Interstitial cystitis/bladder pain syndrome (IC/BPS) symptoms appear bladder related, though little solid evidence exists linking IC/BPS symptoms to dysfunctional bladder epithelium unless ulcers are present. Growing evidence suggests that the bladder may be an innocent bystander in a more diffuse pelvic.  More than 80% of patients with IC/BPS have documented pelvic floor dysfunction on exam.[1] The NIH and industry have sponsored many clinical trials for IC/BPS with treatments directed toward the bladder and most have been no better than placebo.  Two studies were completed by the NIDDK comparing pelvic floor physical therapy to a general body massage and both showed statistically significant improvement in symptoms for those receiving intravaginal or intrarectal myofascial release.[2],[3]   The study objective is to compare IC/BPS symptom improvement in pelvic floor versus bladder directed therapies.

Women 18 to 85 years with history of IC/BPS were randomized to one of two treatment arms: 1. Pelvic Floor Physical Therapy (PFPT), 2. Bladder directed instillation of lidocaine, heparin sulphate, sodium bicarbonate, and Kenalog. All participants received twice weekly treatments for 8 consecutive weeks. Symptom improvement was assessed using 3-day voiding diary, pain assessment, and validated questionnaires: global response assessment (GRA), Interstitial cystitis symptom index (ICSI) and Interstitial cystitis problem index (ICPI), at baseline, treatment mid- and endpoints (V8 and V17), and 6 months follow-up (V18). Statistical analysis was performed using ANOVA followed by Dunnett’s multiple comparison.

31 women were enrolled and randomized to PFPT (n=15) or Instillation (n=16) arm with average age of 46.8 (±14.2) and 48.7 (±14.1) respectively. By end of treatment 67% in PFPT versus 54% in instillation group reported significant improvement of symptoms (GRA). Urinary frequency was significantly reduced in PFPT group at all time points (Fig 1A) and was resolved or improved in 75% of patients in PFPT compared to 33% in instillation group. Both treatments achieved the minimal important difference of at least 2 points on a 10-point visual analog scale for maximum pelvic pain (Fig 1B) and demonstrated a significant reduction in pain on the ICSI pain score. Pain Catastrophizing Scale scores followed the same trend. Urgency did not improve with either treatment. ICSI and ICPI scores were significantly reduced by V8 and remained constant up to V18. No severe adverse events were reported. Four patients developed urinary tract infections during treatment, 1 in PFPT and 3 in instillation group.

IC/BPS is difficult to manage. The name implies that it is a bladder disorder, and many patients are given bladder directed therapies that often fail.  Clinically, IC/BPS is a syndrome that may have many triggers that lead to pain and voiding dysfunction.  A common finding on physical examination is the presence of severe pelvic floor muscle spasm and tenderness.  This spastic pelvic floor can lead to bladder and bowel dysfunction along with dyspareunia and pelvic pain. The purpose of this study was to compare bladder directed treatment to pelvic floor directed therapy. This preliminary analysis demonstrates that both PFPT and bladder instillations can improve symptoms of IC/BPS, but PFPT has a more durable response in reducing urinary frequency and improving the Global Response Assessment. Patients continue to be enrolled and long-term follow up is being collected.  In the future, this database will allow us to examine the durability of symptom change and the impact of baseline pelvic floor dysfunction and psychologic profile on clinical outcomes.

Both treatments significantly improved IC/BPS symptoms, with patients in PFPT reporting higher GRA scores and frequency improvement.

Peters, KM, Carrico DJ, Kalinowski SE, Ibrahim IA, Diokno AC. Prevalence of pelvic floor dysfunction in patients with interstitial cystitis. Urology. 2007 Jul;70(1):16-18.
Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, et al. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-580.
Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, et al. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85.

Continence 7S1 (2023) 100814
DOI: 10.1016/j.cont.2023.100814