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Journal ArticleDOI

Clinical Pathways of Third-Line Treatment of Overactive Bladder in the Elderly

09 Oct 2015-Current Bladder Dysfunction Reports (Springer US)-Vol. 10, Iss: 4, pp 381-390
TL;DR: The available evidence confirms that all three treatment approaches are well tolerated and effective, although only botulinum toxin type A (BoNTA) and SNS can achieve nearly a cure of urgency urinary incontinence (UUI).
Abstract: Overactive bladder (OAB) is a syndrome of urinary urgency, usually accompanied by frequency, nocturia, and sometimes urinary urgency incontinence. There are many guidelines for the OAB treatment which are constructed on a stepwise fashion starting from the least invasive to the more invasive therapy. The emergence of third-line therapy (AUA/SUFU guidelines) has resulted in significant decrease of more invasive surgery and improved patients’ quality of life. The aim of a clinical pathway is to improve the quality of care, reduce risks, increase patient satisfaction, and increase the efficiency in the use of resources. The available options for the third-line OAB treatments include intravesical injection of botulinum toxin A, percutaneous tibial nerve stimulation (PTNS), and sacral nerve stimulation (SNS). The available evidence confirms that all three treatment approaches are well tolerated and effective, although only botulinum toxin type A (BoNTA) and SNS can achieve nearly a cure of urgency urinary incontinence (UUI). The choice among the different third-line treatment depends on patient preference, availability, and local expertise. The application of these pathways can improve incontinence care by letting physicians adequately communicate with patients and select individualized therapy at an early stage especially for elderly patients.

Summary (4 min read)

Introduction

  • Patients with neurologic disorders often experience voiding dysfunction.
  • Also, by having a clear pathway communicated to the patient can gain early acceptance of third-line therapies and avoid the high drop-out noticed with medical therapy.
  • The AUA/SUFU guidelines state that after attempting to treat OAB for 4 to 8 weeks with medications, taking the step towards third-line therapy is worthwhile and justified.

General Principle

  • The importance of understanding patient expectations, goals, and satisfaction is increasingly recognized as an important element in the decision to treat OAB.
  • The general principle for pharmacotherapy of the elderly patient is to start with a low dose and increase it slowly, depending on the agent’s pharmacokinetics and pharmacodynamics and adverse effects.
  • Patient satisfaction with treatment is directly related to improvement of symptoms and expectations, which need adequate follow-up after initial treatment (good motivation).
  • Patients should be aware that OAB especially when severe is a chronic complex condition that can be improved, but is unlikely to be cured [19].
  • Curr Bladder Dysfunct Rep Author's personal copy.

Refractory OAB

  • Refractory OAB could be defined as persistent urgency, frequency, with or without incontinence that remains bothersome despite adequate behavioral and medical therapy for 8 to 12 weeks with at least one medication administered for 4 to 8 weeks [10, 11].
  • There is no current consensus on appropriate definition of such concept neither inclusion of failure secondary to intolerable side effects [20, 21].
  • Physicians should be aware that factors such as psychological well-being and emotional and sexual health outcomes affect patient perceptions of the value of treatment, perceived treatment efficacy, and treatment expectations [20, 22, 23].
  • The reasonable indications for the third-line OAB treatment are as follows: (a) failure of pharmacotherapy of OAB Author's personal copy due to lack of efficacy and loss of efficacy; (b) intolerable side effect; (c) contraindications to pharmacotherapy initiation; (d) inability to achieve patient’s expectations by dose titration, switching medications to different anti-muscarinic or B3 agonist drug.
  • The theoretical benefits of extended release antimuscarinic medications are not well established in elderly population as most of clinical trials had limited number of patients above 65 years of age and frail elderly [24, 25].

Re-evaluation of Patients with Refractory OAB

  • Refractory OAB (R-OAB) patients require a basic assessment in order to exclude any other underlying causes for lower urinary tract dysfunction before the third-line OAB treatment which can be corrected.
  • Clean catch urine should be sent for analysis and culture; significant post void residual urine should also excluded by ultrasound or catheterization.
  • Most R-OAB patients require functional and anatomical studies of the lower urinary tract.
  • Urodynamic or better videourodynamic study is essential to make an accurate diagnosis specially to rule out neurogenic dysfunction prior to get on more invasive or perhaps irreversible therapy.
  • Treatment approach in the elderly depends on the patient’s goals, social setting, and the mental status of the patient.

Botulinum Toxin A (BoNTA)

  • BoNTA have been studied as intradetrusor injection for the treatment of detrusor overactivity since 2000 [26].
  • The level of evidence of effectiveness continues to build with time.
  • A systematic review of BoNTA for both N-OAB and I-OAB supported a level A recommendation for its use in these patients [34].
  • It confirmed that BoNTA with supportive care is cost effective with 100 % probability [36].

Counselling and Adverse Outcomes

  • It is important that patients should be counseled about the risks and benefits of BoNTA injections, which include urinary retention and urinary tract infections which usually due to incomplete voiding.
  • Such retention is usually temporary which may require an indwelling catheter or the need to selfintermittent catheterization temporarily.
  • A more helpful evidence to use in counselling is that at 1 month post-BoNTA injection, about one in four patients will have high residual urine [39].
  • Curr Bladder Dysfunct Rep Author's personal copy BoNTA injection should not be performed in case of positive urinalysis and culture for urinary tract infection (UTI).
  • While the use of antibiotics is not indicatedwith cystoscopy in normal patients, it can be used in cases with voiding dysfunction.

Procedure Considerations

  • SNM requires a preliminary, percutaneous nerve evaluation (PNE), a screening stimulation test that is perform to assess the clinical effect and the integrity of sacral nerve.
  • Such test help the patient and physician to decide whether the benefits of permanent implantable pulse generator (IPG) implantation is worthy, evaluating the benefits, risks, and costs of the therapy.
  • There are two approaches for stimulation test, PNE or stage one out of two-staged implanation.

Post-Procedure Follow-up

  • The patient must be monitored until void urinations are normal.
  • This evaluation involved a urinary diary, postvoid residual urine measurement, and urinalysis.
  • A post-void residual greater than 200 mL and/or symptomatic must be counseled about the use of self-catheterization.

Neuromodulation

  • Neuromodulation techniques have been applied to the sacral nerve roots or their more distal branches like pudendal and posterior tibial.
  • The first is central/high frequency stimulation (sacral nerve stimulation) that uses electrodes which were inserted at the level of the third sacral nerve (S3), which is connected to the implantable pulse generator.
  • SNM is FDA-approved since 1997 for urinary frequency and urgency, and idiopathic non-obstructive urinary retention.
  • PTNS and SNM are other options as third-line treatment that may be offered to selected patient with refractory OAB [10].
  • Both are neuromodulatory therapies presumed to improve or restore normal control of an imbalanced voiding reflex by affecting the central afferents [45].

Patient Selection

  • Patient selection has played an important role on the success rate of SNM.
  • In one study, a success rate of 64 % at 2 years was demonstrated in patients with I-OAB, while all patients withN-OABwho responded initially relapsedwithin 2months [46].
  • Poor results have been reported in elderly cognitively impaired patients and patients with spinal cord injuries [49].
  • Patients with refractory OAB and non-obstructive urinary retention are considered suitable for SNM once they have failed or could not tolerate more conservative treatments [50, 51].
  • There is still significant variability in use according to a standardized treatment algorithm for urinary dysfunction.

PNE

  • The PNE test uses a temporary test lead placed into the S3 foramen and connected to an external pulse generator (EPG).
  • The procedure is usually performed in an outpatient setting under local anesthesia and prone position.
  • The patient’s electrode will be connected to an external pulse generator that gives the patient the ability to control the stimulation intensity.
  • The patient is discharged home with 5–7-day voiding diary.
  • On the other hand, if they do not respond to PNE and there is a question about wire migration, they may have an excellent outcome when they undergo two-staged implantation [52].

Two-Staged Procedure

  • If the patient is not a candidate for test stimulation or did not respond to the outpatient PNE test, stimulationmay be performed Curr Bladder Dysfunct Rep Author's personal copy in the operating room (OR) using the tined lead.
  • The advantage of this procedure is that the same responses should be obtained once the external generator is replaced by the permanent IPG as the lead site does not change.
  • The permanent tined lead has self-anchoring tines that reduce the risk of migration.
  • Due to the decreased risk of migration and the longer test duration, this test has a higher response rate [44, 47, 54].
  • The patient is taught to set the unit at a comfortable setting at which the stimulation can be felt but it is not painful and advised to try different programs to control symptoms [55].

Percutanous Tibial Nerve Stimulation

  • PTNS is a peripheral neuromodulation that may be offered by Stoller [56], to nearly any patient with OAB who has not achieved their treatment goal with medication, excluding those with a pacemaker and who are pregnant [10].
  • PTNS is postulated to achieve detrusor inhibition by acute electrical stimulation of afferent somatic sacral nerve fibers.
  • Most of these afferent somatic fibers reach the spinal cord via the sacral spinal nerves and dorsal roots of the sacral nerves.
  • PTNS may be better for those with less refractory, mild tomoderate symptoms.
  • PTNS was found to be effective in reducing urinary frequency, incontinence episodes, and detrusor overactivity in 37–100 % of patients with OAB [63].

Conclusion

  • The evidence of the third-line OAB treatment continue to develop which make the guidelines and clinical pathways provide more solid base recommendations where optimal management can lead to improvement in the patient outcomes and QoL.
  • Treatment success is usually based on patient expectations.
  • Communicating with and explaining all appropriate options to the patient, based on differing efficacy and AE profile of the treatments available for OAB, as well as eliciting patient input, can enhance outcome.
  • Most published researches on the management of OAB have been focused on which treatment is more effective, but may be should look on what is the best treatment option available for each patient.
  • Eventually, patients do not necessarily choose the more effective treatment, rather the best one that fit their needs, and this remains one of their fundamental rights.

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UC Irvine
UC Irvine Previously Published Works
Title
Clinical Pathways of Third-Line Treatment of Overactive Bladder in the Elderly
Permalink
https://escholarship.org/uc/item/9v36194j
Journal
Current Bladder Dysfunction Reports, 10(4)
ISSN
1931-7212
Authors
Farhan, B
Ghoniem, G
Publication Date
2015-12-01
DOI
10.1007/s11884-015-0341-4
Peer reviewed
eScholarship.org Powered by the California Digital Library
University of California

1 23
Current Bladder Dysfunction Reports
ISSN 1931-7212
Curr Bladder Dysfunct Rep
DOI 10.1007/s11884-015-0341-4
Clinical Pathways of Third-Line Treatment
of Overactive Bladder in the Elderly
Bilal Farhan & Gamal Ghoniem

1 23
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publication is available at link.springer.com”.

GERIATRIC BLADDER DYSFUNCTION (GM GHONIEM, SECTION EDITOR)
Clinical Pathways of Third-Line Treatment of Overactive
Bladder in the Elderly
Bilal Farhan
1
& Gamal Ghoniem
1
#
Springer Science+Business Media New York 2015
Abstract Overactive bladder (OAB) is a syndrome of urinary
urgency, usually accompanied by frequency, nocturia, and
sometimes urinary urgency incontinence . There are many
guidelines for the OAB treatment which are constructed on a
stepwise fashion starting from the least invasive to the more
invasive therapy. The emergence of third-line therapy (AUA/
SUFU guidelines) has resulted in significant decrease of more
invasive surgery and improved patients quality of life. The
aim of a clinical pathway is to improve the quality of care,
reduce risks, increase patient satisfaction, and increase the
efficiency in the use of resources. The available options for
the third-line OAB treatments include intravesical injection of
botulinum toxin A, percutaneous tibial nerve stimulation
(PTNS), and sacral nerve stimulation (SNS). The available
evidence confirms that all three treatment approaches are well
tolerated and effective, although only botulinum toxin type A
(BoNTA) and SNS can achieve nearly a cure of urgency urinary
incontinence (UUI). The choice among the different third-line
treatment depends on patient preference, availability, and local
expertise. The application of these pathways can improve in-
continence care by letting physicians adequately communicate
with patients and select individualized therapy at an early stage
especially for elderly patients.
Keywords Overactivebladder
.
Clinicalpathways
.
Third line
treatment
.
Onabotulinum toxin A
.
Sacral neuromodulation
.
Percutaneous tibial nerve stimulation
Introduction
Idiopathic overactive bladder (I-OAB) is defined by the Inter-
national Continence Society (ICS) as symptom complex of
Burinary urgency that is frequently accompanied by urinary
frequency (voiding eight or more times in a 24-hour period)
and nocturia (awakening two or more times at night to void),
with or without urgency urinary incontinence (UUI), in the
absence of a urinary tract infection or other obvious
pathology^ [1]. Symptoms may or may not be associated with
detrusor overactivity (DO) [24]. Patients with neurologic
disorders often experience voiding dysfunction. When this
voiding dysfunction is consistent with OAB, it is termed neu-
rogenic overactive bladder (N-OAB) [5]. OAB is a common
chronic condition with its prevalence increases with age in
both women and men, and it should not be considered as part
of normal aging process [68].
OAB has a significant burden for patients and healthcare
providers such as negative impact on the social, physical,
psychological, financial, and sexual aspects of quality of life
but generally do not affect survival [9].
In general, a clinical pathway is a structured method for the
patient-care management of a well-defined group of patients
during a well-defined period of time. A clinical pathway clear-
ly states the goals and key elements of care based on evidence-
based medicine (EBM) guidelines, best practice, and patient
expectations. The aim of a clinical pathway is to improve the
quality of care, reduce risks, increase patient satisfaction, and
increase the efficiency in the use of resources. This includes
facilitating the communication and coordinating roles an d
This article is part of the Topical Collection on Geriatric Bladder
Dysfunction
* Gamal Ghoniem
gghoniem@uci.edu
Bilal Farhan
farhanb@uci.edu
1
Department of Urology, University of California, Irvine, 333 City
Blvd. W est, Ste 2100, Orange, CA 92868, USA
Curr Bladder Dysfunct Rep
DOI 10.1007/s11884-015-0341-4
Author's personal copy

sequencing the activities of the multidisciplinary care team,
patie nts, and their relat ives. It also requires documenting,
monitoring, and evaluating variances and providing the nec-
essary resources and outcomes.
This article may help to provide a practical clinical pathway
regarding the third-line treatment for the elderly population
who suffer from refractory lower urinary tract symptoms.
The application of these pathways can improve incontinence
care by letting physicians to adequately communicate with
patients and select individualized therapy at early stage espe-
cially for elderly patients. This is a patient-centeric approach
that improves efficacy of treatment and quality of life and
safety. Keeping patients informed of the plan of care and on
schedule improves their compliance and potentially eliminates
unnecessary testing and achieves cost savings. Also, by hav-
ing a clear pathway communicated to the patient can gain
early acceptance of third-line therapies and avoid the high
drop-out noticed with medical therapy.
The treatment of OAB as recommended by the Internation-
al Consultation on Incontinence (ICI) and AUA/SUFU [10••,
11] are as follows:
First-line therapy: First-line treatments include conserva-
tive measures such as adjustment of fluid habits, review
of drug treatment, timed voiding, bladder retraining, and
pelvic floor muscle therapy. Behavioral therapies and ed-
ucation should be offered first; starting antimuscarinic
therapies at the same time as beha vior therapies may
prove clinically beneficial. This line should be offered
to all patients.
Second-line therapy: Pharmacotherapy for minimum
3 months with either antimuscarinics (extended-release
preparations should be used i nstead of immediate-
release preparations w hen possible) or oral beta-3
adrenoceptor agonist (mirabegron) should be offered
too. Despite the proven efficacy of phar mac othe rapy
treatment, it is difficult to predict the response in the in-
dividual patient, the adverse effects, and lack to adher-
ence for long period, especially for elderly Bfrail^ patients
[12, 13], who should be use with caution as they have a
lower therapeutic index and higher adverse effects (AE)
such as dizziness, dry mouth, blurred vision, and consti-
pation and the effects of multiple medications should be
considered [10••]; the elder Bfrail^ canbedefineasBelder
person who have combining impaired physical activity,
balance, muscle strength, cognition, and nutrition.^
Third-line therapy: Intradetrusor botulinum toxin type A
(BoNTA) and neuromodulation therapies such as sacral
neuromodulation (SNM) o r percutaneous tibial nerve
stimulation (PTNS) for carefully selected patients with
severe refractory OAB symptoms or those who are not
respond to or don not tolerate the second-line therapy and
are willing to undergo a surgical procedure [10••].
The AUA/SUFU guidelines state that after attempting to
treat OAB for 4 to 8 weeks with medications, taking the step
towards third-line therapy is worthwhile and justified.
Third-Line OAB Treatment
General Principle
The importance of understanding patient expectations,
goals, and satisfaction is increasingly recognized as an
important element in the decision to treat OAB. For
either I-OAB or neurogenic detrusor overactivity (N-
OAB), eliciting patient p erceptions and sharing the best
available evidence with relevant options are important in
achieving patient satisfaction [14, 15]. Typically, when
the patient goals are defined, outcomes should be cor-
related with relief of symptom(s), patient satisfaction,
and goal achievement expectations as a result of
treatment.
We believe that the approach treatment to the patient with
OAB in the standard step-wise algorithm pathway is reason-
able (Fig. 1), but in some occasions may subject patients to
unnecessary cost and delay in treatment. The general principle
for pharmacotherapy of the elderly patient is to start with a low
dose and increase it slowly, depending on the agentspharma-
cokinetics and pharmacodynamics and adverse effects.
Treatments of OAB at early stage may help to improve
patient care and minimize overall use of healthcare re-
sources. There is considerable evidence of delay in diag-
nosis, which may be related to embarrassment, belief that
certain bladder symptoms as normal aging process, and
assumption that will get little benefits with the treatment.
In addition, failure to adhere to medical therapy due to
lack of res ponse or adverse effects of pharmacotherapy
usually leads to frustration and abandoning of medica-
tions. The inadequate follow-up after treatment with poor
communication between patients and physician has been
identified as important factor to non-adherence [16]. It has
been shown that 10 % of patients with OAB do not start
the medication 12 months after prescription [17]. Motiva-
tion of the patient with regular follow-up visits to monitor
treatment effects and adherence may be useful [18].
Patient satisfaction with treatment is directly related
to improvement of symptoms and expectations, which
need adequate follow-up a fter initial treatment (good
motivati on) . Discussion of the pati e nt s goals and expec-
tation before starting treatment should be realistic and
agreed upon by the patient and physician. Patients
should be aware that OAB especially when severe is a
chronic complex condition that can be improved, but is
unlikelytobecured[19].
Curr Bladder Dysfunct Rep
Author's personal copy

Citations
More filters
01 Jan 2010
TL;DR: Intravesical injection of botulinum toxin resulted in improvement in medication refractory overactive bladder symptoms, however, the risk of increased post-void residual and symptomatic urinary retention was significant.
Abstract: PURPOSE We systematically reviewed the evidence for the efficacy and safety of botulinum toxin in the management of overactive bladder. MATERIALS AND METHODS We performed a systematic review of the literature to identify articles published between 1985 and March 2009 on intravesical botulinum toxin-A injections for the treatment of refractory idiopathic overactive bladder in men and women. Databases searched included MEDLINE, CENTRAL and Embase. Data were tabulated from case series and from randomized controlled trials, and data were pooled where appropriate. RESULTS Our literature search identified 432 titles and 23 full articles were included in the final review. Three randomized placebo controlled trials addressing the use of botulinum toxin-A were identified (99 patients total). The pooled random effects estimate of effect across all 3 studies was 3.88 (95% CI -6.15, -1.62), meaning that patients treated with botulinum toxin-A had 3.88 fewer incontinence episodes per day. Urogenital Distress Inventory data revealed significant improvements in quality of life compared with placebo with a standardized mean difference of -0.62 (CI -1.04, -0.21). Data from case series demonstrated significant improvements in overactive bladder symptoms and quality of life, despite heterogeneity in methodology and case mix. However, based on the randomized controlled trials there was a 9-fold increased odds of increased post-void residual after botulinum toxin-A compared with placebo (8.55; 95% CI 3.22, 22.71). CONCLUSIONS Intravesical injection of botulinum toxin resulted in improvement in medication refractory overactive bladder symptoms. However, the risk of increased post-void residual and symptomatic urinary retention was significant. Several questions remain concerning the optimal administration of botulinum toxin-A for the patient with overactive bladder.

103 citations

Journal ArticleDOI
Steven P. Petrou1
TL;DR: The authors provide an excellent technical analysis and state that when using this technique they are able to salvage approximately three out of four patients, which has a potential to achieve a great deal of popularity in this very difficult to treat population.
Abstract: Editorial Comment This paper discusses the use of a salvage spiral urethral sling in a very difficult to treat patient population, that is, females who have failed multiple vaginal operations for urinary incontinence The authors provide an excellent technical analysis and state that when using this technique they are able to salvage approximately three out of four Of interest is that they describe the use of both autologous fascia as well as synthetic graft Operative tactics are described in the event of a bladder injury at the time of dissection (laterally placed spiral sling); this is very valuable in view of the potential for injury during the periurethral dissection in this patient population with a history of multiple surgeries In addition, the authors discuss the use of this operation as opposed to the use of artificial urinary sphincter Given the success rate of this operation mirrors that reported for artificial urinary sphincter in female patients, it has a potential to achieve a great deal of popularity in this very difficult to treat population (1)

51 citations

Journal Article
TL;DR: Intradetrusor injection of BTX-A and PTNS are both effective to manage refractory idiopathic OAB, and BTx-A is more effective than PTNS and is also durable, minimally invasive, reversible, and safe, but it also has more side effects.
Abstract: Introduction To compare the safety and efficacy of posterior tibial nerve stimulation (PTNS) versus an intradetrusor injection of botulinum toxin type-A (BTX-A) 100 U in the management of refractory idiopathic overactive bladder (OAB). Materials and methods We randomized 60 patients with refractory idiopathic OAB to receive an intradetrusor injection of BTX-A 100 U or PTNS. We assessed the patients at baseline, 6 weeks, 3 months, 6 months, and 9 months, and determined their clinical symptoms, overall OAB symptom score, urgency score, quality-of-life score, and urodynamic study parameters. Results The two patient groups had similar baseline characteristics. After treatment, the patients in the BTX-A group had significant improvements in all parameters compared to their baseline values. Patients in the PTNS group initially had significant improvements in all parameters, but by 9 months, this was no longer true for most parameters. In general, the improvements were more significant in the BTX group, especially at 9 months. In the BTX-A group, two patients (6.6%) needed clean intermittent catheterization; 3 patients (2 women and 1 man; 10% of patients) had mild hematuria, and 2 patients (6.6%) had urinary tract infections (UTIs). In the PTNS group, local adverse effects included minor bleeding spots and temporary pain. Conclusions Intradetrusor injection of BTX-A and PTNS are both effective to manage refractory idiopathic OAB. BTX-A is more effective than PTNS and is also durable, minimally invasive, reversible, and safe, but it also has more side effects.

11 citations


Additional excerpts

  • ...Arch Gynecol Obstet 2012;286(6):1453-1457....

    [...]

Journal ArticleDOI
TL;DR: Percutaneous Tibial Nerve Stimulation is a safe and effective treatment in patients with neurological disorders, associated with significant improvements in overactive bladder symptoms and quality of life.
Abstract: Background Percutaneous Tibial Nerve Stimulation (PTNS) is a minimally invasive neuromodulation technique for treatment of overactive bladder (OAB). The aim of this study was to assess safety and efficacy in neurological patients. Methods In this prospective evaluation over 18 months at a tertiary centre, patients finding first-line treatments for OAB ineffective or intolerable underwent standard 12-week course of PTNS (Urgent PC, Uroplasty). Symptoms were evaluated using standardised questionnaires (ICIQ-OAB and ICIQLUTS-QoL) and bladder diaries. Results Of 74 consecutive patients (52 males; mean age 57; 25(33.8%) idiopathic OAB, 19 (25.7%) multiple sclerosis (MS), 30 (40.5%) other neurological conditions), 64(86%) completed treatment. Significant improvements (p Conclusions PTNS is a safe and effective treatment in patients with neurological disorders, associated with significant improvements in overactive bladder symptoms and quality of life.

7 citations

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TL;DR: The durability of response demonstrates the effectiveness of percutaneous tibial nerve stimulation as a viable, long-term therapy for overactive bladder.

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TL;DR: The good results of the two-stage implant technique used indicate that the development of better PNE electrodes may lead to an improvement of the testing technique and better selection between nonresponders and technical failures.

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TL;DR: The long-term efficacy and safety of percutaneous tibial nerve stimulation with the Urgent® PC Neuromodulation System for overactive bladder after 3 years of therapy is reported.

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Frequently Asked Questions (1)
Q1. What are the contributions mentioned in the paper "Clinical pathways of third-line treatment of overactive bladder in the elderly" ?

The aim of a clinical pathway is to improve the quality of care, reduce risks, increase patient satisfaction, and increase the efficiency in the use of resources.