Research and innovation in women’s health is shifting towards more patient-centred, personalised, and translational approaches. This change is particularly evident in the field of female pelvic floor dysfunction (PFD). Obstetricians, gynaecologists, urogynaecologists, urologists, basic scientists, and general practitioners with an interest in O&G need to adapt to this paradigm shift. Researchers need to keep up with these emerging trends and newer directions to improve patient care.
Patient-reported outcomes (PROMs) have become an important focus in healthcare research and treatment in recent years. Functional outcomes, such as sexual function and quality of life, are particularly relevant to patients and are often listed as their primary treatment goals. PROMs can provide valuable insights into patients’ experiences and treatment outcomes, which can help to inform clinical decision making and improve patient satisfaction. Various measures are available to assess PROMs in both research and clinical settings, including IMPACT1 and PROMIS2 for pelvic floor complaints and the OAB-Bladder Assessment Tool for overactive bladder symptoms.3 Telemedicine has emerged as a viable solution for many medical situations, including urogynecology and female urology, particularly in light of the COVID-19 pandemic.4
Non-surgical management of PFD
Pelvic floor muscle training (PFMT) has been shown to be an effective treatment for stress urinary incontinence (SUI) and other urinary conditions in women.5 Electrical stimulation can be combined with PFMT to enhance its effectiveness.6 Non-surgical treatments such as yoga,7 transcutaneous electrical nerve stimulation,8 and acupuncture9 have also shown promise in managing lower urinary tract symptoms. Sacral neuromodulation10 is a safe and effective therapy for urinary incontinence but may not be accessible to all due to expertise and funding limitations. Contrary to traditional approach, there is strong evidence that Botulinum toxin (BoNT-A) injections for overactive bladder have been found to be more effective when injected into the trigone area rather than in a ‘trigone-sparing’, particularly for neurogenic detrusor overactivity.11
Stem cell therapy has shown promise for treating bladder dysfunction, but it is not yet available for clinical use.12 Clinical studies of stem cell therapy for pelvic floor disorders have produced mixed results, and more research is needed to compare the efficacy of stem cell therapy to existing treatments. In a systematic review published in 2021,13 A total of 11 prospective clinical studies were included in the final assessment, specifically seven single-arm studies dealing with SC therapy for stress urinary incontinence and four with anal incontinence. No papers concerning the use of SC for prolapse repair were retrieved. Due to the great heterogeneity, data pooling was not possible. A clear beneficial impact of SC treatment for the treatment of pelvic floor disorders could not be demonstrated. A recent study found that single-incision mini-slings were as effective as standard midurethral slings for treating stress urinary incontinence, with similar rates of complications over a 36-month follow-up period (SIMS study).14. Robotic surgery has also gained popularity for pelvic floor reconstruction, and a group of experts concluded that robotics is a suitable indication for pelvic floor reconstructive surgery. A meta-analysis and systematic review of 49 studies found that robotic-assisted surgery may have some advantages over conventional laparoscopic surgery, but high-quality, large-sample randomised trials are needed to compare the two techniques.15,16
Vaginal mesh removal for pain or exposure continues to be problematic. A recent study found that after complete vaginal mesh excision, only 33.3% of women with pain alone reported improved symptoms compared to 73.9% with exposure and 58.3% with exposure plus pain.17 Basic science research is needed to rectify the product development strategies of the past that led to the mesh debacle as discussed below.18-20
Basic science innovation
There is enormous basic science interest in PFD. For instance, one recent interesting insight is that in the bladder microbiome, higher bacterial diversity in the absence of Lactobacillus dominance has been found to be associated with urgency UI and resistance to anticholinergic treatment for this condition.21 Three-dimensional (3D) printing has shown promise in the field of urogynecology, with a pilot study demonstrating that tailor-made pessaries created using transvaginal ultrasound and 3D printing technology may offer better solutions for women with pelvic organ prolapse (POP).22 Additionally, a proof-of-concept study has demonstrated the potential of using fused deposition modelling (FDM) and 3D printing (thermoplastic polyurethane (TPU) meshes that eluted 17-β-oestradiol (E2) were produced by fused deposition modelling (FDM) to investigate a new generation of safer mesh implants for POP treatment with fracture force testing showing these meshes appearing to be more elastic.23 Current clinical meshes trigger unfavourable foreign body responses, which lead to graft failure in the long term, so researchers are investing in a variety of emerging technologies such as electrospinning and 3D printing to design new meshes. Researchers are also exploring cell-based tissue engineering strategies to augment the new class of meshes to improve biocompatibility and immunomodulation.24
Functional neuroimaging has been used to investigate central lower urinary tract (LUT) control and the coordination between pelvic floor muscle contraction (PFMC) and micturition. In a systematic review, core brain areas of LUT motor control were determined, and it was found that the involved brain areas for PFMC and micturition are partially distinct.25 This opens the gates to better understand the pathophysiology of prevalent diseases within functional female urology, such as overactive and underactive bladder (OAB/UAB), bladder pain syndrome (BPS), and dysfunctional voiding. Precision medicine is increasingly being applied in the field of urogynecology. In a study by Orlicky et al,26 a Pelvic Organ Prolapse Histologic Quantification (POP-HQ) system was developed to systematically evaluate the cervical portion of the uterosacral ligament in women with POP. Three distinct histologic phenotypes were identified in the POP group with varying overlap with the control specimens: POP-V, dominated by vascular alterations; POP-A, characterised by the preponderance of adipose infiltration; and POP-I, with the prevailing increase in inflammatory neutrophils. The authors used these to further hypothesise how they developed in the subset leading to POP. The major goal of quantitative phenotyping is to enable rigorous genotypephenotype correlations and the development of reliable biomarkers to predict POP progression and an individual patient’s therapeutic response, neither of which is currently possible.
Artificial intelligence (AI) and decision support systems
Like every other field of life, this has arrived, whether or not health professionals feel prepared to embrace it. These systems use big data, including PROMs, to develop algorithms and diagnostics that can improve healthcare. However, the quality of the output is only as good as the input, and poorly labelled data can lead to inaccurate results. This in engineering language is the GIGO paradigm: ‘Garbage in-Garbage out’! The development of accurate and reliable decision support systems is essential in providing patient-centred solutions tailored to each woman’s characteristics, symptomatology, and expected goals for outcomes.27 Moosavi et al28 utilised 12 risk factors to accurately predict de novo SUI such that the accuracy of this model was more than 90%, compared favourably to other conventional state-of art SUI risk prediction models.
Societal and population-related aspects
Research is ongoing into the relationship between caesarean birth rates and pelvic floor dysfunction rates in the population. Caesarean birth can reduce the risk of PFD in some women.29 However, it can also increase the risk of other complications such as surgical site infections, bleeding, and longer hospital stays. More research is needed to fully understand the impact of increasing caesarean section rates on PFD, considering factors such as maternal age, parity, and the reason for the caesarean section.
Numerous studies have investigated the influence of health disparities among women with pelvic floor disorders, with varied results. Racial/ethnic disparities and inadequate ethnic labelling inconsistently indicate differences in prevalence of disease, disease severity, and treatment outcomes. For instance, future studies should differentiate and subclassify Hispanic and Asian ethnicity30 and incorporate strategies to address barriers for clinical trial enrolment of racial and ethnic minorities. Diversity in research leads to improved understanding, which leads to improved patient care for all.
There is increasing focus on personalised medicine and translational and interdisciplinary approach to cutting-edge research in the field of urogynaecology. Shared decision-making in the current setting implies the practitioners be aware and agile to these so that they can provide their clients with best possible and evidence-based care.
- Zhuo Z, Wang C, Yu H, Li J. The Relationship Between Pelvic Floor Function and Sexual Function in Perimenopausal Women. Sex Med. 2021;9(6):100441.
- Dao A, Dunivan G. Patient-Centered Goals for Treatment of Pelvic Floor Disorders. Curr Bladder Dysfunct Rep. 2022;17(4):210-8.
- Chapple C, Kelleher C, Siddiqui E, al. Validation of the Overactive Bladder-Bladder Assessment Tool (OAB-BAT): A Potential Alternative to the Standard Bladder Diary for Monitoring OAB Outcomes. Eur Urol Focus. 2021;7(5):1176-83.
- D’Almeida Lucas Macharet DV, Mendes LN, Pereira GMV, de Castro Monteiro MV. Implementing telemedicine in urogynecology: A feasibility study. Int Urogynecol J. 2022:1-7.
- Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews. 2018(10).
- Lim H, Kang JA, Park H. The Effect of Electrical Stimulation Therapy With Pelvic Floor Muscle Exercise on Stress Urinary Incontinence in Middle-Aged Women: A NonequivalentComparison Cohort Study. J Wound Ostomy Continence Nurs. 2021;48(4):325-31.
- Wieland LS, Shrestha N, Lassi ZS, et al. Yoga for treating urinary incontinence in women. Cochrane Database Syst Rev. 2019;2(2):Cd012668.
- Sharma N, Rekha K, Srinivasan KJ. Efficacy of Transcutaneous Electrical Nerve Stimulation in the Treatment of Overactive Bladder. J Clin Diagn Res. 2016;10(10):Qc17-qc20.
- Yang N, Ge X, Ye J, et al. Efficacy of acupuncture for urinary incontinence in middle-aged and elderly women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2021;257:138-43.
- Tilborghs S, De Wachter S. Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects. Expert Rev Med Devices. 2022;19(2):161-87.
- Cui Y, Cai T, Dong T, et al. Trigonal-Sparing vs. Trigonal-Involved OnabotulinumtoxinA Injection for the Treatment of Overactive Bladder: A Systematic Review and Meta-Analysis. Frontiers in Neurology. 2021;12.
- Shin JH, Ryu CM, Yu HY, et al. Current and Future Directions of Stem Cell Therapy for Bladder Dysfunction. Stem Cell Rev Rep. 2020;16(1):82-93.
- Manodoro S, Frigerio M, Barba M, et al. Stem Cells in Clinical Trials for Pelvic Floor Disorders: a Systematic Literature Review. Reprod Sci. 2022;29(6):1710-20.
- Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. New England Journal of Medicine. 2022;386(13):1230-43.
- Simoncini T, Panattoni A, Aktas M, et al. Robot-assisted pelvic floor reconstructive surgery: an international Delphi study of expert users. Surgical Endoscopy. 2023:1-11.