025.pdf: Protocol file
48778_Consent form_V1.1_08Dec2025.pdf: Other files
48778_PIS_Phase I_V1.1_08Dec2025.pdf: Participant information sheet
48778_PIS_Phase II_V1.1_08Dec2025.pdf: Participant information sheet

Editorial Notes

22/01/2026: Study’s existence confirmed by the NHS Greater Glasgow and Clyde, Renal Services: Transplant Surgery, UK.