Hypothesis / aims of study
iAluRil® is the first Intravesical GAG replacement therapy designed to effectively and efficiently restore the bladder epithelium which has a protective function in preventing urinary tract infections and bladder pain. Current indications for the use of intravesical iAluRil® includes recurrent urinary tract infections, interstitial cystitis/painful bladder syndrome; chemical and radiotherapy induced cystitis caused by damage to the bladder lining by chemotherapy agents and pelvic radiotherapy respectively.
This study was a prospective study designed to evaluate the effectiveness of iAluril in our tertiary hospital, to understand the demographics of patient undergoing intravesical iAluril therapy and improve these patients’ symptoms and quality of life (QoL).
Study design, materials and methods
A prospective maintained database of all patients who had Intravesical glycosaminoglycans (GAG) replacement therapy within a 2-year period was reviewed. Patients’ demographics, Indication for iAluril administration, co-morbidity, investigations performed and treatment outcome were recorded. Pre-treatment quality of life (QoL) and post treatment PGI-I (Patient global impression of improvement) Scale were measured. For patients with recurrent UTIs, the number of infections/year, urine culture result (causative bacterial organism and antibiotic sensitivities) were also reviewed.
The following administration regimes was followed: for recurrent urinary tract infection, patients received weekly for 4 weeks, then monthly for 5 months with a total of 9 instillation. Patients with a diagnosis of chronic pelvic pain syndrome (CPPS) received weekly instillation for 4 weeks, then at weeks 6 and 8, the need for further instillation was agreed upon in our MDT and with the patients consent while patients with radiation /BCG cystitis received weekly intravesical instillation for 4 weeks, then at weeks 6, 8 and 12.
iAluRil was administered intravesical as a 50 ml bladder instillation via catheter (with Luer-Lock adapter) or using the ialuadapter®. Some of our patients performed self-administration of iAluRil following appropriate training.
Results
Outcomes are detailed in the table 1.
A total number of 48 patients received Intravesical GAG with (median age 55.1 years (18-81 year) and (Male 5, Female 43). Indications for therapy were chronic pelvic pain syndrome (CPPS): 26 (54.2%), recurrent urinary tract infection (UTI): 18 (37.5%), Radiation /BCG cystitis: 4 (8.3%). Overall, 37 (77.1%) of patients had good improvement on the PGI-I scale after the treatment, 10 patients (20.8%) had no improvement while receiving Intravesical GAG and 1 patient discontinued treatment (2.1%). Patients with CPPS benefited the most with 22 (84.6%) showing significant improvement in their quality of life
Interpretation of results
A total number of 48 patients received received intravesical iAluRil® within a 2 year period ( August 2020- August 2022). Most of our patients were females (89.5%) and this further illustrates the huge percentage of women suffering from chronic pelvic pain, recurrent UTIs and non-bacterial cystitis. These conditions significantly affects their quality of life leading to an increase in health care cost.
The commonest indication for administration in our hospital was chronic pelvic pain syndrome (CPPS) with 54.2% patients followed by recurrent UTIs 37.5%. Patients only received this therapy after exhausting other management modalities including conservative management. For recurrent UTIs, patients were adequately educated on general cystitis preventive measures, placed on appropriate antibiotics, methenamine hippurate and oestrogen cream for women with atrophic vaginitis.
Patients seen in our clinic were discussed in our functional urology MDT and the appropriate therapeutic regime was agreed and this was discussed with the patient either via a face to face or a telephone clinic appointment before commencing intravesical administration. All our patients were offered training/support on clean intermittent self catheterization by our specialist functional urology nurses.
Overall, 37 (77.1%) of patients had good improvement on the PGI-I scale after the treatment, 10 patients (20.8%) had no improvement while receiving Intravesical GAG and these cases was further discussed at our functional urology MDT with alternate treatment options offered to these patients. We noted that Patients with CPPS benefited the most with 22 (84.6%) showing significant improvement in their quality of life.
Overall, there was significant improvement in symptoms and quality of life in most of our patients.