Intravesical Infusion of Resiniferatoxin by a Temporary in Situ Drug Delivery System to Treat Interstitial Cystitis

A Pilot Study

M. Lazzeri, M. Spinelli, P. Beneforti, S. Malaguti, G. Giardiello, D. Turini

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Purpose: Interstitial cystitis (IC), a syndrome characterized by motor and sensory dysfunction of the lower urinary tract, represents a diagnostic and therapeutic challenge even to highly skilled physicians. We investigated the technical feasibility and the clinical efficacy of a prolonged intravesical instillation of RTX by in situ drug delivery system in patients with IC. Material and Methods: 5 female patients (mean age 48.7 years) received a prolonged infusion of a saline solution containing 10 nM of resiniferatoxin at the flow rate 25 μl/h by the MiniMed 407C Infusion Pump (MiniMed Sylmar, CA, USA), connected to sovrapubic 5 Fr mono Pigtail catheter, for 10 days. All patients reported frequency, nocturia and urgency, and symptoms of pelvic pain for at least six months. They showed the absence of urinary tract infection within the last three months, the absence of functional disorders of lower urinary tract and no other vesical or urethral pathology. The pre-treatment (PT) frequency/volume (FV) chart and a pain score (VAS score) were recorded. Patients were evaluated after 30 days from the end of infusion (primary end point, PEP) and after three months (secondary end point, SEP). Results: At PEP frequency reduced from 11.3 ± 1.39 to 7.4 ± 1.51 (p <0.01) and nocturia from 3.6 ± 0.54 to 1.2 ± 0.44 (p <0.01). A highly significant reduction of pain score was observed at PEP: it decreased to 2.4 ± 0.54 from 6.7 ± 0.83 (p <0.01). The pain score remained significantly lower at SEP (3.2 ± 0.44 p <0.05). Nocturia was also statistically reduced at SEP (1.9 ± 0.74) as well as frequency (8.7 ± 1.76). No side effects were reported during the infusion as well as after the removal of the catheter. Conclusion: The present study demonstrates that the prolonged intravesical instillation of a drug by in situ drug delivery system is a feasible procedure and seems to support the efficacy of RTX in the treatment of IC patients. However further studies are necessary and mandatory to confirm our results and to define the exact action mechanism of prolonged infusion of RTX, the dosage and the treatment schedule.

Original languageEnglish
Pages (from-to)98-102
Number of pages5
JournalEuropean Urology
Volume45
Issue number1
DOIs
Publication statusPublished - Jan 2004

Fingerprint

Interstitial Cystitis
Drug Delivery Systems
Nocturia
Intravesical Administration
Urinary Tract
Pain
Catheters
Infusion Pumps
Pelvic Pain
Therapeutics
Sodium Chloride
Urinary Tract Infections
Appointments and Schedules
Urinary Bladder
resiniferatoxin
Pathology
Physicians
Pharmaceutical Preparations

Keywords

  • Interstitial cystitis
  • Intravesical therapy
  • Resiniferatoxin
  • Sensory nerves

ASJC Scopus subject areas

  • Urology

Cite this

Intravesical Infusion of Resiniferatoxin by a Temporary in Situ Drug Delivery System to Treat Interstitial Cystitis : A Pilot Study. / Lazzeri, M.; Spinelli, M.; Beneforti, P.; Malaguti, S.; Giardiello, G.; Turini, D.

In: European Urology, Vol. 45, No. 1, 01.2004, p. 98-102.

Research output: Contribution to journalArticle

Lazzeri, M. ; Spinelli, M. ; Beneforti, P. ; Malaguti, S. ; Giardiello, G. ; Turini, D. / Intravesical Infusion of Resiniferatoxin by a Temporary in Situ Drug Delivery System to Treat Interstitial Cystitis : A Pilot Study. In: European Urology. 2004 ; Vol. 45, No. 1. pp. 98-102.
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N2 - Purpose: Interstitial cystitis (IC), a syndrome characterized by motor and sensory dysfunction of the lower urinary tract, represents a diagnostic and therapeutic challenge even to highly skilled physicians. We investigated the technical feasibility and the clinical efficacy of a prolonged intravesical instillation of RTX by in situ drug delivery system in patients with IC. Material and Methods: 5 female patients (mean age 48.7 years) received a prolonged infusion of a saline solution containing 10 nM of resiniferatoxin at the flow rate 25 μl/h by the MiniMed 407C Infusion Pump (MiniMed Sylmar, CA, USA), connected to sovrapubic 5 Fr mono Pigtail catheter, for 10 days. All patients reported frequency, nocturia and urgency, and symptoms of pelvic pain for at least six months. They showed the absence of urinary tract infection within the last three months, the absence of functional disorders of lower urinary tract and no other vesical or urethral pathology. The pre-treatment (PT) frequency/volume (FV) chart and a pain score (VAS score) were recorded. Patients were evaluated after 30 days from the end of infusion (primary end point, PEP) and after three months (secondary end point, SEP). Results: At PEP frequency reduced from 11.3 ± 1.39 to 7.4 ± 1.51 (p <0.01) and nocturia from 3.6 ± 0.54 to 1.2 ± 0.44 (p <0.01). A highly significant reduction of pain score was observed at PEP: it decreased to 2.4 ± 0.54 from 6.7 ± 0.83 (p <0.01). The pain score remained significantly lower at SEP (3.2 ± 0.44 p <0.05). Nocturia was also statistically reduced at SEP (1.9 ± 0.74) as well as frequency (8.7 ± 1.76). No side effects were reported during the infusion as well as after the removal of the catheter. Conclusion: The present study demonstrates that the prolonged intravesical instillation of a drug by in situ drug delivery system is a feasible procedure and seems to support the efficacy of RTX in the treatment of IC patients. However further studies are necessary and mandatory to confirm our results and to define the exact action mechanism of prolonged infusion of RTX, the dosage and the treatment schedule.

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