Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study

Kaaki, Bilal; Gupta, Digant

doi:10.1371/journal.pone.0235961

Cited by 15 publications

(17 citation statements)

References 42 publications

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“…In our study, we found that 53,6% of our patients had success in the evaluation stage and went on to the implantation stage. Compared to our results, other studies showed marginally higher success rates ranging between 76% and 93.2% [8][9][10][11][12][13][14].…”

Section: Discussioncontrasting

confidence: 96%

Unsuccessful Progression of Sacral Neuromodulation From the Evaluation to the Implantation Stage: A Single-Center Experience

Alghafees¹,

Alageel²,

Alqahtani³

et al. 2021

Cureus

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IntroductionOver the years, sacral neuromodulation (SNM) has become an established and effective treatment for chronic urinary system retention and incontinence. The process of SNM is performed in two stages, the first is an evaluation phase and the second an implant phase. This study aimed to assess the rate of failure of progression from the evaluation to the implantation stage and the factors predicting the outcome of this commonplace procedure. Materials and methodsThis retrospective cross-sectional study took place at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia. All the patients who underwent SNM implantation from January 1, 2016 to January 1, 2021 were included. Patients younger than 14 years and patients who had the SNM implantation in a different hospital and were only followed-up at KAMC were excluded. Patient-related information were extracted from the BESTCare system. Frequency and percentage were used for the categorical variables, and the mean, median, and standard deviation to display the continuous variables. Chi-square test and Mann-Whitney U test were used to test for the association of the categorical variables. ResultsAmong 28 patients, 46.4% (n=13) failed to progress from the evaluation phase to the implantation phase. Gender, age, having a co-morbidity, and SNM indication were not significant factors for predicting the outcome of the SNM evaluation phase. ConclusionThe observed failure rate was marginally higher than the ones detected in other studies. Although no significant association was detected between evaluation stage failure and the assigned predictors, the results need to be interpreted with caution due to the small population size. Larger multicenter studies need to be done in order to investigate the link between patient characteristics and the efficacy of SNM. Establishing a concrete evidence would further refine the targeted patient population and indications for SNM.

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Section: Discussioncontrasting

confidence: 96%

Unsuccessful Progression of Sacral Neuromodulation From the Evaluation to the Implantation Stage: A Single-Center Experience

Alghafees¹,

Alageel²,

Alqahtani³

et al. 2021

Cureus

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“…In 19 studies, both test stimulation outcome and permanent SNM outcome were investigated [41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][59]. In 14 studies, only permanent SNM outcome was investigated [60][61][62][63][64][65][66][67][68][69][70][71][72][73].…”

Section: Quality Assessment Of the Included Literaturementioning

confidence: 99%

Section: Agementioning

confidence: 99%

“…Overactive Bladder Syndrome Twelve studies investigated age as a predictive factor in patients with OAB [8,21,22,31,34,37,43,56,57,62,63,72]. Five of these studies included only women [21,34,56,57,72]. Two of these found younger age to be predictive in successful test stimulation outcome [21] and longterm outcome [57].…”

Section: Agementioning

confidence: 99%

“…Overactive Bladder Syndrome Six studies reported on patients with OAB [8,21,62,63,72,79]. Two of these reported on outcome after test stimulation [8,21] of which one found a shorter duration of complaints to be successful in test stimulation outcome [21].…”

Section: Duration Of Symptomsmentioning

confidence: 99%

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Predictive Factors in Sacral Neuromodulation: A Systematic Review

et al. 2021

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Introduction: Sacral neuromodulation (SNM) is an effective treatment in patients with overactive bladder syndrome or nonobstructive urinary retention when conservative treatment fails. Several factors that could impact outcome with SNM have been studied. This systematic review investigated these predictive factors and their relevance for clinical practice. Methods: Systematic review according to the PRISMA guidelines was conducted. This review is registered in the PROSPERO register (CRD42015016256). Results: Seventy-eight studies (of which 11 abstracts) were included. Females, younger patients, and a tined lead procedure tend to be predictive in successful SNM outcome. Factors that did not influence SNM outcome were prior back surgery, surgery for stress urinary incontinence, affective symptoms, and duration of complaints. Reduced detrusor contractility is associated with a lower success rate. The level of evidence of most studies (graded according to the Centre for Evidence-Based Medicine) was 3b. Conclusion: Even though this systematic review investigated predictive factors (gender, age, type of procedure, type of lead, and detrusor contractility), no general consensus on predictive factors could be made. Most studies are small, retrospective, and involve a heterogeneous population. Therefore, prospective research in larger specific patient groups remains necessary to find predictors of SNM outcome.

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A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence

Heesakkers,

Toozs‐Hobson,

Sutherland

et al. 2024

Neurourology and Urodynamics

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BackgroundOveractive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third‐line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic.ObjectiveA minimally invasive implantable device activated by a battery‐operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available.MethodsA prospective, multicenter, single‐arm, open‐label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1‐month post‐implantation of the device, participants delivered therapy at their convenience and completed a 7‐day voiding diary before visits 6‐ and 12‐months post‐treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency‐related incontinence episodes) and incidence of adverse events from implantation to 12‐month post‐activation.ResultsA total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6‐ and 12‐month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12‐months post‐activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent‐to‐treat analysis. Of the 139 participants with completed 12‐month diaries, 82% were responders, 50% were classified as “dry” (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device.ConclusionsiTNM, delivered and powered by a patient‐controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient‐centric therapy for the treatment of UUI.

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Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study

Cited by 15 publications

References 42 publications

Unsuccessful Progression of Sacral Neuromodulation From the Evaluation to the Implantation Stage: A Single-Center Experience

Unsuccessful Progression of Sacral Neuromodulation From the Evaluation to the Implantation Stage: A Single-Center Experience

Predictive Factors in Sacral Neuromodulation: A Systematic Review

A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence

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