Prospective Trial Comparing Intravesical Chondroitin Sulphate 2% and DMSO in the Treatment of PBS/Interstitial Cystitis

NCT04268810 | Terminated Phase 4 DMC

• 2 other identifiers: S52212Uracyst study
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Painful bladder syndrome/interstitial cystitis (PBS/IC)is a disease of unknown origin with a significant impact on the quality of life. Next to oral treatment with tricyclic antidepressants or pentosan polysulphate, intravesical treatment can be used as well. The purpose of this treatment is to restore the protective lining of the bladder that consists of glycan structures (GAG). Currently only dimethylsulfoxide (DMSO) is FDA approved for this. Several other compounds have been introduced. We want to compare a solution of chondroitin sulphate 2% with the standard DMSO solution. We will compare the patient perception of benefit,but also pain scores, quality of life and micturition diaries.

Conditions

Painful Bladder Syndrome; Interstitial Cystitis

Keywords

painful bladder syndrome; interstitial cystitis; chondroitin sulphate; DMSO

Outcome Measures

Primary Outcomes (1)

• Global response assessment scale

  Primary endpoint: Global response assessment scale. This is a 7 point scale asking: As compared to when you started the current study, how would you rate your overall bladder symptoms now? Seven response options are given to the patient: Markedly worse, moderately worse, slightly worse, no change, slightly improved, moderately improved, markedly improved.

  4 weeks after last treatment

Secondary Outcomes (5)

• Urinary Frequency

  4 weeks after last treatment

• Nocturia Episodes

  4 weeks after last treatment

• Functional bladder capacity

  4 weeks after last treatment

• VAS pain scale

  4 weeks after last treatment

• O'Leary Sant

  4 weeks after last treatment

Other Outcomes (1)

• Drop-out

  any time during study

Study Arms (2)

Chondroitin sulphate 2%

EXPERIMENTAL

chondoritin sulphate 2% ( Uracyst) for bladder instillation. One bladeer instillation per week during 6 weeks.

Procedure: Bladder instillations

DMSO 50%

ACTIVE COMPARATOR

DMSO 50% in saline for bladder instillation. One bladder instillation per week during 6 weeks

Procedure: Bladder instillations

Interventions

Bladder instillations PROCEDURE

bladder instillations with either solution (DMSO or Uracyst)

Chondroitin sulphate 2%; DMSO 50%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients from 18-75 years
• A history of symptoms of bladder pain/discomfort described as suprapubic pain related to bladder filling, accompanied by other symptoms such as daytime and/or nighttime frequency in the absence of infection or other pathology, with or without the typical cystoscopic findings of interstitial cystitis
• Patients willing and able to complete the necessary questionnaires

You may not qualify if:

• Patients with transitional cell carcinoma of the bladder or other significant malignancy
• Pregnant women
• Breastfeading women
• Patients with significant bacteriuria
• Patients with hematuria
• Neurogenic bladder
• Patients with indwelling catheters
• Chronic bacterial prostatitis
• Currently receiving or having received investigational drugs thirty (30) days or less prior to screening
• Currently receiving or having had prior therapy with intravesical treatment (eg. Uracyst, Cystistat®, heparin or BCG)
• Receiving therapy for less than three months with antidepressants, antihistaminics, hormonal agonists or antagonists; hence patient not stabilized on therapy. (Stable therapy defined as continuous treatment for at least three months.)
• IC symptoms relieved by antimicrobials, anticholinergics or antispasmodics
• Functional Bladder capacity of greater than 400 ml
• Neurologic disease affecting bladder function; any previous surgery or procedure having affected bladder function
• Current diagnosis of chemical, tuberculous or radiation cystitis

Sponsors & Collaborators

• National Multiple Sclerosis Center: lead

Study Sites (1)

Urology, University Hospitals KU Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Tutolo M, Ammirati E, Castagna G, Klockaerts K, Plancke H, Ost D, Van der Aa F, De Ridder D. A prospective randomized controlled multicentre trial comparing intravesical DMSO and chondroitin sulphate 2% for painful bladder syndrome/interstitial cystitis. Int Braz J Urol. 2017 Jan-Feb;43(1):134-141. doi: 10.1590/S1677-5538.IBJU.2016.0302.

  PMID: 28124536 BACKGROUND

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Administration, Intravesical

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)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dirk JM De Ridder, MD, PhD

  University Hospitals KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2013
• First Posted: February 13, 2020
• Study Start: March 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: December 31, 2013
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

BE (1)