j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 6 ( 2 0 1 5 ) 3 0 7 e3 1 2
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Laparoscopic sleeve gastrectomy effects on overactive bladder symptoms Giovanni Palleschi, MD, PhD,a,b Antonio Luigi Pastore, MD, PhD,a,b,* Mario Rizzello, MD,c Giuseppe Cavallaro, MD, PhD,c Gianfranco Silecchia, MD,c and Antonio Carbone, MDa,b a
Department of Sciences and Medico-Surgical Biotechnologies, Urology Unit, ICOT, Sapienza University of Rome, Latina, Italy b Uroresearch Association, Non Profit Association for Basic, Clinical and Surgical Research in Urology, Latina, Italy c Centre of Excellence for Bariatric and Metabolic Surgery, Department of Sciences and Medico-Surgical Biotechnologies, ICOT, Sapienza University of Rome, Latina, Italy
article info
abstract
Article history:
Background: Morbidly obese patients may experience lower urinary tract symptoms. How-
Received 7 January 2015
ever, most studies focus only on urinary incontinence, with little regard to other symptoms
Received in revised form
as those suggestive for overactive bladder (OAB) syndrome. Laparoscopic sleeve gastrec-
7 February 2015
tomy (LSG) is commonly used to treat obesity; this procedure is effective, safe, and capable
Accepted 13 March 2015
of reducing the impact of comorbidities associated with severe increase in body weight.
Available online 18 March 2015
Therefore, we investigated if LSG improves OAB symptoms in morbidly obese patients. Methods: We prospectively recruited 120 morbidly obese patients (60 men and 60 women),
Keywords:
evaluated by history taking, comorbidity assessment, physical examination, urinalysis and
Obesity
urine culture, renal and pelvic ultrasound, a 3-d voiding diary, and the OAB questionnaire
Overactive bladder
short form. Outcomes of these investigations were assessed 7 d before and 180 d after LSG
Sleeve gastrectomy
was performed. Controls were obese individuals (60 men and 60 women) from an LSG
Body mass index
waiting list. Results: Symptoms of OAB were common in the morbidly obese cohort, affecting more women than men. Compared with untreated patients, patients treated with LSG had significantly reduced body mass index 180 d postoperatively; this outcome was associated with improvement in OAB symptoms, whereas no change occurred in untreated controls. Conclusions: OAB symptoms improve in morbidly obese patients successfully treated by LSG. ª 2015 Elsevier Inc. All rights reserved.
1.
Background
Obesity is a pathology characterized by excessive fat accumulation that presents a risk to health and is consistent with a body mass index (BMI) 30 kg/m2 [1]. Obesity is associated with increased incidence of a number of conditions, including
diabetes mellitus, cardiovascular and respiratory diseases, and nonalcoholic fatty liver disease, with an increased risk of disability and a moderate increase in all-cause mortality [2]. Some evidence suggests that lower urinary tract symptoms (LUTS) may develop in morbidly obese patients [3] and that various urogenital complications are directly associated with
* Corresponding author. Via Ernesto Monaci 13, 00161 Rome, Italy. Tel.: þ39 3401138648; fax: þ39 0773 6513333. E-mail address: [email protected] (A.L. Pastore). 0022-4804/$ e see front matter ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2015.03.035
308
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 6 ( 2 0 1 5 ) 3 0 7 e3 1 2
obesity [4]. However, most studies focus on urinary incontinence (UI) and pelvic floor disorders, whereas little information is available on the overactive bladder (OAB) syndrome, which is urgency with/without urinary urgency incontinence (UUI), usually with frequency and nocturia [5]. Laparoscopic sleeve gastrectomy (LSG) is now a common surgical procedure for obesity, and within the last decade, several authors have proposed that it is the definitive treatment for morbid obesity basing on its efficacy and safety in large randomized trials [6]. Various disorders associated with obesity significantly improve after BMI reduction achieved by LSG. Therefore, the aim of the present study was to assess prevalence of OAB symptoms in a morbidly obese population and to evaluate if these symptoms improved after LSG.
2.
Methods
We prospectively enrolled 120 patients (group A: 60 women and 60 men) attending the Centre of Excellence for Bariatric and Metabolic Surgery of the Department of Sciences and Medico-Surgical Biotechnologies of Sapienza University of Rome in this study between September 2011 and December 2012. These patients were from a cohort of 192 individuals with preliminary evaluation based on history, physical examination (including a rectal and vaginal exploration, respectively, in men and women), BMI assessment, blood analysis, urinalysis and urine culture, renal and pelvic ultrasound, uroflowmetry with evaluation of postvoid residue, and a neurologic and psychological evaluation. Inclusion criteria were morbid obesity (BMI >40 kg/m2), age 18 and 60 y, and eligibility for laparoscopic surgery. Exclusion criteria were urine infection, previous gynecologic or urologic surgery, previous or concomitant neoplastic conditions, any pathologic finding on renal or pelvic ultrasonography,
significant urinary bladder residue (100 mL), pathologic findings on uroflowmetry (peak flow 1.5 mg/dL. Patients meeting the inclusion criteria and recruited for the study filled in a 3-d voiding diary, which included fluid intake count (OAB is characterized by at least eight episodes of micturition per day, presence of urgency, and a strong and sudden desire to void) and the OAB shortform questionnaire (OABq SF), a specific investigational tool developed to assess OAB severity (Figure) [7]. This protocol was performed at 1 wk (baseline) and 180 d after LSG (control). Based on the same inclusion and exclusion criteria, another 120 obese patients (60 women and 60 men) waiting for bariatric surgery and scheduled to undergo surgery in 2014 were selected as a control population (group B). Preliminary statistical data were used to compare sex, age, and weight distributions in the two study populations; then, the following parameters were compared before and after surgery: number of micturitions per day, urgency episodes per day, number of UUI episodes per day, mean-voided volume for micturition, liquid intake count per day, and OABq SF score. Statistical assessment was based on the c2 test and odds ratios for categorical variables, and the Student t-test for evaluating differences in continuous measurements. Considering the strong association between obesity and diabetes, a multiple linear regression model was used to evaluate the correlation between OABq SF scores and glycosylated hemoglobin (HbA1c) values in diabetics. All the study participants signed a consent form, and the study was approved by the local ethical committee and performed according to the Declaration of Helsinki.
Figure e The OABq SF. This questionnaire has been specifically developed to diagnose OAB, is easy to fill, and is selfadministered.
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 6 ( 2 0 1 5 ) 3 0 7 e3 1 2
309
Table 1 shows the study data. No difference was found between the two groups in terms of patient age, BMI, and distribution of comorbidities and between men and women in each group. In order of prevalence, comorbidities included diabetes, dyslipidemia, obstructive sleep apnea syndrome (OSAS), hypertension, and dysthyroidism. All diabetic patients were prescribed oral therapy. OSAS diagnosis was based on polysomnography findings, with determination of the apneahypopnea index and the respiratory disturbance index, which had already been determined during preoperative evaluation for LSG. OSAS was diagnosed in 79 patients in group A (22 used continuous positive air pressure therapy) and 72 patients in group B (20 used continuous positive air pressure therapy).
in group B also had OSAS. Differences in hypertension and dysthyroidism were not significant. Eight women in group A and 5 women in group B reported UUI episodes. No man reported an UUI episode in both groups. The OABq SF mean standard deviation score was 18.69 8.9 in group A and 16.4 1.5 in group B, showing a slight, nonsignificant difference between the two groups. A slightly higher OABq SF was found in women than in men in both groups and in those with diabetes and OSAS. Voiding diaries confirmed the results of the OABq SF, showing at least eight micturitions per day associated with one or more urinary urgency episodes in all these subjects; no statistical difference regarding daily fluid intake and the other parameters assessed by the voiding diary was observed between the two groups and between men and women in each group; furthermore, none of the patients in both groups reported >3 L of urinary voided volume/d, which could have induced a suspicion of polyuria and consequently confounded the diagnosis of OAB.
3.2.
3.3.
3.
Results
3.1.
Clinical findings
OAB questionnaire and voiding diary outcomes
Patients were asked to report data on the OABq SF referring to symptoms in the previous 4 wk and to fill the voiding diary starting 3 d before the assessment. Based on the OABq SF outcome and voiding diary examination, OAB was diagnosed in 21 subjects (35%) in group A and 17 subjects (28%) in group B; these patients were included in subsequent statistical analysis. In both groups, symptoms were more prevalent in women than in men (15 women and 6 men in group A and 12 women and 5 men in group B). No difference was found in mean age and BMI in subpopulations with OAB between the two groups. All patients with OAB also had diabetes and dyslipidemia; 16 of 21 subjects in group A and 11 of 17 subjects
Table 1 e Demographic and clinical features two groups enrolled. Features Males Age: range, mean, and SD BMI: mean and SD Diabetes Dyslipidemia OSAS Hypertension Dysthyroidism Females Age: range, mean, and SD BMI: mean and SD Diabetes Dyslipidemia OSAS Hypertension Dysthyroidism
Group A
Group B
27e57 y, 42.4 8.24 40 4.9 44 40 37 18 13
31e55 y, 44 6.34 41 5.5 45 44 35 16 14
59e74 y, 64.4 7.77 41 2.8 41 49 42 22 9
56e73 y, 63.6 3.3 40 2.7 40 43 37 20 6
NS ¼ not significant; SD ¼ standard deviation. The results show that the two cohorts do not present significant difference about sex, age, BMI, and comorbidities distribution. Diabetes, dyslipidemia, and OSAS were the most represented disorders associated with obesity.
Surgical outcomes
All patients in group A underwent LSG. For all these patients, LSG was the first bariatric surgical treatment. Mean operative time was 64 9.4 min; mean blood loss, 45 32 mL; and mean hospital stay, 3 1.8 d. No significant intraoperative or postoperative complications were observed.
3.4.
Comparison of preoperative and postoperative data
Table 2 compares preoperative data and data obtained at the 180-d follow-up. In group A, a significant decrease in BMI was observed in all patients who underwent LSG, with no significant difference between men and women. In the subgroup with OAB diagnosis, normal blood glucose levels were restored in all the patients, with a statistically significant reduction in mean HbA1c. A concomitant reduction in the number of subjects with OSAS was observed (from 21 individuals to 9). For lower urinary symptoms, the OABq SF score significantly improved (showing a significant reduction in total score) and a statistically significant improvement in voiding diary parameters was observed, in particular, urgency episodes and urinary frequency. UUI still occurred in one of the eight women who reported this symptom at baseline. The diary and OABq SF score outcomes showed that 11 of the 21 patients with OAB diagnosis at baseline did not meet the same diagnostic criteria at follow-up. A statistical subanalysis showed a nonsignificant difference in OABq SF scores and voiding diary improvement between OAB subjects with diabetes and OSAS with respect to the remainder of the cohort. In group B, no significant change in BMI and comorbidities was observed. In the subgroup of patients with OAB, no significant change was seen in voiding diary parameters and OABq SF scores. The number of patients with OAB diagnosis in this group remained unchanged. Furthermore, a slight increase in mean BMI was found in this population, and the indication to perform LSG was therefore confirmed in all these subjects. As mentioned previously, all the patients in our cohort who had obesity and OAB also had diabetes; therefore, the correlation between OABq SF scores and HbA1c value was investigated.
310
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 6 ( 2 0 1 5 ) 3 0 7 e3 1 2
Table 2 e Comparison of baseline and control parameters in group A and B. Parameters Group A Mean, BMI, and, SD Males Females Total fluid intake per 24 h (mL) Total micturitions per 24 h Urgency episodes per 24 h UUI episodes per 24 h Nocturnal micturitions 24 h Mean voided volume (mL) OABq score Group B Mean BMI Males Females Total fluid intake per 24 h (mL) Total micturitions per 24 h Urgency episodes per 24 h UUI episodes per 24 h Nocturnal micturitions per 24 h Mean voided volume (mL) OABq score
Preoperative Postoperative
P
40.7 4.9 41.2 2.8 1280 (67.9)
31 0.9 32 1.8 1309 (68.4)
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Laparoscopic sleeve gastrectomy effects on overactive bladder symptoms Giovanni Palleschi, MD, PhD,a,b Antonio Luigi Pastore, MD, PhD,a,b,* Mario Rizzello, MD,c Giuseppe Cavallaro, MD, PhD,c Gianfranco Silecchia, MD,c and Antonio Carbone, MDa,b a
Department of Sciences and Medico-Surgical Biotechnologies, Urology Unit, ICOT, Sapienza University of Rome, Latina, Italy b Uroresearch Association, Non Profit Association for Basic, Clinical and Surgical Research in Urology, Latina, Italy c Centre of Excellence for Bariatric and Metabolic Surgery, Department of Sciences and Medico-Surgical Biotechnologies, ICOT, Sapienza University of Rome, Latina, Italy
article info
abstract
Article history:
Background: Morbidly obese patients may experience lower urinary tract symptoms. How-
Received 7 January 2015
ever, most studies focus only on urinary incontinence, with little regard to other symptoms
Received in revised form
as those suggestive for overactive bladder (OAB) syndrome. Laparoscopic sleeve gastrec-
7 February 2015
tomy (LSG) is commonly used to treat obesity; this procedure is effective, safe, and capable
Accepted 13 March 2015
of reducing the impact of comorbidities associated with severe increase in body weight.
Available online 18 March 2015
Therefore, we investigated if LSG improves OAB symptoms in morbidly obese patients. Methods: We prospectively recruited 120 morbidly obese patients (60 men and 60 women),
Keywords:
evaluated by history taking, comorbidity assessment, physical examination, urinalysis and
Obesity
urine culture, renal and pelvic ultrasound, a 3-d voiding diary, and the OAB questionnaire
Overactive bladder
short form. Outcomes of these investigations were assessed 7 d before and 180 d after LSG
Sleeve gastrectomy
was performed. Controls were obese individuals (60 men and 60 women) from an LSG
Body mass index
waiting list. Results: Symptoms of OAB were common in the morbidly obese cohort, affecting more women than men. Compared with untreated patients, patients treated with LSG had significantly reduced body mass index 180 d postoperatively; this outcome was associated with improvement in OAB symptoms, whereas no change occurred in untreated controls. Conclusions: OAB symptoms improve in morbidly obese patients successfully treated by LSG. ª 2015 Elsevier Inc. All rights reserved.
1.
Background
Obesity is a pathology characterized by excessive fat accumulation that presents a risk to health and is consistent with a body mass index (BMI) 30 kg/m2 [1]. Obesity is associated with increased incidence of a number of conditions, including
diabetes mellitus, cardiovascular and respiratory diseases, and nonalcoholic fatty liver disease, with an increased risk of disability and a moderate increase in all-cause mortality [2]. Some evidence suggests that lower urinary tract symptoms (LUTS) may develop in morbidly obese patients [3] and that various urogenital complications are directly associated with
* Corresponding author. Via Ernesto Monaci 13, 00161 Rome, Italy. Tel.: þ39 3401138648; fax: þ39 0773 6513333. E-mail address: [email protected] (A.L. Pastore). 0022-4804/$ e see front matter ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2015.03.035
308
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 6 ( 2 0 1 5 ) 3 0 7 e3 1 2
obesity [4]. However, most studies focus on urinary incontinence (UI) and pelvic floor disorders, whereas little information is available on the overactive bladder (OAB) syndrome, which is urgency with/without urinary urgency incontinence (UUI), usually with frequency and nocturia [5]. Laparoscopic sleeve gastrectomy (LSG) is now a common surgical procedure for obesity, and within the last decade, several authors have proposed that it is the definitive treatment for morbid obesity basing on its efficacy and safety in large randomized trials [6]. Various disorders associated with obesity significantly improve after BMI reduction achieved by LSG. Therefore, the aim of the present study was to assess prevalence of OAB symptoms in a morbidly obese population and to evaluate if these symptoms improved after LSG.
2.
Methods
We prospectively enrolled 120 patients (group A: 60 women and 60 men) attending the Centre of Excellence for Bariatric and Metabolic Surgery of the Department of Sciences and Medico-Surgical Biotechnologies of Sapienza University of Rome in this study between September 2011 and December 2012. These patients were from a cohort of 192 individuals with preliminary evaluation based on history, physical examination (including a rectal and vaginal exploration, respectively, in men and women), BMI assessment, blood analysis, urinalysis and urine culture, renal and pelvic ultrasound, uroflowmetry with evaluation of postvoid residue, and a neurologic and psychological evaluation. Inclusion criteria were morbid obesity (BMI >40 kg/m2), age 18 and 60 y, and eligibility for laparoscopic surgery. Exclusion criteria were urine infection, previous gynecologic or urologic surgery, previous or concomitant neoplastic conditions, any pathologic finding on renal or pelvic ultrasonography,
significant urinary bladder residue (100 mL), pathologic findings on uroflowmetry (peak flow 1.5 mg/dL. Patients meeting the inclusion criteria and recruited for the study filled in a 3-d voiding diary, which included fluid intake count (OAB is characterized by at least eight episodes of micturition per day, presence of urgency, and a strong and sudden desire to void) and the OAB shortform questionnaire (OABq SF), a specific investigational tool developed to assess OAB severity (Figure) [7]. This protocol was performed at 1 wk (baseline) and 180 d after LSG (control). Based on the same inclusion and exclusion criteria, another 120 obese patients (60 women and 60 men) waiting for bariatric surgery and scheduled to undergo surgery in 2014 were selected as a control population (group B). Preliminary statistical data were used to compare sex, age, and weight distributions in the two study populations; then, the following parameters were compared before and after surgery: number of micturitions per day, urgency episodes per day, number of UUI episodes per day, mean-voided volume for micturition, liquid intake count per day, and OABq SF score. Statistical assessment was based on the c2 test and odds ratios for categorical variables, and the Student t-test for evaluating differences in continuous measurements. Considering the strong association between obesity and diabetes, a multiple linear regression model was used to evaluate the correlation between OABq SF scores and glycosylated hemoglobin (HbA1c) values in diabetics. All the study participants signed a consent form, and the study was approved by the local ethical committee and performed according to the Declaration of Helsinki.
Figure e The OABq SF. This questionnaire has been specifically developed to diagnose OAB, is easy to fill, and is selfadministered.
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 6 ( 2 0 1 5 ) 3 0 7 e3 1 2
309
Table 1 shows the study data. No difference was found between the two groups in terms of patient age, BMI, and distribution of comorbidities and between men and women in each group. In order of prevalence, comorbidities included diabetes, dyslipidemia, obstructive sleep apnea syndrome (OSAS), hypertension, and dysthyroidism. All diabetic patients were prescribed oral therapy. OSAS diagnosis was based on polysomnography findings, with determination of the apneahypopnea index and the respiratory disturbance index, which had already been determined during preoperative evaluation for LSG. OSAS was diagnosed in 79 patients in group A (22 used continuous positive air pressure therapy) and 72 patients in group B (20 used continuous positive air pressure therapy).
in group B also had OSAS. Differences in hypertension and dysthyroidism were not significant. Eight women in group A and 5 women in group B reported UUI episodes. No man reported an UUI episode in both groups. The OABq SF mean standard deviation score was 18.69 8.9 in group A and 16.4 1.5 in group B, showing a slight, nonsignificant difference between the two groups. A slightly higher OABq SF was found in women than in men in both groups and in those with diabetes and OSAS. Voiding diaries confirmed the results of the OABq SF, showing at least eight micturitions per day associated with one or more urinary urgency episodes in all these subjects; no statistical difference regarding daily fluid intake and the other parameters assessed by the voiding diary was observed between the two groups and between men and women in each group; furthermore, none of the patients in both groups reported >3 L of urinary voided volume/d, which could have induced a suspicion of polyuria and consequently confounded the diagnosis of OAB.
3.2.
3.3.
3.
Results
3.1.
Clinical findings
OAB questionnaire and voiding diary outcomes
Patients were asked to report data on the OABq SF referring to symptoms in the previous 4 wk and to fill the voiding diary starting 3 d before the assessment. Based on the OABq SF outcome and voiding diary examination, OAB was diagnosed in 21 subjects (35%) in group A and 17 subjects (28%) in group B; these patients were included in subsequent statistical analysis. In both groups, symptoms were more prevalent in women than in men (15 women and 6 men in group A and 12 women and 5 men in group B). No difference was found in mean age and BMI in subpopulations with OAB between the two groups. All patients with OAB also had diabetes and dyslipidemia; 16 of 21 subjects in group A and 11 of 17 subjects
Table 1 e Demographic and clinical features two groups enrolled. Features Males Age: range, mean, and SD BMI: mean and SD Diabetes Dyslipidemia OSAS Hypertension Dysthyroidism Females Age: range, mean, and SD BMI: mean and SD Diabetes Dyslipidemia OSAS Hypertension Dysthyroidism
Group A
Group B
27e57 y, 42.4 8.24 40 4.9 44 40 37 18 13
31e55 y, 44 6.34 41 5.5 45 44 35 16 14
59e74 y, 64.4 7.77 41 2.8 41 49 42 22 9
56e73 y, 63.6 3.3 40 2.7 40 43 37 20 6
NS ¼ not significant; SD ¼ standard deviation. The results show that the two cohorts do not present significant difference about sex, age, BMI, and comorbidities distribution. Diabetes, dyslipidemia, and OSAS were the most represented disorders associated with obesity.
Surgical outcomes
All patients in group A underwent LSG. For all these patients, LSG was the first bariatric surgical treatment. Mean operative time was 64 9.4 min; mean blood loss, 45 32 mL; and mean hospital stay, 3 1.8 d. No significant intraoperative or postoperative complications were observed.
3.4.
Comparison of preoperative and postoperative data
Table 2 compares preoperative data and data obtained at the 180-d follow-up. In group A, a significant decrease in BMI was observed in all patients who underwent LSG, with no significant difference between men and women. In the subgroup with OAB diagnosis, normal blood glucose levels were restored in all the patients, with a statistically significant reduction in mean HbA1c. A concomitant reduction in the number of subjects with OSAS was observed (from 21 individuals to 9). For lower urinary symptoms, the OABq SF score significantly improved (showing a significant reduction in total score) and a statistically significant improvement in voiding diary parameters was observed, in particular, urgency episodes and urinary frequency. UUI still occurred in one of the eight women who reported this symptom at baseline. The diary and OABq SF score outcomes showed that 11 of the 21 patients with OAB diagnosis at baseline did not meet the same diagnostic criteria at follow-up. A statistical subanalysis showed a nonsignificant difference in OABq SF scores and voiding diary improvement between OAB subjects with diabetes and OSAS with respect to the remainder of the cohort. In group B, no significant change in BMI and comorbidities was observed. In the subgroup of patients with OAB, no significant change was seen in voiding diary parameters and OABq SF scores. The number of patients with OAB diagnosis in this group remained unchanged. Furthermore, a slight increase in mean BMI was found in this population, and the indication to perform LSG was therefore confirmed in all these subjects. As mentioned previously, all the patients in our cohort who had obesity and OAB also had diabetes; therefore, the correlation between OABq SF scores and HbA1c value was investigated.
310
j o u r n a l o f s u r g i c a l r e s e a r c h 1 9 6 ( 2 0 1 5 ) 3 0 7 e3 1 2
Table 2 e Comparison of baseline and control parameters in group A and B. Parameters Group A Mean, BMI, and, SD Males Females Total fluid intake per 24 h (mL) Total micturitions per 24 h Urgency episodes per 24 h UUI episodes per 24 h Nocturnal micturitions 24 h Mean voided volume (mL) OABq score Group B Mean BMI Males Females Total fluid intake per 24 h (mL) Total micturitions per 24 h Urgency episodes per 24 h UUI episodes per 24 h Nocturnal micturitions per 24 h Mean voided volume (mL) OABq score
Preoperative Postoperative
P
40.7 4.9 41.2 2.8 1280 (67.9)
31 0.9 32 1.8 1309 (68.4)
