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The Cochrane Database of Systematic... Jun 2019This is an updated version of the original Cochrane Review published in Issue 10, 2013.Extramammary Paget's disease is a rare form of superficial skin cancer. The most...
BACKGROUND
This is an updated version of the original Cochrane Review published in Issue 10, 2013.Extramammary Paget's disease is a rare form of superficial skin cancer. The most common site of involvement is the vulva. It is seen mainly in postmenopausal white women. Paget's disease of the vulva often spreads in an occult fashion, with margins extending beyond the apparent edges of the lesion. There is a range of interventions from surgical to non-invasive techniques or treatments. The challenges of interventions are to remove or treat disease that may not be visible, without overtreatment and with minimisation of morbidity from radical surgery. There is little consensus regarding treatment. Surgery, by default, is the most common treatment, but it is challenging to excise the disease adequately, and recurrence is common, leading to repeated operations, and destruction of anatomy. Alternative treatments of photodynamic therapy, laser therapy, radiotherapy, topical treatments or even chemotherapy have been mooted, and it is important to evaluate the available evidence. It is essential to assess whether newer cell-specific treatments, such as photodynamic therapy and imiquimod, can reduce the need for radical surgery.
OBJECTIVES
To evaluate the benefits and harms of different treatment modalities for the management of Paget's disease of the vulva.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid) and Embase (via Ovid) up to 8 May 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) and well-designed non-randomised studies that compared different interventions in women with Paget's disease of the vulva, DATA COLLECTION AND ANALYSIS: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no trials and, therefore, analysed no data.
MAIN RESULTS
The search for the original version of the review identified 635 unique references. We found 31 references (which reported on 30 studies) in full text after inspection of titles and abstracts, but we excluded them all as they did not meet the inclusion criteria. However, we have included a comprehensive narrative account of studies where we identified an analysis of more than 10 women, as this forms the only evidence base in this rare disease. Surgery continues to be the mainstay of treatment in the current literature, with other treatments limited to case reports or treatment of inoperable or recurrent disease.This update between September 2013 and May 2018 identified 35 new studies. None of these met the inclusion criteria. There was only one prospective study of 5% imiquimod in recurrent Paget's disease of the vulva, which although of good quality only included eight women.
AUTHORS' CONCLUSIONS
Since the last version of the review was published there are many more cases in the literature reporting a clinical response to 5% imiquimod cream. There is one prospective study of eight women treated with 5% imiquimod for recurrent Paget's disease of the vulva, and one prospective trial of 20 women was due to be reported. This increasing evidence for the safety and efficacy of 5% imiquimod will be helpful for women and clinicians alike. Ideally, a multicentre RCT of reasonable size is needed, but ongoing publications of high-quality non-randomised prospective studies will enhance the current available literature.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Female; Humans; Imiquimod; Laser Therapy; Middle Aged; Paget Disease, Extramammary; Photochemotherapy; Randomized Controlled Trials as Topic; Vulvar Neoplasms
PubMed: 31167037
DOI: 10.1002/14651858.CD009245.pub3 -
PloS One 2015To systematically review previous studies and to evaluate the feasibility and safety of video endoscopic inguinal lymphadenectomy (VEIL) in vulvar cancer. (Review)
Review
OBJECTIVE
To systematically review previous studies and to evaluate the feasibility and safety of video endoscopic inguinal lymphadenectomy (VEIL) in vulvar cancer.
METHODS
We conducted a comprehensive review of studies published through September 2014 to retrieve all relevant articles. The PubMed, EMBASE, Web of Science, Cochrane Library, Wan Fang Data and Chinese National Knowledge Infrastructure databases were systematically searched for all relevant studies published in English or Chinese through September 2014. Data were abstracted independently by two reviewers, and any differences were resolved by consensus.
RESULTS
A total of 9 studies containing 249 VEIL procedures involving 138 patients were reviewed. Of the 249 VEIL procedures, only 1 (0.4%) was converted to an open procedure for suturing because of injury to the femoral vein. The range of operative time was 62 to 110 minutes, and the range of estimated blood loss was 5.5 to 22 ml. The range of the number of harvested lymph nodes was 7.3 to 16. The length of hospital stay varied from 7 to 13.6 days across reports. The incidence of lymph node metastasis was 19.7% (27/138), and the recurrence rate was 4.3% (3/70) within 3 to 41 months of follow-up. One or more short-term complications were documented in 18 of 138 (13.0%) patients. Complications after VEIL were observed in 14 (10.13%) patients and in 15 (6.0%) of the VEIL cases, including major lymphocyst formation in 9 (3.6%), lymphorrhea in 2 (0.8%), inguinal wound infection without wound breakdown in 3 (1.2%) and lymphedema in 1 (0.4%).
CONCLUSIONS
VEIL appears to be a feasible procedure in the management of vulvar cancer. There may be potential benefits that result in lower morbidity compared to traditional methods, but this has yet to be objectively proven.
Topics: Bacterial Infections; Blood Loss, Surgical; Female; Humans; Length of Stay; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Lymphocele; Operative Time; Postoperative Complications; Treatment Outcome; Video-Assisted Surgery; Vulva; Vulvar Neoplasms
PubMed: 26496391
DOI: 10.1371/journal.pone.0140873 -
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 -
International Journal of Molecular... Nov 2022Lichen sclerosus (LS) is defined as a chronic mucocutaneous inflammatory disease with a localization predominantly to the anus and genitals (vulvar sclerosus (VLS)).... (Review)
Review
Lichen sclerosus (LS) is defined as a chronic mucocutaneous inflammatory disease with a localization predominantly to the anus and genitals (vulvar sclerosus (VLS)). Pediatric lichen sclerosus (LS) is a chronic inflammatory skin condition with predilection for the anogenital area that if untreated can lead to scarring. Vulvar LS is characterized by two peaks in incidence: it occurs in prepubertal girls and in postmenopausal women. To date, several mechanisms and risk factors have been proposed in the pathogenesis of pediatric vulvar LS; however, the etiology of this condition is still not fully understood and constitutes a challenge for scientists and clinicians. The presented research aimed to systematically review the existing literature on the pathogenesis of pediatric LS and to identify possible underlying autoimmune mechanisms and molecular networks. The clinical presentation of pediatric lichen sclerosus and available treatment modalities are also presented to acquaint a broader audience with this underdiagnosed and undertreated condition. As a result of our review, we discuss several potential mechanisms, molecules, and pathways that have been recognized in this disease. The purpose of our review was also to summarize what we can induce in further studies, which will ultimately help to identify the mechanism responsible for the disease and aid in the development of new, more effective treatment strategies for diagnosis and treatment by clinicians and researchers.
Topics: Humans; Female; Child; Lichen Sclerosus et Atrophicus; Vulva; Immune System Diseases; Genitalia; Treatment Outcome
PubMed: 36430687
DOI: 10.3390/ijms232214212 -
Gynecological Endocrinology : the... Aug 2021It is estimated that 50% of women will suffer a severe form of vulvovaginal atrophy (VVA) related to menopause. Equally, young women may temporarily present this...
INTRODUCTION
It is estimated that 50% of women will suffer a severe form of vulvovaginal atrophy (VVA) related to menopause. Equally, young women may temporarily present this clinical problem while receiving various pharmacological or endocrine treatments or radiotherapy.
AIM
To determine clinical and diagnostic exams required to confirm the presence of VVA (also referred to as atrophic vaginitis, urogenital atrophy, or genitourinary syndrome of menopause) and rule out other genital or pelvic clinical conditions.
MATERIALS AND METHODS
Literature review searches were carried out on the main scientific article search engines (PubMed, SciELO, Cochrane) using different clinical terms, treatments or interventions and comorbidity related to VVA.
RESULTS
The development and severity of VVA depend mainly on the duration of hypoestrogenism. Hypoestrogenism causes changes in the urogenital tissue, generating signs and symptoms, such as dryness, burning, soreness, itching, and irritation of the genital skin. The diagnosis can be made through anamnesis (patient history), questionnaires, physical exam, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be completed with the Vaginal Health Index, the Vaginal Maturation Index, or vaginal pH in the absence of infection or semen. The exclusion of other vulvovaginal organic pathology is essential to reach an accurate diagnosis and provide adequate treatment.
CONCLUSIONS
The specialist should be able to identify VVA, rule out other pathologies that make a differential diagnosis and conduct proper management.
Topics: Atrophic Vaginitis; Atrophy; Diagnosis, Differential; Dyspareunia; Estrogens; Female; Female Urogenital Diseases; Humans; Postmenopause; Surveys and Questionnaires; Syndrome; Urogenital Diseases; Vagina; Vaginal Diseases; Vulva; Vulvar Diseases
PubMed: 34036849
DOI: 10.1080/09513590.2021.1931100 -
Gynecologic and Obstetric Investigation 2017Extramammary Paget's disease of the vulva (EPDV) is a rare adenocarcinoma in situ of the vulvar skin and is often resected with involved margins due to its reticular... (Review)
Review
BACKGROUND
Extramammary Paget's disease of the vulva (EPDV) is a rare adenocarcinoma in situ of the vulvar skin and is often resected with involved margins due to its reticular growth pattern. Adjuvant treatment with the immunomodulator imiquimod may be suitable to avoid repeated and mutilating surgery.
CASE PRESENTATION
We present the case of a 73-year-old woman with EPDV, initially treated with surgical resection and re-resection for involved margins. Final histology revealed Paget's disease of the left vulva with 8 cm in the largest diameter and again involved margins. Subsequently, topical therapy with imiquimod 5% cream twice weekly was applied for 3 months. Vulvoscopy and local biopsies confirmed complete remission (CR). Based on a literature search using PubMed and the Cochrane Central Register of Controlled Trials, 21 reports on the therapeutic efficacy of imiquimod in 70 women with EPDV have been published. Pooled rates of CR and partial remission were 71% (50/70) and 16% (11/70), respectively. There were 4 cases of disease progression under imiquimod and the therapy was generally well tolerated with mild to moderate local reactions in >50% of cases.
CONCLUSION
EPDV is a rare genital neoplasia and may be successfully treated with the topical immunomodulator imiquimod. Specifically, adjuvant imiquimod is a feasible and efficacious treatment option for women with involved resection margins after surgery.
Topics: Adjuvants, Immunologic; Administration, Topical; Aminoquinolines; Antineoplastic Agents; Female; Humans; Imiquimod; Paget Disease, Extramammary; Skin Cream; Vulvar Neoplasms
PubMed: 27655036
DOI: 10.1159/000449158 -
Expert Review of Vaccines Feb 2022Vaccine effectiveness and impact studies are typically observational, generating evidence after vaccine launch in a real-world setting. For human papillomavirus (HPV)...
INTRODUCTION
Vaccine effectiveness and impact studies are typically observational, generating evidence after vaccine launch in a real-world setting. For human papillomavirus (HPV) vaccination studies, the variety of data sources and methods used is pronounced. Careful selection of study design, data capture and analytical methods can mitigate potential bias in such studies.
AREAS COVERED
We systematically reviewed the different study designs, methods, and data sources in published evidence (1/2007-3/2020), which assessed the quadrivalent HPV vaccine effectiveness and impact on cervical/cervicovaginal, anal, and oral HPV infections, anogenital warts, lesions in anus, cervix, oropharynx, penis, vagina or vulva, and recurrent respiratory papillomatosis.
EXPERT OPINION
The rapid growth in access to real-world data allows global monitoring of effects of different public health interventions, including HPV vaccination programs. But the use of data which are not collected or organized to support research also underscore a need to develop robust methodology that provides insight of vaccine effects and consequences of different health policy decisions. To achieve the WHO elimination goal, we foresee a growing need to evaluate HPV vaccination programs globally. A critical appraisal summary of methodology used will provide timely guidance to researchers who want to initiate research activities in various settings.
Topics: Condylomata Acuminata; Female; Humans; Information Storage and Retrieval; Male; Papillomavirus Infections; Papillomavirus Vaccines; Uterine Cervical Neoplasms; Vaccination
PubMed: 34845951
DOI: 10.1080/14760584.2022.2008243 -
International Journal of Gynecological... May 2018Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures...
OBJECTIVES
Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs.
METHODS/MATERIALS
A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients.
RESULTS
The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level.
CONCLUSIONS
Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials.
Topics: Female; Humans; Patient Reported Outcome Measures; Quality of Life; Vulvar Neoplasms
PubMed: 29420364
DOI: 10.1097/IGC.0000000000001211 -
International Journal of Gynaecology... Feb 2017Counselling is a routine practice done before deinfibulation in women with type III female genital mutilation (FGM). However, cultural and social pressures, in addition... (Review)
Review
BACKGROUND
Counselling is a routine practice done before deinfibulation in women with type III female genital mutilation (FGM). However, cultural and social pressures, in addition to maladaptation to the changes in the body post deinfibulation, cause some women to choose to be reinfibulated after being deinfibulated.
OBJECTIVE
To conduct a systematic review of the impact of counselling prior to deinfibulation on patient satisfaction, marital satisfaction, and rate of requests for reinfibulation among women living with type III FGM. The secondary aim was to assess the impact of male partner involvement in counselling on patient satisfaction, marital satisfaction, and rate of requests for reinfibulation.
SEARCH STRATEGY
Major databases including Cochrane Central Register of Controlled Trials, Medline, SCOPUS, and ClinicalTrials.gov were searched until August 2015.
SELECTION CRITERIA
Studies comparing women with type III FGM who received counselling before deinfibulation versus no counselling were included.
DATA COLLECTION AND ANALYSIS
Two team members independently screened and collected data.
RESULTS
No eligible studies were identified.
CONCLUSION
There is no evidence to conclude that counselling before deinfibulation influences patients' satisfaction with overall quality of care or rates of request for reinfibulation.
PROSPERO REGISTRATION
CRD42015024675.
Topics: Cicatrix; Circumcision, Female; Counseling; Female; Humans; Patient Satisfaction; Quality of Health Care; Reoperation; Vulva
PubMed: 28164284
DOI: 10.1002/ijgo.12044 -
Climacteric : the Journal of the... Aug 2017To evaluate the efficacy and safety of estriol for the treatment of vulvovaginal atrophy in postmenopausal women. (Review)
Review
OBJECTIVES
To evaluate the efficacy and safety of estriol for the treatment of vulvovaginal atrophy in postmenopausal women.
METHODS
A systematic literature review was performed. We searched the following electronic databases: Medline, Cochrane, Embase, Lilacs, CINHAL and Google Scholar. The studies selected included controlled clinical trials and quasi-experimental studies. Selections were made in pairs and independently, first by title and abstract and then complete texts.
RESULTS
We identified 188 studies, 22 of which met the inclusion criteria; 13 were controlled clinical trials and nine were quasi-experimental, and 1217 women were included. These studies confirmed the efficacy of local estrogens to treat symptoms of vulvovaginal atrophy with few adverse effects reported. Following treatment, serum estriol levels rose, peaking at 1 h. At the 6-month follow-up, there was no increase in serum estriol in treated women.
CONCLUSIONS
The available evidence (of low and moderate quality) shows that, when administered vaginally, estriol preparations appear to be safe for women who have risk factors related to systemic estrogen therapy.
Topics: Administration, Intravaginal; Adult; Aged; Aged, 80 and over; Atrophy; Endometrium; Estriol; Female; Female Urogenital Diseases; Humans; Hydrogen-Ion Concentration; MEDLINE; Middle Aged; Postmenopause; Vagina; Vulva
PubMed: 28622049
DOI: 10.1080/13697137.2017.1329291