DMSO Efficacy in IC/PBS Patients During and After Treatment

Not Applicable

• Conditions: Cystitis, Interstitial
• Interventions: Drug: DMSO cocktail

• Registration Number: NCT01074567
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 weeks, 3, 6 and 12 month).

Detailed Description

The modern treatment of IC is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g. Amitryptiline) and intra-vesical instillation (e.g. DMSO, steroids, heparin). These treatments were found to be effective in a number of studies and are approved by the FDA. However, the optimal duration of intra-vesical instilation is not known.

All patients with IC (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of DMSO. All patients will fill an O'leary-Sant questionaire and a urination diary before treatment, after 3, 6, 9 and 12 treatments and at 6 weeks, 3, 6 and 12 month after the end to the treatment.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Status Verified: 2010-03
• Last Update Submitted: 2011-04-04
• Last Update Posted: 2011-04-05
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• patients with IC according to International Continence Society:

  • more than 6 month of pelvic pain
  • urinary frequency, urgency, dyspareunia

Exclusion Criteria

• genitourinary tract infection
• known genitourinary malformation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DMSO cocktail	DMSO cocktail	intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%

Primary Outcome Measures

Name	Time	Method
O'leary-Sant interstitial cystitis symptom and problem questionaire	before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment

Secondary Outcome Measures

Name	Time	Method
urination diary	before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Zeriffin, Israel