
==== Front
Sci Rep
Sci Rep
Scientific Reports
2045-2322
Nature Publishing Group UK London

39223151
68313
10.1038/s41598-024-68313-x
Article
Prevalence and risk factors for overactive bladder symptoms in patients with artificial urinary sphincter
Taniguchi Hisanori
Takizawa Nae
http://orcid.org/0000-0002-6481-1967
Kinoshita Hidefumi kinoshih@hirakata.kmu.ac.jp

https://ror.org/001xjdh50 grid.410783.9 0000 0001 2172 5041 Department of Urology and Andrology, Kansai Medical University, 2-3-1 Shin-machi, Hirakata, Osaka 573-1191 Japan
2 9 2024
2 9 2024
2024
14 2033214 10 2023
22 7 2024
© The Author(s) 2024
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.
To demonstrate the prevalence and risk factors for overactive bladder symptoms associated with artificial urinary sphincter implantation, we investigated the patients who underwent primary artificial urinary sphincter implantation with severe urinary stress incontinence. Forty-eight patients who completely answered the questionnaires of the overactive bladder symptom score before surgery were included. Patient characteristics, urinary status at pre and 1, 3, 6, and 12 months post-device activation, and predictive factors for overactive bladder symptoms were examined. Sixty percent of the patients had preoperative overactive bladder symptoms. Until 12 months after device activation, 35–40% of all patients had overactive bladder symptoms. The rate of persistent and de novo postoperative overactive bladder symptoms was 44.8% and 26.3%, respectively. Daily pad use was not different between patients w/wo overactive bladder symptoms. The only risk factor for postoperative overactive bladder symptoms was a max cystometoric capacity < 200 mL measured by a preoperative urodynamic study. Attention must be given to both persistent and de novo overactive bladder symptoms associated with artificial urinary sphincter implantation for patients with stress incontinence. Counsel should equally be provided for preoperative overactive bladder symptoms, especially in cases with a cystometric capacity < 200 mL.

Subject terms

Signs and symptoms
Urological manifestations
issue-copyright-statement© Springer Nature Limited 2024
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pmcIntroduction

Artificial urinary sphincter (AUS) implantation is the gold-standard treatment for patients with moderate to severe stress urinary incontinence mainly after radical prostatectomy, potentially transurethral surgery, or trauma1,2. Regarding about postprostatectomy urinary incontinence, several baseline parameters were proposed as predicting factor such as age, tumor stage, prostate volume and preoperative urinary symptoms3–5.

Although acceptable efficacies of AUS implantation for incontinence, durability, and safety have been reported6,7, some patients complain of overactive bladder (OAB) symptoms post-AUS implantation. Previous reports revealed post-AUS implantation OAB symptoms in both cases of concomitant pre-AUS implantation OAB and de novo OAB post-AUS implantation8,9.

Since we established a severe male incontinence outpatient clinic in January 2019, we have been actively carrying out AUS implantation. A certain number of patients with post-AUS implantation OAB symptoms exist in clinical practice.

OAB is defined as the presence of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology10. AUS implantation-associated OAB symptoms are usually assessed by a physician from patient complaints8,9.

In this study, to reveal the status of OAB symptoms in relation to AUS implantation, we evaluated the prevalence and risk factors for OAB associated with AUS implantation using a validated OAB symptom score (OABSS) questionnaire.

Materials and methods

Among all 52 patients who underwent single-surgeon primary AUS implantation between March 2019 and October 2022 at our institution, 48 reported OABSS questionnaires both pre- and post-AUS implantation were enrolled in this study. Three patients who did not completely answer the OABSS questionnaire before AUS implantation were excluded. Flexible cystoscopy was performed in all patients to check for the absence of a urethral stricture as a standard pre-AUS implantation examination. The 60 min pad weight test was done in all patients. Including medical interview, severe stress incontinence in all patients were confirmed both subjectively and objectively before surgery. A urodynamic study was done in 38 of 48 patients before AUS implantation without anticholinergic or beta-3 agonist therapy. Urodynamic study was performed in the standing position. Patients with significant gravitational incontinence (total incontinence in the standing position) were excluded.

All AUS implantations were done using AMS800® (Boston Scientific, Marlborough, MA, USA) and a standard procedure using the perineal approach was performed8. Almost all patients received 4.0 or 4.5 cm urethral cuffs. The implant was placed in the abdominal reservoir filled with 22 mL normal saline at the pre-vesical space through an additional supra-inguinal incision site. A control pump was implanted in the right scrotum through the same supra-inguinal incision site. The pump was deactivated at the end of the surgery.

All patients were admitted 6 weeks after AUS implantation, and AUS devices were activated. Patients were discharged a few days after confirming that there were no problems with the self-operation of the AUS devices.

OAB was assessed using patient-reported outcomes, OABSS, and International prostate symptom score (IPSS) questionnaires in every outpatient visit at pre and 1, 3, 6, and 12 months post-AUS device activation. Voiding function, urinalysis, and the continence status of the number of daily pad use were also evaluated.

The OABSS is a validated objective assessment tool used to evaluate OAB symptoms that has been published in many languages11–13. The OABSS consists of four questions and a higher score indicates more severe symptoms. Patients were said to have an OAB when they met the criteria (urgency score of ≥ 2, with a total score of ≥ 3) and categorized as mild, moderate, and severe by a total score of 3–5, 6–11, and 12–15, respectively14. In this study, we identified patients as having OAB when they met the criteria at the last follow-up point until 12 months post-AUS device activation.

Pre-AUS implantation urodynamic data was obtained to confirm unobstructed sphincters and normal detrusor pressure status. We measured the cystometric capacity and detrusor overactivity (DO). DO was defined as an increase in detrusor pressure observed during the filling phase regardless of amplitude and not associated with urgency.

Patient characteristics, the prevalence of OAB defined using OABSS questionnaires pre and post-AUS implantation, demographics of patients with and without post-AUS implantation OAB, and risk factors for post-AUS implantation OAB were examined. This study was approved by the Kansai Medical University institutional review board (IRB approval No. 2018086) and written informed consent was obtained from all participants.

Data of continuous variables and categorical variables are presented as the mean ± standard deviation (SD) and number (percentage). Two-sided unpaired t-tests and the chi-square test were used to compare numerical and categorical variables, respectively. The Cox proportional hazards model was used for univariate analysis. These analyses were performed using SPSS Statistics version 28.0.1 (IBM Corp., Armonk, NY, USA). A p-value < 0.05 was considered statistically significant. This study was carried out following the Helsinki Declaration and ethical guidelines regarding clinical studies.

Results

Prevalence of pre and post-AUS implantation OAB

The presence of OAB defined objectively from the OABSS questionnaire is shown in Fig. 1. An OAB was identified in 60.4% (29/48) of patients and 54.2% (26/48) patients were categorized as moderate to severe at pre-AUS implantation. The rate of OAB decreased to 36.2% (17/47) at one-month post-AUS activation and was maintained around 35–40% until 12 months. The rate of patients with total and moderate-severe OAB identified by OABSS was 39.0% (26.8%), 38.5% (33.3%), and 35.3% (29.4%) at 3, 6, and 12 months post-AUS activations, respectively.Figure 1 Prevalence of OAB pre and post AUS implantation.

Patient characteristics and Pre-AUS OAB

Baseline characteristics of all patients and the presence of concomitant pre-AUS implantation OAB symptoms are summarized in Table 1. The mean patient age was 73.2 ± 6.1 years and the mean duration from the initial cause of incontinence to AUS implantation was 72.5 ± 54.6 months. The causes of incontinence were radical prostatectomy in 45 patients, transurethral prostate surgery in two patients, and pelvic injury in one patient. From the medical interview, incontinence in all patients occurred just after considered causes such as prostatectomy, transurethral prostate surgery and trauma. The 60 min pad weight test assessed pre-AUS implantation demonstrated severe incontinence in all patients. Before AUS implantation, 25% of patients received radiation therapy. The mean number of daily pad use was 4.8 ± 2.4. From urodynamic studies, detrusor overactivity was present in 23.7% of patients. The IPSS questionnaire showed that the mean OQL score of pre-AUS implantation patients (5.4 ± 1.1) was severe. Except for the IPSS storage sub-score, which was worse in concomitant OAB patients than no OAB patients (8.7 ± 3.7 vs 5.3 ± 4.9; p = 0.03), patients’ backgrounds were not significantly different between w/wo concomitant OAB groups.Table 1 Patient clinical, urodynamic and IPSS scores pre-AUS treatment.

Variable	All	OAB ( +)	OAB ( −)	p-value	
Number (%) or mean ± SD	
Number of patients	48	29 (60.4)	19 (39.6)	-	
Age (year)	73.2 ± 6.1	72.3 ± 6.9	74.5 ± 4.3	0.17	
Body mass index (kg/m2)	24.0 ± 3.3	23.9 ± 3.2	24.2 ± 3.6	0.77	
Diabetes mellitus ( +)	12 (25)	8 (27.5)	4 (21.1)	0.86	
Duration from initial cause of incontinence to AUS (mo.)	72.5 ± 54.6	78.0 ± 60.3	64.1 ± 44.7	0.36	
Follow-up period after AUS (mo.)	25.0 ± 10.9	22.1 ± 10.8	22.1 ± 10.8	0.21	
Cause of incontinence	
 Radical prostatectomy	45	27	19	–	
 Transurethral surgery of prostate	2	1	0		
 Injury	1	1	0		
Radiation therapy before AUS	12 (25.0)	5 (17.2)	7 (36.8)	0.23	
Number of daily pads use	4.8 ± 2.4	4.6 ± 2.5	5.1 ± 2.2	0.45	
Sensation results of urodynamic study	
 Normal desire (mL)	160.6 ± 77.1	149.7 ± 59.0	179.2 ± 101	0.33	
 % of normal desire ≤ 125 mL	36.8	33.3	14.3	0.27	
 Max cystometric capacity (mL)	244.0 ± 83.5	236.8 ± 78.7	257.3 ± 93.4	0.49	
 % of max cystometric capacity ≤ 200 mL	30.0	30.8	28.6	0.95	
% Detrusor overactivity	23.7	21.9	14.3	0.70	
IPSS total	13.3 ± 9.8	14.7 ± 9.2	10.6 ± 10.5	0.21	
 Voiding sub-score	5.8 ± 6.3	6.0 ± 6.3	5.2 ± 6.3	0.71	
 Storage sub-score	7.5 ± 4.4	8.7 ± 3.7	5.3 ± 4.9	0.03	
QOL score	5.4 ± 1.1	5.7 ± 0.5	5.0 ± 1.6	0.11	

OAB prevalence pre and post-AUS implantation

From the OABSS questionnaire, the rate of OAB patients at post-AUS implantation was examined (Fig. 2). Among pre-OAB patients, 44.8% (13/29) were defined as having persistent OAB at post-AUS implantation. Conversely, among no pre-OAB patients, 26.3% (5/19) were defined as de novo post-AUS implantation OAB. About half of all post-AUS OAB patients (8/18) were prescribed a beta-3 agonist (mirabegron) by a physician.Figure 2 Dendrogram of OAB prevalence pre and last follow-up of AUS implantation.

Demographics of patients w/wo OAB at post-AUS implantation

Table 2 shows the comparison between patients w/wo post-AUS implantation OAB symptoms. Although not statistically significant, OAB patients tended to use more pads per day than no OAB patients (p = 0.07). Radiation therapy before AUS implantation did not affect OAB symptoms. All IPSS and quality of life (QOL) scores of OAB patients were significantly worse than those of no OAB patients (p < 0.01).Table 2 Demographics of patients with and without OAB at post-AUS implantation.

Variable	OAB ( +)	OAB ( −)	p-value	
Number (%) or mean ± SD	
Number of patients	18 (37.5)	30 (62.5)	–	
Age (year)	72.9 ± 7.7	73.3 ± 4.7	0.86	
Body mass index (kg/m2)	23.3 ± 4.0	24.5 ± 2.7	0.32	
Diabetes mellitus ( +)	4 (22.2)	8 (26.6)	0.49	
Duration initial cause of incontinence to AUS implantation (mo.)	91.5 ± 65.4	61.0 ± 41.9	0.10	
Follow-up period after AUS (mo.)	26.0 ± 10.8	24.2 ± 11.3	0.58	
Radiation therapy before AUS	6 (33.3)	6 (20.0)	0.49	
Number of daily pads use	1.6 ± 1.3	0.86 ± 1.1	0.07	
IPSS total	14.1 ± 6.8	4.9 ± 3.4	 < 0.001	
 Voiding sub-score	6.6 ± 5.2	1.6 ± 2.4	 < 0.01	
 Storage sub-score	7.5 ± 2.9	3.3 ± 1.9	 < 0.001	
QOL score	3.6 ± 1.6	1.5 ± 1.2	 < 0.001	

Predictive factors associated with OAB symptoms post-AUS implantation

Risk factors for OAB including patient baseline characteristics, urodynamic study, and IPSS questionnaires were assessed (Table 3). From our study, the presence of pre-AUS implantation OAB symptoms was not a predictive factor. Only maximum cystometoric capacity < 200 mL measured by a urodynamic study was a predictive factor for post-AUS implantation OAB symptoms (p = 0.03; hazard ratio 5.00, confidence interval 1.17–21.4). Pre-AUS implantation detrusor overactivity was not associated with post-AUS OAB symptoms.Table 3 Predictive factors associated with OAB symptoms post-AUS implantation.

	HR	95% CI	p value	
Age (year)	0.99	0.90–1.09	0.84	
Body mass index (kg/m2)	0.90	0.75–1.09	0.28	
Radiation therapy before AUS	2.00	0.53–7.54	0.31	
Diabetes mellitus ( +)	0.75	0.19–2.97	0.68	
Duration initial cause of incontinence to AUS implantation (mo.)	1.01	0.99–1.02	0.07	
Follow-up period after AUS (mo.)	1.02	0.96–1.08	0.46	
OAB pre-AUS implantation (+ / −)	2.27	0.65–7.99	0.20	
Urodynamic study pre-AUS implantation	
 Detrusor overactivity (+ / −)	1.52	0.33–6.96	0.59	
 Normal desire ≤ 125 mL	1.50	0.39–5.83	0.56	
 Max cystometric capacity ≤ 200 mL	5.00	1.17–21.4	0.03	
IPSS scores pre-AUS implantation	
 Total score	1.03	0.97–1.10	0.34	
  Voiding sub-score	1.02	0.92–1.13	0.69	
  Storage sub-score	1.13	0.97–1.32	0.12	
QOL score	1.63	0.67–3.96	0.29	

Discussion

This retrospective, observational, single-center study focusing on the prevalence and risk factors for OAB associated with AUS implantation assessed OAB symptoms using validated objective quantifiable questionnaires revealed that (1) 60% of all candidates had pre-AUS implantation OAB and maintained to 35–40% until 12 months post-AUS implantation. (2) There was no significant difference in patient characteristics between patients with pre-AUS implantation OAB and those without except for the IPSS storage sub-score. (3) Among pre-OAB patients, around half had persistent OAB post-AUS implantation. Conversely, among patients without pre-AUS implantation OAB, a quarter were defined as de novo post-AUS implantation OAB. (4) Although there was no significant difference in the number of daily pad use between patients with post-AUS implantation OAB and those without, lower urinary tract symptoms (LUTS) and LUTS-related QOL were significantly worse in OAB patients than in no OAB patients. (5) Only a max cystometoric capacity < 200 mL measured by a urodynamic study was a predictive factor for post-AUS implantation OAB symptoms.

AUS implantation for severe stress incontinence is proven to improve patients’ quality of life15. A greater than 90% satisfaction rate was reported after long-term follow-up after AUS implantation16. However, contrary to the QOL improvement and satisfactory continence rate, OAB symptoms in the perioperative period have been reported.

Sebesta et al. reported that one-third of the cases of urinary incontinence after prostatectomy were urge incontinence17. Ko et al. reported that 37.5% (30/80) of post-AUS implantation patients had self-reported symptoms defined as de novo OAB9. Son et al. reported that approximately half of the patients had post-AUS implantation OAB and 36.5% received medical therapy for OAB management18. Regarding the onset of post-AUS implantation OAB, Lai reported that in a quarter of patients with de novo OAB after prostatectomy, the median time from AUS implantation to OAB onset was 9.0 ± 6.1 months, with 70% of patients developing OAB by 12 months post-AUS implantation19. These reports indicate that OAB is present in a non-negligible proportion of patients in the perioperative period of AUS implantation and that de novo OAB appears relatively early until 12 months post-AUS implantation.

There are several hypothesized mechanisms for the development of OAB in patients with urinary stress incontinence. Heesakkers J et al. reported that for patients with radical prostatectomy, neural damage may lead to secondary detrusor overactivity, which decreases bladder compliance20. Golboff et al. observed that 43% of post-prostatectomy patients showed bladder dysfunction21. In a human study, Shafik et al. reported that urethral distention by stress urine incontinence causes vesical contraction through the stimulation of urethral stretch receptors22. A relatively high patient age and preexisting bladder dysfunction are also suggested causes of OAB20. Jung et al. revealed by a female rat study that urine leakage into the proximal urethra stimulates urethral afferents and facilitates voiding reflexes and could induce and/or increase detrusor instability23. This study suggested that post-AUS implantation OAB symptom is not only de novo OAB, but also AUS implantation induced OAB. However, it is difficult to clinically distinguish these two etiologies.

From the present study, OAB symptoms already existed in over half of all patients pre-AUS implantation and continued in 35–40% until the first year post-AUS implantation. Although the response to the OABSS may also take into account symptoms due to stress incontinence pre-AUS implantation, remained after urinary continence was acquired post-AUS implantation. Even after AUS implantation, urinary leakage from the bladder neck to the urethral cuff is remained. Even though there was no significant difference in the number of daily pad use between OAB and no OAB patients post-AUS implantation in the present study, if there is persistent stress urinary incontinence, it is recommended to consider unrecognized de novo OAB24. Moreover, in patients with post-AUS implantation OAB symptoms, treatment with a beta-3 agonist should be considered25,26.

In the present study, a maximum bladder capacity of < 200 mL was the only predictive factor for OAB symptoms after AUS implantation. This corroborates the findings of previous studies by Ko et al. and Lai et al. and is newly evident when defining OAB using an objective quantifiable questionnaire9,19. Despite the recommendation of urodynamic studies to screen for detrusor overactivity or poor bladder compliance in patients with a history of mixed urinary incontinence, a previous pelvic fracture, or neurological disorders24, it is wildly recognized that detrusor overactivity itself does not correlate with the presence of OAB9,27. Several previous studies showed that detrusor overactivity was not significantly different between pre-AUS implantation and post-AUS implantation pad usages19,27,28. Thus, a pre-AUS implantation urodynamic study may be useful in terms of measuring bladder capacity as a predictor of post-AUS implantation OAB symptoms. Although the duration of the cause of incontinence prior to AUS implantation was not a predictor of post-AUS implantation OAB symptoms in the present study, Thai et al. considered that a chronically empty bladder is no longer accustomed to holding a significant volume and OAB may manifest when sphincter integrity is restored27. Conversely, Deruyver et al. reported that each hundred milliliters increase in cystometric bladder capacity was associated with increased patient satisfaction post-AUS implantation29.

Radiation therapy before AUS was also not a predictive factor in the present study. Some previous studies showed a higher prevalence of urinary urgency in patients who received radiation therapy than in those who did not30. Jahromi et al. reported that radiation is a risk factor for continued OAB after AUS activation31. Further study including a large sample with variety causes of incontinence is required to clarify this controversial issue. In this study, one of three patients other than postprostatectomy remained OAB symptom post-AUS implantation.

The strength of the present study is that it assessed AUS implantation-associated OAB symptoms using validated OABSS questionnaires and evaluated from a short duration until the first year of AUS implantation. However, the present study had some limitations. First, the small number of patients included in this study. Contrariwise, AUS implantation was performed by the same surgeon in relatively the same manner in a short duration. Therefore, the technical difference was considered minimal. Second, the retrospective nature is also a limitation of this study. We evaluated OAB on the last follow-up date of the first year post-AUS implantation. We followed our patients systematically. Further, longitudinal follow-up is required to evaluate the durability of these results. Third, OABSS questionnaire itself is not validated for the specific patients’ group such as post-prostatectomy. Despite these limitations, we believe that the present study would be useful to counsel patients about AUS implantation-related OAB symptoms. Additional adequately powered and prospective studies with well-characterized populations are required to provide more valuable information about OAB symptoms peri-AUS implantation.

In conclusion, OAB symptoms are prevalent in both pre and post-AUS implantation periods. Although the outcome of incontinence is not significantly different between OAB and no OAB patients in the post-AUS implantation period, QOL was impaired in OAB patients. OAB symptoms are present in 35–40% of patients post-AUS implantation. Patients should be counseled on pre-AUS implantation OAB symptoms, especially those with a cystometric capacity < 200 mL.

Author contributions

Conception and design: HT. Acquisition of Data: HT, NT. Analysis and Interpretation of Data: HT. Drafting the Article: HT Revising it for Intellectual Content: NT, HK Final Approval if the Complete Article: HK.

Data availability

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Competing interests

The authors declare no competing interests.

Publisher's note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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