Interstitial Cystitis, Painful Bladder Syndrome
Conditions
Keywords
dimethyl sulfoxide (DMSO), Intravesical instillations, bupivacaine, triamcinolone, and heparin (BTH), Bladder instillations
Brief summary
A comparative study of subjective outcomes following intravesical treatment of interstitial cystitis (IC) is lacking in the literature. Furthermore, an objective measure to determine the efficacy of intravesical treatment for interstitial cystitis has yet to be defined. Change in bladder capacity following therapy has been investigated; however, a formal statistical analysis of its utility in determining efficacy has yet to be performed. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in subjective improvement in IC symptoms in women with newly diagnosed IC when treated with either dimethyl sulfoxide (DMSO) or bupivacaine, triamcinolone, and heparin (BTH) instillations. The secondary objective is to determine whether change in bladder capacity can be used as an objective measure of response to intravesical therapy for newly diagnosed interstitial cystitis. Our long-term goals are to improve the scientific understanding of therapy for interstitial cystitis, to improve patient counseling prior to initiation of treatment, and to better identify patients likely to receive inadequate relief of symptoms following intravesical treatment so that an alternative treatment can be pursued.
Interventions
DRUGbupivacaine, triamcinolone, and heparin (BTH)
30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)
50mL of DMSO and 1mL of triamcinolone (10mg/mL)
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients, investigators, and outcomes assessors were blinded to treatment patients received
Intervention model description
At each of the six weekly treatment visits, bladder capacity was determined, followed by the intravesical treatment of either DMSO or BTH.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed interstitial cystitis/painful bladder syndrome
Exclusion criteria
* History of pelvic radiation, a history of bladder cancer, or a history of bladder resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of at least 29.5% in ICSI score | 6 weeks | reduction of at least 29.5% in ICSI score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bladder capacity | 6 weeks | measurement of bladder capacity as determined by retro fill volume |
Outcome results
None listed