Interstitial Cystitis Archives

Major news on the Interstitial Cystitis front

Elmiron, the first and ONLY FDA-approved oral medication for the relief of bladder pain or discomfort associated with interstitial cystitis (IC) has been shown to be mostly ineffective.

This is going to be bad news(pyschologically) for a lot of suffering women and men who take this(and have grown dependent on it, mostly for the placebo effect it turns out) and haven't tried Skilled Relaxation and Pelvic Floor Physical Therapy.

Most women/men aren't even aware of Skilled Relaxation for IC, the vast majority of Urologists don't mention it(or know about it??), however this could be changing with the book A Headache in the Pelvis and the positive results more people are having with this(and Dr. Stoll's) approach.

The Journal of Urology September 2003; 170(3):810-81

A Pilot Clinical Trial of Oral Pentosan Polysulfate And Oral Hydroxyzine in Patients With Interstitial Cystitis

G. R. SANT; K. J. PROPERT; P. M. HANNO; D. BURKS; D. CULKIN; A. C. DIOKNO; C. HARDY; J. R. LANDIS; R. MAYER; R. MADIGAN; E. M. MESSING; K. PETERS; T. C. THEOHARIDES; J. WARREN; A. J. WEIN; W. STEERS; J. W. KUSEK; L. M. NYBERG; the Interstitial Cystitis Clinical Trials Group

ABSTRACT

Purpose:

This pilot study was designed to evaluate the feasibility of a multicenter, randomized, clinical trial in interstitial cystitis (IC). Secondary objectives were to evaluate the safety and efficacy of oral pentosan polysulfate sodium (PPS), hydroxyzine, and the combination to consider their use in a larger randomized clinical trial.

Materials and Methods:

A 2 × 2 factorial study design was used to evaluate PPS and hydroxyzine. Participants met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency for a minimum of 6 months before study entry. The primary end point was a patient reported global response assessment. Secondary end points included validated symptom indexes and patient reports of pain, urgency and frequency. The target sample size was 136 participants recruited during 10 months.

Results:

A total of 121 (89% of goal) participants were randomized over 18 months and 79% provided complete followup data. The response rate for hydroxyzine was 31% for those treated and 20% for those not treated (p = 0.26). A nonsignificant trend was seen in the PPS treatment groups (34%) as compared to no PPS (18%, p = 0.064). There were no treatment differences for any of the secondary end points. Adverse events were mostly minor and similar to those in previous reports.

Conclusions:

The low global response rates for PPS and hydroxyzine suggest that neither provided benefit for the majority of patients with IC. This trial demonstrated the feasibility of conducting a multicenter randomized clinical trial in IC using uniform procedures and outcomes. However, slow recruitment underscored the difficulties of evaluating commonly available IC drugs.

Key Words: clinical trial, hydroxyzine

Major news on the Interstitial Cystitis front (drug bites the dust) Archive