Validation of the Lithuanian version of the Prolapse Quality-of-Life questionnaire.

INTRODUCTION AND HYPOTHESIS: We aimed to translate and validate the Lithuanian version of the Prolapse Quality-of-Life (P-QOL) questionnaire. METHODS: The P-QOL questionnaire was translated into Lithuanian and administered to women recruited from a gynaecology outpatient clinic at a tertiary referral centre. The scores of the final version were compared in symptomatic (n = 137) and asymptomatic (n = 137) women and with findings on vaginal examination using the Pelvic Organ Prolapse Quantification system. The reliability was assessed by calculating Cronbach's alpha and by performing a test-retest analysis. RESULTS: There was a significant difference in median score for each P-QOL domain between symptomatic and asymptomatic women (p < 0.001). P-QOL scores correlated significantly with the stage of urogenital prolapse in most domains. High internal consistency was shown in all domains with a Cronbach's alpha range of 0.775 to 0.958, except for the "social limitations" domain, which was shown to be acceptable (0.647). Test-retest reliability was also high in all domains (p < 0.05). CONCLUSION: The Lithuanian version of the P-QOL questionnaire has proven to be a valid, reliable and easily comprehensible instrument for assessing symptom severity and impact on the quality of life of Lithuanian-speaking women with urogenital prolapse.

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

BACKGROUND: Overactive 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. OBJECTIVE: A 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. METHODS: A 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. RESULTS: A 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. CONCLUSIONS: iTNM, 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.

Validation of the Russian Version of the Prolapse Quality-of-life Questionnaire and its Application to Assess the Impact of Pelvic Organ Prolapse on Quality of Life and the Effect of Treatment in Women Undergoing Reconstructive Surgery.

INTRODUCTION AND HYPOTHESIS: The objective was to validate the translated Russian version of the prolapse quality-of-life (P-QoL) questionnaire and test its applicability to assess the impact of pelvic organ prolapse (POP) on QoL and the effect of treatment in women undergoing reconstructive surgery. METHODS: Following a forward- and back-translation of the original English P-QOL questionnaire into Russian, the translated questionnaire was reviewed by a group of patients as well as an expert panel. Women with POP who were admitted to a university hospital for reconstructive surgery were recruited. All the women completed the P-QoL questionnaire, Pelvic Floor Distress Inventory (PFDI-20) and 36-Item Short Form Survey (SF-36) questionnaires before surgery. Clinical data and POP Quantification (POP-Q) Index according to the International Continence Society were obtained. Psychometric properties of the questionnaire were assessed. RESULTS: A total of 303 women with POP were included in the study. Most patients presented with POP-Q >2. The P-QoL questionnaire demonstrated good psychometric properties. High internal consistency was shown in all domains (Cronbach's alpha coefficient from 0.65 to 0.92). The test-retest reliability confirmed a highly significant stability between the total scores for each domain. Significant correlations of the P-QoL domains with the PFDI-20 and SF-36 scales (p < 0.05) were obtained, demonstrating satisfactory convergent validity. Discriminative construct validity was proved by the differences in the mean scores for P-QoL domains across POP-Q stages (p < 0.05): general health perceptions, role limitations, physical limitations, social limitations and severity measures were significantly higher for POP-Q stages 3 and 4 than for POP-Q stage 2 (p < 0.01); general health perceptions and severity measures were higher for POP-Q stage 4 than for POP-Q stage 3 (p < 0.05); sleep/energy was higher for POP-Q stage 3 than for POP-Q stage 2 (p < 0.05). Significant improvement of QoL in the 2 months after surgery (p < 0.05) indicated that the P-QoL questionnaire is sensitive to change. CONCLUSIONS: The Russian version of the P-QoL questionnaire is characterized by appropriate psychometric properties. The P-QoL questionnaire is a useful tool for describing the QoL profile in women with POP before reconstructive surgery and evaluating treatment outcomes after the procedure.

The use of animal models in preclinical investigations for the development of a surgical mesh for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Polypropylene (PP) mesh for the treatment of pelvic organ prolapse (POP) has raised substantial concerns over long-term complications, leading to its ban in multiple countries. In response, emerging materials are being explored as alternatives for prolapse surgery. Preclinical animal models have historically played a pivotal role in validating medical devices, prior to clinical trials. Successful translation of these materials necessitates the identification of suitable animal models that replicate the female human pelvis and its biomechanical properties. Preclinical in vivo testing assesses the safety of surgical mesh and treatment efficacy in preventing POP recurrence. METHODS: The research critically reviews animal models used for preclinical pelvic mesh testing over the last decade and proposes a promising model for future preclinical studies. RESULTS: Rats were the most common mammal used for toxicity and biocompatibility investigations through abdominal implantation. Although non-human primates serve as a gold standard for efficacy testing, ethical considerations limit their use owing to their close biological and cognitive resemblance to humans. Consequently, sheep were the most preferred large animal model owing to their reproductive system similarities and propensity for spontaneous POP following parity. CONCLUSION: The study contributes valuable insights into the selection of appropriate animal models for preclinical pelvic mesh testing, offering guidance that is crucial for enhancing the safety and efficacy of novel surgical interventions in the treatment of POP.

Efficacy and safety of the implantable, magnetic resonance imaging-compatible StimRouter neuromodulation system in the treatment of refractory lower urinary tract symptoms in multiple sclerosis patients.

BACKGROUND AND PURPOSE: Lower urinary tract symptoms (LUTS) significantly affect quality of life (QoL) of multiple sclerosis (MS) patients, and pharmacotherapy has limited efficacy. We investigated efficacy and safety of the implantable StimRouter neuromodulation system for treating refractory LUTS in MS. METHODS: This prospective, single-center, clinical trial was conducted at the Multiple Sclerosis Center of Lugano, Switzerland, involving MS patients treated with self-administered percutaneous tibial nerve stimulation delivered by StimRouter over 24 weeks. Changes in video-urodynamic parameters as well as LUTS severity were measured by Overactive Bladder Questionnaire (OAB-q), QoL using the Multiple Sclerosis Quality of Life (MSQoL-54), and treatment satisfaction using a 1-10 visual analogue scale. Adverse events were also recorded. RESULTS: Of 23 MS patients recruited, six had neurogenic detrusor overactivity (NDO), five had detrusor sphincter dyssynergia (DSD), and 12 had both NDO and DSD. Of patients with NDO, median bladder volume at first uninhibited contraction significantly increased from baseline to week 24 (median = 136 mL, interquartile range [IQR] = 101-244 mL vs. 343 mL, IQR = 237-391 mL; ß = 138.2, p = 0.001). No significant changes of urodynamic parameters were found in patients with DSD. OAB-q symptom scores progressively decreased, and OAB-q quality of life scores increased (ß = -0.50, p < 0.001 and ß = 0.47, p < 0.001, respectively), whereas MSQoL-54 scores did not significantly change (ß = 0.24, p = 0.084) in the overall population. Treatment satisfaction was overall high (median = 8, IQR = 6-9). No serious adverse events were recorded. CONCLUSIONS: StimRouter represents a minimally invasive, magnetic resonance imaging-compatible, self-administered neuromodulation device leading to objective and subjective improvements of OAB symptoms and related QoL in MS patients with refractory LUTS.

Sacral nerve modulation for patients with fecal incontinence: long-term outcome and effects on sexual function.

Sacral nerve modulation has become an established treatment for fecal and urinary incontinence, and sexual disorders. The objective of this study was to evaluate the long-term outcome of sacral neuromodulation in patients with fecal or combined fecal and urinary incontinence (double incontinence), assessing its safety, efficacy, and impact on quality of life and sexual function. This was a multicentric, retrospective, cohort study including patients with fecal or double incontinence who received sacral neuromodulation at seven European centers between 2007 and 2017 and completed a 5-year follow-up. The main outcome measures included improvements of incontinence symptoms and quality of life compared with baseline, evaluated using validated tools and questionnaires at 1-, 6-, 12-, 36- and 60-month follow-up. 108 (102 women, mean age 62.4 ± 13.4 years) patients were recruited, of whom 88 (81.4%) underwent definitive implantation of the pacemaker. Patients' baseline median Cleveland Clinic Incontinence Score was 15 (10-18); it decreased to 2 (1-4) and 1 (1-2) at the 12- and 36-month follow-up (p < 0.0001), remaining stable at the 5-year follow-up. Fecal incontinence quality of life score improved significantly. All patients with sexual dysfunction (n = 48) at baseline reported symptom resolution at the 5-year follow-up. The study was limited by the retrospective design and the relatively small patient sample. Sacral nerve modulation is an effective treatment for fecal and double incontinence, achieving satisfactory long-term success rates, with resolution of concomitant sexual dysfunction.

Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future?

BACKGROUND: Polypropylene (PP) pelvic mesh is a synthetic mesh made of PP polymer used to treat pelvic organ prolapse (POP). Its use has become highly controversial due to reports of serious complications. This research critically reviews the current management options for POP and PP mesh as a viable clinical application for the treatment of POP. The safety and suitability of PP material were rigorously studied and critically evaluated, with consideration to the mechanical and chemical properties of PP. We proposed the ideal properties of the 'perfect' synthetic pelvic mesh with emerging advanced materials. METHODS: We performed a literature review using PubMed/Medline, Embase, Cochrane Library (Wiley) databases, and ClinicalTrials.gov databases, including the relevant keywords: pelvic organ prolapse (POP), polypropylene mesh, synthetic mesh, and mesh complications. RESULTS: The results of this review found that although PP is nontoxic, its physical properties demonstrate a significant mismatch between its viscoelastic properties compared to the surrounding tissue, which is a likely cause of complications. In addition, a lack of integration of PP mesh into surrounding tissue over longer periods of follow up is another risk factor for irreversible complications. CONCLUSIONS: PP mesh has caused a rise in reports of complications involving chronic pain and mesh exposure. This is due to the mechanical and physicochemical properties of PP mesh. As a result, PP mesh for the treatment of POP has been banned in multiple countries, currently with no alternative available. We propose the development of a pelvic mesh using advanced materials including emerging graphene-based nanocomposite materials.

Innovative training modality for sacral neuromodulation (SNM): Patient-specific computerized tomography (CT) reconstructed 3D-printed training system: ICS School of Modern Technology novel training modality.

INTRODUCTION: Sacral neuromodulation (SNM) is an effective treatment of urinary and bowel dysfunction, including secondary to neurological disorders. The learning curve for the optimal electrode placement for SNM is steep, expensive, and limited by patient factors such as obesity and previous injuries. We aim to create a patient specific 3-dimensional (3D) model for successful SNM training. MATERIALS AND METHODS: A total of 26 urology residents who had different level of knowledge and experience were enrolled to the 3D SNM training program. The creation of 3D sacrum model has been started with evaluation of real patient computerized tomography images and creation of Digital Imaging and Communications in Medicine files. The segmented anatomic structures from the files then edited and stereolithographic files were generated for 3D-model prints via Mimics© software. The 3D-printed models were used for training and evaluation of participants during the SNM intervention was performed. The evaluation of 3D SNM model training was led by one mentor who is expert on SNM. RESULTS: On the preprinted 3D sacrum model all 26 participants were requested to perform the essential steps to complete a SNM procedure and individual procedure time was recorded. The mean and median scores were 18.8 and 19, respectively according to Likert scores (min 11 max 28). CONCLUSIONS: SNM is increasing in popularity as a treatment option with physicians and patients with refractory symptoms. Few experienced specialists exist, and more effective training methods are needed to tackle the increasing demand, and individual patient anatomy.

Patient-tailored healthcare and tibial nerve neuromodulation in the treatment of patients with overactive bladder symptoms.

PURPOSE: The aim of this study was to demonstrate features predictive of treatment response for patient-tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors. MATERIALS AND METHODS: This study was designed as a follow-up study based on parameter settings and patients' preferences during the pilot and extended study of the implantable tibial nerve stimulator (RENOVA™ iStim system). For this study, we compared all treatment parameters (stimulation amplitude, frequency, and pulse width) and usage data (duration of treatment) during the different follow-up visits. RESULTS: We obtained usage data from a total of 32 patients who were implanted with the system between February and September 2015. Age, sex, body mass index (BMI) and previous experience with percutaneous tibial nerve stimulation (PTNS) treatment were considered as possible prediction factors for treatment success. However, only BMI was considered a statistically significant prediction factor (p = 0.042). A statistically significant increase in mean treatment level was seen in the responder group during the 3 month follow-up visit (mean: 6.7 mA, SD 0.416) as compared with the initial system activation visit (mean: 5.8 mA, SD 0.400) (p = 0.049). No other visits demonstrated statistically significant changes in both groups (responders and nonresponders) during the defined timepoints. CONCLUSION: This data underscores the need to use patient-tailored OAB treatment. BMI was found to be a negative predictive factor for treatment success. However, it was not possible to develop a specific responder model. A model predicting response to treatment could be useful for implementing shared decision making.

Ultrasound assessment of urethral structure and bladder neck position in women with different parities.

INTRODUCTION AND HYPOTHESIS: The study aims to compare the urethral sphincter size and bladder neck position and mobility in women with different parities. METHODS: Women referred to the urodynamics clinic for lower urinary tract and prolapse symptoms were included in the study. A detailed history was taken, and transperineal two- and three-dimensional ultrasound was performed on all the women. The women were divided into four groups according to the vaginal parity. Group 1 had no vaginal childbirths. Group 2 had one, group 3 had two and group 4 had three or more vaginal childbirths. The data was analysed and compared among the groups. RESULTS: One hundred fifty women were included in the study. There were 34, 22, 48 and 46 women in groups 1 to 4 respectively. The distribution of different urodynamic diagnoses was similar in all four groups. The urethral sphincter measurements were significantly larger in the vaginally nulliparous group than in all other groups. The measurements were not smaller in multiparous women than in primiparous women. The bladder neck was at a lower position at rest in parous women than nulliparous women. The bladder neck movement was not more in groups 2 to 4 than in group 1. CONCLUSION: The urethral sphincter was smaller and the bladder neck position was lower in parous women than nulliparous women. These differences were not progressive with increasing parity. Request for elective caesarean section during the second pregnancy to protect the urethra is not supported by this study.

Update in Transvaginal Grafts: The Role of Lightweight Meshes, Biologics, and Hybrid Grafts in Pelvic Organ Prolapse Surgery.

Transvaginal mesh/grafts have been popularized over the past 20 years in an attempt to improve the longevity of traditional vaginal pelvic organ prolapse (POP) surgery. Several national bodies have concluded that the proposed benefits of mesh/graft implantation are outweighed by the significant increase in surgery complications related to these products. As a consequence mesh products for vaginal POP surgery have been withdrawn from use in many countries. This article is a narrative review of newer mesh and graft products including lightweight polypropylene mesh products, biological grafts, hybrid grafts, and tissue engineered grafts.

Mental health among clinicians: what do we know and what can we do?

Mental health and mental health disorders among clinicians remain a taboo, despite increasing evidence showing the direct impact on medical teams and patient care. This editorial is aimed at increasing awareness of mental issues amongst healthcare professionals, identifying perceived barriers to seeking help, and suggesting ways in which to seek help. Mental health disorders, including anxiety and depression, are prevalent from medical school, leading to increased burnout and suicide risks at later stages of a clinician's career. There is often a reluctance to seek help, particularly amongst the surgical specialties, caused by self-criticism, lack of convenient access and the potential negative impact on medical licensure. This editorial has been written in loving memory of our colleague, friend and board member Dr. Nikolaus Veit-Rubin, who sadly passed away at the beginning of the year. It is written in the hope of highlighting the importance of maintaining mental wellbeing amongst the medical team, supporting help-seeking behaviour and changing attitudes toward mental health disorders amongst clinicians.

Female pelvic medicine & reconstructive surgery (FPMRS) challenges on behalf of the collaborative research in pelvic surgery consortium (CoRPS): managing complicated cases series 7: can fibroids worsen incontinence?

This case presents the work-up and management of a patient with a fibroid uterus and urinary incontinence. Five international experts also provide their evaluation and approach to this case. According to the literature, there is uncertainty surrounding the relationship between fibroids and urinary incontinence. The experts emphasize patient counseling and a staged approach.

Urethral sphincter volume and urodynamic diagnosis.

AIM: To compare urethral sphincter measurements in women with different urodynamic diagnoses using three-dimensional transperineal ultrasound (TPU). METHODS: Women with lower urinary tract dysfunction having urodynamic studies (UDS) were prospectively recruited to this study. A detailed history and vaginal examination were conducted. Saline cystometry was performed and the women were divided into groups according to their urodynamic diagnosis, which were nondiagnostic urodynamics (NUDS), pure detrusor overactivity (PureDO), pure urodynamic stress incontinence (PureUSI) and mixed urinary incontinence (MUDS). Three-dimensional TPU was performed to measure total urethral sphincter volume, striated sphincter volume, core volume, sphincter length and maximum cross-sectional area. The ultrasound measurements were compared with the diagnostic urodynamics. RESULTS: One hundred fifty women were included in the study. There were 37, 53, 22 and 38 women in the groups of NUDS, PureDO, PureUSI and MUDS respectively. The average striated sphincter volumes in these groups were 1.84 ml, 2.24 ml, 1.32 ml and 1.98 ml respectively. There was no difference in average age, body mass index or presence of prolapse in these groups. All measurements were larger in the PureDO and smaller in the PureUSI group compared with the NUDS group. The measurements in the MUDS group were larger than in the NUDS group and smaller than in the PureDO group but this difference was not statistically significant. CONCLUSION: The urethral sphincter of women with PureDO is larger than in women with PureUSI. The value in women with MUDS was between the two. The size of the urethral sphincter appears to be related to the pathophysiology.

Vaginal laser for overactive bladder syndrome.

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually with urinary frequency and nocturia, with or without urge urinary incontinence. The prevalence of OAB in adult women ranges between 11% and 42%, is particularly common in elderly people, and can overlap with the genitourinary syndrome of menopause (GSM). There is a wide approach to the treatment of symptoms, often in a stepwise fashion, including lifestyle changes, bladder retraining and pelvic floor muscle rehabilitation, drug therapy, intra-vesical botulinum toxin injections or neuromodulation. Recently, vaginal laser therapy has been proposed as an emerging minimal invasive effective treatment option for women with OAB. We explore this further.

How can we improve the diagnosis and management of bladder pain syndrome? Part 1: ICI-RS 2018.

BACKGROUND: This paper summarizes the discussion in a think tank at the ICI-RS 2018 about the diagnosis of bladder pain syndrome (BPS). AIMS: To review the guidelines, investigations and subtypes of BPS. MATERIALS AND METHODS: Review of literature in the light of the think tank discussion. RESULTS: All guidelines recommend completing history, physical examination, urine analysis, urine culture, and urine cytology to define the BPS phenotype but there are differences on further investigations. In those guidelines which recommend cystoscopy, the identification of Hunner's lesions (HLs) is recommended as this changes the treatment plan and outcome. CONCLUSION: We propose that the differentiation of Hunner's ulcers is an important step in the assessment of these patients. Further suggestions for research are suggested.

Burch colposuspension.

AIMS: To evaluate the historic and pathophysiologic issues which led to the development of Burch colposuspension, to describe anatomic and technical aspects of the operation and to provide an update on current evidence. METHODS: We have performed a focused literature review and have searched the current available literature about historic dimension, technical descriptions, and efficacy of Burch colposuspension. RESULTS: Burch colposuspension, performed either by an open or a laparoscopic approach, is an effective surgical treatment for stress urinary incontinence. CONCLUSIONS: In current recommendations, Burch colposuspension remains an option for secondary treatment. Because midurethral slings have recently become under scrutiny, it may return as a first-line treatment procedure. Both open and laparoscopic Burch colposuspension should therefore nowadays be provided in fellowship programs worldwide.

What is the exact working mechanism of botulinum toxin A and sacral nerve stimulation in the treatment of overactive bladder/detrusor overactivity? ICI-RS 2017.

AIMS: Botulinum toxin A (BTX-A) and sacral nerve stimulation (SNS) are established treatments for overactive bladder (OAB) and are standard of care in refractory cases in international guidelines. Despite long term use over decades their "exact" working mechanisms are not entirely clear. At the ICI-RS meeting in Bristol in 2017 a think tank was convened to address the question. METHODS: The think tank conducted a literature review and an expert consensus meeting focusing on current mechanisms and what could be learned from clinical experience and objective urodynamic data. RESULTS: BTX-A results suggests effects on both filling and voiding parts of the micturition cycle. The salient data in this regard is presented as well as additional studies related to the urothelium and evidence for central effects. Urodynamics have consistently shown increases in bladder capacity, compliance, and reductions in detrusor pressures during filling, however post void residuals also increase in a dose-dependent fashion. During SNS activation of somatic afferents inhibits bladder sensory pathways and reflex bladder hyperactivity. Evidence in cats suggest the inhibition of bladder activity occurs primarily in the CNS by inhibition of the ascending or descending pathways of the spinobulbospinal micturition reflex. Urodynamics have suggested improvement in bladder capacity and reduction in detrusor pressures during filling with little observed effects on voiding parameters. CONCLUSIONS: The working mechanism of BTX-A and SNS is complex. The exact mechanisms are still unknown, although considerable progress has been made in our understanding. Further research proposals are suggested to help further elucidate these mechanisms.