-
The British Journal of General Practice... Jun 2024Vulvovaginal Candidiasis (VVC) is a fungal infection causing inflammation of the vagina and/or the vulva. Symptoms include itching, irritation, and discharge. VVC... (Comparative Study)
Comparative Study Review
BACKGROUND
Vulvovaginal Candidiasis (VVC) is a fungal infection causing inflammation of the vagina and/or the vulva. Symptoms include itching, irritation, and discharge. VVC presents commonly across primary care and, despite its mild symptoms, carries psychological burden and has a significant impact on women's quality of life. UK guidelines support treatment via oral or topical azole antifungal agents. Recent evidence attests to the superiority of novel non-azole antifungals. Thus, rigorous financial assessment of both antifungals is necessary for optimal VVC treatment allocation in UK primary care.
AIM
To evaluate the cost-effectiveness of ibrexafungerp against the gold standard fluconazole as first-line treatment of VVC within the NHS.
METHOD
A systematic review on the efficacy of ibrexafungerp and fluconazole in acute VVC was conducted. Cost-effectiveness analysis was initiated using health outcome data from the DOVE trial, a Phase 2 RCT. Costs in pound sterling were ascertained in monetary units, and effectiveness determined as reduced need for follow-up medication.
RESULTS
An incremental cost-effectiveness ratio of £2185.74 was determined. This suggests oral ibrexafungerp being largely more costly yet slightly more effective than fluconazole, and thus has unfavourable net benefit. Two sensitivity analyses were conducted considering follow-up medication combination and market price, which provided confidence in the calculated cost-effectiveness ratio.
CONCLUSION
This analysis highlights fluconazole's cost-effectiveness in current UK guidelines and favourability.
Topics: Humans; Fluconazole; Female; Cost-Benefit Analysis; Candidiasis, Vulvovaginal; Antifungal Agents; Administration, Oral; United Kingdom; Amphotericin B; State Medicine; Primary Health Care; Acute Disease; Treatment Outcome; Cost-Effectiveness Analysis; Glycosides; Triterpenes
PubMed: 38902100
DOI: 10.3399/bjgp24X738189 -
Annals of Surgical Oncology May 2024Extended pelvic surgery with neurovascular or bony resections in gynecological oncology has significant impact on quality of life (QoL) and high morbidity. The objective...
BACKGROUND
Extended pelvic surgery with neurovascular or bony resections in gynecological oncology has significant impact on quality of life (QoL) and high morbidity. The objective of this systematic review was to provide an overview of QoL, morbidity and mortality following these procedures.
METHODS
The registered PROSPERO protocol included database-specific search strategies. Studies from 1966 onwards reporting on QoL after extended pelvic surgery with neurovascular or bony resections for gynecological cancer were considered eligible. All others were excluded. Study selection (Rayyan), data extraction, rating of evidence (GRADE) and risk of bias (ROBINS-I) were performed independently by two reviewers.
RESULTS
Of 349 identified records, 121 patients from 11 studies were included-one prospective study, seven retrospective studies, and three case reports. All studies were of very low quality and with an overall serious risk of bias. Primary tumor location was the cervix (n = 78, 48.9%), vulva (n = 30, 18.4%), uterus (n = 21, 12.9%), endometrium (n = 15, 9.2%), ovary (n = 8, 4.9%), (neo)vagina (n = 3, 1.8%), Gartner duct/paracolpium (n = 1, 0.6%), or synchronous tumors (n = 3, 1.8%), or were not reported (n = 4, 2.5%). Bony resections included the pelvic bone (n = 36), sacrum (n = 2), and transverse process of L5 (n = 1). Margins were negative in 70 patients and positive in 13 patients. Thirty-day mortality was 1.7% (2/121). Three studies used validated QoL questionnaires and seven used non-validated measurements; all reported acceptable QoL postoperatively.
CONCLUSIONS
In this highly selected patient group, mortality and QoL seem to be acceptable, with a high morbidity rate. This comprehensive study will help to inform eligible patients about the outcomes of extended pelvic surgery with neurovascular or bony resections. Future collaborative studies can enable the collection of QoL data in a validated, uniform manner.
Topics: Female; Humans; Quality of Life; Retrospective Studies; Prospective Studies; Pelvic Bones; Sacrum
PubMed: 38459419
DOI: 10.1245/s10434-023-14649-z -
Frontiers in Oncology 2024Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic...
INTRODUCTION
Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic modalities, such as extensive surgical resection, chemotherapy, and radiotherapy. The most important emerging treatment modalities are immune checkpoint inhibitors. This systematic review and meta-analysis aims to assess the efficacy and safety of pembrolizumab, an immune checkpoint inhibitor, in women with advanced vulvar cancer.
MATERIALS AND METHODS
Following a comprehensive search, review, and appraisal, two relevant single-arm studies were included. Meta-analysis was conducted using R4.3.0 software and RStudio 2023.03.0, presenting the overall effect size with a 95% confidence interval. Heterogeneity was assessed using I and the Cochrane Q χ2 statistics.
RESULTS
Out of 154 studies screened for eligibility, two single-arm studies involving 119 patients receiving pembrolizumab for advanced vulvar cancer were included. The pooled objective response rate (ORR) was overall 10% (95% CI: 0.00-0.84) and 9% (95% CI: 0.00-0.89) in the PD-L1 positive subgroup. In the intention-to-treat (ITT) population, 31% (95% CI: 0.04-0.85) exhibited any clinical benefit (complete response, partial response, or stable disease). In the ITT population at six months, progression-free survival (PFS) was 19% (95% CI: 0.01-0.82), and overall survival (OS) was 48% (95% CI: 0.08-0.90). At 12 months, PFS decreased to 9% (95% CI: 0.00-0.85), and OS was 33% (95% CI: 0.04-0.85). No statistically significant heterogeneity was observed in PFS and OS analyses.
DISCUSSION AND CONCLUSION
This study suggests that one-third of women with advanced or recurrent vulvar cancer may, without the influence of PD-L1 status, benefit from pembrolizumab treatment despite a decline in both PFS and OS at 12 months. These findings provide support for considering pembrolizumab in the treatment paradigm for this specific subset of cancer patients.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier CRD42023391888.
PubMed: 38440225
DOI: 10.3389/fonc.2024.1352975 -
Urology Apr 2024To review the literature and report the incidence of vaginal stenosis (VS) after vaginoplasty and compare the incidence rates by surgical technique and follow-up...
OBJECTIVE
To review the literature and report the incidence of vaginal stenosis (VS) after vaginoplasty and compare the incidence rates by surgical technique and follow-up duration.
METHODS
We performed a systematic literature review according to PRISMA guidelines. Original research on primary vaginoplasty was included. Exclusion criteria included non-English studies, mixed cohorts without subgroup analysis, revision vaginoplasty, and papers without stenosis rates. The search was ran in Pubmed, Embase, Scopus, and Cochrane on September 9, 2022. Stenosis rates were compared with descriptive statistics using SPSS.
RESULTS
Fifty-nine studies with a cumulative 7338 subjects were included. The overall incidence of VS was 5.83% (range 0%-34.2%). Combining VS with introital stenosis (IS) and contracture results in a cumulative incidence of 9.68%. The rate of VS in the penile inversion vaginoplasty subgroup (PIV) was 5.70%, compared to 0.20% in primary intestinal vaginoplasty. The rate of IS in the PIV group was 3.13% and 4.7% in the intestinal vaginoplasty subgroup.
CONCLUSION
The overall rate of VS was 5.83%, which is lower than previously documented. This may be related to the inclusion of more recent studies and analysis limited to primary vaginoplasty. The similar rate of IS in PIV and intestinal vaginoplasty subgroups may be secondary to multiple suture lines and the need for dilation through this anastomosis. Our research demonstrates a need for a standardized definition of VS.
Topics: Male; Humans; Female; Constriction, Pathologic; Vagina; Vulva; Penis; Intestines; Sex Reassignment Surgery; Retrospective Studies
PubMed: 38364980
DOI: 10.1016/j.urology.2024.02.005 -
European Journal of Obstetrics,... Dec 2023Botulinum toxin (BoNT) administration has been proposed in the gynecologic field for pelvic, vulvar and vaginal disorders. On this regard, we aimed assessing the... (Review)
Review
INTRODUCTION
Botulinum toxin (BoNT) administration has been proposed in the gynecologic field for pelvic, vulvar and vaginal disorders. On this regard, we aimed assessing the therapeutic effectiveness and safety of BoNT usage in the treatment of vaginal, vulvar and pelvic pain disorders.
METHODS
We searched for all the original articles without date restriction until 31.12.2021. We included all the original articles which administered botulinum toxin in the vulva or vagina of women suffering from vaginismus, dyspareunia, and chronic pelvic pain. Only English language studies and those performed in humans were eligible. We excluded all case reports and pilot study from the qualitative analysis, although we accurately evaluated them. 22 original studies were finally included in the systematic review.
RESULTS
Botulinum toxin injection was found to be effective in improving vulvar and vaginal dyspareunia, vaginismus, and chronic pelvic pain. No irreversible side effects were detected. Major side effects reported were transient urinary or fecal incontinence, constipation and rectal pain. The risk of bias assessment proved original articles to be of medium quality. No metanalysis could have been performed since lack of congruency in the definition of pathology and methods of botulinum toxin administration.
CONCLUSION
Data extraction pointed out different endpoints and different methods of analysis. Studies focus on different types of participants and use various techniques and timing. According to the best evidence available, different techniques provide evidence about positive outcomes, with the need for a standardized protocol.
Topics: Female; Humans; Dyspareunia; Vaginismus; Pilot Projects; Botulinum Toxins; Vulva; Pelvic Pain; Chronic Pain; Pelvic Floor; Vagina; Botulinum Toxins, Type A
PubMed: 38353087
DOI: 10.1016/j.ejogrb.2023.10.028 -
European Journal of Pediatric Surgery :... Feb 2024All types of cloacal malformations may be associated with anatomic variations of the external genitalia, including hypoplasia of the labia minora and enlarged...
Anatomical Variations of the External Genitalia in Posterior Cloaca: Clinical Consequences of Misdiagnosis-A Systematic Review of the Literature and the ARM-Net Consortium Experience.
PURPOSE
All types of cloacal malformations may be associated with anatomic variations of the external genitalia, including hypoplasia of the labia minora and enlarged clitoris; these variations could be even higher in posterior cloacas (PCs). If a careful physical examination is not performed, patients may be misdiagnosed with ambiguous genitalia (AG), leading to subsequent unnecessary testing, surgeries, or even wrong gender assignment. The aim was to analyze data of patients with PC within the ARM-Net registry, focusing on the description of the genitalia, gender assignment, and its consequences. Additionally, we investigated the presence of AG diagnosis in utero or at birth in patients with PC in the literature.
METHODS
The ARM-Net registry was scanned for PC cases and data on diagnosis were collected. A systematic literature search was conducted using the PubMed, EMbase, and Web-of-Science databases. Descriptive statistics was used to report data.
RESULTS
Nine patients with PC were identified in the ARM-Net registry. Five patients (55%) were diagnosed with AG, two (22%) were assigned as males and only two patients were correctly assigned as females and diagnosed with PC with respective variations of external genitalia. All patients diagnosed with AG had extensive blood testing including karyotype and hormonal studies. One of the patients who was diagnosed as a male, had surgery for pelvic cystic mass removal, which ultimately led to unaware salpingo-oophorectomy, hysterectomy, and vaginectomy. In the literature we identified 60 patients, 14 (23%) with AG, 1 with clitorolabial transposition and 1 with undeveloped vulva and vagina; 4 patients had normal anatomy. In 40 (67%) patients the anatomy of genitalia was not mentioned.
CONCLUSION
Patients with PC are at high risk of being diagnosed with AG or even assigned the wrong gender at birth. In our series two patients were assigned as males, and consequently one of them underwent a highly mutilating surgery. A thorough physical examination together with a high index of suspicion and laboratory workup are mandatory to identify these variations, avoiding further investigations, unnecessary surgeries, and parental stress.
PubMed: 38216143
DOI: 10.1055/a-2244-4551 -
Journal of Obstetrics and Gynaecology... Apr 2024There is no consensus on the best option for the management of Bartholin's gland abscesses. This systematic review and meta-analysis aimed to compare the Word catheter... (Meta-Analysis)
Meta-Analysis Comparative Study Review
OBJECTIVE
There is no consensus on the best option for the management of Bartholin's gland abscesses. This systematic review and meta-analysis aimed to compare the Word catheter placement and marsupialization methods in the management of women with a cyst or abscess of the Bartholin's glands.
DATA SOURCES
The PubMed, Scopus, Embase, Web of Science, and Cochrane Library databases, as well as Google Scholar, were searched to retrieve articles published between January 1990 and July 2023, comparing the Word catheter treatment with marsupialization for women with a cyst or abscess of the Bartholin's glands.
STUDY SELECTION
Both observational studies and randomized controlled trials (RCTs) were included in this meta-analysis.
DATA EXTRACTION AND SYNTHESIS
After the review, out of 9 relevant articles, only 4 (2 observational studies and 2 RCTs) were included in this meta-analysis, providing the data of 735 patients (396 in the Word catheter group vs. 339 in the marsupialization group). The data was extracted from the selected articles, using a data extraction form. Comparison of the Word catheter and marsupialization methods suggested that the risk of recurrence was approximately 7.6% in the Word catheter group and 9.4% in the marsupialization group. The findings indicated no significant difference in the recurrence of cysts or abscesses when comparing the Word catheter treatment with marsupialization (odds ratio = 0.99, 95% confidence interval: 0.29-3.43, P = 0.990, I = 77%).
CONCLUSION
This meta-analysis found no significant difference in the rate of recurrence between the Word catheter and marsupialization methods. In general, marsupialization and Word catheter placement in the treatment of Bartholinitis seem to be equally effective.
Topics: Humans; Bartholin's Glands; Female; Abscess; Vulvar Diseases; Cysts
PubMed: 38215822
DOI: 10.1016/j.jogc.2024.102357 -
Journal of Ethnopharmacology Feb 2024The genus Alchemilla L. (lady's mantle) comprises 1000 species, of which more than 300 have been characterized from Europe. Notably, as folk medicines, Alchemilla... (Review)
Review
ETHNOPHARMACOLOGICAL RELEVANCE
The genus Alchemilla L. (lady's mantle) comprises 1000 species, of which more than 300 have been characterized from Europe. Notably, as folk medicines, Alchemilla species have long been prescribed for the treatment of dysmenorrhea, pruritus vulvae, menopausal complaints, and related diseases in women. This review summarizes the traditional uses, highlights promising plant species, and focuses on phytochemical and biological studies to highlight future areas of research.
AIM OF THE REVIEW
This literature review aims to provide a comprehensive overview of Alchemilla species, covering their botany, traditional uses, phytochemistry, and biological and pharmacological activities, and to summarize the current research status to better understand the application value of Alchemilla plants in modern phytotherapy.
MATERIALS AND METHODS
The search strategy utilized the major thematic platforms Reaxys, Web of Science, Google Scholar, Scopus, ScienceDirect, PubMed, the USDA Plant Database and Kew Science (Royal Botanic Gardens) and was performed with the term Alchemilla. These platforms were systematically searched for articles published from 1960 to 2023.
RESULTS AND DISCUSSION
Alchemilla species, as members of the Rosaceae family, produce tannins, phenolic acids, flavonoids, anthocyanins, coumarins, triterpenes and violet compounds. Effort has been made with this comprehensive review of Alchemilla plants to highlight the recent developments and milestones achieved in modern phytochemistry and phytotherapy, underlaying a broad spectrum of the activities of these plants, such as antioxidant, anti-inflammatory, neuroprotective, antimicrobial, antiobesity, cardiovascular, anticancer, and wound healing effects.
CONCLUSIONS
An increasing number of studies on the plants in the Alchemilla genus have provided data about the main constituents and their importance in modern medicine. Both in vitro and in vivo studies have indicated that Alchemilla plants possess an extensive spectrum of biological activities. Regardless of the remarkable medical potential of Alchemilla extracts, clinical studies are limited and need to be performed to produce safer and less expensive plant-based drugs.
Topics: Female; Humans; Ethnopharmacology; Plants, Medicinal; Alchemilla; Rosaceae; Anthocyanins; Phytotherapy; Plant Extracts; Phytochemicals
PubMed: 37981119
DOI: 10.1016/j.jep.2023.117439 -
Tumori Apr 2024Bartholin gland carcinoma is an extremely rare disease. Information regarding treatment is scarce and there is no strict consensus on best practice. All studies... (Review)
Review
Bartholin gland carcinoma is an extremely rare disease. Information regarding treatment is scarce and there is no strict consensus on best practice. All studies reporting cases of Bartholin's gland cancer were screened and evaluated for inclusion. Baseline characteristics of studies were extracted. A total number of 290 manuscripts collected were available for the review process. Studies included in a previous systematic review were not duplicated. In total, details of 367 patients were collected, as follows: histological features, clinical presentation, treatment, recurrent rate, treatment of recurrence and outcome. About 35% of Bartholin gland carcinoma were squamous cell carcinoma. Almost 50% of patients presented with advanced stage. The therapeutic approach was mainly surgery, and in 61% of those women lymph node assessment was performed. Recurrence occurred in 21% of cases. Bartholin gland cancer remains a challenge for gynecologic oncologists. Guidelines, centralization to referral centers and standardized therapy are needed.
Topics: Female; Humans; Bartholin's Glands; Vulvar Neoplasms; Carcinoma, Squamous Cell; Referral and Consultation
PubMed: 37953636
DOI: 10.1177/03008916231208308 -
Reproductive Sciences (Thousand Oaks,... Feb 2024The metastasis of a gynecological malignancy to the Bartholin gland is rare. We report the case of a 62-year-old patient who had undergone extensive treatment of...
The metastasis of a gynecological malignancy to the Bartholin gland is rare. We report the case of a 62-year-old patient who had undergone extensive treatment of metastatic ovarian cancer that involved the liver, spleen, and peritoneum. She presented with painful swelling of the left vulva. Clinical and sonographic examinations showed a solid tumor in loco typico of the Bartholin gland. Surgical excision was performed. The patient died 3 months after the diagnosis of this metastasis. We performed a systematic search of PubMed, which yielded 453 entries. We selected those with at least an abstract available in English that described metastatic lesions on the Bartholin gland (n = 5). The review showed that a variety of primary cancers (colorectal, medullary thyroid, breast cancer, and endometrial cancers) metastasize to this location. Some patients showed signs of visceral metastasis. Bartholin gland metastases appeared as initial and metachronous manifestations. Most patients were symptomatic, with painful swelling or abscess. Genetic alterations were mentioned in some cases. The main pathways of metastasis discussed were lymphatic, but the mechanism of such metastasis remains unclear. Surgical resection was the preferred treatment option. The literature review indicated that Bartholin gland metastasis of ovarian cancer is rare and associated with poor prognosis. Oncological reasons for vulvar pathologies should be taken into consideration in patients with metastases.
Topics: Humans; Female; Middle Aged; Bartholin's Glands; Ovarian Neoplasms; Breast Neoplasms; Gynecology
PubMed: 37794197
DOI: 10.1007/s43032-023-01373-y