Hypothesis / aims of study
To describe the early real-world outcomes of intravesical instillations with chondroitin sulfate and bovine colostrum (Controcyst) in women with recurrent urinary tract infection (rUTI) and bladder pain syndrome/interstitial cystitis (BPS/IC), and to characterise the baseline clinical profile of both phenotypes in routine practice.
Study design, materials and methods
A prospective observational real-world clinical practice study was conducted at two referral centres. Patients with BPS/IC and/or recurrent urinary tract infection (rUTI) treated with a standardized protocol of intravesical instillations of chondroitin sulfate and bovine colostrum were included. All patients received four initial weekly instillations, followed by two maintenance instillations at weeks 8 and 12. Assessments were performed at weeks 0, 4, 8, and 12, including bladder pain measured using the Visual Analogue Scale (VAS), urinary symptoms and quality of life assessed with the BPIC-SS and CACV questionnaires, global perception of improvement measured with the PGI-I, as well as infection-related variables such as the number of symptomatic UTIs and time to recurrence.
Results
At the time of analysis, 14 patients had available clinical data: 11 for rUTI subgroup and 3 to the bladder pain/BPS subgroup.
In the rUTI subgroup, all patients were women. Among the 10 evaluable patients with follow-up, mean age was 62.0 ± 17.3 years, with a median of 69 years (IQR 53.3–75.3). Seven patients (70%) were postmenopausal and three (30%) reported postcoital UTI. Symptom duration was prolonged, with a mean of 35.5 ± 48.3 months and a median of 20 months (IQR 12–33). Baseline infectious burden was high, with a mean of 9.3 ± 2.2 UTIs/year and a median of 9 episodes (IQR 8–12). Most patients had received multiple preventive strategies before inclusion: 90% probiotics/nutraceuticals, 90% prophylactic antibiotics, and 50% autovaccines.
Mean follow-up was 103 ± 58.9 days, with a median of 90 days (IQR 65–142.5). Seven of ten patients (70%) completed the full 12-week protocol, whereas 3/10 (30%) discontinued treatment early before weeks 4 due to early recurrence or insufficient benefit rather than adverse events. No discontinuations were related to safety. Baseline and recurrence microbiology showed predominance of Escherichia coli, including ESBL+. Kaplan-Meier analysis showed an early decline in infection-free survival followed by stabilisation. At 3 months, approximately 60% of patients remained recurrence free.
In the bladder pain/BPS subgroup, mean age was 33.3 ± 9.2 years, with a median of 28 years (IQR 28–36). Mean follow-up was 186.7 ± 11.5 days, with a median of 180 days (IQR 180–190). No UTIs or adverse events occurred. Progressive improvement was observed across all patient-reported outcomes. Mean VAS pain decreased from 5.0 ± 1.7 at baseline to 2.0 ± 0.0 at week 12; BPIC-SS from 18.3 ± 11.0 to 11.3 ± 4.0; CACV symptom and bother scores were both 3.3 ± 2.3 at week 12; and PGI-I was 2.33 ± 0.58, consistent with patient-perceived improvement.
Interpretation of results
These early real world findings suggest that intravesical chondroitin sulfate and bovine colostrum may provide clinically meaningful benefit in two distinct chronic bladder phenotypes. In rUTI, despite a refractory baseline profile with high infectious burden and resistant microorganisms, 60% of evaluable patients remained recurrence-free during early follow-up. In bladder pain/BPS, improvement was consistent across pain, symptom burden, and global impression, supporting a benefit beyond transient fluctuation.
Concluding message
Intravesical chondroitin sulfate and bovine colostrum showed encouraging early real-world outcomes and excellent tolerability in both rUTI and bladder pain/BPS phenotypes. In rUTI, despite high baseline disease burden, 60% remained recurrence-free during early follow-up. In bladder pain/BPS, consistent symptom improvement was observed across pain, urinary symptoms, and global impression of improvement. These preliminary findings support further prospective studies with larger phenotype-stratified cohorts.