Clinical Effectiveness of Single Pigtail Suture Stent on Patient Comfort: A Double-Blind Prospective Randomized Trial.

Background: A double-pigtail ureteral stent (DPUS) can cause untoward symptoms, such as urgency, frequency, urinary incontinence, hematuria, and body pain that are bothersome to patient's quality of life (QoL). By reducing the quantity of material in the bladder, it could be reasonable to decrease stent-related symptoms (SRSs). We aimed to evaluate the tolerability of single pigtail suture stent (SPSS) with a validated questionnaire after uncomplicated retrograde semirigid ureteroscopic lithotripsy (URSL). Materials and Methods: A total of 130 patients who underwent ureteral stent placement after URSL for unilateral symptomatic ureteral stones with <15 mm diameter were randomized prospectively into two groups. Polyurethane ureteral stent (6 Fr, 24 or 26 cm) was placed in all patients, which was removed postoperatively with a mean of 14 days. There were 65 patients in both groups. All subjects completed the ureteral stent symptoms questionnaire (USSQ), which explores the SRSs. The questionnaires were conducted on the day of stent removal (at week 2) with the stent in situ and 4 weeks after removal (at week 6, poststent). The severity of SRSs and QoL were compared between the two groups. Results: SPSS was associated with perfect effect on all domains of USSQ, except from sexual and general health index scores. Pain index scores, visual analog scores (VAS), and analgesic requirements in SPSS group were found significantly low compared with those in the DPUS group. The QoL scores were significantly better in patients indwelling SPSS. Conclusion: SPSS is a potentially beneficial option to minimize ureteral SRSs after uncomplicated URSL.

Development of a Disease-Specific Ureteral Calculus Patient Reported Outcome Measurement Instrument.

INTRODUCTION: Patient reported outcome measures (PROMs) are powerful instruments to assess the impact of a disease on health from the patient's perspective. We describe the process of designing, testing, and validating the Cambridge Ureteral Stone PROM (CUSP). MATERIALS AND METHODS: Patients recently diagnosed with ureteral stones were approached for participation in focus groups, structured interviews, and test-retest validation studies. Statistical tests included Cronbach's alpha for internal consistency, Spearman's and Pearson's correlation coefficients for test-retest validity, permutation tests of equality of means and Spearman's correlation coefficients for discriminant validity. RESULTS: Forty-three patients participated in the development of the CUSP. Twenty-two patients were involved in the focus groups and structured interviews and a further 21 participated in the prospective test-retest study. Expressed comments were grouped into seven broad health domains: pain, fatigue, sleep disturbance, work and daily activities, anxiety, gastrointestinal (GI) symptoms, and urinary symptoms. Items were selected from established PROM platforms to form the draft (dCUSP) instrument, which was then used for test-retest validation and item reduction. All domains scored highly for Cronbach's alpha (>0.8), with the exception of GI symptoms. Large Spearman's (>0.76) and Pearson's correlation estimates (>0.83) were obtained for test-retest validity, suggesting that answers were reliable through the time period tested. The estimates of the Spearman's correlation coefficient between each pair of domains ranged from 0.17 to 0.78 and the upper bounds of the corresponding 95% confidence intervals were all smaller than 0.95, suggesting that each domain measures something different. The tests of equality of the mean of scores of the control (n = 25) and patient groups were all significant, suggesting that CUSP successfully discriminated patients suffering from ureteral stones for every domain. CONCLUSION: CUSP is a patient-derived ureteral stone PROM, which can be used to measure ureteral stone disease health outcomes from the patient's point of view.

Listening to music during shock wave lithotripsy decreases anxiety, pain, and dissatisfaction : A randomized controlled study.

BACKGROUND: We analyzed the effects of music on pain, anxiety, and overall satisfaction in patients undergoing a shock wave lithotripsy (SWL) procedure. METHODS: A total of 200 patients scheduled to undergo SWL were included in this study. Group 1 consisted of 95 patients who listened to music during the SWL session while group 2 included 105 patients who did not listen music during the procedure. State-Trait Anxiety Inventory (STAI) was used to assess state and trait anxiety (STAI-S/T). A visual analog scale (VAS) was used at the end of the session in order to assess pain, willingness to repeat the procedure, and overall patient satisfaction. Hemodynamic parameters including systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) were recorded before and after the session. RESULTS: No statistically significant difference was found between the two groups in terms of stone characteristics, SWL parameters, pre-SWL STAI-T/S scores, and pre-SWL hemodynamic parameters. Post-SWL STAI-S scores were found to be lower in patients who listened to music (p = 0.006). At the end of the SWL, VAS scores of pain, satisfaction, and willingness to repeat procedure were significantly different in favor of the music group (p = 0.007, p = 0.001, p = 0.015, respectively). SBP, DBP, and HR were significantly higher in patients who did not listen to music (p = 0.002, p = 0.024, p = 0.001, respectively). CONCLUSION: Music can be an ideal adjunctive treatment modality for patients undergoing SWL treatment. It has the potential to enhance patient compliance and treatment satisfaction by reducing the procedure-related anxiety and pain perception.

Effect of medical expulsive therapy on the health-related quality of life of patients with ureteral stones: a critical evaluation.

PURPOSE: To evaluate the possible effects of medical expulsive therapy (MET) on the health-related quality of life (HRQOL) of the patients under watchful waiting for ureteral stones. PATIENTS AND METHODS: A total 120 patients with ureteral stones were included into this study program. Patients were divided into two subgroups. While patients in group 1 received medical therapy only for colic pain if needed, patients in group 2 received MET (tamsulosin 0.4 mg/once daily) in addition to medical therapy. All cases were evaluated weekly during 1-month period, and the patients with persistent stones after this period in both groups were evaluated with respect to the analgesic requirement, number of renal colic attacks as well as emergency department (ED) visits along with the QOL scores. RESULTS: Mean values of patient age and stone burden were 37.14 ± 2.46 years and 42.04 ± 2.03 mm(2), respectively. Evaluation of the cases with residing stones after 4 weeks (28 cases in group 1 and 27 cases in group 2) with or without MET revealed following findings; renal colic, total amount of analgesic required and the mean number of ED visits were significantly lower in cases receiving MET. Evaluation of the mean HRQOL in terms of EQ-5D index and EQ-5D VAS values in both groups again demonstrated higher mean values in patients undergoing MET (p < 0.05). CONCLUSION: Our findings indicated that MET for ureteral calculi during watchful waiting period could increase the HRQOL scores by lowering the number of both renal colic attacks and ED visits resulting in decreased analgesic need.

Health related quality of life in ureteral stone patients: post-ureterolithiasis.

Ureteral stones disease is among the most painful and prevalent among urologic disorders that can substantially impact health-related quality of life (HRQoL), particularly in patients with a history of recurrent stones. The aim of the study is to assess the QoL in patients with ureteral calculi after surgical intervention and identifying the most significant factors that could impact their QoL. The target population included two groups: post-lithotripsy patients and comparator group comprising healthy individuals selected from the general population. Both groups were matched for age and gender. The study continued through a period of 9 months. An observation period of 4-10 months following the last surgical intervention was applied before interviewing patients. Information regarding socio-demographics, medical data and presence of co-morbidities were recorded. The Medical Outcome Study Short-Form 36-item survey (SF-36) was used to assess HRQoL for both groups. Based on the SF-36 questionnaire, there were no significant differences between patients and healthy volunteers in the mean scores for eight of the HRQoL domains, except for pain and social functioning subscales. Patient's age, distal ureteral stones and ureteral stent, in addition to DM and low back pain appeared to significantly affect the HRQoL of patients. In conclusion, the promising end point in the management of urolithiasis is improvement of HRQoL. The results of the current study support the notion that urinary stone disease is not a life threatening disease and patients can return to normal life after surgical intervention. Prospective studies are warranted for elucidating the factors influencing HRQoL in ureteral stone patients to optimize patient care.

Sublingual hyoscyamine sulfate in combination with ketorolac tromethamine for ureteral colic: a randomized, double-blind, controlled trial.

STUDY OBJECTIVE: We evaluate the safety and efficacy of a single dose of hyoscyamine sulfate in combination with ketorolac tromethamine for the reduction of pain in emergency department patients with ureteral colic. METHODS: We conducted a prospective, randomized, double-blind study at 2 EDs with residency programs in emergency medicine. Patients were at least 18 years old and presented to the ED with an initial history and physical examination consistent with ureteral colic. Patients received a single intravenous dose of 30 mg of ketorolac tromethamine given over a 1-minute period with either a single sublingual dose of 0.125 mg of hyoscyamine sulfate or a placebo. If inadequate analgesia was noted after 30 minutes, a standard dose of meperidine could be administered for rescue. All other treatments including intravenous fluids and antiemetics were standardized. The main study outcome was change in visual analog scale pain score from baseline to 30 minutes. RESULTS: Seventy-two patients were evaluated for inclusion. Thirteen patients who had self-administered pain medications within 4 hours of presentation were excluded before randomization. Sixteen patients who did not have a renal calculus confirmed by either intravenous urogram or helical computed tomography were also excluded from efficacy analysis. There did not appear to be any clinically important differences in the baseline characteristics between the 2 groups. The repeated-measures analysis of the remaining 43 patients showed no clinically important difference in pain score using the visual analog scale at any time point. There were no clinically important differences between the 2 study groups for amount of rescue meperidine administered or end-of-study global satisfaction scores. CONCLUSION: Hyoscyamine sulfate did not provide any additional pain relief from ureteral colic when administered with ketorolac tromethamine. There was no clinically important difference in change of pain scores at 30 minutes in patients with ureteral colic receiving supplemental hyoscyamine sulfate.

Anxiety and patient participation in clinical decision-making: the case of patients with ureteral calculi.

Ninety-six patients with a ureteral calculus participated in a study whose purpose was to identify those subjects who would benefit from participation in clinical decision-making. Forty-two of the subjects (the experimental group) were given information about two alternative treatments, Extra Corporeal Shock Wave Lithotripsy (ESWL) and ureteroscopy, and were asked to choose which therapy they preferred. Fifty-four subjects (the control group) were not given information, not allowed to choose, and were treated according to the physician's decision. Subjects' level of anxiety was compared within each group on three occasions: before meeting with the physician, immediately afterwards and upon hospitalization for treatment of the stone. Patients perception of receipt of information and participation in clinical decision-making, coping style, educational level, and knowledge about treatment alternatives were also measured. A statistically significant decrease in anxiety after meeting with the urologist was found among patients who were not asked to participate in the decision-making process and among patients who perceived that they had received information. A decrease in anxiety after meeting with the physician was also found among patients who, according to their own perception, did not participate in decision-making. Patients' educational level and coping style were related to their anxiety. A decline in anxiety was found among those with a lower educational level who perceived that they had received information and among higher educated patients who perceived that they participated in clinical decision-making. Anxiety also declined among patients with a passive coping style who perceived that they had received information or had participated in the decision-making process. The results emphasize the need to tailor the therapeutic approach to patient characteristics.

[Physician-patient relations--participation of patients with ureteral calculi in clinical decision making and level of anxiety].

In a study examining the relationship between patient participation in clinical decision making and levels of anxiety, patients were offered a choice of treatment for ureteral calculus. 42 received information about 2 treatment options, ultrasound fragmentation of the stone through a ureteroscope and extracorporeal shock wave lithotripsy (ESWL), and were asked to choose the method that they preferred. 54 received treatment decided on by the physician without their participation in the decision making process. Anxiety was measured before meeting with the physician, immediately after the meeting and on hospitalization for treatment. The contribution of the patient's perception of participation in the decision-making process and level of education was also examined. There was a decrease in level of anxiety after meeting with the physician only among those who did not actually participate in the decision-making process (p < 0.05). There was no change in the level of anxiety among those offered choice of treatment. However, a decrease in anxiety was evident among patients who perceived that they had received information about their illness and its treatment (p < 0.01). This was not the case for patients who perceived themselves as participants in decision making unless they had a relatively high-level of education (p = 0.05).

Artificial ureteral calculosis in rats: behavioural characterization of visceral pain episodes and their relationship with referred lumbar muscle hyperalgesia.

In a rat model of artificial ureteral calculosis, the aim of the study was to characterize the behavioural manifestations of direct visceral pain and to evaluate the relationship between number, duration and complexity of the visceral episodes and the extent of referred lumbar muscular hyperalgesia. As evidenced by non-stop video-tape recordings over 4-14 days, almost 98% of stone-implanted rats showed episodes similar to the writhing behaviour characteristic of noxious visceral stimulation in animals. From one rat to another, these episodes varied from very few (1-3) to a very high number (+/- 60), lasted a few minutes to over 45 min and were of variable complexity, as evaluated via an arbitrary scale on the basis of the combination of movements. Their number and duration decreased significantly, in a linear fashion, as time passed after the operation, so that they were mostly concentrated during the first 3 days. Number, duration and complexity of episodes were reduced by chronic treatment with morphine in a dose-dependent fashion. Stone-implanted rats displaying visceral episodes also showed hyperalgesia of the ipsilateral oblique musculature, as evidenced by a decrease in the vocalization threshold to electrical muscle stimulation, which was maximum on the first 3-4 days after implantation but lasted up to 10 days. The visceral episodes and the muscle hyperalgesia showed a strict relationship of interdependence: a significant, direct linear correlation was found between number and duration of episodes and tendency to also develop a contralateral muscle hyperalgesia. By applying the results of the study to the interpretation of human pathology, referred lumbar muscle hyperalgesia from ureteral calculosis would appear to be a strict function of the colic pain experienced.