Antibiotic prophylaxis in invasive urodynamics, a Delphi consensus of the Italian Society of Urodynamics (SIUD).

INTRODUCTION: Although antibiotic prophylaxis (AB) demonstrated a statistically significant reduction in bacteriuria after invasive urodynamics (UDS), no significant decrease in the incidence of urinary tract infections (UTI) has been confirmed. No absolute recommendations on the use of AB in case of relevant potential risk of UTI have been reported, though some categories of patients at increased infective probability after UDS have been recognized. The aim of this study is to report the experts' consensus on the best practice for the use of AB before UDS in the main categories of patients at potential risk of developing UTI. MATERIALS AND METHODS: A systematic literature review was performed on AB before UDS in males and females. A panel of experts from the Italian Society of Urodynamics, Continence, Neuro-Urology, and Pelvic Floor (SIUD) assessed the review data and decided by a modified Delphi method on 16 statements proposed and discussed by the panel. The cut-off percentage for the consensus was a ≥70% of positive responses to the survey. The study was a Delphi consensus with experts' opinions, not a clinical trial involving directly patients. RESULTS: The panel group was composed of 57 experts in functional urology and UDS, mainly urologists, likewise gynaecologists, physiatrists, infectivologists, pediatric urologists, and nurses. A positive consensus was achieved on 9/16 (56.25%) of the statements, especially on the need for performing AB before UD in patients with neurogenic bladder and immunosuppression. Urine analysis and urine culture before UDS are mandatory, and in the event of their positivity, UDS should be postponed. A consensus was reached on avoiding AB in menopausal status, diabetes, age, gender, bladder outlet obstruction, high postvoid residual, chronic catheterization, previous urological surgery, lack of urological abnormalities, pelvic organ prolapse, and negative urine analysis. CONCLUSIONS: Antibiotic prophylaxis is not recommended for patients without notable risk factors and with a negative urine test due to the potential morbidities that may result from antibiotic administration. However, AB can be used for risk categories such as neurogenic bladder and immunosuppression. The evaluation of urine analysis and urine culture and postponing UDS in cases of positive tests were considered good practices, as well as performing AB in the neurogenic bladder and immunosuppression.

The association between vulvodynia and interstitial cystitis/bladder pain syndrome: A systematic review.

BACKGROUND: Vulvodynia (VVD) is a debilitating chronic vulvar pain significantly affecting patients' quality of life. Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic and complex illness characterized by an unpleasant sensation related to the filling of the bladder and it strongly impacts patients' lives. The exact mechanisms of the two syndromes remain unknown, but there is an overlap between suspected pathophysiologies. OBJECTIVE: To present an overview of the current research on the association between VVD and IC/BPS. SEARCH STRATEGY: A systematic search of three electronic databases was conducted. Studies examining the correlation between VVD and IC/BPS with male and female patients aged over 18 years were included. SELECTION CRITERIA: Studies assessing the coexistence of VVD and IC/BPS were included. Reviews, letters to the editor, conference abstracts, book chapters, guidelines, Cochrane reviews, and expert opinions were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers screened the studies for eligibility. Eligible studies were screened for quality. MAIN RESULTS: A total of 13 studies were included in the final review. Among them, 11 presented a positive association between the two syndromes. The studies highlighted that VVD and IC/BPS share common comorbidities and possibly etiopathogenic pathways. CONCLUSION: VVD and IC/BPS are both complex and multifactorial syndromes. This review highlights an association between them, but additional studies on the topic should be conducted for a more precise conclusion.

Prevalence and severity of bowel disorders in the third trimester of pregnancy.

BACKGROUND: Bowel-related disorders are common conditions associated with pregnancy and are a cause of significant distress and healthcare burden. However, there is a lack of data in the literature about these disorders. OBJECTIVE: This study aimed to investigate bowel dysfunctions during the third trimester of pregnancy in a large cohort of women using the validated bowel domain of the Italian version of the Pelvic Floor Questionnaire for Pregnant and Postpartum Women. STUDY DESIGN: This was a secondary analysis of a multicenter cross-sectional study conducted in hospitals in Italy and Italian-speaking Switzerland. Women in the third trimester of pregnancy were asked to complete the Italian Pelvic Floor Questionnaire for Pregnant and Postpartum Women. RESULTS: During the study period, 927 pregnant women in the third trimester of pregnancy responded to the questionnaire and were included in the analysis. Overall bowel dysfunctions were reported by 29.6% of patients. Constipation was reported by 66.6% of pregnant women, whereas symptoms of obstructed defecation were reported by 49.9% of patients. In contrast, urgency was reported by 41.1% of patients. Incontinence to flatus and incontinence to stool were reported by 45.1% and 2.8% of patients, respectively. Moreover, age >35 years, familiarity with pelvic floor disorders, nicotine abuse, and pelvic floor contraction inability were identified as independent risk factors for at least 1 bowel symptom. CONCLUSION: Bowel symptoms are extremely common in the third trimester of pregnancy and can greatly affect a patient's quality of life; therefore, bowel symptoms deserve to be investigated and managed properly. The use of validated questionnaires represents a precious tool to investigate functional symptoms that could be very frequent and disabling in this particular period of life for women.

Italian validation of the Pelvic Floor Distress Inventory (PFDI-20) questionnaire.

INTRODUCTION AND HYPOTHESIS: The use of validated Quality of Life (QoL) questionnaires is useful in the standardization and interpretation process of pelvic floor patient symptoms, due to their functional nature and high prevalence. The Pelvic Floor Distress Inventory QoL questionnaire (PFDI-20) serves both as a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. It includes items related to pelvic organ prolapse and lower gastrointestinal and bladder dysfunction. METHODS: After consensus translation and a comprehension test, the Italian version of the questionnaire was submitted to patients reporting bowel, bladder, or pelvic disorders (cases) and to asymptomatic women (controls). Cases received the questionnaire once again 2 weeks later by email. RESULTS: A total of 254 patients answered the questionnaire. Construct validity was demonstrated by discriminating between cases and controls. Convergent validity was demonstrated for each domain (F < 0.001). In-ernal consistency reliability showed a satisfactory range (0.816-0.860). CONCLUSIONS: The PFDI-20 allows a comprehensive assessment of the effect of pelvic floor disorders on the quality of life of women. Moreover, the PFDI-20 represents a very solid QoL tool, since it has been extensively used in literature, and its use is highly recommended by the International Consultation on Incontinence. The present study demonstrated good features for the Italian version of the PFDI-20 questionnaire.

Prevalence and severity of lower urinary tract symptoms in the third trimester of pregnancy.

INTRODUCTION AND HYPOTHESIS: Pregnancy is a risk factor for urinary disorders, mainly in the third trimester. Lower urinary tract symptoms (LUTS) are often underreported by health care professionals and significantly impact the quality of life of pregnant women. Our objective is to analyse lower urinary tract function during the third trimester of pregnancy and assess the impact of traditional risk factors for pelvic floor dysfunctions on bladder health in pregnant women. METHODS: This is a secondary analysis of a multicentre cross-sectional study. Third-trimester pregnant women aged 18 years or older anonymously filled in the "Italian Pelvic Floor Questionnaire for pregnant and postpartum women" questionnaire, validated for pelvic floor disorders in pregnancy and postpartum. RESULTS: A total of 927 pregnant patients completed the questionnaire. Among them, 97.3% complained of at least one urinary disorder. Frequency was the symptom reported most often (77.3%), whereas nocturnal enuresis was the least reported (17%). Despite the high prevalence of LUTS in our sample, only 13.4% reported that they negatively impact their quality of life. Overweight and obesity, advanced maternal age, smoking, family history of pelvic floor disorders and poor pelvic floor contraction capacity were confirmed to be risk factors for the onset of LUTS, even in our population. CONCLUSIONS: Urinary symptoms are extremely common in the third trimester and significantly affect the quality of life of pregnant women. Since overweight, obesity, smoking and reduced pelvic floor contractility emerged as modifiable risk factors for the development of these symptoms, prevention and adequate counselling are cornerstones of pregnancy care.

Prevalence and Severity of Pelvic Floor Disorders during Pregnancy: Does the Trimester Make a Difference?

(1) Background: Women experience pelvic floor dysfunction symptoms during pregnancy. This study is the first to investigate and compare variances in the prevalence and severity of pelvic floor symptoms between trimesters using a valid pregnancy-targeted questionnaire. (2) Methods: A retrospective cohort study was conducted between August 2020 to January 2021 at two university-affiliated tertiary medical centers. Pregnant women (n = 306) anonymously completed the Pelvic Floor Questionnaire for Pregnancy and Postpartum with its four domains (bladder, bowel, prolapse, and sexual). (3) Results: Thirty-six women (11.7%) were in the 1st trimester, eighty-three (27.1%) were in the 2nd trimester, and one hundred and eighty-seven (61.1%) were in the 3rd trimester. The groups were similar in age, pregestational weight, and smoking habits. A total of 104 (34%) had bladder dysfunction, 112 (36.3%) had bowel dysfunction, and 132 (40.4%) reported sexual inactivity and/or sexual dysfunction. Least prevalent (33/306; 10.8%) were prolapse symptoms. Increased awareness of prolapse and significantly higher rates of nocturia and the need to use pads due to incontinence were recorded in the 3rd trimester. Sexual dysfunction or abstinence were equally distributed in all three trimesters. (4) Conclusions: Bladder and prolapse symptoms, equally frequent throughout pregnancy, significantly intensified in the 3rd trimester. Bowel and sexual symptoms, equally frequent throughout pregnancy, did not intensify in the third trimester.

Update on Italian-validated questionnaires for pelvic floor disorders.

INTRODUCTION: Pelvic floor disorders (PFDs), which include urinary incontinence, pelvic organ prolapse, sexual dysfunction and gastrointestinal disorders, affect over 20% of the adult population. Prevalence may also be underestimated, since a certain portion of patients may be reluctant to talk to physicians about PFDs due to embarrassment. Consequently, there is a need for self-assessed diagnostic tools with the capability to screen population and collect clinical information. Symptom and quality of life (QoL) questionnaires - also identified as patient-reported outcomes (PROs) - have been developed with this purpose. Despite the large number of questionnaires available for the assessment of PFDs and QoL-related issues in the English language, few of them have been validated for the Italian language. The objective of this article is to update the list of Italian-validated PROs for PFDs along with practical information concerning literature references and suggestions on how to obtain every single questionnaire. EVIDENCE ACQUISITION: PubMed/MEDLINE databases and websites were used to update the list of available Italian-validated questionnaires about PFDs. Once identified, the possibility to get a copy of the questionnaire was verified and steps to obtain it are reported in the tables. EVIDENCE SYNTHESIS: Eight additional questionnaires validated into the Italian language, for diagnosis and overall management of common urinary, vaginal, sexual and bowel conditions, were retrieved. The complete list of PFDs PROS is reported in a modular format for consultation. CONCLUSIONS: This format is intended to serve as a tool to promote appropriateness in PROs adoption while investigating PFDs in Italian patients.

Coexisting overactive-underactive bladder and detrusor overactivity-underactivity in pelvic organ prolapse.

OBJECTIVE: The coexisting overactive-underactive bladder (COUB) syndrome could be related to the increased urethral resistance caused by severe pelvic organ prolapse (POP). We aimed to evaluate the clinical and urodynamic findings of patients with COUB and/or detrusor overactivity-underactivity (DOU) in a cohort of patients scheduled for POP surgery and the possible risk factors of COUB after surgery. METHODS: This retrospective study analyzed all patients who underwent POP repair between 2008 and 2013, excluding women with a history of pelvic floor surgery. Patients were divided into COUB and non-COUB according to baseline symptoms and into DOU and non-DOU based on urodynamic findings. A multivariate model was performed to identify risk factors for COUB symptoms after surgery. RESULTS: A total of 533 women underwent POP surgery. Preoperatively, patients with COUB had more severe anterior compartment prolapse (Pelvic Organ Prolapse Quantification staging system Aa point, P = 0.008) and more frequently had overactive bladder compared with controls (P = 0.023). The rate of COUB decreased significantly after surgery. Preoperative opening detrusor pressure resulted as the only independent predictor of postoperative COUB symptoms (P = 0.034). CONCLUSION: POP is a valid pathogenetic model for COUB development. POP repair induced a significant decrease in COUB symptoms with low opening detrusor pressure resulting as the only independent predictor of postoperative COUB.

Coexistent Detrusor Overactivity-Underactivity in Patients with Pelvic Floor Disorders.

INTRODUCTION AND HYPOTHESIS: Pelvic floor disorders represent a series of conditions that share, in part, the same etiological mechanisms, so they tend to be concomitant. Recently, awareness of a new lower urinary tract clinical syndrome has risen, namely the coexisting overactive-underactive bladder (COUB). The etiopathogenetic process, prevalence, and related instrumental findings of COUB are not well-established. We aimed to evaluate the prevalence, clinical features, and urodynamic findings of patients with COUB in a large cohort of patients with pelvic floor disorders. Methods: A cohort of 2092 women was retrospectively analyzed. A clinical interview, urogenital examination, and urodynamic assessment were performed by a trained urogynecologist. Based on baseline symptoms, patients were divided into COUB and non-COUB groups, and the degree of concordance between COUB and urodynamic findings, and other parameters related to the clinical aspects of these patients were measured and analyzed. Results: 18.8% of patients were classified as COUB. The association between COUB and patients with coexisting detrusor overactivity-underactivity (DOU) was statistically significant and there were substantial similarities in terms of population characteristics, symptoms, and urodynamic findings. Conclusions: Our study showed a high prevalence of COUB, and a link between this clinical syndrome and DOU was demonstrated. They showed substantial similarities in terms of clinical and urodynamics correlates. Based on these findings, we do think that urodynamic tests can be useful to improve knowledge on COUB and may be of help in the management of this condition.

Prevalence and severity of sexual disorders in the third trimester of pregnancy.

BACKGROUND: Female sexual function in pregnancy is an under-investigated topic by care providers. This study aimed to investigate the sexual function and the impact of traditional risk factors for pelvic floor disorders (PFDs) during the third trimester of pregnancy. METHODS: This is a secondary analysis of a multicentre cross-sectional study conducted in eight hospitals in Italy and Italian-speaking Switzerland. Women at the third trimester of pregnancy aged 18 years and over completed the Italian-PFQPP questionnaire anonymously. RESULTS: 927 patients in the third trimester of pregnancy answered the questionnaire. 29.5% of women reported reduced or absent sexual activity. The less reported symptom was coital incontinence (1.3%), while painful intercourses was the most frequent one (50.3%). Nicotine abuse was associated with traumatic sexual intercourses, impaired vaginal sensibility, and negative impact on sexual life and well-being. Familiarity for pelvic floor disorder resulted as a risk factor for coital incontinence (OR=3.61). CONCLUSIONS: Sexual symptoms, with pain during intercourses being the most widely reported, are extremely common in the third trimester of pregnancy and can greatly affect quality of life. Familiarity for pelvic floor disorders and nicotine abuse resulted as significant risk factors for at least one sexual symptom.

Correlation between urinary symptoms and urodynamic findings: Is the bladder an unreliable witness?

OBJECTIVE: The role of urodynamics as the gold standard to investigate bladder function has recently been questioned. We aimed to evaluate the agreement of lower urinary tract symptoms and urodynamic diagnosis and to build predictive models. STUDY DESIGN: Patients who underwent urodynamics for pelvic floor disorders between 2008 and 2016 were retrospectively analyzed. Clinical evaluation investigated the presence of genital prolapse, stress urinary incontinence (SUI), overactive bladder (OAB), urge urinary incontinence (UUI), voiding symptoms (VS), and bulging symptoms. The degree of concordance/agreement between symptoms and corresponding urodynamic findings was measured. Multivariate models to predict specific urodynamic findings were built. RESULTS: 1972 women were analyzed. The best agreement was found for SUI and urodynamic SUI, with a proportion of agreement of 0.68 and a Cohen's Kappa of 0.37. Very poor agreement was found for OAB/UUI and detrusor overactivity, voiding dysfunction, and positive post-void residuals. Multivariate models resulted in poor accuracy for all urodynamic findings (AUC range 0.64-0.72). CONCLUSION: Lower urinary tract symptoms and gynecological examination are poor predictors of urodynamic findings. This confirms the role of urodynamic assessment in defining bladder function and providing precious information to counsel patients and establishing optimal clinical guidance.

Native-tissue prolapse repair: Efficacy and adverse effects of uterosacral ligaments suspension at 10-year follow up.

OBJECTIVE: To evaluate the 10-year outcomes of high uterosacral ligaments suspension as a primary repair for apical prolapse and to evaluate the long-term impact of prognostic factors. METHODS: A retrospective study analyzed 10-year follow up after repair of primary apical prolapse through high uterosacral ligament suspension. Bulging symptoms and postoperative prolapse stage II or above were considered subjective and objective recurrences, respectively. Patient Global Impression of Improvement score was used to evaluate subjective satisfaction after surgery. RESULTS: A total of 287 women were analyzed. Ten-year recurrence rates were 19.1% for objective recurrence and 6.3% for subjective recurrence; surgical retreatment rate was 2.1%. Premenopausal status was related to 15-fold increased risk of developing either objective or subjective recurrence. Conversely, anterior and posterior repair were protective factors against reoperation. CONCLUSION: High uterosacral ligaments suspension is a safe and long-lasting effective procedure for the treatment of uterovaginal prolapse even 10 years after index surgery. Premenopausal status and lack of anterior and posterior repair represented long-term risk factors for surgical failure.

Learning Curve of Botulinum Toxin Bladder Injection for the Treatment of Refractory Overactive Bladder.

PURPOSE: Intradetrusor botulinum toxin injections is an established second-line treatment for patients with refractory overactive bladder syndrome (OAB). We aimed to evaluate the learning curve of intradetrusor injections with botulinum toxin for the treatment of refractory OAB. PATIENTS AND METHODS: This retrospective study analyzed all women with idiopathic and refractory OAB who underwent botulinum toxin bladder injections performed by residents with no previous experience with operative cystoscopy under consultant supervision. Baseline International Consultation on Incontinence Questionnaire-Short Form questionnaire (ICIQ-SF) and Euroqol (EQ-5D) questionnaires were collected. Procedural data (operative time, number of valid injections, complications, subjective easiness, perceived tolerability) and patients' outcomes (Patients Global Impression of Improvement (PGI-I), ΔICIQ-SF, ΔEQ-5D, need for self intermittent catheterization, duration of efficacy) were considered as markers to evaluate learning curves for each resident. RESULTS: Twenty-seven patients underwent intravesical injection of botulinum toxin performed by residents. Only a grade 1 Clavien-Dindo complication occurred, and none of the patients had urinary retention. PGI-I was very satisfactory, scoring 1.4 ± 0.9. Both ICIQ-SF and EQ-5D 2-2 were statistically improved (p < 0.00001 and p = 0.04, respectively). The mean duration of efficacy resulted to be 8.0±4.3 months. A positive effect of the learning curve was observed only for operative time, subjective easiness, and perceived tolerability. CONCLUSION: Intradetrusor botulinum toxin injection for the treatment of refractory OAB is characterized by high efficacy and very low complications even at the very beginning of the learning curve when performed under proper mentorship.

Risk factors for obstetric anal sphincter injury recurrence: A systematic review and meta-analysis.

BACKGROUND: Women with previous obstetric anal sphincter injuries (OASIs) are at a higher risk of recurrence in the subsequent pregnancy, which may lead to the development or worsening of anal incontinence. Due to a lack of evidence, few recommendations can be made about the factors that may affect the risk of OASI recurrence. OBJECTIVE: We sought to conduct a systematic review and meta-analysis to investigate potential risk factors for recurrent OASIs. SEARCH STRATEGY: Studies up to May 2019 were identified from PubMed, Scopus, Cochrane Library, and ISI Web of Science. SELECTION CRITERIA: Studies assessing the impact of risk factors on OASI recurrence in subsequent pregnancies were included. Reviews, letters to the editor, conference abstracts, book chapters, guidelines, Cochrane reviews, and expert opinions were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent reviewers. Odds ratio and standardized mean difference were chosen as effect measures. Pooled estimates were calculated using the random-effects model. MAIN RESULTS: The meta-analysis showed that maternal age, gestational age, occiput posterior presentation, oxytocin augmentation, operative delivery, and shoulder dystocia were associated with the risk of recurrent OASIs in the subsequent delivery. CONCLUSION: Prenatal and intrapartum risk factors are associated with recurrence of OASI. PROSPERO registration no. CRD42020178125.

Cesarean section rate is a matter of maternal age or parity?

OBJECTIVE: To determine the impact of women's age on the cesarean section (CS) rate according to Robson groups 1, 2A, 3 and 4A. STUDY DESIGN: Retrospective cohort study of term, livebirth, singleton pregnancies with spontaneous or induced labor who delivered at the San Paolo Hospital from 1996 through 2019, and had the Robson group assigned. Women were grouped in 5 age classes (≤24, 25-29, 30-34, 35-39 and ≥40 years). The primary outcome was the rate of CS. RESULTS: 24 843 women were included: 36.4% classified as Robson group 1, 18.9% as Robson group 2A, 34.4% as Robson group 3 and 10.2% as Robson group 4A. The CS rate of women in Robson groups 1, 2A, 3 and 4A was 6.6%, 21.8%, 1.6% and 4.3% respectively. In nulliparous women [Robson groups 1 and 2A] group 1, the adjusted OR of CS increased steadily from 30 to ≥40 years, when compared to women aged 25-29 years. On the contrary, in multiparous women [Robson groups 3 and 4A] significant increased OR were present only for women ≥40 years. In young women [≤24 years] there was a significant reduction in the number of cesarean sections only in Robson group 1. CONCLUSION: The results of our study show that multiparous women aged ≥40, either in spontaneous or induced labor have an independent twofold increased risk of delivering by cesarean section when compared to women of 25-29 years. On the contrary, in nulliparous women, the risk slightly, but significantly, increases with age and again becomes twofold in women ≥40 years.

Clinical and urodynamic predictors of Q-tip test urethral hypermobility.

BACKGROUND: Urodynamics and Q-tip test represent diagnostic tools for the assessment of stress urinary incontinence. The aim of the present study was to investigate the possibility to predict the Q-tip test urethral hypermobility on the basis of clinical and urodynamic parameters. METHODS: We analyzed all women performed urodynamics between 2008 and 2016 presenting urodynamic stress urinary incontinence. Symptoms were collected by the Incontinence Questionnaire-Short Form Questionnaire. RESULTS: A total of 501 women presented urodynamic stress incontinence, of which 270 had urethral hypermobility, according to the Q-tip test. Patients with urethral hypermobility were younger (P<0.0001) and presented a more advanced anterior compartment descensus according to the POP-Q system (Aa point P=0.0155; Ba point P=0.0374), a higher detrusor pressure at maximum flow (P=0.0075) and maximum flow rate compared to controls. CONCLUSIONS: Age, Aa POP-Q point and detrusor pressure at maximum flow were found to be independent predictors of Q-tip test urethral hypermobility. However, the final model cannot be used as an effective predictor of the Q-tip test result.

Detrusor underactivity prevalence and risk factors according to different definitions in women attending urogynecology clinic.

INTRODUCTION AND HYPOTHESIS: There is still no consensus on definitions of detrusor underactivity; therefore, it is difficult to estimate the prevalence. The primary objective of the study was to evaluate the prevalence of detrusor underactivity in a cohort of patients with pelvic floor disorders according to different proposed urodynamics definitions. The secondary objectives were to estimate the association between detrusor underactivity and symptoms, anatomy and urodynamic findings and to build predictive models. METHODS: Patients who performed urodynamic evaluation for pelvic floor disorders between 2008 and 2016 were retrospectively analyzed. Detrusor underactivity was evaluated according to Schafer's detrusor factor, Abrams' bladder contractility index and Jeong cut-offs. The degree of concordance between each method was measured with Cohen's kappa, and differences were tested using Student's t test, Wilcoxon test and Pearson's chi-squared test. RESULTS: The prevalence of detrusor underactivity among a cohort of 2092 women, concerning the three urodynamic definitions, was 33.7%, 37.0% and 4.1%, respectively. Age, menopausal status, voiding/bulging symptoms, anterior and central prolapse, first desire to void and positive postvoid residual were directly related to detrusor underactivity. Conversely, stress urinary incontinence, detrusor pressures during voiding and maximum flow were inversely associated. Final models for detrusor underactivity resulted in poor accuracy for all considered definitions. CONCLUSIONS: The prevalence of detrusor underactivity varies depending on the definition considered. Although several clinical variables resulted as independent predictors of detrusor underactivity, instrumental evaluation still plays a key role in the diagnosis.

Stem Cells in Clinical Trials for Pelvic Floor Disorders: a Systematic Literature Review.

Pelvic floor disorders (PFDs) include a series of conditions that can be poorly tolerated, negatively affecting the quality of life. Current treatment options show unsatisfactory results and new ones are therefore needed. Stem cell (SC) therapy might be an alternative treatment strategy. This systematic review aims to define the state of art of SC therapy for PFDs in clinical trials, by systematically reviewing the available evidence. A systematic search strategy was conducted up to November 7, 2020, in PubMed, Scopus, Cochrane Library, and ISI Web of Science. Preclinical studies on animal models were not considered. Studies were included when the patients were affected by any PFDs and cells were isolated, cultured, and characterized as SC. The study protocol was registered in PROSPERO (CRD42020216551). A total of 11 prospective clinical studies were included in the final assessment, specifically 7 single-arm studies dealing with SC therapy for stress urinary incontinence and 4 with anal incontinence. Among the latter, there were two prospective, single-arm studies and two randomized controlled trials. No papers concerning the use of SC for prolapse repair were retrieved. Due to the great heterogeneity, data pooling was not possible. Stem cell injection resulted in a safe procedure, with few mild adverse side effects, mostly related to harvesting sites. However, a clear beneficial impact of SC treatment for the treatment of pelvic floor disorders could not be demonstrated. Further larger targeted studies with control arms are needed before any conclusions can be made.