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

NCT05223244 | Completed Phase 4

• 1 other identifier: EH11-081
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Interstitial Cystitis; Painful Bladder Syndrome

Keywords

dimethyl sulfoxide (DMSO); Intravesical instillations; bupivacaine, triamcinolone, and heparin (BTH); Bladder instillations

Outcome Measures

Primary Outcomes (1)

• Reduction of at least 29.5% in ICSI score

  reduction of at least 29.5% in ICSI score

  6 weeks

Secondary Outcomes (1)

• Bladder capacity

  6 weeks

Study Arms (2)

dimethyl sulfoxide (DMSO)

ACTIVE COMPARATOR

Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)

Drug: dimethyl sulfoxide (DMSO)

bupivacaine, triamcinolone, and heparin (BTH)

EXPERIMENTAL

Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

Drug: bupivacaine, triamcinolone, and heparin (BTH)

Interventions

bupivacaine, triamcinolone, and heparin (BTH) DRUG

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

bupivacaine, triamcinolone, and heparin (BTH)

dimethyl sulfoxide (DMSO) DRUG

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

dimethyl sulfoxide (DMSO)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed interstitial cystitis/painful bladder syndrome

You may not qualify if:

• History of pelvic radiation, a history of bladder cancer, or a history of bladder resection

Sponsors & Collaborators

• Endeavor Health: lead

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Bupivacaine; Triamcinolone; Heparin; Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Glycosaminoglycans; Polysaccharides; Carbohydrates; Sulfoxides; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, investigators, and outcomes assessors were blinded to treatment patients received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: At each of the six weekly treatment visits, bladder capacity was determined, followed by the intravesical treatment of either DMSO or BTH.

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: October 1, 2011
• Primary Completion: April 1, 2019
• Study Completion: March 30, 2020
• Last Updated: February 3, 2022

Record last verified: 2022-01