Category: Clinical Stones: Medical Management

MP10-6 - Randomized clinical trial on urinary pH monitoring and nutraceutical intervention in the prevention of ureteral stent calcification: preliminary results

Fri, Sep 21
2:00 PM - 4:00 PM

Introduction & Objective :

Use of double J ureteral stent is widely extended in the management of obstructive uropathy. One of the more common complications associated with its use is calcification, which can even impede its removal depending on the incrustation severity. It is known that stent calcification is related to urinary pH. We are conducting a clinical trial to evaluate the efficacy of a monitoring medical device with a nutraceutical (NC) in the control of urinary pH to prevent calcification in patients indwelling a double J ureteral stent.


Methods :

This is a multicenter, controlled, double blind and randomized clinical trial conducted in Spain with an expected sample size of 105 patients. The main inclusion criterion selects patients with a recent (less than a week) or already scheduled double J ureteral stent implantation. Patients with radiolucent stones or known cystine or uric acid stone formers were excluded. Patients are randomized into two groups: experimental (device + NC) or control (device + placebo). The device used is a pH meter and the NC is a protected formulation combining urine acidifiers and crystallization inhibitors. Urinary pH is monitored daily. Dose of NC and placebo is 3 capsules/day. The maximum double J indwelling period should not exceed 8 weeks to be acceptable for the statistical analysis (Figure 1). All data is registered in an eCRD.


Results :

Interim results from 56 patients are presented (Table 1). A urinary pH reduction on day 21 vs. day 1 was observed: in the control group from 6.1 (±0.6) to 5.9 (±0.6) (p = 0.142) and in the experimental group from 6.2 (±0.4) to 5.6 (±0.6) (p < 0.0001, Figure 2). Furthermore, stent removal on the first attempt in the experimental group was 100% compared to the control group 81% (p = 0.022, Figure 2).


Conclusions :

The combined use of a urinary pH meter device with a nutraceutical in patients indwelling a double J ureteral stent could result in fewer calcifications, making the removal process easier for the urologist and safer for the patient. 

Jaime Fernández-Concha

Urology resident
Lithiasis Unit, Hospital Universitari de Bellvitge
Barcelona, Catalonia, Spain

I was born the 9th of October of 1986 in Lima, Perú. I decided upon medicine as a career towards the end of highschool and studied in Lima. After I graduated as a physician there, I applied for the Urology Residency in Spain and got into one of the best hospitals in Barcelona. Now I'm a 5th year resident with a soft spot for Lithiasis.

Carlos Torrecilla

Urologist
Lithiasis Unit, Hospital Universitari de Bellvitge
Barcelona, Catalonia, Spain

Jordi Cuñé

Medical Director - R&D Director Medical Foods
Devicare
Barcelona, Catalonia, Spain