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Biomedical subjects

Christopher K Payne

Publications and source records attributed to Christopher K Payne.

9 recordsLinked to original sources

Solifenacin in overactive bladder syndrome.

Overactive bladder (OAB) syndrome is a prevalent condition, increasingly recognised as a cause of reduced quality of life that places a substantial economic burden on healthcare provision. While antimuscarinic agents are the therapy of choice for OAB, their use is associated with a number of drawbacks, not least of which is the high rate of adverse events, which is intimately linked with poor compliance with treatment. Solifenacin succinate is a novel antimuscarinic agent approved in Europe and the US for the treatment of men and women with OAB. The recommended starting dose of solifenacin is 5 mg once daily and, if needed, the dose may be increased to 10 mg once daily. In multiple clinical trials, solifenacin treatment has been associated with statistically significant reductions in all key symptoms of OAB (notably frequency, urgency and incontinence) as well as increases in volume voided. Solifenacin has been shown to be well tolerated, producing few adverse effects, which are usually mild in nature. Furthermore, possibly because of this favourable efficacy and tolerability, solifenacin treatment has been associated with a high rate of patient persistence with therapy, with 81% of 1802 patients who completed 12-week, double-blind trials enrolling in and completing a 40-week open-label extension study. Solifenacin has been shown to display selectivity for bladder versus salivary tissue in vitro, and studies in healthy men have shown that absorption is slow but extensive with an absolute bioavailability of 88%. Solifenacin is a well tolerated and efficacious agent for the treatment of OAB, significantly reducing symptoms and improving patients' quality of life.

Animals↗

Office bladder distention with electromotive drug administration (EMDA) is equivalent to distention under general anesthesia (GA).

BACKGROUND: Bladder distention is commonly used in diagnosis and treatment of interstitial cystitis (IC). Traditionally performed in the operating room under general or spinal anesthesia (GA), it is expensive and associated with short term morbidity. Office bladder distention using electromotive drug administration (EMDA) has been suggested as an alternative that is well tolerated by patients. We report the first comparative findings of patients undergoing both office distention with EMDA and distention in the operating room (OR) with GA. METHODS: This retrospective chart review identified 11 patients participating in two protocols of EMDA bladder distention who also underwent bladder distention under GA either prior to or after the EMDA procedure. RESULTS: The median absolute difference in bladder capacity between GA and EMDA was only 25 cc; the median percent difference was 5%. Cystoscopic findings, while not prospectively compiled, appear to have been similar. CONCLUSION: This study represents the first comparison between distention with EMDA versus GA and confirms the technical feasibility of performing bladder distention in an office setting. The distention capacity achieved in the office was nearly identical to that in the OR and the cystoscopic findings very similar. Further investigation into the comparative morbidity, cost, and other outcome measures is warranted to define the ultimate role of EMDA bladder distention in the clinical evaluation and care of patients with IC.

Adult↗

Pilot study of the feasibility of in-office bladder distention using electromotive drug adminstration (EMDA).

PURPOSE: Cystoscopic bladder distention is an important tool in the diagnosis and treatment of interstitial cystitis (IC). We investigated the feasibility of performing bladder distention in the office using two different anesthetic strategies: simple instillation of alkalized lidocaine and electromotive drug administration (EMDA) of lidocaine. MATERIALS AND METHODS: Patients presenting with urinary frequency, urgency, and bladder pain were recruited for an office evaluation protocol which included bladder distention under local anesthesia. An initial group of 10 patients underwent bladder distention after instillation of 5 mg/kg alkalized lidocaine. A second group of 11 patients had lidocaine EMDA anesthesia prior to distention. RESULTS: In the alkaxlized lidocaine group, 6 of the 10 distentions were aborted after less than 5 minutes at only 40 cm H(2)O. In the EMDA group, 7 of 11 of the distentions were completed using 60 cm H(2)O for 7 minutes. EMDA afforded a more effective distention as manifest by a greater percent increase in distention capacity over cystometric capacity compared to alkalized lidocaine (135% vs. 70%). Despite the lower pressure used in the alkalized lidocaine group, the median distention time was only 3 minutes compared to 7 minutes using EMDA. CONCLUSIONS: These results represent the first study of the efficacy of EMDA as local anesthesia for bladder distention compared to another method of anesthesia. Lidocaine EMDA is superior to alkalized lidocaine in that it allows for a greater distention of the bladder for a longer period of time but does not eliminate the pain of bladder distention.

Adult↗

A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.

PURPOSE: We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC). MATERIALS AND METHODS: Subjects who 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, were randomized to 6 weekly double-blinded intravesical instillations of either BCG or placebo, and then followed for a total of 34 weeks. The primary outcome was a patient reported global response assessment at week 34, supplemented with medications for IC during weeks 31 to 34. Secondary outcomes included a 24-hour voiding diary, pain, urgency, validated IC symptom indexes and adverse events. The target sample size was 260 participants, designed to detect a difference in response rates between placebo and BCG of 30% and 50%, respectively. RESULTS: A total of 265 participants were randomized and 17 (6%) patients withdrew from study. The response rates for the primary outcome were 12% for placebo and 21% for BCG (p = 0.062). Small improvements were observed for all secondary outcomes, some more so with BCG, but these differences were of borderline statistical significance. Although a large number of adverse events were reported in the BCG arm, there was no statistically significant difference between the treatment arms in overall adverse event rates. CONCLUSIONS: Although the BCG safety profile was acceptable, the response rate for the primary outcome was low. Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive.

Administration, Intravesical↗

Correlation between 2 interstitial cystitis symptom instruments.

PURPOSE: Two statistically validated interstitial cystitis (IC) symptom instruments have been used in clinical research. In this study we report what is to our knowledge the first direct comparison of the University of Wisconsin Symptom Instrument (UWI) with the O'Leary-Sant instruments, that is the IC Symptom Index (ICSI) and IC Problem Index (ICPI). MATERIALS AND METHODS: A convenience sampling of 107 patients with IC evaluated at the urology clinic at our institution from March through August 2000 were asked to complete ICSI, ICPI and UWI. The scores were analyzed and graphed. RESULTS: Mean ICSI, ICPI and UWI scores +/- SD were 12.6 +/- 4.3, 10.5 +/- 3.8 and 25.5 +/- 10.8, respectively. UWI and ICSI scores correlated at r = 0.80 (p <0.01) and ICSI/ICPI scores correlated at r = 0.83 (p <0.01). ICSI and ICPI contain 4 symptom-problem pairs. There are relevant differences in the correlation of symptom severity (ICSI question) and its associated problem (ICPI question). The symptom of urgency correlated best with the associated problem (r = 0.84), followed by nocturia (r = 0.82), pain (r = 0.70) and frequency (r = 0.68). CONCLUSIONS: The ICSI and UWI symptom instruments correlate strongly in a large population of patients with IC. The data presented will aid in interpreting the literature. A relatively poor correlation between pain symptom-problem pairs in the O'Leary-Sant instruments is probably an artifact of wording. The word pressure appears in ICPI but not in ICSI. We suggest using parallel wording of the pain symptom-problem pair containing the identical phrase, burning, pain, discomfort or pressure, to improve the ICSI/ICPI correlation and more accurately reflect the clinical condition.

Adult↗

Intravesical resiniferatoxin for the treatment of interstitial cystitis: a randomized, double-blind, placebo controlled trial.

PURPOSE: Interstitial cystitis is a painful bladder condition of unknown etiology and poorly understood pathophysiology. Current therapies have met with limited success. Vanilloid receptor agonists such as resiniferatoxin (RTX) desensitize C-fibers that transmit pain; it is hypothesized that such drugs will be effective in the treatment of interstitial cystitis and painful bladder syndrome by decreasing the pain that leads to urinary frequency and urgency. MATERIALS AND METHODS: A randomized, double-blind, placebo controlled study was conducted in 163 patients with interstitial cystitis. Participants were randomly assigned to receive a single intravesical dose of 50 ml of either RTX 0.01 microM, 0.05 microM, 0.10 microM, or placebo. Safety and efficacy was evaluated over 12 weeks. The primary efficacy endpoint was the Global Response Assessment, a 7-point scale rating overall change in symptoms of interstitial cystitis after 4 weeks. Secondary efficacy endpoints included reduction in pain, urgency, frequency, nocturia, average void volume, and the O'Leary-Sant Symptom and Problem Indexes. RESULTS: RTX did not improve overall symptoms, pain, urgency, frequency, nocturia, or average void volume during 12 weeks followup. RTX resulted in a dose-dependent increase in the incidence of instillation pain, but was otherwise generally well tolerated. CONCLUSIONS: In the largest prospective, randomized clinical trial reported to date with intravesical vanilloid therapy, single administration of RTX at doses of 0.01 microM to 0.10 microM was not effective in patients with interstitial cystitis.

Administration, Intravesical↗

Sacral neuromodulation in patients with interstitial cystitis: a multicenter clinical trial.

Female patients with interstitial cystitis (IC) unresponsive to standard oral and intravesical therapy were enrolled at three clinical sites for percutaneous sacral nerve root stimulation (PNS) in a prospective, observational pilot study. Evaluation was in the form of a 3-day voiding diary completed both prior to and following the commencement of sacral nerve root stimulation. Symptoms were also assessed by the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices (ICSI and ICPI). Baseline and test stimulation values for voiding diary parameters and O'Leary-Sant scores were compared to determine treatment efficacy. A total of 33 patients were enrolled. Statistically significant improvements were seen in frequency, pain, average voided volume and maximum voided volume. Significant improvements were also seen in ICSI and ICPI scores. Subacute PNS appears to be effective in reducing symptom severity and increasing voided volumes in patients with IC previously unresponsive to standard therapy.

Adult↗

Research criteria versus clinical criteria for interstitial cystitis.

In March 2003 experts on interstitial cystitis (IC) from around the world met in Kyoto, Japan for a series of workshops intended to define areas of agreement and difference in the approach to this disease. This workshop explored the diagnostic criteria IC in the clinical and research settings. The NIDDK criteria are used almost universally for research but there is tremendous disparity in the clinics and no consensus at all as to the best practice in diagnosing IC for clinical purposes. Throughout the world many physicians use the NIDDK research criteria for clinical diagnosis; in some countries this is standard. Undoubtedly, this mandates under-diagnosis and denies treatment to many patients. Still, a majority feel that one diagnostic system is mandatory to promote clarity in communication. The group called for two initiatives to help advance this area of controversy: (1) a large-scale, prospective study critically examining the role of cystoscopy, bladder distention, and biopsy in the diagnosis of IC; (2) a concerted effort to develop a single evidence-based guideline or algorithm that would be flexible enough to meet the needs of clinicians, researchers, and patients.

Biomedical Research↗

Synchronous rectovaginal, urinary bladder, and pulmonary endometriosis.

BACKGROUND: Extragenital endometriosis is an uncommon condition that can affect almost any organ system and tissue in the human body. Disease involving multiple distant sites is extremely uncommon. METHODS: We report a rare case of synchronous rectovaginal, urinary bladder, and pulmonary endometriosis. We performed a Medline literature search using keywords "endom etriosis," "recto vaginal," "pulmonary," "bladder," "ureteral," "bowel," "extrapelvic," and "extragenital" and were unable to find any prior case reports of such findings. A 31-year-old female presented with catamenial dysuria of 1-year duration, pleurisy associated with spontaneous pneumothoraces of 7 months' duration and a long-standing history of pelvic pain. A multispecialty team with experience in endoscopic techniques was assembled, consisting of a thoracic, a urologic, and a gynecologic surgeon. Video-assisted thoracoscopic surgery with fulguration of all visible pleural endometriosis and pleurodesis was performed, followed by laparoscopic segmental bladder wall endometrioma excision and resection of rectovaginal endometriosis. Twelve months after surgery and without additional hormonal treatment, the patient is symptom free. CONCLUSION: Extragenital endometriosis may coexist in multiple sites. A high index of suspicion aids in the diagnosis. A multidisciplinary approach in a tertiary center, followed by appropriate surgical eradication of visible disease, can successfully treat endometriosis even in such extreme cases.

Adult↗