This retrospective study was conducted in accordance with the principles delineated in the World Medical Association Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects.” The study protocol received approval from the Institutional Ethics Committee (Approval Number: 05.03.2025.83, Date: 2025-03-07). All data were sourced from hospital records and patient confidentiality was maintained throughout the study.
A retrospective review was conducted of patients diagnosed with IC/BPS between January 2022 and June 2025. The inclusion criteria required the presence of symptoms consistent with IC/BPS as defined by the International Continence Society (ICS), characterized by bladder-related pain, pressure, or discomfort accompanied by at least one lower urinary tract symptom, such as urinary frequency or urgency [6].
Only patients with a follow-up period of at least 12 months were included in the study. The exclusion criteria included a positive urine culture, active vaginal infection, urolithiasis, genitourinary neoplasia, pelvic organ prolapse of stage ≥3 in any compartment according to the Pelvic Organ Prolapse Quantification System (POP–Q), pregnancy or lactation, a history of pelvic surgery, history of pelvic radiotherapy, those receiving active immunosuppressive therapy and known neurological disorders. Additionally, patients aged < 18 years and those with incomplete data were also excluded.
All patients underwent a thorough evaluation, which included detailed medical history, physical examination, urinalysis, urine culture, and cystoscopy. Patients with Hunner’s lesions identified during cystoscopy were excluded from the study due to their distinct pathophysiology and treatment response patterns, which may introduce clinical heterogeneity. The baseline demographic data, body mass index (BMI), and comorbidities were recorded. Patients who did not respond to initial lifestyle modifications, such as elimination of known bladder irritants (e.g., caffeine, artificial sweeteners, spicy foods) and bladder training, were considered for medical therapy.
Initially, all patients received oral PPS (Elmiron®, Janssen Pharmaceuticals, Titusville, NJ, USA) at a dose of 100 mg three times daily. PPS treatment was considered successful if patients reported at least “much improvement” on the PGI-C scale after a minimum treatment duration of three months and continued therapy due to perceived clinical benefit. Those who experienced inadequate benefits or adverse effects were transitioned to intravesical instillation of 80 mg 0.2% sodium chondroitin sulfate (Gepan® Instill, Pohl-Boskamp, Hohenlockstedt, Germany) administered once weekly for four sessions. Responders to this treatment received an additional four weekly sessions, followed by monthly maintenance instillations for up to one year.
Patients who exhibited either a lack of response or adverse effects following four sessions of intravesical sodium chondroitin sulfate instillation were subsequently offered an intravesical administration of Onabotulinum toxin A (Allergan, Irvine, CA, USA). This intervention involved the intravesical injection of 100 units of the toxin, diluted in normal saline, into the detrusor muscle via a cystoscopic technique. The injections were strategically administered at multiple sites evenly distributed across the bladder wall, employing a trigone-sparing approach. The procedure was performed under local or regional anesthesia, contingent upon patient preference and institutional protocols. Patients who received Onabotulinum toxin A were reassessed after one month, and if therapeutic benefits were observed, repeat injections were not performed routinely but were offered in cases of symptom recurrence following an initial favorable response.
Patients who did not respond to Onabotulinum toxin A were directed towards experimental therapies, including acupuncture, posterior tibial nerve stimulation (PTNS), or intravesical ozone instillation. Patient satisfaction was measured using the Patient Global Impressions of Change (PGI-C) scale, a seven-point Likert scale that assesses changes in clinical status. This scale rates patient satisfaction with surgery, with 1 indicating very much improvement, 4 indicating no change, and 7 indicating very much worse. PGI-C scales reflected patient-perceived symptom changes relative to the most recently initiated treatment modality, rather than baseline at initial diagnosis. A participant flowchart is provided in Figure 1 (Figure 1).
Therapeutic escalation was conducted in a systematic manner, guided by patient-reported outcomes and treatment tolerability. Patients were classified as insufficient responders if they exhibited no change or only minimal improvement on the PGI-C scale following an adequate duration of treatment, or if treatment was discontinued due to adverse effects. In such instances, patients were transitioned to the subsequent treatment modality in accordance with the predefined treatment algorithm.
Statistical Analysis
Statistical analyses were conducted using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables are reported as mean ± standard deviation or median (interquartile range (IQR)), contingent upon the distribution ascertained by the Shapiro–Wilk test. Categorical variables are presented as frequencies and percentages.
MATERIALS AND METHODS
This retrospective study was conducted in accordance with the principles delineated in the World Medical Association Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects.” The study protocol received approval from the Institutional Ethics Committee (Approval Number: 05.03.2025.83, Date: 2025-03-07). All data were sourced from hospital records and patient confidentiality was maintained throughout the study.
A retrospective review was conducted of patients diagnosed with IC/BPS between January 2022 and June 2025. The inclusion criteria required the presence of symptoms consistent with IC/BPS as defined by the International Continence Society (ICS), characterized by bladder-related pain, pressure, or discomfort accompanied by at least one lower urinary tract symptom, such as urinary frequency or urgency [6].
Only patients with a follow-up period of at least 12 months were included in the study. The exclusion criteria included a positive urine culture, active vaginal infection, urolithiasis, genitourinary neoplasia, pelvic organ prolapse of stage ≥3 in any compartment according to the Pelvic Organ Prolapse Quantification System (POP–Q), pregnancy or lactation, a history of pelvic surgery, history of pelvic radiotherapy, those receiving active immunosuppressive therapy and known neurological disorders. Additionally, patients aged < 18 years and those with incomplete data were also excluded.
All patients underwent a thorough evaluation, which included detailed medical history, physical examination, urinalysis, urine culture, and cystoscopy. Patients with Hunner’s lesions identified during cystoscopy were excluded from the study due to their distinct pathophysiology and treatment response patterns, which may introduce clinical heterogeneity. The baseline demographic data, body mass index (BMI), and comorbidities were recorded. Patients who did not respond to initial lifestyle modifications, such as elimination of known bladder irritants (e.g., caffeine, artificial sweeteners, spicy foods) and bladder training, were considered for medical therapy.
Initially, all patients received oral PPS (Elmiron®, Janssen Pharmaceuticals, Titusville, NJ, USA) at a dose of 100 mg three times daily. PPS treatment was considered successful if patients reported at least “much improvement” on the PGI-C scale after a minimum treatment duration of three months and continued therapy due to perceived clinical benefit. Those who experienced inadequate benefits or adverse effects were transitioned to intravesical instillation of 80 mg 0.2% sodium chondroitin sulfate (Gepan® Instill, Pohl-Boskamp, Hohenlockstedt, Germany) administered once weekly for four sessions. Responders to this treatment received an additional four weekly sessions, followed by monthly maintenance instillations for up to one year.
Patients who exhibited either a lack of response or adverse effects following four sessions of intravesical sodium chondroitin sulfate instillation were subsequently offered an intravesical administration of Onabotulinum toxin A (Allergan, Irvine, CA, USA). This intervention involved the intravesical injection of 100 units of the toxin, diluted in normal saline, into the detrusor muscle via a cystoscopic technique. The injections were strategically administered at multiple sites evenly distributed across the bladder wall, employing a trigone-sparing approach. The procedure was performed under local or regional anesthesia, contingent upon patient preference and institutional protocols. Patients who received Onabotulinum toxin A were reassessed after one month, and if therapeutic benefits were observed, repeat injections were not performed routinely but were offered in cases of symptom recurrence following an initial favorable response.
Patients who did not respond to Onabotulinum toxin A were directed towards experimental therapies, including acupuncture, posterior tibial nerve stimulation (PTNS), or intravesical ozone instillation. Patient satisfaction was measured using the Patient Global Impressions of Change (PGI-C) scale, a seven-point Likert scale that assesses changes in clinical status. This scale rates patient satisfaction with surgery, with 1 indicating very much improvement, 4 indicating no change, and 7 indicating very much worse. PGI-C scales reflected patient-perceived symptom changes relative to the most recently initiated treatment modality, rather than baseline at initial diagnosis. A participant flowchart is provided in Figure 1 (Figure 1).
Therapeutic escalation was conducted in a systematic manner, guided by patient-reported outcomes and treatment tolerability. Patients were classified as insufficient responders if they exhibited no change or only minimal improvement on the PGI-C scale following an adequate duration of treatment, or if treatment was discontinued due to adverse effects. In such instances, patients were transitioned to the subsequent treatment modality in accordance with the predefined treatment algorithm.
Statistical Analysis
Statistical analyses were conducted using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables are reported as mean ± standard deviation or median (interquartile range (IQR)), contingent upon the distribution ascertained by the Shapiro–Wilk test. Categorical variables are presented as frequencies and percentages.