Original Research
JOURNAL OF ENDOUROLOGY Volume XX, Number XX, XXXX 2014 ª Mary Ann Liebert, Inc. Pp. ---–--DOI: 10.1089/end.2014.0294
The Impact of Ureteral Stent Type on Patient Symptoms as Determined by the Ureteral Stent Symptom Questionnaire: A Prospective, Randomized, Controlled Study Hyoung Keun Park, MD, PhD,1 Sung Hyun Paick, MD, PhD,1 Hyeong Gon Kim, MD, PhD,1 Yong Soo Lho, MD, PhD,1 and Sangrak Bae, MD 2
Abstract
Purpose: To minimize stent-related symptoms, the proximal part of the PolarisTM stent is composed of a firm material and its distal part is composed of a soft material. The aim of this study was to compare stent-related symptoms of Polaris and Percuflex stents and to assess the impacts of these stents on quality of life. Patients and Methods: A total of 144 patients were randomized to a ‘‘test’’ group (Polaris; n = 64) or a ‘‘conventional’’ group (Percuflex; n = 80) at the time of ureteral stent insertion after ureteroscopic stone removal surgery. Stents were allocated using a randomization program. At 1 week postoperatively, patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire (USSQ), and patients were asked complete a 10 cm visual analogue scale (VAS). Mean scores for USSQ domains and mean VAS scores were compared. Results: Mean patient age was 50.3 years, and the male-to-female ratio was 1:0.85. No significant intergroup differences were found in the domain scores of urinary symptoms (P = 0.58), pain (P = 0.87), general health (P = 0.20), work (P = 0.24), sexual activity (P = 0.64), or additional problems (P = 0.24). In addition, VAS scores were nonsignificantly different (P = 0.11). Analysis of USSQ item scores, however, revealed the test group had better results for ‘‘presence of pain,’’ ‘‘frequency of pain killer use,’’ ‘‘difficulties with respect to hard physical activity,’’ ‘‘fatigue,’’ ‘‘frequency of rest,’’ ‘‘stent-related impact on work,’’ ‘‘antibiotics use’’ than the conventional group except for ‘‘outpatient department visits’’. Conclusion: Compared with the conventional Percuflex ureteral stent, the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms, pain, general health, sexual matters, or additional problems as determined by the USSQ or in VAS determined pain. Sub-analysis, however, showed that the Polaris has some advantages with respect to pain, physical activities, impact on work, and additional problems. Accordingly, the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent. Several questionnaires have been developed to identify ureteral stent-related symptoms. The Ureteral Stent Symptom Questionnaire (USSQ) has been translated in various languages and is widely used.19–22 Recently, a Korean version of the USSQ was validated.21 The aim of this study was to compare the stent-related symptoms of the Polaris stent and a conventional ureteral stent (Percuflex) using the USSQ and a visual analogue scale (VAS), and to assess the impacts of these ureteral stents on health-related QoL.
Introduction
U
reteral stents are used for a variety of purposes in urology.1 They may cause various ureteral stent-related symptoms, however, such as pain and hematuria, and bladder irritation symptoms such as urgency, frequency, and incontinence.1–5 These bothersome symptoms influence quality of life (QoL) during the indwelling period. To minimize stent-related symptoms, various methods, such as correct choice of stent length, use of alpha blockers, drug-eluting stents, and changes in stent material have been studied.2,6–18 In particular, the distal portion of the recently introduced PolarisTM stent is composed of soft material and its proximal portion is composed of a firmer material. This distal soft portion is believed to minimize bladder irritation compared with the firmer distal portion of conventional ureteral stents. 1 2
Patients and Methods
A total of 164 consecutive patients undergoing ureteral stent insertion after ureterorenoscopy (URS) between August 2012 and December 2013 were prospectively enrolled. Our
Department of Urology, Konkuk University School of Medicine, Seoul, Republic of Korea. Department of Urology, The Catholic University of Korea, Uijeongbu St. Mary’s Hospital, Uijeongbu, Republic of Korea.
1
2
Institutional Ethics Committee approved the study, and informed consent was obtained from all patients. The enrolled patients were aged 16 to 80 years, and had a urinary stone necessitating temporary ureteral stent insertion after URS, as determined by surgeon discretion. The exclusion criteria applied included noncalculous disease (e.g., malignant obstruction, retroperitoneal fibrosis), recurrent ureteral stricture, loss to follow-up, pregnancy, or bilateral or long-term stent placement. Patients were randomized to either the Polaris stent group (the test group) or the conventional Percuflex stent group (the conventional group) in a single-blinded manner (patients were unaware of allocations). Group allocations were performed using a random number generating program in the operating room before stent insertion. All stents were inserted via a retrograde approach under fluoroscopic guidance. All stents were 6F, and stent lengths were determined based on patient height, as follows: Height 180 cm, 26 cm stent. All stents were inserted under fluoroscopic guidance, and in no patient did the inserted stent cross midline. At 1 week after stent insertion, patients visited the outpatient department for stent removal and were asked to complete the USSQ. Stent-related symptoms were evaluated at 1 week after stent insertion by using the Korean version of the USSQ, which is composed of several domains—that is, urinary symptoms, pain, general health, work performance, sexual activity, and additional questions. In addition, patients were asked to indicate degree of pain on a 10-cm VAS scale. The sample size was calculated based on the results of previous studies on stents. A total of 128 patients (64 patients per arm) appeared sufficient to detect a difference of 15% between mean index scores for urinary symptoms, pain, and general health, respectively, with 80% power. All patients were administered antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs) (talniflunate) for 3 days after discharge. In addition, when patients were prescribed additional NSAIDs, dosages were recorded. Alpha blockers and anticholinergics were not administered. The primary outcome measure was the results of the questionnaire. Sec-
PARK ET AL.
Table 1. Patient Characteristics
Age Sex BMI VAS
Polaris (n = 64)
Percuflex (n = 80)
P value
50.95 – 14.85 1:1.15 23.66 – 3.08 5.19 – 2.60
49.61 – 14.30 1:0.88 24.83 – 3.61 5.46 – 2.93
0.758 0.779 0.135 0.111
BMI = body mass index; VAS = visual analogue scale.
ondary outcome measures included adverse events—e.g., early stent removal because of stent-related symptoms or stent migration. Statistical analysis was performed using PASW ver. 17.0. Mean domain scores of the test and conventional groups were compared using the Student t test. Categorical data were analyzed using the chi-square test. Statistical significance was accepted for P values
JOURNAL OF ENDOUROLOGY Volume XX, Number XX, XXXX 2014 ª Mary Ann Liebert, Inc. Pp. ---–--DOI: 10.1089/end.2014.0294
The Impact of Ureteral Stent Type on Patient Symptoms as Determined by the Ureteral Stent Symptom Questionnaire: A Prospective, Randomized, Controlled Study Hyoung Keun Park, MD, PhD,1 Sung Hyun Paick, MD, PhD,1 Hyeong Gon Kim, MD, PhD,1 Yong Soo Lho, MD, PhD,1 and Sangrak Bae, MD 2
Abstract
Purpose: To minimize stent-related symptoms, the proximal part of the PolarisTM stent is composed of a firm material and its distal part is composed of a soft material. The aim of this study was to compare stent-related symptoms of Polaris and Percuflex stents and to assess the impacts of these stents on quality of life. Patients and Methods: A total of 144 patients were randomized to a ‘‘test’’ group (Polaris; n = 64) or a ‘‘conventional’’ group (Percuflex; n = 80) at the time of ureteral stent insertion after ureteroscopic stone removal surgery. Stents were allocated using a randomization program. At 1 week postoperatively, patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire (USSQ), and patients were asked complete a 10 cm visual analogue scale (VAS). Mean scores for USSQ domains and mean VAS scores were compared. Results: Mean patient age was 50.3 years, and the male-to-female ratio was 1:0.85. No significant intergroup differences were found in the domain scores of urinary symptoms (P = 0.58), pain (P = 0.87), general health (P = 0.20), work (P = 0.24), sexual activity (P = 0.64), or additional problems (P = 0.24). In addition, VAS scores were nonsignificantly different (P = 0.11). Analysis of USSQ item scores, however, revealed the test group had better results for ‘‘presence of pain,’’ ‘‘frequency of pain killer use,’’ ‘‘difficulties with respect to hard physical activity,’’ ‘‘fatigue,’’ ‘‘frequency of rest,’’ ‘‘stent-related impact on work,’’ ‘‘antibiotics use’’ than the conventional group except for ‘‘outpatient department visits’’. Conclusion: Compared with the conventional Percuflex ureteral stent, the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms, pain, general health, sexual matters, or additional problems as determined by the USSQ or in VAS determined pain. Sub-analysis, however, showed that the Polaris has some advantages with respect to pain, physical activities, impact on work, and additional problems. Accordingly, the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent. Several questionnaires have been developed to identify ureteral stent-related symptoms. The Ureteral Stent Symptom Questionnaire (USSQ) has been translated in various languages and is widely used.19–22 Recently, a Korean version of the USSQ was validated.21 The aim of this study was to compare the stent-related symptoms of the Polaris stent and a conventional ureteral stent (Percuflex) using the USSQ and a visual analogue scale (VAS), and to assess the impacts of these ureteral stents on health-related QoL.
Introduction
U
reteral stents are used for a variety of purposes in urology.1 They may cause various ureteral stent-related symptoms, however, such as pain and hematuria, and bladder irritation symptoms such as urgency, frequency, and incontinence.1–5 These bothersome symptoms influence quality of life (QoL) during the indwelling period. To minimize stent-related symptoms, various methods, such as correct choice of stent length, use of alpha blockers, drug-eluting stents, and changes in stent material have been studied.2,6–18 In particular, the distal portion of the recently introduced PolarisTM stent is composed of soft material and its proximal portion is composed of a firmer material. This distal soft portion is believed to minimize bladder irritation compared with the firmer distal portion of conventional ureteral stents. 1 2
Patients and Methods
A total of 164 consecutive patients undergoing ureteral stent insertion after ureterorenoscopy (URS) between August 2012 and December 2013 were prospectively enrolled. Our
Department of Urology, Konkuk University School of Medicine, Seoul, Republic of Korea. Department of Urology, The Catholic University of Korea, Uijeongbu St. Mary’s Hospital, Uijeongbu, Republic of Korea.
1
2
Institutional Ethics Committee approved the study, and informed consent was obtained from all patients. The enrolled patients were aged 16 to 80 years, and had a urinary stone necessitating temporary ureteral stent insertion after URS, as determined by surgeon discretion. The exclusion criteria applied included noncalculous disease (e.g., malignant obstruction, retroperitoneal fibrosis), recurrent ureteral stricture, loss to follow-up, pregnancy, or bilateral or long-term stent placement. Patients were randomized to either the Polaris stent group (the test group) or the conventional Percuflex stent group (the conventional group) in a single-blinded manner (patients were unaware of allocations). Group allocations were performed using a random number generating program in the operating room before stent insertion. All stents were inserted via a retrograde approach under fluoroscopic guidance. All stents were 6F, and stent lengths were determined based on patient height, as follows: Height 180 cm, 26 cm stent. All stents were inserted under fluoroscopic guidance, and in no patient did the inserted stent cross midline. At 1 week after stent insertion, patients visited the outpatient department for stent removal and were asked to complete the USSQ. Stent-related symptoms were evaluated at 1 week after stent insertion by using the Korean version of the USSQ, which is composed of several domains—that is, urinary symptoms, pain, general health, work performance, sexual activity, and additional questions. In addition, patients were asked to indicate degree of pain on a 10-cm VAS scale. The sample size was calculated based on the results of previous studies on stents. A total of 128 patients (64 patients per arm) appeared sufficient to detect a difference of 15% between mean index scores for urinary symptoms, pain, and general health, respectively, with 80% power. All patients were administered antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs) (talniflunate) for 3 days after discharge. In addition, when patients were prescribed additional NSAIDs, dosages were recorded. Alpha blockers and anticholinergics were not administered. The primary outcome measure was the results of the questionnaire. Sec-
PARK ET AL.
Table 1. Patient Characteristics
Age Sex BMI VAS
Polaris (n = 64)
Percuflex (n = 80)
P value
50.95 – 14.85 1:1.15 23.66 – 3.08 5.19 – 2.60
49.61 – 14.30 1:0.88 24.83 – 3.61 5.46 – 2.93
0.758 0.779 0.135 0.111
BMI = body mass index; VAS = visual analogue scale.
ondary outcome measures included adverse events—e.g., early stent removal because of stent-related symptoms or stent migration. Statistical analysis was performed using PASW ver. 17.0. Mean domain scores of the test and conventional groups were compared using the Student t test. Categorical data were analyzed using the chi-square test. Statistical significance was accepted for P values
