The treatment of Bladder Pain Syndrome (BPS) remains clinically challenging and typically requires a multimodal approach. Management often begins with conservative measures, such as dietary modifications and physical therapy. If symptoms persist, oral medications or intravesical instillations are employed to repair the bladder lining and reduce chronic inflammation.
According to the EAU Guidelines on Chronic Pelvic Pain, glycosaminoglycan (GAG) layer replenishment therapy—including intravesical instillations of hyaluronic acid, chondroitin sulfate, or a combination of both—is a recommended treatment option for BPS. These substances aim to restore the protective lining of the bladder mucosa, thereby reducing permeability and alleviating pain symptoms. The aim of this study was to evaluate the efficacy of a new compound containing purified colostrum and chondroitin sulfate sodium (Controcyst®) in the treatment of BPS.

We conducted a prospective, interventional, non-inferiority pilot study comparing the new compound (Controcyst®) with a standard hyaluronic acid/chondroitin sulfate compound (Ialuril Prefill®). A total of 40 female patients with BPS were randomized 1:1 into two groups: 
•Group A: Received instillations of Controcyst®. 
•Group B: Received instillations of Ialuril Prefill®. 
Patients were evaluated before and after a cycle of 8 weekly intravesical administrations using the Visual Analogue Scale (VAS) for pain, the International Prostatic Symptoms Score (IPSS), and the IPSS Quality of Life (QoL) index. At the end of the treatment, patients completed the Patient-Global-Impression of Improvement (PGI-I) scale. Follow-up visits were scheduled at 3 and 6 months. Non-inferiority was defined as a reduction in VAS for pain in Group A that was at least 80% of the reduction observed in Group B.

All 40 patients (age range 33–76 years) completed the study. Baseline characteristics were comparable between the two groups. 
• Group A (Controcyst®): VAS decreased from 4.75 to 2.95 (p=0.01); IPSS decreased from 18.25 to 14.00 (p=0.045); IPSS QoL improved from 3.8 to 2.55 (p<0.01); Mean PGI-I was 2.35. 
• Group B (Control): VAS decreased from 4.9 to 3.05 (p=0.01); IPSS decreased from 19.1 to 16.05 (p=0.04); IPSS QoL improved from 4.8 to 3.15 (p<0.01); Mean PGI-I was 2.85. 
Follow-up at 3 and 6 months confirmed that these improvements remained stable over time. Non-inferiority was successfully demonstrated, as both groups showed a nearly identical reduction in VAS pain scores (-37.9% in Group A vs. -37.8% in Group B).

Although this pilot study presents preliminary data, the results are highly promising. The significant reduction in VAS and IPSS scores suggests that Controcyst® is not only non-inferior to established GAG-replenishment therapies but may offer additional synergistic benefits due to the inclusion of purified colostrum in the product. The colostrum extract enriches the microenvironment with proteins, which perform a trophic action and contribute to maintaining the integrity of the tissue. This dual action—restoring the GAG layer via chondroitin sulfate while promoting tissue healing via colostrum—could explain the superior trend in IPSS reduction observed in Group A.

These preliminary data indicate that the new compound containing purified colostrum and chondroitin sulfate sodium is an effective and safe option for treating BPS and associated lower urinary tract symptoms. Its ability to reduce pain and improve quality of life warrants further investigation in larger, multicenter randomized controlled trials.