Background: Baseline evaluation of the National Institutes of Health (NIH) Interstitial
Cystitis Clinical Research Network (ICCRN) bacille Calmette-Guérin study showed that
sexual functioning was one of the strongest predictors of poor quality of life (QOL) in
refractory patients diagnosed with interstitial cystitis/painful bladder syndrome (IC/PBS).
The purpose of this analysis was to examine the relationship between symptom reduction
and sexual functioning in patients with IC/PBS.
Methods: In a previously published, multicenter, randomized, clinical trial, patients with a diagnosis of IC/PBS underwent screening and baseline assessments, were randomized to treatment with 300 mg, 600 mg, or 900 mg pentosan polysulfate sodium (PPS) for 32
weeks, and completed the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI), the
Short Form (SF)-12 QOL questionnaire (physical and mental components), and the Medical Outcomes Study (MOS) sexual functioning scale. The MOS sexual functioning scale evaluates libido, arousal, orgasmic, and enjoyment parameters associated with sex, with higher scores representing better sexual functioning. This subanalysis represents those patients who were treated with 300 mg/day PPS (N=128) and completed the ICSI, SF-12, and MOS sexual functioning scale at 8, 16, 24, and 32 weeks (N=106). Treatment responders were defined as those achieving a ¡≥30% reduction in ICSI from baseline. An intent-to-treat, last observation-carried-forward (LOCF) analysis was performed.
Results: Mean baseline ICSI, SF-12 physical, SF-12 mental, and MOS sexual functioning scores were 12.4 (range 5 to 20), 41.7 (range 16 to 60), 46.3 (range 12 to 64), and 56.0 (range 0 to 100), respectively. Positive correlations were observed between the MOS sexual functioning scale and the SF-12 physical and mental components (0.20 and 0.30, respectively; P<.05). Patients showed significant improvement in ICSI and MOS sexual functioning scores over time from Week 8 through Week 32 (P<.05). At the end of study (Week 32, LOCF), among all patients, mean change from baseline in MOS sexual functioning scores was 8.9±32.9 (P=.0054). Responders (n=47; 44%), patients reporting a ¡≥30% reduction in ICSI, had a mean change in MOS sexual functioning score of 19.2±34.5, while nonresponders (n=59; 56%) had a mean change of 0.0±28.7 (between groups P=.0023). Reduction in ICSI score was moderately correlated with improvement in MOS sexual functioning score (r= -0.35; P=.0002) from baseline to study end point.
Conclusions: Sexual dysfunction was reported to be moderate to severe in patients with
IC/PBS and impacted QOL. Reduction in symptoms of IC/PBS was associated with
improvement in the patient-reported outcomes of sexual function.
Study funded by Ortho Women's Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc.