DMSO Efficacy in IC/PBS Patients During and After Treatment

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Cystitis, Interstitial

Treatments: Drug: DMSO cocktail

Study type: Interventional

Funder types: Other

Identifiers

NCT01074567

174/09

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

DMSO cocktail

Experimental group

Description:

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

Treatment:

Drug: DMSO cocktail