Should hormone replacement therapy (any route of administration) be considered in all postmenopausal women with lower urinary tract symptoms? Report from the ICI-RS 2023.

AIMS: This International Consultation on Incontinence-Research Society report aims to summarize the evidence and uncertainties regarding the use of hormone replacement therapy by any route in the management of lower urinary tract symptoms (LUTS) including recurrent urinary tract infections (rUTI), with a review of special considerations for the elderly. Research question proposals to further this field have been highlighted. METHODS: An overview of the existing evidence, guidelines, and consensus regarding the use of topical or systemic estrogens in the management of LUTS. RESULTS: There are currently evidence and recommendations to offer topical estrogens to postmenopausal women with overactive bladder symptoms as well as postmenopausal women with rUTIs. Systemic estrogens however have been shown in a meta-analysis to have a negative effect on LUTS and, therefore are not currently recommended. CONCLUSIONS: Although available evidence and recommendations exist for the use of topical estrogens, few women are commenced on these in primary care. There remain large gaps still within our knowledge of the use of estrogens within the management of LUTS, particularly on when it should be commenced, the length of time treatment should be continued for, and barriers to prescribing.

The incidence of anal incontinence following obstetric anal sphincter injury graded using the Sultan classification: a network meta-analysis.

OBJECTIVE: This study aimed to systematically determine and compare the incidence of anal incontinence between those with different grades of obstetric anal sphincter injury. DATA SOURCES: Ovid MEDLINE, Embase, and the Cochrane Library were searched from January 2000 to April 2021. STUDY ELIGIBILITY CRITERIA: Observational studies investigating the incidence of anal incontinence following an obstetric anal sphincter injury that was graded using the Sultan classification were eligible for inclusion. To allow comparison between individual tear grades (3a, 3b, 3c, fourth), a network meta-analysis was performed using Stata (version 15.1). METHODS: For binary outcomes, odds ratios with corresponding 95% confidence intervals were reported. Obstetric anal sphincter injury grades were ranked from the best clinical outcome to the worst clinical outcome. The percentage chance of each grade taking each rank with regards to outcome was calculated. Study quality and risk of bias was assessed using the relevant tool from the Joanna Briggs Institute. RESULTS: Of the 696 studies identified, 10 were eligible for inclusion and were included in the network meta-analysis (n=2467 women). The mean incidence of anal incontinence among those with 3a tears was 22.4% (range, 6.1%-51.2%), 24.9% (range, 6.9%-46.7%) among those with 3b tears, 26.8% (range, 0%-55.6%) among those with 3c tears, and 28.6% (0%-71.4%) among those with fourth-degree tears. Anal incontinence incidence was found to be significantly higher among those with 3c (odds ratio, 1.79; 95% confidence interval, 1.09-2.94) and fourth-degree tears (odds ratio, 2.37; 95% confidence interval, 1.40-4.02) than among those with 3a tears. In addition, anal incontinence incidence was significantly higher among those with fourth-degree tears (odds ratio, 1.89; 95% confidence interval, 1.10-3.22) than among those with 3b tears. Those with 3a tears had the highest probability of having the best clinical outcome; those with 3b; second-, 3c; third- and fourth-degree tears had the highest probability of having the worst clinical outcome. Overall, all studies had a high or unclear risk of bias across 1 or more assessed element. CONCLUSION: This was a network meta-analysis comparing the incidence of anal incontinence among those with different grades of obstetric anal sphincter injury. Increasing tear-grade severity is associated with worse clinical outcomes. This study provides useful, clinically applicable information that can assist clinicians in the counseling of women following an obstetric anal sphincter injury. In addition, it highlights the importance of accurately diagnosing the obstetric anal sphincter injury grade and subsequently performing the appropriate repair.

Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women.

BACKGROUND: Pelvic organ prolapse (POP) is the descent of a woman's uterus, bladder, or rectum into the vagina. It affects 50% of women over 50 years old who have given birth to at least one child, and recognised risk factors are older age, higher number of births, and higher body mass index. This review assesses the effects of oestrogen therapy, alone or in combination with other treatments, on POP in postmenopausal women. OBJECTIVES: To assess the benefits and harms of local and systemic oestrogen therapy in the management of pelvic organ prolapse symptoms in postmenopausal women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register (up to 20 June 2022), which includes CENTRAL, MEDLINE, two trials registers, and handsearching of journals and conference proceedings. We also checked the reference lists of relevant articles for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, multi-arm RCTs, and cross-over RCTs that evaluated the effects of oestrogen therapy (alone or in combination with other treatments) versus placebo, no treatment, or other interventions in postmenopausal women with any grade of POP. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included trials using prespecified outcome measures and a piloted extraction form. The same review authors independently assessed the risk of bias of eligible trials using Cochrane's risk of bias tool. Had data allowed, we would have created summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE. MAIN RESULTS: We identified 14 studies including a total of 1002 women. In general, studies were at high risk of bias in terms of blinding of participants and personnel, and there were also some concerns about selective reporting. Owing to insufficient data for the outcomes of interest, we were unable to perform our planned subgroup analyses (systemic versus topical oestrogen, parous versus nulliparous women, women with versus without a uterus). No studies assessed the effects of oestrogen therapy alone versus no treatment, placebo, pelvic floor muscle training, devices such as vaginal pessaries, or surgery. However, we did identify three studies that assessed oestrogen therapy in conjunction with vaginal pessaries versus vaginal pessaries alone and 11 studies that assessed oestrogen therapy in conjunction with surgery versus surgery alone. AUTHORS' CONCLUSIONS: There was insufficient evidence from RCTs to draw any solid conclusions on the benefits or harms of oestrogen therapy for managing POP symptoms in postmenopausal women. Topical oestrogen in conjunction with pessaries was associated with fewer adverse vaginal events compared with pessaries alone, and topical oestrogen in conjunction with surgery was associated with reduced postoperative urinary tract infections compared with surgery alone; however, these findings should be interpreted with caution, as the studies that contributed data varied substantially in their design. There is a need for larger studies on the effectiveness and cost-effectiveness of oestrogen therapy, used alone or in conjunction with pelvic floor muscle training, vaginal pessaries, or surgery, for the management of POP. These studies should measure outcomes in the medium and long term.

The consequences of undiagnosed obstetric anal sphincter injuries (OASIS) following vaginal delivery.

INTRODUCTION AND HYPOTHESIS: We aimed to compare anal and urinary incontinence symptoms and anal manometry between women with undiagnosed obstetric anal sphincter injuries (OASIS) and women who had OASIS diagnosed and repaired. METHODS: This was a matched retrospective cohort study. Each missed OASI was matched with a diagnosed OASI for severity [minor (3a/b) or major (3c)], parity and length of follow-up. Women completed the modified St Mark's Incontinence Score and International Consultation on Incontinence Questionnaire. Women with OASIS or those without OASIS but with anal incontinence symptoms were seen in perineal clinic for perineal examinations, anorectal manometry and three-dimensional endoanal ultrasound 8-12 weeks postnatally or in a subsequent pregnancy. RESULTS: Forty missed OASIS were matched with 40 recognised OASIS (16 3a/b; 24 3c). The median modified St Mark's scores were higher for missed tears [11 (4, 15) vs. 1 (0, 4), p < 0.001] as well as the urinary incontinence scores [4 (0, 6) vs. 0 (0, 2), p = 0.01] than for the control group. Missed OASIS patients had a shorter perineal body [1.6 ± 1.3 vs. 2.4 ± 0.8, p = 0.009]. All missed OASIS had larger defects on endoanal ultrasound. One in four missed OASIS required further surgery [aOR 4.1 (95% CI 1.0-16.3), p = 0.04] and almost all needed colorectal input [aOR 24.1 (95% CI 7.3-80.0), p < 0.0001]. There were no differences in anal manometry. CONCLUSIONS: Women with symptomatic missed OASIS are compromised in terms of anal and urinary incontinence symptoms, sphincter defect size and perineal body size requiring additional colorectal input. This highlights the importance of preventing OASIS and perseverance with training to diagnose OASIS.

A one-stop perineal clinic: our eleven-year experience.

INTRODUCTION AND HYPOTHESIS: The perineal clinic is a dedicated setting offering assessment for various childbirth-related presentations including obstetric anal sphincter injuries (OASIs), perineal wound complications, pelvic floor dysfunction and other conditions such as female genital mutilation(FGM). We describe the clinical presentation and outcomes of women from a tertiary perineal clinic based on data collected over an 11-year period. METHODS: This is a retrospective observational study. A one-stop outpatient service was offered to all women who sustained OASIs (postnatally and antenatally in a subsequent pregnancy), perineal complications (within 16 weeks postpartum), FGM and/or peripartum symptoms of urinary/anal incontinence or prolapse. Assessment included history with validated questionnaires, examination and anal manometry and endoanal ultrasound when appropriate. Outcomes were compared among different grades of OASIs. Management of each type of presentation was reported with outcomes. RESULTS: There were 3254 first attendance episodes between 2006 and 2016. The majority (58.1%) were for OASIs, followed by perineal wound complications. Compared to the lower grades, the higher grades of OASI were associated with poorer outcomes in terms of symptoms, investigations and complications. Women with OASIs had unrelated symptoms such as urinary incontinence, perineal pain and wound infections that needed further intervention. A high proportion(42%) of wound complications required further specialist management. CONCLUSION: We describe a dedicated, one-stop perineal clinic model for antenatal and postnatal women for management of perineal and pelvic floor disorders. This comprehensive and novel data will enable clinicians to better counsel women regarding of outcomes after OASI and focus training to minimize risks of morbidities.

Is endoanal, introital or transperineal ultrasound diagnosis of sphincter defects more strongly associated with anal incontinence?

INTRODUCTION AND HYPOTHESIS: Our aim was to explore the association between anal incontinence (AI) and persistent anal sphincter defects diagnosed with 3D endoanal (EAUS), introital (IUS) and transperineal ultrasound (TPUS) in women after obstetric anal sphincter injury (OASI) and study the association between sphincter defects and anal pressure. METHODS: We carried out a cross-sectional study of 250 women with OASI recruited during the period 2013-2015. They were examined 6-12 weeks postpartum or in a subsequent pregnancy with 3D EAUS, IUS and TPUS and measurement of anal pressure. Prevalence of urgency/solid/liquid AI or flatal AI and anal pressure were compared in women with a defect and those with an intact sphincter (diagnosed off-line) using Chi-squared and Mann-Whitney U test. RESULTS: At a mean of 23.6 (SD 30.1) months after OASI, more women with defect than those with intact sphincters on EAUS had AI; urgency/solid/liquid AI vs external defect: 36% vs 13% and flatal AI vs internal defect: 27% vs 13%, p < 0.05. On TPUS, more women with defect sphincters had flatal AI: 32% vs 13%, p = 0.03. No difference was found on IUS. Difference between defect and intact sphincters on EAUS, IUS and TPUS respectively was found for mean [SD] maximum anal resting pressure (48 [13] vs 55 [14] mmHg; 48 [12] vs 56 [13] mmHg; 50 [13] vs 54 [14] mmHg) and squeeze incremental pressure (33 [17] vs 49 [28] mmHg; 37 [23] vs 50 [28] mmHg; 36 [18] vs 50 [30] mmHg; p < 0.01). CONCLUSIONS: Endoanal ultrasound had the strongest association with AI symptoms 2 years after OASI. Sphincter defects detected using all ultrasound methods were associated with lower anal pressure.

Comparing the diagnostic accuracy of 3 ultrasound modalities for diagnosing obstetric anal sphincter injuries.

BACKGROUND: The optimal imaging modality of obstetric anal sphincter injuries needs to take into consideration convenience, availability, and ability to assess the sphincter morphologic condition. Endoanal ultrasound imaging currently is regarded as the reference standard, but it is not widely available in obstetric units. Exoanal alternatives exist, such as 3-dimensional introital or transperineal ultrasound imaging, which are already readily available in most obstetrics and gynecology units. OBJECTIVE: The primary objective was to evaluate the diagnostic accuracy of 3-dimensional introital and 3-dimensional transperineal ultrasound imaging compared with 3-dimensional endoanal ultrasound imaging as the reference standard for the detection of anal sphincter defects in women who sustained obstetric anal sphincter injuries. The secondary objective was to correlate a diagnosis of anal sphincter defect on imaging to symptoms of anal incontinence, and to assess patient discomfort that is experienced for each imaging modality. STUDY DESIGN: A cross-sectional study was conducted of 250 women who sustained obstetric anal sphincter injuries, all of whom underwent 3-dimensional introital, transperineal, and endoanal ultrasound imaging. Introital and transperineal ultrasound imaging were assessed with tomographic ultrasound imaging. All of the women completed a validated modified St Mark's Score and Visual Analogue Score for discomfort. Optimal cut-off values for a significant defect on tomographic ultrasound imaging were defined as those with the greatest sensitivity and specificity based on receiver operating characteristic curves with endoanal ultrasound imaging as the reference standard. Diagnostic test characteristics of introital and transperineal ultrasound imaging were calculated with the use of these optimal cut-offs. RESULTS: Optimal cut-off for a significant external anal sphincter defect was ≥3 of 7 slices; sensitivity and specificity were 0.65 and 0.75 on introital imaging and 0.70 and 0.69 on transperineal ultrasound imaging. Optimal cut-off for a significant internal anal sphincter defect was ≥2 of 5 slices; sensitivity and specificity were 0.59 and 0.84 on introital imaging and 0.43 and 0.97 on transperineal ultrasound imaging. The area under the curve for the diagnosis of external and internal anal sphincter defects ranged from 0.70-0.74 (P<.001) for introital and transperineal imaging. Positive predictive value for external and internal sphincter defects ranged from 0.37-0.63, and negative predictive value ranged from 0.85-0.93 for introital and transperineal ultrasound imaging. Endoanal ultrasound imaging was the only modality for a defect to correlate with symptoms; mean modified St. Mark's score for a defect sphincter was 2.4 (standard deviation, 4.1) and for an intact sphincter was 0.9 (standard deviation, 2.7; P<.01). Introital and transperineal ultrasound imaging were associated with less discomfort than endoanal ultrasound imaging. CONCLUSION: Endoanal ultrasound imaging remains the most accurate diagnostic imaging modality. With low positive predictive values, introital and transperineal ultrasound imaging are not suitable for the identification of sphincter defects; however, high negative predictive values show a good ability to detect an intact sphincter. The optimal cut-off number of slices on tomographic ultrasound imaging for external and internal anal sphincters allows for standardization of a significant defect. In women with a history of obstetric anal sphincter injuries, introital and transperineal ultrasound imagings are suitable to screen for an intact sphincter if endoanal ultrasound imaging is not available. When defects are found, women should then have endoanal ultrasound imaging to verify the diagnosis.

Clinical application of 2D and 3D pelvic floor ultrasound of mid-urethral slings and vaginal wall mesh.

INTRODUCTION AND HYPOTHESIS: This mini-review demonstrates the clinical application of pelvic floor ultrasound for imaging women with mesh following incontinence and prolapse surgical procedures. METHODS: The images are obtained using two-dimensional (2D) perineal pelvic floor ultrasound (pPFUS) and three-dimensional (3D) endovaginal ultrasound (EVUS). RESULTS: 2D pPFUS and 3D EVUS provide confirmation of the presence or absence of vaginal wall mesh (VWM), bulking agents, and the type of mid-urethral sling (MUS). Residual mesh following excision can be located, and presence in the bladder/urethra may be demonstrated. These are crucial for surgical planning and counselling, with the potential to be useful intraoperatively also. The shape and position relative to urethral length and lumen can be assessed, which may correspond with voiding dysfunction or recurrent incontinence. Evidence of inflammation/sepsis or folding of the VWM may be useful in the investigation of pain. CONCLUSIONS: Pelvic floor ultrasound is the standard of care where imaging is available and utilised and is the only modality capable of reliably visualising mesh. It is clear that there are significant benefits and uses for the clinician for investigating complications of VWM or MUS; although many of the findings may be associated with clinical symptoms, some are incidental findings. Therefore, these scans should be performed by pelvic floor specialists with core competency in pelvic floor ultrasound and interpreted by those familiar with their significance, as an adjunct to patient history, examination and other investigations to assist in the most appropriate management plan for the patient. In addition, there is still a need for standardisation in terminology and measurement techniques, to allow for consistent and comparable reporting.

Ospemifene for Genitourinary Syndrome of Menopause: Patient Selection.

Vulvar vaginal atrophy is a common condition affecting postmenopausal women, significantly impacting their quality of life. Fortunately, various treatment options are available, ranging from hormonal to non-hormonal therapies. Ospemifene has emerged as a promising non-hormonal alternative for managing vulvar vaginal atrophy. Its targeted approach, unique mechanism of action, favorable safety profile particularly for breast tissue, and efficacy make it a valuable option for women seeking relief from symptoms such as vaginal pain, dryness and dyspareunia and cannot receive estrogen supplementations. This is particularly the case for breast cancer survivors or women with a significant family history of estrogen-dependent cancers. Hence, tailored treatment plans, considering individual preferences and health circumstances, are essential in optimizing outcomes and improving the overall well-being of affected individuals.

Treating and Managing Urinary Incontinence: Evolving and Potential Multicomponent Medical and Lifestyle Interventions.

Incontinence is defined by either ICS 2002 or IUGA/ICS 2010 as the involuntary loss of urine and includes urgency urinary incontinence (UUI), stress urinary incontinence (SUI) or mixed urinary incontinence (MUI). It has a high worldwide prevalence with an associated impact on quality of life. Despite existing management options for the management of urinary incontinence, patients continue to be troubled by symptoms or side effects of existing treatment. There is therefore a requirement for ongoing research into treatment options for the management of UUI and SUI, that are more effective and tolerable to patients. Advances in treatment of UUI include a more selective beta 3 agonist, Vibegron, which has less impact on cardiac function than Mirabegron. Hormonal treatment, including Ospemifene and Prasterone, may improve GSM and in turn symptoms of UUI. There are advances in the types of neuromodulators available, including those that are rechargeable at home and are MRI safe. Laser has shown promising initial results. There is developing interest in the microbiome, and how this may impact future treatment modalities. Advances in treatment of SUI include the use of mobile health applications to support delivery of pelvic floor muscle training. Litoxetine, a selective serotonin reuptake inhibitor, has shown promising results at phase III trials. Functional magnetic stimulation is being developed to improve contractility of pelvic floor muscles. We also discuss interventions that improve tissue elasticity and regeneration, such as platelet rich plasma, autologous stem cell transplantation, laser therapy and radiofrequency treatment, which show short term benefits.

Management of subsequent pregnancies following fourth-degree obstetric anal sphincter injuries (OASIS).

OBJECTIVES: The management of subsequent pregnancy in women who sustained OASIS remains an enigma. Nearly all studies include all grades of OASIS including fourth-degree tears. In addition, most protocols require endoanal ultrasound and anal manometric assessment to provide advice regarding mode of delivery. In reality, most women who sustain an OASI do not undergo these investigations. The aims of our study were firstly to evaluate outcomes of fourth-degree OASIS in terms of sphincter defects, anal manometry and anal incontinence symptoms. Secondly, we wished to review recommendations made regarding subsequent mode of delivery after fourth-degree OASIS according to different published protocols. STUDY DESIGN: An observational study of all women who had undergone a primary repair of a fourth-degree tear and seen in the perineal clinic of a tertiary urogynaecology unit between January 2006 and December 2017. Three-dimensional endoanal ultrasound and anal manometry were performed on all women, and symptoms assessed using the validated modified St Mark's Score for anal incontinence. Diagnostic test accuracy analysis was performed for use of symptoms in predicting abnormal investigations. RESULTS: 74 fourth-degree tears were identified (mean follow-up 5.9 months; SD 11.5). Endoanal scan showed an internal anal sphincter defect in 77 % and an external anal sphincter defect in 49 %. Only 18 % had no defect. The mean incremental pressure rise was 12.6 mmHg (SD 15.5). 61 % were asymptomatic with a mean St Mark's Score of 3.8 (SD 5.4). The presence of symptoms alone had poor accuracy in predicting abnormal investigations. Based on Royal College of Obstetricians and Gynaecologists guidance, only 7% would not be offered a caesarean section as they are asymptomatic women with normal scan and manometry findings and would be counselled for a vaginal delivery. CONCLUSIONS: Given that only a few units offer these specialist investigations to their OASI population, it would be reasonable to offer caesarean section to all women who have sustained a fourth-degree tear. However, in centres where endoanal ultrasound and anal manometry are available, individualised counselling can be offered.