Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed IC

Interstitial Cystitis Clinical Trial

Official title:

Bladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223244
• Other study ID #: EH11-081
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2011
• Est. completion date: March 30, 2020

Study information

• Verified date: January 2022
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 30, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Painful Bladder Syndrome

Intervention

Drug:
• bupivacaine, triamcinolone, and heparin (BTH)
30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)
• dimethyl sulfoxide (DMSO)
50mL of DMSO and 1mL of triamcinolone (10mg/mL)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of at least 29.5% in ICSI score	reduction of at least 29.5% in ICSI score	6 weeks
Secondary	Bladder capacity	measurement of bladder capacity as determined by retro fill volume	6 weeks