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OpenTrials
Completed

NCT Number: NCT05223244

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupivacaine, triamcinolone, and heparin (BTH)

Drug

30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

Dimethyl sulfoxide (DMSO)

Drug

50mL of DMSO and 1mL of triamcinolone (10mg/mL)

Primary outcomes

  1. Reduction of at least 29.5% in ICSI score

    Time frame: 6 weeks

    reduction of at least 29.5% in ICSI score

Secondary outcomes

  1. Bladder capacity

    Time frame: 6 weeks

    measurement of bladder capacity as determined by retro fill volume

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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