Intractable ureteric obstruction Urological and Genital Diseases
Conditions
Interventions
Potentially eligible patients will be approached before the stent surgery is due to take place, either during routine clinic visits and /or by sending a study invite letter. At this point, a copy of t
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Dependent on JJ stent for management of unilateral or bilateral ureteric obstruction 2. Benign or malignant obstruction 3. Life expectancy of more than 2 years 4. Renal unit function of more than 20, as assessed by nuclear medicine scan 5. Normal ureter below and above the level of obstruction as observed by retrograde pyelogram or ureteroscopy 6. Stricture not suitable or patient unfit for reconstructive surgery (OR patient choice as documented in clinic letter or medical notes) 7. Fit to undergo retrograde MK-051 insertion under general or regional anaesthesia
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years 2. Allergy to nickel 3. Renal unit function less than 20, as assessed by nuclear medicine scan 4. Pelvic ureteric junction (PUJ) involved in stricture 5. Vesico-ureteric junction (VUJ) involved in stricture 6. Primary PUJ obstruction or Mega Ureter 7. Not on JJ stent 8. Life expectancy less than 2 years 9. Previous active stone (stones present in the kidney, metabolic stone disease, forming stones within 2 years before recruitment) 10. Disease that requires ureteric instrumentation for treatment 11. Lack of capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life is measured using EQ-5D on two occasions 3 months apart with JJ stent in situ, and after Memokath insertion at 3, 6, 12, 18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stent-related symptoms are measured using the validated Urology Stent Symptom Questionnaire (USSQ) on two occasions 3 months apart with JJ stent in situ, and after Memokath insertion at 3, 6, 12, 18 and 24 months. 2. Renal function preservation is measured using estimated glomerular filtration rate (eGFR) and nuclear medicine scan once with JJ stent in situ. After Memokath insertion eGFR is checked at 3, 6, 12, 18 and 24 months. Nuclear medicine scan is performed at 3, 12 and 24 months. 3. Cost-effectiveness measured using NHS resource use data capture on two occasions 3 months apart with JJ stent in situ, and after Memokath insertion at 3, 6, 12, 18 and 24 months. 4. The longevity of Memokath is measured by observing the function and drainage of the renal units after Memokath insertion by eGFR and X-ray KUB at 3, 6, 12, 18 and 24 months. Nuclear medicine scan is performed at 3, 12 and 24 months. | — |
Countries
England, United Kingdom
Outcome results
None listed