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Renal, Urogenital

ALTAR - Closed

ALTAR- Alternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women

  • Study stage: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Renal and Urogenital
  • Type of study: CTIMP

Aim: A multicentre, pragmatic patient-randomised non-inferiority trial comparing two drugs for the prevention of recurrent urinary tract infection in women both during a 12-month period of use and in the subsequent 6-months following completion of the prophylactic medication. 

Primary outcome: To determine the relative clinical effectiveness and cost-effectiveness for the NHS of two types of licensed preventative treatments for women with recurrent uncomplicated urinary tract infection (rUTI) over a 12 month treatment period.

  • Population: Adult
  • Clinical Phase: Phase IV
  • Design: RCT, Qualitative and Health Economic
  • Setting: Secondary Care

Antic - Closed

Treatment for Intermittent Bladder Catheterisation: A Randomised Controlled Trial of Once Daily Prophylaxis 

  • Study stage: Closed
  • Sponsor: Newcastle upon Tyne Hospital
  • Funder: NIHR HTA
  • Therapeutic area: Renal and Urogenital
  • Type of study: CTIMP

Aim: To determine whether antibiotic prophylaxis results in a clinically significant reduction in the rate of symptomatic, antibiotic-treated urinary tract infection suffered by people performing intermittent self bladder catheterisation over 12 months and is cost-effective for the UK NHS

Primary Outcome:

Relative incidence of symptomatic antibiotic-treated UTI between the trial groups over 12 months

  • Population: Adult
  • Design: Pragmatic, superiority patient RCT
  • Setting: Secondary Care

I-KID - Closed

I-KID - Infant Kidney Dialysis and filtration – Evaluation of Efficacy, Outcomes and Safety of a New Infant Haemodialysis and Ultrafiltration Machine in Clinical Use

  • Study stage: Closed
  • Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR - Efficacy and Mechanism Evaluation Programme (EME)
  • Therapeutic area: Renal and Urogenital
  • Type of study: Clinical Investigation (non-CE Marked Device)

Aim: To compare the Newcastle Infant Dialysis Ultrafiltration (NIDUS) machine with the other existing renal replacement therapy methods (including Peritoneal Dialysis (PD), and Continuous Haemofiltration and Dialysis (CVVH-D)) in order to make recommendations about which machine should be used in the future for babies under 8kg. Conventional dialysis machines currently used in practice have been adapted from systems for larger babies and adults. The NIDUS has been designed especially for babies who weigh less than 8kgs who are receiving dialysis in PICU (Paediatric Intensive Care Unit).

Primary outcome: Accuracy of fluid removal compared with prescription – a measure that includes fluid removal prevision of the dialysis system (Does the dialysis methodology provide the hourly fluid removal that the clinical team wanted?).

  • Population: Paediatrics
  • Design: Stepped wedge
  • Setting: Secondary Care
  • Planned Sample Size: 95

Multi-Cath - In Follow-up

A non-inferiority randomised controlled trial to compare mixed (multi/single-use) catheter management with single-use catheter management by intermittent catheter users over 12 months.

  • Study stage: In Follow-up
  • Sponsor: University of Southampton
  • Funder: National Institute for Health Research (NIHR) Programme Grant for Applied Research programme (PGfAR)
  • Therapeutic area: Renal and Urogenital
  • Type of study: CE Marked Device

Aim: To determine if a strategy of intermittent urinary catheter mixed use is no worse than a strategy of intermittent urinary catheter single (sterile) use only, in terms of incidence of microbiologically-confirmed symptomatic and help-seeking UTI over 12 months (post two week learning period) using a randomised controlled trial design.

Primary Outcome:

At least one episode over the 12 month follow-up period of Microbiologically Confirmed Symptomatic Urinary Tract Infection with Help-seeking behaviour (MC SH- UTI ) defined as:

  • Presence of at least one sign or symptom (S; new or worsening; listed on the trial symptom set or other symptoms reported by the participant)

AND

  • Help-seeking behaviour (i.e. participant seeks help and/or treatment from GP/researcher or other HCP or implements own self-help strategy e.g. increase fluid intake, self-administration of antibiotics)

AND

  • ⩾103 colony-forming units (cfu)/mL of ⩾1 bacterial species in a single catheter urine specimen during a symptomatic episode before or after starting antibiotic treatment.

 

  • Population: Adult
  • Design: RCT and Health Economics
  • Setting: Primary and  Secondary Care

Website: https://www.southampton.ac.uk/multicath/index.page

Open - Closed

Clarifying the management of men with recurrent urethral stricture:a pragmatic, randomised, multicentre superiority trial of open urethroplasty versus endoscopic urethrotomy

  • Study stage: Closed
  • Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Renal and Urogenital
  • Type of study: Surgical

Aim:

1. Determine the intervention for recurrent bulbar urethral stricture that offers the most effective symptom control over 24 months.

2. Determine the relative cost-effectiveness of each intervention over 24 months.

Primary outcome:

Area under curve (AUC) for serial repeated measurement of ICIQ-Male Short Form (ICIQ-Male SF) questionnaire over 24 months following randomisation.

  • Population: Adults (males)
  • Design: Pragmatic RCT, Qualitative and Health Economics.
  • Setting: Secondary Care
  • Planned Sample Size: 210

Website: www.opentrial.co.uk

SETS - aHUS - Closed

SETS aHUS: Stopping Eculizumab Treatment Safely in aHUS - Multicentre, open label, prospective, single arm study of the safety and impact of eculizumab withdrawal in patients with atypical haemolytic uraemic syndrome

  • Study stage: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Renal and Urogenital
  • Type of study: CTIMP (Rare disease)

Aim: To establish an evidence base for an alternative treatment strategy for patients with aHUS that includes the use of Eculizumab to establish remission, safe withdrawal of treatment and the reintroduction of Eculizumab in those patients who relapse. 

Primary outcome:

To determine the safety of Eculizumab withdrawal in patients with Ahus

  • Population: Adults and Paediatrics
  • Clinical Phase: Phase IIb
  • Design: Cohort
  • Setting: Secondary care

Website: http://www.atypicalhus.co.uk/clinical-trials/sets-ahus-2/

PREMISE - Recruiting

A randomised controlled trial of minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate in the National Health Service

  • Study stage: Recruiting
  • Sponsor: Newcastle upon Tyne Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Renal and Urogenital
  • Type of study: Surgical

Aim: To compare the clinical effectiveness of 3 minimally invasive treatments (MITS) to transurethral resection of prostate (TURP) for treatment of bladder outlet obstruction (BOO) due to enlarged prostate over 12 months

Primary Outcome: Change in international prostate symptom score (IPSS) from baseline to 12 months post-intervention

  • Population: Adult
  • Design: Multi-arm, multi-centre, non-inferiority randomised controlled trial, with 6-month internal pilot
  • Setting: Secondary care
  • Planned Sample Size: 536
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