Study design, materials and methods
Retrospective study
n=132 women age 25 to 80 years , clinically diagnosed as Bladder pain syndrome (bladder-centric)
Duration: 6 years and 3 months (June 2018 to September 2024), followed up till March 2025.
The participants were asked to record 3-day voiding diaries and scored for
1)O’Leary-Sant symptom and pain indices (ICSI and ICPI),
2)Pelvic pain Urgency and Frequency (symptom+bother score),
3)FGUPI,
4)BPIC-SS
After discussion of treatment options, by informed choice and consent,
52 patients (Group 1) chose to have behavioural modification + Amitriptyline +/- oral Pentosan polysulfate and
80 patients (Group 2) took weekly intravesical cocktail instillation, consisting of
Heparin 10000U, 25ml Bupivacaine 0.25%, Inj Triamcinolone 40mg and 50-100 ml of Inj Sodium bicarbonate 7.5%,
instilled aseptically through a transurethral catheter and left in situ for 30-60 minutes (dwell time) for 4-8weeks.
After completion of either modality of treatment, all the scores were repeated to evaluate and compare the outcome
All patients were followed up for 8-24 weeks.
Statistical analysis was done using two-sample t-test.
5) GRA (Global response assessment) was done at the end of the follow up period, on a Likert scale of 1-5
Adverse effects of the medicines, episodes of cystitis and disease flares, if any, were noted.
Results
There was improvement in the ICSI, ICPI, PPUF, FGUPI, BPIC-SS and GRA scores in both the groups
A comparative analysis between Group 2 (intravesical cocktail instillation) and Group 1 (Behavioural+/- Pharmacotherapy) demonstrated statistically significant improvements across all evaluated outcome measures.
Interstitial Cystitis Symptom Index (ICSI): t = 4.09, p = 0.000
Interstitial Cystitis Problem Index (ICPI): t = 4.33, p = 0.000
Bladder Pain Syndrome Score (BPSS): t = 5.31, p = 0.000
Symptom Score: t = 3.76, p = 0.00026
Female Genitourinary Score (FGU): t = 3.11, p = 0.0023
Global Response Assessment (GRA): t = 2.38, p = 0.0186
All p-values were statistically significant (p < 0.05), indicating superior outcomes in the Group 2
The improvement was faster in Group 2 as compared to Group 1 (statistically significant)
The side effects were more acceptable in Group 2 than in Group 1
No episode of cystitis or flares were noted in the follow up period in Group 2
Interpretation of results
Patients receiving intravesical cocktail instillation as an adjunct to first-line therapy experienced significant symptomatic relief and overall improvement in quality of life compared to those receiving first-line therapy alone or with pharmacotherapy (TCA+/-Pentosan polysulfate).
The recovery period in patients receiving Cocktail therapy was significantly shorter than in the comparative group.
The consistent statistical significance across all symptom indices and patient-reported outcomes and the faster recovery - reinforce the efficacy of the Intravesical cocktail instillation approach in managing bladder pain syndrome.
These findings align with AUA guidelines supporting Intravesical therapy as a second line therapy [1]
and previous studies highlighting the efficacy of Intravesical agents in symptom relief [2]