Impact of Body Mass Index on the Efficacy of Treatment Modalities in Women with Refractory Overactive Bladder

doi:10.21203/rs.3.rs-4929290/v1

Background

Overactive bladder (OAB) is a prevalent condition that substantially impairs quality of life. Obesity and overweight status are recognized as significant risk factors for OAB, but their influence on treatment efficacy is not well understood.

Methods

This cross-sectional study was conducted from January 2023 to July 2024 at a tertiary care hospital. Women diagnosed with refractory OAB were classified into normal weight, overweight, and obese groups according to their body mass index (BMI). Treatment options included combination pharmaceutical therapy and Botulinum toxin injections. Outcomes were assessed using the Overactive Bladder Symptom Score (OABSS) and quality of life questionnaires, administered before and 12 weeks after treatment.

Results

A total of 143 women were included in the study. Normal weight women demonstrated significant improvements in OAB symptoms and quality of life following both combination therapy and Botulinum toxin injection. Conversely, overweight and obese women showed limited improvement with pharmaceutical therapy but responded better to Botulinum toxin injections.

Conclusion

The findings suggest that Botulinum toxin injection may be a more effective treatment modality for overweight or obese women with refractory OAB compared to pharmaceutical therapy. Normal weight women might benefit from initiating treatment with combination medication therapy.

Health sciences/Urology

Health sciences/Urology/Urogenital diseases

Health sciences/Urology/Urogenital diseases/Urinary incontinence

Body mass index

Overweight

Obesity

Overactive bladder

Quality of life

Overactive bladder (OAB) is characterized by increased daytime urinary frequency, urgency, and nocturia, with or without incontinence, in the absence of a urinary tract infection, as defined by the International Continence Society/International Urogynecological Association [1]. Diagnosis is primarily based on these symptoms, which significantly impair daily quality of life. The condition is relatively common, with a large-scale population-based study reporting a prevalence of 12% among women, increasing with age and menopausal status [1]. Additionally, several studies have identified overweight and obesity as risk factors for OAB [2]. One study even found that obese patients experience urgency urinary incontinence episodes more frequently and suffer from worsening symptoms and quality of life compared to their normal or overweight counterparts [3]. Therefore, identifying appropriate treatments for these patients is critical.

The standard pharmaceutical treatments for OAB include anticholinergics. Another option is the beta-3-adrenergic agonist, a novel medication approved by the United States Food and Drug Administration in 2012 [4]. The effectiveness and safety of these medications have been validated in multiple clinical trials and meta-analyses [4, 5]. Patients who fail to respond to at least one medication after 4 to 8 weeks are classified as having refractory OAB, a common yet challenging condition due to the unsatisfactory outcomes of traditional treatments. While overweight and obesity have been shown to be independent risk factors for urinary incontinence and OAB, the efficacy of various treatment modalities in these patients remains unclear [3]. This study aimed to evaluate the impact of body mass index (BMI) on the effectiveness of different treatment modalities in women with refractory OAB by comparing symptom relief and quality of life after pharmaceutical therapy and Botulinum toxin injections in normal-weight versus overweight and obese patients.

Methods

Study Design and Participants: This cross-sectional study was conducted at a tertiary referral hospital between January 2023 and July 2024. Ethical approval was obtained from the Institutional Review Board of Mackay Memorial Hospital (22MMHIS039e). The research was performed in accordance with relevant regulations, and informed consent was obtained from all individual participants included in the study. Women presenting with OAB symptoms were reviewed, and those with current urinary tract infection, advanced pelvic organ prolapse, use of vaginal pessary, contraindications to anticholinergic or β3-agonist medications, or any neurological disorders affecting lower urinary tract symptoms were excluded.

Interventions: Participants were initially prescribed either anticholinergic drugs or β3-adrenergic agonists. Patients who did not respond to either medication after one month were offered combination therapy (Solifenacin 5 mg once daily plus 0.5 g conjugated estrogen intravaginal cream [0.625 mg/g] twice weekly or Solifenacin 5 mg plus Mirabegron 25 mg per day). Botulinum toxin injection was also available, with the choice of therapy based on patient preference.

Outcome Measures: OAB symptoms, including micturition urgency, frequency, and nocturia episodes, were evaluated within 24 hours before and 12 weeks after treatment. Participants completed the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) to assess incontinence-related symptom distress and quality of life [7]. The severity of OAB symptoms was quantified using the Overactive Bladder Symptom Score (OABSS) [8]. Patients were categorized into normal, overweight, and obese groups based on their BMI, and treatment outcomes were compared across these groups.

Statistical Analysis: One-way analysis of variance was used to assess differences between groups. Paired-sample t-tests and the McNemar test were employed for intragroup comparisons of questionnaire scores and OAB symptoms. Statistical analyses were conducted using SPSS version 26.0 for Windows (SPSS, Chicago, IL, USA), with a p-value of less than 0.05 considered statistically significant.

During the study period, 143 women with refractory OAB were included. Of these, 90 (62.9%) were of normal weight, 41 (28.7%) were overweight, and 12 (8.3%) were obese. Regarding treatment modalities, 40 (28.0%) received Solifenacin and local estrogen treatment, 70 (49.0%) received Solifenacin and Mirabegron, and 33 (23.0%) underwent Botulinum toxin injection. The baseline quality of life scores and patient characteristics are presented in Table 1. Significant differences were observed in BMI (normal: 21.8 ± 2.0, overweight: 27.4 ± 1.6, and obese: 32.6 ± 4.1 kg/m², respectively; p < 0.001), incidence of hypertension (14.4%, 7.4%, and 50.0%, respectively, p < 0.001), and prior pelvic surgeries (4.4%, 14.6%, and 25.0%, respectively, p = 0.018). Baseline quality of life scores were worse in overweight women, with a higher OABSS score (normal: 8.0 ± 3.4, overweight: 9.5 ± 3.2, and obese: 9.1 ± 3.6, respectively; p = 0.034), although other differences were not statistically significant.

Table 1

Demographic and clinical characteristics of participants
	Normal weight 18.5 ≦ BMI<24 (n = 90)	Overweight 24 ≦ BMI<27 (n = 41)	Obese 27 ≦ BMI (n = 12)	p
Age, y	58.2 ± 13.3	63.3 ± 10.8	58.9 ± 14.8	0.062
Parity, n	1.9 ± 1.2	2.4 ± 1.4	2.1 ± 1.5	0.079
Vaginal delivery, n	1.6 ± 1.3	2.1 ± 1.6	1.5 ± 1.8	0.098
Cesarean section, n	0.3 ± 0.6	0.3 ± 0.7	0.4 ± 0.8	0.613
Body mass index, kg/m²	21.8 ± 2.0	27.4 ± 1.6	32.6 ± 4.1	< 0.001
Hypertension, n	13(14.4%)	2(7.4%)	6(50.0%)	< 0.001
Diabetes mellitus, n	9(10.0%)	5(12.2%)	5(41.7%)	0.016
Hyperlipidemia, n	3(3.3%)	11(40.7%)	5(41.7%)	0.556
Hysterectomy, n	4(4.4%)	7(17.0%)	6(50.0%)	0.120
Prior pelvic surgery. n	4(4.4%)	6(14.6%)	3(25.0%)	0.018
Mean episodes of voids per 24 hours, n	9.7 ± 4.4	8.9 ± 4.0	8.3 ± 3.3	0.319
Mean episodes of nocturia per night, n	2.8 ± 1.7	3.1 ± 1.9	2.6 ± 1.5	0.484
Mean episodes of urgent micturition per 24 hours, n	4.0 ± 3.5	4.7 ± 4.4	3.7 ± 3.7	0.571
Mean episodes of urinary incontinence per day, n	2.3 ± 2.7	2.7 ± 2.9	1.8 ± 1.5	0.519
UDI-6	7.7 ± 4.0	8.4 ± 3.8	6.4 ± 3.0	0.198
IIQ-7	9.0 ± 6.3	10.4 ± 5.8	10.1 ± 6.1	0.408
OABSS	8.0 ± 3.4	9.5 ± 3.2	9.1 ± 3.6	0.034
Data are presented as mean ± standard deviation or as number (percent) of patients.
UDI-6: the short form of the Urogenital Distress Inventory, IIQ-7: the short form of the Incontinence Impact Questionnaire, OABSS: overactive bladder symptom score

Table 2 presents the outcomes for women with different BMIs who received Solifenacin 5 mg once daily plus 0.5 g conjugated estrogen intravaginal cream (0.625 mg/g) twice weekly. In normal-weight women, all OAB symptoms and quality of life scores significantly improved after Solifenacin and local estrogen therapy, except for urgency episodes within 24 hours (before and 12 weeks after treatment: 3.0 ± 2.7 vs. 2.5 ± 1.9, p = 0.505). For overweight women, OABSS scores (9.5 ± 3.4 vs. 7.7 ± 3.4, p = 0.038), micturition episodes within 24 hours (9.0 ± 4.1 vs. 7.9 ± 3.8, p = 0.038), and nocturia episodes per night (3.2 ± 2.1 vs. 2.5 ± 1.2, p < 0.001) significantly improved. However, for obese women, only micturition episodes significantly improved (8.3 ± 1.7 vs. 7.5 ± 1.0, p < 0.001), with no significant changes observed in other parameters.

Table 2

Treatment outcomes based on different body mass index before and after Solifenacin and estrogen intravaginal cream treatment
	Normal weight 18.5 ≦ BMI<24 (n = 22)	Overweight 24 ≦ BMI<27 (n = 14)	Obese 27 ≦ BMI (n = 4)	P (intergroup)
UDI-6
Pre-treatment	6.6 ± 3.6	8.9 ± 4.0	5.3 ± 3.9	0.040
Post-treatment	5.5 ± 3.8	6.1 ± 2.9	2.8 ± 1.9	0.230
Difference	-0.7 ± 3.6	-2.1 ± 4.2	-1.8 ± 1.0	0.482
P (intragroup)	0.005	0.147	0.055
IIQ-7
Pre-treatment	6.4 ± 5.8	9.1 ± 5.4	8.4 ± 6.8	0.222
Post-treatment	6.9 ± 5.8	5.7 ± 3.7	4.5 ± 4.8	0.571
Difference	0.8 ± 5.0	-3.3 ± 6.0	-0.5 ± 2.5	0.063
P (intragroup)	0.010	0.358	0.141
OABSS
Pre-treatment	6.8 ± 3.5	9.5 ± 3.4	8.0 ± 3.9	0.019
Post-treatment	6.3 ± 3.3	7.7 ± 3.4	4.5 ± 2.5	0.187
Difference	0.5 ± 4.2	-1.7 ± 4.6	-1.5 ± 3.0	0.234
P (intragroup)	0.030	0.038	0.300
Micturition episodes
Pre-treatment	9.8 ± 4.0	9.0 ± 4.1	8.3 ± 1.7	0.543
Post-treatment	8.3 ± 3.7	7.9 ± 3.8	7.5 ± 1.0	0.865
Difference	-0.5 ± 4.6	-0.9 ± 4.4	-1.8 ± 0.5	0.841
P (intragroup)	0.034	0.038	< 0.001
Nocturia episodes
Pre-treatment	2.7 ± 1.6	3.2 ± 2.1	2.1 ± 1.3	0.417
Post-treatment	1.8 ± 1.1	2.5 ± 1.2	1.5 ± 1.0	0.138
Difference	-0.3 ± 1.3	-0.2 ± 0.9	0.3 ± 0.5	0.607
P (intragroup)	< 0.001	< 0.001	0.130
Urgency episodes
Pre-treatment	3.0 ± 2.7	4.6 ± 4.7	2.0 ± 1.6	0.118
Post-treatment	2.5 ± 1.9	4.0 ± 4.9	1.4 ± 1.0	0.254
Difference	-0.2 ± 3.2	-1.8 ± 7.7	-0.6 ± 1.4	0.633
P (intragroup)	0.505	0.708	> 0.999
Urinary incontinence episodes
Pre-treatment	1.0 ± 1.3	2.3 ± 2.1	1.7 ± 1.5	0.014
Post-treatment	1.2 ± 1.4	2.2 ± 2.8	0.1 ± 0.2	0.145
Difference	0.3 ± 1.2	0.1 ± 4.6	-1.6 ± 1.5	0.560
P (intragroup)	0.021	0.156	0.801
Data are presented as mean ± standard deviation or as number (percent) of patients.
UDI-6: the short form of the Urogenital Distress Inventory, IIQ-7: the short form of the Incontinence Impact Questionnaire, OABSS: overactive bladder symptom score

Table 3 shows the outcomes for women with different BMIs who received Solifenacin 5 mg plus Mirabegron 25 mg per day. All OAB symptoms and quality of life scores significantly improved in the normal-weight group after combination medication therapy (all p < 0.05). However, none of the items significantly improved in overweight or obese women (all p > 0.05), indicating that combination medication therapy may not adequately address OAB symptoms in women with higher BMIs.

Table 3

Treatment outcomes based on different body mass index before and after a *combination* therapy with Vesicare and Mirabegron treatment
	Normal weight 18.5 ≦ BMI<24 (n = 51)	Overweight 24 ≦ BMI<27 (n = 15)	Obese 27 ≦ BMI (n = 4)	p
UDI-6
Pre-treatment	8.1 ± 4.2	7.8 ± 4.0	7.5 ± 1.9	0.939
Post-treatment	6.1 ± 4.8	7.8 ± 3.8	3.3 ± 1.3	0.207
Difference	-2.5 ± 4.3	0.3 ± 5.6	-4.7 ± 2.1	0.123
P (intragroup)	0.001	0.874	0.060
IIQ-7
Pre-treatment	9.9 ± 6.2	10.1 ± 5.6	12.8 ± 3.6	0.656
Post-treatment	6.5 ± 6.1	8.7 ± 5.9	7.8 ± 4.8	0.526
Difference	-3.9 ± 5.2	-0.7 ± 6.1	-5.0 ± 5.0	0.195
P (intragroup)	< 0.001	0.700	0.225
OABSS
Pre-treatment	8.6 ± 3.3	9.1 ± 3.4	8.8 ± 3.6	0.877
Post-treatment	5.7 ± 4.0	6.4 ± 3.0	7.3 ± 3.6	0.684
Difference	-2.6 ± 3.6	-2.4 ± 4.5	-2.0 ± 3.5	0.954
P (intragroup)	< 0.001	0.112	0.423
Micturition episodes
Pre-treatment	9.6 ± 4.5	9.2 ± 4.2	5.3 ± 3.8	0.167
Post-treatment	6.9 ± 4.7	8.2 ± 4.3	4.5 ± 1.3	0.370
Difference	-2.7 ± 4.7	-0.4 ± 3.2	-1.0 ± 5.6	0.328
P (intragroup)	0.001	0.702	0.785
Nocturia episodes
Pre-treatment	2.6 ± 1.6	3.0 ± 1.3	2.3 ± 1.3	0.603
Post-treatment	2.2 ± 1.7	2.0 ± 0.8	2.0 ± 1.4	0.917
Difference	-0.4 ± 1.1	-0.6 ± 1.1	-0.3 ± 0.6	0.835
P (intragroup)	0.027	0.089	0.423
Urgency episodes
Pre-treatment	4.2 ± 3.4	3.9 ± 3.5	3.3 ± 2.1	0.858
Post-treatment	2.7 ± 4.0	2.7 ± 2.8	2.8 ± 1.7	> 0.999
Difference	-1.2 ± 3.3	-1.2 ± 4.6	-0.7 ± 1.2	0.973
P (intragroup)	0.039	0.414	0.423
Urinary incontinence episodes
Pre-treatment	2.8 ± 2.4	3.2 ± 4.3	1.3 ± 2.3	0.600
Post-treatment	1.2 ± 1.6	1.5 ± 1.6	1.5 ± 1.9	0.849
Difference	-1.7 ± 2.1	-1.9 ± 5.2	1.0 ± 1.4	0.446
P (intragroup)	< 0.001	0.277	0.500
Data are presented as mean ± standard deviation or as number (percent) of patients.
UDI-6: the short form of the Urogenital Distress Inventory, IIQ-7: the short form of the Incontinence Impact Questionnaire, OABSS: overactive bladder symptom score

Table 4 presents the outcomes for women who underwent Botulinum toxin injection. All OAB symptoms and quality of life scores significantly improved in the normal-weight group after Botulinum toxin injection, except for micturition episodes (before and 12 weeks after treatment: 9.7 ± 5.0 vs. 6.3 ± 3.3, p = 0.113) and nocturia episodes (3.2 ± 2.2 vs. 2.1 ± 1.6, p = 0.220). Similarly, in the overweight group, all OAB symptoms and quality of life scores significantly improved after Botulinum toxin injection, except for micturition episodes (8.3 ± 4.1 vs. 4.6 ± 4.3, p = 0.092) and incontinence episodes (2.6 ± 1.8 vs. 1.2 ± 1.5, p = 0.092). For obese women, all OAB symptoms and quality of life scores significantly improved, except for nocturia episodes (3.8 ± 1.5 vs. 1.5 ± 0.6, p = 0.157) and incontinence episodes (2.3 ± 0.6 vs. 0.3 ± 0.5, p = 0.205).

Table 4

Treatment outcomes based on different body mass index before and after *Botulinum* toxin injection therapy
	Normal weight 18.5 ≦ BMI<24 (n = 17)	Overweight 24 ≦ BMI<27 (n = 12)	Obese 27 ≦ BMI (n = 4)	p
UDI-6
Pre-treatment	9.0 ± 3.7	8.4 ± 3.3	7.3 ± 1.5	0.644
Post-treatment	3.9 ± 3.8	3.3 ± 3.0	3.3 ± 2.1	0.913
Difference	-4.3 ± 4.0	-4.9 ± 4.5	-4.0 ± 4.8	0.566
P (intragroup)	0.020	0.007	0.039
IIQ-7
Pre-treatment	12.1 ± 6.0	12.9 ± 6.5	10.3 ± 7.2	0.763
Post-treatment	5.4 ± 8.2	3.3 ± 3.8	2.5 ± 3.3	0.676
Difference	-5.5 ± 7.9	-10.3 ± 7.3	-7.5 ± 6.6	0.282
P (intragroup)	0.050	0.003	0.045
OABSS
Pre-treatment	9.2 ± 2.9	10.0 ± 2.9	11.3 ± 2.9	0.409
Post-treatment	5.0 ± 4.0	4.5 ± 4.4	4.3 ± 3.7	0.949
Difference	-3.9 ± 5.9	-5.5 ± 4.7	-7.3 ± 5.5	0.747
P (intragroup)	0.016	0.007	0.003
Micturition episodes
Pre-treatment	9.7 ± 5.0	8.3 ± 4.1	11.3 ± 2.5	0.497
Post-treatment	6.3 ± 3.3	4.6 ± 4.3	4.8 ± 2.6	0.647
Difference	-3.4 ± 4.5	-4.9 ± 6.6	-6.0 ± 5.9	0.820
P (intragroup)	0.113	0.092	0.045
Nocturia episodes
Pre-treatment	3.2 ± 2.2	3.1 ± 2.1	3.8 ± 1.5	0.858
Post-treatment	2.1 ± 1.6	1.5 ± 1.6	1.5 ± 0.6	0.657
Difference	-2.5 ± 5.2	-1.5 ± 1.2	-1.3 ± 3.3	0.811
P (intragroup)	0.220	0.007	0.157
Urgency episodes
Pre-treatment	6.0 ± 4.6	5.7 ± 4.9	8.3 ± 5.8	0.686
Post-treatment	2.4 ± 3.5	1.3 ± 1.6	1.4 ± 1.5	0.380
Difference	-4.0 ± 5.2	-5.6 ± 6.1	-6.3 ± 5.1	0.752
P (intragroup)	0.044	0.026	0.045
Urinary incontinence episodes
Pre-treatment	3.4 ± 4.7	2.6 ± 1.8	2.3 ± 0.6	0.800
Post-treatment	0.6 ± 0.8	1.2 ± 1.5	0.3 ± 0.5	0.336
Difference	-2.7 ± 13.0	-1.7 ± 2.4	-1.9 ± 1.9	0.597
P (intragroup)	0.038	0.092	0.205
Data are presented as mean ± standard deviation or as number (percent) of patients.
UDI-6: the short form of the Urogenital Distress Inventory, IIQ-7: the short form of the Incontinence Impact Questionnaire, OABSS: overactive bladder symptom score

This study indicates that normal-weight women with refractory OAB respond well to combination medication therapy or Botulinum toxin injection; however, overweight and obese women may not find pharmaceutical therapy as effective. For these patients, Botulinum toxin injection may be a more effective treatment option compared to medication therapies.

While the prevalence of OAB symptoms in women is reportedly related to increasing BMI [9], the exact mechanisms by which obesity or overweight status affects OAB remain unclear. Increased BMI could lead to higher intra-abdominal and intravesical pressure. One theory suggests that the increased mechanical load may stimulate bladder sensory afferents, increase oxidative stress, and precipitate systemic inflammation and insulin resistance. These processes could result in chronic pelvic ischemia and urothelial dysfunction [10, 11]. Another study reported that increased abdominal visceral fat associated with inflammatory cytokine production could lead to inflammatory changes in adipose tissue surrounding the bladder, subsequently causing OAB symptoms [11, 12]. Obesity or overweight status is considered a chronic inflammatory state, contributing to OAB symptoms. Similar pathophysiological mechanisms have been reported in studies on inflammatory bowel disease, where visceral adiposity was associated with a more severe inflammatory phenotype [13]. These conditions may explain why overweight or obese patients experience worse OAB symptoms than those of normal weight [3].

The efficacy of combination therapy with Solifenacin and Mirabegron has been documented in several well-conducted studies [4, 5]. Combination therapy has shown a significantly greater improvement in daily incontinence, micturition frequency, and urgency episodes compared to Solifenacin monotherapy [4]. The effect of combining antimuscarinic medication with local estrogen has also been confirmed [14]. A randomized controlled trial comparing tolterodine alone with tolterodine combined with local estrogen showed that the combination therapy had a synergistic effect, resulting in greater improvement in incontinence-related quality of life [14]. However, in our study, refractory OAB symptoms in overweight and obese women persisted despite combination therapies. This may be due to the association of refractory OAB with urothelial dysfunction, chronic bladder ischemia, and chronic bladder inflammation, conditions also linked to overweight or obesity [15]. These factors may explain why normal-weight women showed significant improvement while overweight and obese women did not, even with combination therapy.

There is limited data evaluating the impact of BMI on treatment efficacy in women with OAB. To the best of our knowledge, only one prospective study has assessed the efficacy of β-3-adrenoreceptor treatment between normal-weight and overweight or obese women [3]. That study enrolled 169 women who received 50 mg of Mirabegron daily. After 12 weeks of treatment, micturition urgency and nocturia episodes within 24 hours significantly improved across all BMI categories, as did quality of life. The authors concluded that body weight did not influence the treatment outcome of Mirabegron. However, that study focused on monotherapy with β-3-adrenoreceptor, and there is no existing data on the impact of BMI on refractory OAB treated with combination therapies or Botulinum toxin injections until now. Our study highlights that overweight or obese women with refractory OAB may not be satisfied with combination medication therapy and might benefit more from starting with Botulinum toxin injection therapy. This is the first study, to our knowledge, to report the treatment outcomes of different modalities in women with refractory OAB across different BMI categories. The strength of this study lies in its use of multiple validated questionnaires to comprehensively evaluate quality of life and OAB symptoms. The main limitations include the short duration of treatment and the small sample size. A larger cohort and long-term follow-up are warranted to further evaluate the outcomes. Nonetheless, our study provides important insights suggesting that Botulinum toxin injection should be considered for overweight or obese women with refractory OAB, whereas normal-weight women may start with combination medication therapy. Categorizing patients according to their BMI may lead to improved treatment outcomes.

Overweight or obese women with refractory OAB may benefit more from Botulinum toxin injection therapy compared to pharmaceutical therapies. Normal-weight women can consider starting with combination medication therapy. Stratifying patients by BMI could lead to more effective and personalized treatment strategies.

Funding

None.

Author Contribution

HH Lau and TH Su contribution to the conception or design of the work.JC Hwang contributes to the acquisition, analysis, or interpretation of data.PE Liu and JC Hwang have drafted the work and substantively revised it.HH Lau and TH Su have approved the submitted version.

Data Availability

The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.

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No competing interests reported.

Impact of Body Mass Index on the Efficacy of Treatment Modalities in Women with Refractory Overactive Bladder

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