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Status unknownNCT01074567Updated Apr 5, 2011

DMSO Efficacy in IC/PBS Patients During and After Treatment

An interventional study of DMSO cocktail in Cystitis, Interstitial, sponsored by Assaf-Harofeh Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-05.

Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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).

Read the 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.

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Conditions studied

  • Cystitis, Interstitial
03

In context

Cystitis

235 studies on the registry are indexed under Cystitis; 22 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 170 interventional studies indexed under Cystitis.

Browse Cystitis studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • patients with IC according to International Continence Society:

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

Exclusion criteria

Exclusion Criteria:

  • genitourinary tract infection
  • known genitourinary malformation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    DMSO cocktail

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

    Drug: DMSO cocktail

Interventions

  • DrugDMSO cocktail

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

    Also known as: Dimethyl sulfoxide

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What researchers measure

Primary outcomes

  1. O'leary-Sant interstitial cystitis symptom and problem questionaire

    Time frame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment

Secondary outcomes

  1. urination diary

    Time frame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment

07

Study locations

1 of 1 sites recruiting
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01074567
Lead sponsor
Assaf-Harofeh Medical Center
First posted
Feb 24, 2010
Start date
Dec 2009
Primary completion
Dec 2011 (estimated)
Completion
Dec 2012 (estimated)
Last update
Apr 5, 2011

Study contacts

Kobi Stav, MD
Contact
stavkobi@gmail.com
+972-8-9779400
Miki Haifler, MD
Contact
mikihaifler@gmail.com
+972-8-9401
Kobi Stav, MD
principal investigator · Assaf-Harofe MC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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