Objectives: This prospective comparative cohort study aims to evaluate the safety and efficacy of transvaginal mesh compared to native tissue repair (NTR) in the surgical correction of anterior and apical compartment pelvic organ prolapse (POP) over a 36-month follow-up period.
Methods: Prospective comparative cohort study to prove superiority for efficacy and non-inferiority for serious adverse events (SAEs). The setting was 49 sites across the United States, Canada, Europe, and Australia.
Objective: To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.
Design: Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.
Setting: 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.
J Minim Invasive Gynecol
February 2024
Study Objective: To investigate the feasibility and safety of the retropubic mid-urethral sling (MUS) procedure with a resorbable mesh implant made of poly-4-hydroxybutyrate (P4HB).
Design: A prospective clinical cohort study with 24 months follow-up.
Setting: A tertiary academic hospital.
In pelvic organ prolapse (POP) patients, the uterus, bladder and/or rectum descends into vagina due to weakened support tissues. High recurrence rates after POP surgery suggest an urgent need for improved surgical outcomes. Our aim is to promote connective tissue healing that results in stimulated tissue support functions by surgically applying a hydrogel functionalized with biological cues.
View Article and Find Full Text PDFObjectives: The objective of the study was to better understand the extent of the ischemic trauma and the effects of surgical repair on the vaginal microcirculation in patients with obstetric vesicovaginal fistula (VVF).
Design: In this observational study, we evaluated the vaginal microvasculature surrounding VVF using handheld vital microscopy (HVM) before, during, and 2 weeks after surgical VVF repair.
Participants: Seventeen women undergoing VVF repair were included in this study.
There is an urgent need for improved outcomes in the treatment of pelvic organ prolapse (POP). Success of primary surgery relies on the load bearing capacity of plicated connective tissue underneath the vaginal wall, which is compromised due to an altered vaginal fibroblast function and collagen composition. There is an important factor in connective tissue repair that relates to changes in stiffness of the vaginal fibroblast microenvironment, which influences cell activity through cellular mechanosensing.
View Article and Find Full Text PDFObjective: To evaluate the effect of iatrogenic menopause on the physiology of the vagina of the ewe and to evaluate if vaginal changes in ewes can be translated to women with genitourinary syndrome of menopause (GSM).
Methods: Preclinical research with Dohne Merino ewes. Iatrogenic menopause was induced by bilateral ovariectomy (OVX).
Vaginal inflammation increases the risk for sexual HIV-1 transmission but underlying mechanisms remain unclear. In this study we assessed the impact of immune activation on HIV-1 susceptibility of primary human vaginal Langerhans cells (LCs). Vaginal LCs isolated from human vaginal tissue expressed a broad range of TLRs and became activated after exposure to both viral and bacterial TLR ligands.
View Article and Find Full Text PDFThe clinical assessment of pelvic organ prolapse (POP) and associated treatment strategies is currently limited to anatomical and subjective outcome measures, which have limited reproducibility and do not include functional properties of vaginal tissue. The objective of our study was to evaluate the feasibility of using cutometry and indentometry for non-invasive biomechanical assessment of the vaginal wall in women with POP. Both techniques were applied on the vaginal wall of 20 women indicated for surgical correction of POP stage two or higher.
View Article and Find Full Text PDFJ Mech Behav Biomed Mater
March 2023
Introduction: Amniotic membranes (AM) have shown its great potential in reconstructive surgery due to their regenerative capacity. However, AM is regarded to be relatively weak when applied for load-bearing purposes. This study aims to produce an AM-based scaffold that can withstand the mechanical loads applied in vesicovaginal fistula repair.
View Article and Find Full Text PDFObjective: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up.
Design: Prospective, two-arm cohort study with 2-year follow-up.
Setting: International multicentre.
Introduction And Hypothesis: Predictors of surgical outcomes in patients with an obstetric fistula who have been operated before should be identified in order to guide surgical strategy and optimize counseling of the patient.
Methods: This retrospective study is aimed at identifying predictors of outcomes for repeat surgery in 346 patients who had been operated on before for an obstetrics fistula at the Fistula Care Center (FCC) in Lilongwe, Malawi. Repeat cases were only undertaken by advanced and expert surgeons.
Importance: Pelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase.
Objective: To investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.
Study Objective: This study aimed to investigate the potential role of transvaginal mesh bacterial colonization in the development of mesh-related complications (MRCs).
Design: An observational and exploratory study.
Setting: Tertiary referral center (Amsterdam UMC, location AMC, Amsterdam, The Netherlands).
Amniotic membrane (AM) has great potential as a scaffold for tissue regeneration in reconstructive surgery. To date, no systematic review of the literature has been performed for the applications of AM in wound closure of internal organs. Therefore, in this systematic review and meta-analysis, we summarize the literature on the safety and efficacy of AM for the closure of internal organs.
View Article and Find Full Text PDFIntroduction And Hypothesis: A representative, large animal model of vesicovaginal fistulas is needed for the training of surgeons and for the development of new surgical techniques and materials for obstetric fistula repair.
Methods: The safety, feasibility, and reproducibility of vesicovaginal fistula creation were studied in 4 adult female sheep. A 1-cm fistula was created between the vagina and the bladder through a transvaginal approach.
Pelvic organ prolapse (POP) is the descent of the bladder, uterus, and/or rectum into the vagina. POP is associated with altered vaginal fibroblast functionality and connective tissue composition in the vaginal wall. The results of surgical intervention are poor, which may be related to the lack of true restoration of the connective tissue.
View Article and Find Full Text PDFBackground: Peri-urethral bulking injections (PBI) gain popularity for the treatment of stress urinary incontinence (SUI), but - in contrast to mid-urethral sling (MUS) surgery - little is known about its impact on sexual function.
Methods: This was a secondary analysis of a prospective cohort study that included patients with moderate to severe SUI undergoing either MUS surgery or PBI with polydimethylsiloxane Urolastic (PDMS-U). The validated Dutch and English version of the 'Pelvic Organ Prolapse and/or Urinary Incontinence Sexual Function Questionnaire - IUGA Revised' (PISQ-IR) was used to assess sexual function at baseline, at 6 and 12 months of follow-up.
Polypropylene (PP) implants for the vaginal surgical correction of pelvic organ prolapse (POP) are known for adverse events, like vaginal or visceral exposures. It is hypothesized that this is a result of a prolonged inflammatory response. One of the triggering factors of prolonged inflammation might be bacterial contamination.
View Article and Find Full Text PDFObjective: To analyse the efficacy of sacrospinous ligament (SSL) suture removal on the reduction of pain symptoms in the case of suspected pudendal nerve entrapment after sacrospinous ligament fixation (SSLF).
Design: Retrospective cohort study.
Setting: Tertiary referral centre, the Netherlands.
Objectives: Vinyl dimethyl polydimethylsiloxane (VDPDMS) is a urethral bulking agent used for female stress urinary incontinence (SUI), that is clearly visible on computed tomography (CT). Clinical effects are promising, but it remains difficult to identify factors predicting clinical success. Clinical outcome might depend on the shape and position of the implants after injection.
View Article and Find Full Text PDFBMC Womens Health
December 2021
Background: Female pelvic organ prolapse (POP) has a negative effect on female sexual functioning and with an increasing life expectancy female sexual dysfunction caused by POP will be an arising global issue.
Aim: Improvement in female sexual functioning, measured with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR), 24-months after pessary or surgery, for both sexually active (SA) and sexually inactive women (NSA) presenting with POP.
Methods: A multicenter prospective comparative cohort study was conducted in 22 Dutch hospitals.