Hypothesis / aims of study
The International Continence Society (ICS) defines Painful Bladder Syndrome (PBS) as suprapubic pain during bladder filling, along with increased frequency(1), without proven infection or clear cause. Diagnosis is challenging due to symptom overlap with other conditions like Urinary Tract Infection or endometriosis. The prevalence of PBS varies from 0.01% to 2.3% due to different study populations and definitions(2).
The exact cause of PBS is unknown. The various proposed mechanisms includes chronic infection, bladder urothelium issues, mast cell activation, autoimmune factors and nervous system dysfunction. Treatments targeting these mechanisms have had mixed results. PBS is found to be associated with other pain syndromes like irritable bowel syndrome, chronic fatigue syndrome, and fibromyalgia, suggesting a unique phenotype within this complex condition.
PBS commonly presents as pelvic discomfort with urinary urgency and frequency. Pain, pressure sensations, burning, throbbing pain are also experienced. Discomfort worsens with bladder filling and lessens with voiding. Severe cases may have continuous discomfort in various regions. PBS impacts quality of life through urological symptoms causing sexual dysfunction and psychological disorders.
The American Urological Association recommends conservative therapies as the primary treatment for PBS, including behavior modifications, physiotherapy, and oral medications. Second-line options include amitriptyline, cimetidine, hydroxyzine, or pentosane polysulfate. These drugs may help with symptoms but can have adverse side effects. Intravesical Hyaluronic acid instillation is a third-line treatment for PBS/Interstitial cystitis.
We aim to discuss intravesical treatment for patient with PBS and its effectiveness.
Study design, materials and methods
This retrospective study was undertaken at a tertiary hospital located in India, spanning over a period of eighteen months from January 2022 to July 2023. The Institutional Review Board of the hospital granted approval for this study protocol (No.AIIMSA00009). Prior to participation in the study, every patient provided written informed consent. A total of eighteen patients who underwent cocktail therapy for PBS were recruited. Case files were retrieved. The pre-treatment evaluation involved a detailed examination of the patient's medical history, urine analysis, and functional bladder capacity assessment. Also O'Leary-Sant index and a 10- point pain visual analog scale(VAS), were conducted to monitor symptomatic improvement before and after treatment. O'Leary-Sant Interstitial Cystitis symptom index (ICSI) and problem index (ICPI) both include 4 questions that assess the severity of urgency, frequency of urination, nocturia and level of bladder pain in the previous 4 weeks. Each of the questions was rated on a severity scale of 0–5. The total scores for symptom and problem score were then calculated. After ruling out urinary tract infection, we recommend behavioral modifications such as avoiding spicy foods, practicing relaxation exercises or reverse kegel exercise. Furthermore, we prescribe amitriptyline 5mg at night to our patients.
All patients underwent 4 cycle of intravesical cocktail regimen as used by Lukban et al(3) .They used 50 ml 0.5% bupivacaine(long acting analgesic),100mg hydrocortisone(Anti inflammatory), 50 ml 8.4% NaHCO3( urinary alakalization), 80 mg Gentamicin(antibiotic), 10000 IU heparin (Glycosaamineglycans replacement). We, in our institute followed same regimen except we used dexamethasone 4mg instead of hydrocortisone and Lignocaine in place of bupivacaine. All patient received four weekly intravesical instillations containing 100ml cocktail solution for 4 cycles.The treatment regimen lasted for 4 months, with patients retaining the solution for 30 minutes before voiding. The study compared treatment outcomes at first treatment cycle , at 3 month and at 6 months post-treatment, defining success as moderate to marked improvement in symptoms.
Clinical data were analyzed using statistical methods in SPSS version 20, with a significance level set at p<0.05. The study presented results in mean ± standard deviation or percentage format, based on the variables assessed. The treatment regimen and evaluation methods were consistent with previous studies, with minor modifications in medication choices.
Results
All questionnaires were completed both prior to and following the cocktail treatment, utilizing case files as well as telephonic correspondence, which were included for data analysis. .The average age of the 18 patients diagnosed with PBS at the onset of treatment was 41.5+6.03 years old. The mean duration of their symptoms was 4.5 years, ranging from 1 to 11 years prior to receiving therapy. In comparison to before treatment, there were notable improvement in frequency, nocturia, bladder capacity, VAS pain score, ICSI(Interstitial cystitis symptom score) and ICPI ( Interstitial cystitis problem score) after six months of cocktail therapy with sustained improvements lasting up to nine or twelve months post-treatment. At six months following cocktail therapy, a significant majority (72.2%) of patients reported moderately or markedly improved responses; this figure remained high at nine months post-treatment with approximately 77.7% (15) showing improvement in symptoms severity levels as well.
Interpretation of results
The painful bladder syndrome is an incapacitating condition that significantly impairs the quality of life for patients. With this cocktail regimen, almost 77.7% of patients have shown moderate to marked improvements in their symptoms during the follow-up period and also show improved VAS score. However, one patient relapsed and had to restart on cocktail therapy while two others reported no relief from their symptoms despite treatment.