How common is ballooning? Hiatal area on 3D transperineal ultrasound in urogynecological patients and its association with lower urinary tract symptoms.

INTRODUCTION: Pelvic floor ultrasound plays a major role in urogynecologic diagnostics. Using 3D ultrasound we can identify integrity of levator ani and measure hiatal area in the axial plane. The main goal of our study was to measure hiatal area on Valsalva in a cohort of urogynecological patients. Furthermore, we aimed to correlate hiatal area with urogynecological symptoms, levator integrity and evaluate cut-off values for pelvic organ prolapse. MATERIALS AND METHODS: In a retrospective analysis, we included 246 patients seen for urogynecological problems in our tertiary urogynecological unit. After a standardized interview and physical examination, a 3D pelvic floor ultrasound was performed. According to the cardinal urogynecological symptoms and signs, patients were categorized into three groups: pelvic organ prolapse, stress urinary incontinence and overactive bladder symptoms. RESULTS: Median age of our study population was 66 (range 29-94) years, median parity was 2.1 (range 0-9) with 17 (6.9 %) nulliparous women. Symptoms of overactive bladder in 71.1 % were most common, followed by 54.5 % symptoms of stress incontinence and 32.1 % symptoms of prolapse. On examination 49.2 % showed signs of prolapse. Levator avulsions on 3D ultrasound were detected in 20.7 %. Hiatal area was normally distributed with a median of 28.7 cm2 (range 10.4-50.0 cm2). Patients with levator avulsion had a significantly larger hiatal area (p < 0.001). Also patients with signs of prolapse had a significantly larger hiatal area (p < 0.001). There was no correlation between hiatal area and symptoms of overactive bladder (p = 0.374). Although not reaching statistical significance there was evidence of a smaller hiatal area for patients with stress incontinence (p = 0.016). In our cohort there were 33.7 % (83) women without ballooning, 27.2 % (67) showed mild, 18.3 % (45) moderate, 12.3 % (30) marked and 8.5 % (21) severe ballooning. The ROC curve analysis for hiatal area on patients with prolapse yielded an AUC of 0.755 [95 % CI (0.696-0.814)]. Using the Youden-Index we obtained 27.53 cm2 as a cut-off with a sensitivity of 0.70 and a specificity of 0.69. DISCUSSION: Hiatal area is a new repeatable diagnostic parameter. Its clinical application could improve our understanding of the pathophysiology of pelvic organ prolapse as a form of hiatal hernia.

Assessment of pelvic floor muscle contractility: digital palpation versus 2D and 3D perineal ultrasound.

PURPOSE: The aim of our study was to investigate 2D and 3D ultrasound assessment of pelvic floor muscle contractility as an objective non-invasive diagnostic tool in urogynecologic patients. METHODS: Patients from our urogynecological outpatient clinic were examined clinically by a single investigator including digital palpation as well as 2D and 3D perineal ultrasound. Muscle contractility was graded according to the modified Oxford Score and ultrasound images were saved for later analysis. Stored images were evaluated offline by another investigator blinded to all clinical data at a later stage. Bladder neck distance from pubic symphysis and symphysis-levator distance were measured in 2D at rest and during maximal pelvic floor muscle contraction. Hiatal area at the level of minimal hiatal dimensions as a 3D ultrasound parameter was measured at rest and during maximal pelvic floor muscle contraction, too. Spearman's rho was used to calculate statistical correlation between ultrasound parameters and digital assessment. RESULTS: A total of 114 patients were examined in our study. We found a significant correlation between modified Oxford Score and 2D ultrasound parameters of elongation of bladder neck length (Spearman's rho 0.292, p = 0.002) and reduction of symphysis-levator distance (Spearman's rho 0.0.301, p = 0.001), respectively. In addition, we detected a statistical significant correlation of modified Oxford Score and reduction of hiatal area in 3D ultrasound (Spearman's rho 0.458, p < 0.001), too. CONCLUSIONS: In this study, we found a significant correlation of subjective digital assessment of pelvic floor muscle strength with 2D and 3D ultrasound parameters as an objective diagnostic tool.

Pelvic floor dysfunction after levator trauma 1-year postpartum: a prospective case-control study.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to evaluate pelvic floor dysfunction and anatomical signs of pelvic organ prolapse (POP) in patients with levator ani muscle (LAM) trauma compared with patients with an intact LAM 1 year postpartum. METHODS: In a prospective case-control study, primiparous women after vaginal delivery, with LAM trauma diagnosed on 3D ultrasound, were included in the case group. Controls consisted of patients who fulfilled the same inclusion criteria but had an intact levator. All women were investigated 1 year postpartum in respect of bladder, bowel, prolapse, and sexual function using the Australian Pelvic Floor Questionnaire. POP was assessed according to the Pelvic Organ Prolapse Quantification (POP-Q) system and pelvic floor muscle strength using the Oxford Grading Scale. RESULTS: Forty patients were included: 20 with and 20 without levator trauma. Urinary symptoms were significantly more frequent in women with LAM trauma compared with controls (p = 0.01). The two groups were comparable in respect of bowel, sexual, and prolapse symptoms (p = 0.24, p = 0.60, p = 0.99 respectively). Unlike POP stages II and III, POP stage I was significantly more common in LAM trauma patients (n = 19, 95 %) than in controls (n = 10, 50 %) (p =0.003). A positive association was noted between POP stage I and LAM trauma (RR = 7.2). The involvement of multiple compartments was significantly more frequent in cases than in controls (p = 0.003). CONCLUSIONS: Except for urinary symptoms, LAM trauma was asymptomatic in nearly all patients 1 year postpartum. However, POP stage I involving multiple compartments occurred more frequently in LAM trauma patients than in controls.

Long-term outcomes of the Ajust Adjustable Single-Incision Sling for the treatment of stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to evaluate the effectiveness and overall safety of the Ajust Adjustable Single-Incision Sling in the treatment of female stress urinary incontinence. METHODS: This was a prospective, multicenter study conducted in women diagnosed with stress urinary incontinence. The Ajust Sling was implanted and patients were followed postoperatively for up to 29 months. Evaluations were performed to assess postoperative rate of continence, complications, and patient quality of life (QOL). RESULTS: From November 2008 through May 2009, 52 patients were enrolled and underwent a procedure to implant the Ajust Sling. Overall, 86.3 % of the patients who successfully received the Ajust Sling demonstrated total restoration or improvement of continence at the last study visit. QOL scores related to global bladder feeling and lifestyle improved. Only one patient reported the occurrence of mild pain which resolved without treatment or sequelae. CONCLUSIONS: In long-term follow-up, the Ajust Sling was safe and effective, restoring or improving continence in 86.3 % of patients.

Sexual function and quality of life following retropubic TVT and single-incision sling in women with stress urinary incontinence: results of a prospective study.

PURPOSE: The objective of this prospective cohort study was to compare effectiveness, morbidity, quality of life (QoL) and sexual function in women treated with tension-free vaginal tape (TVT) versus single-incision sling (SIS) in the treatment of female stress urinary incontinence (SUI). METHODS: Retropubic TVT sling or SIS was implanted in local anesthesia and patients were followed post-operatively for 6 months. Evaluation was performed to assess post-operative rate of continence, complications, changes in sexual function and patient reported quality of life. Female sexual function was evaluated before and after sling procedure using Female Sexual Function Index (FSFI) in sexually active patients. RESULTS: From January 2009 to December 2011, 150 patients were enrolled and underwent a procedure to implant the retropubic TVT (n = 75) or the MiniArc(®) and Ajust(®) SIS (n = 75). Overall, 93.3 % of the patients who successfully received SIS demonstrated total restoration (84 %) or improvement of continence (9.3 %) at the 6 month post-operative study visit. In TVT group we found 88 % total continence and 6.7 % improvement, respectively. Improvements were seen in the QoL scores related to global bladder feeling (89.3 %) in SIS group and 96 % for TVT. Post-operative FSFI score improves significantly and were comparable in both groups (SIS pre-operative 24.30 ± 4.56 to 27.22 ± 4.66 (P < 0.001) post-operative; TVT 24.63 ± 6.62 to 28.47 ± 4.41, respectively). CONCLUSIONS: The SIS procedure appears to be as effective in improving incontinence-related quality of life and sexual function as the TVT through 6 months of post-operative follow-up. No differences in complications and sexual function were demonstrated between the groups.

The effect of genital and lower urinary tract symptoms on steroid receptor expression in women with genital prolapse.

INTRODUCTION AND HYPOTHESIS: This study evaluates the expression of estrogen receptor (ER) isoforms alpha (α) and beta (ß) and progesterone receptor (PR) in vaginal and periurethral tissue in women with genital prolapse in relation to genital and lower urinary tract symptoms (LUTS). METHODS: Forty-seven postmenopausal women without systemic estrogen therapy underwent pelvic organ prolapse quantification and urodynamic assessment. LUTS were evaluated by CATI questionnaire. Biopsies from vaginal and periurethral tissue were obtained during prolapse surgery. The steroid receptor gene expression was measured by RT-PCR. RESULTS: The expression of PR in periurethral and ER ß in vaginal tissue varied with prolapse extent. Nulliparous women showed a significantly higher expression of PR in periurethral tissue. Women with a positive stress test and those with overactive bladder symptoms showed a significantly lower amount of PR in vaginal tissue. CONCLUSION: Changes in PR expression in vaginal or periurethral tissue might be a marker of structural and endocrine changes.

Supraclavicular Metastases from Distant Primary Solid Tumours: A Retrospective Study of 41 Years.

OBJECTIVES: Approximately 1 % of all malignant solid tumours of the head and neck area are metastases from primary tumours beneath the clavicles. The aim of this study was to analyse the distribution of primary tumours since meta-analyses might have been biased due to the usually extraordinary character of case reports. MATERIALS AND METHODS: All patient files from 1970 to 2012 from the Oral and Maxillofacial Surgery unit at a University Hospital were analysed regarding the existence of metastases to the head and neck area from distant primaries. RESULTS: Of the seventy-three patients 18 had breast cancers (25 %), 9 melanomas (12 %), 8 tumours of the kidneys and 8 of the lungs (each 12 %), 3 colon cancers (6 %), 2 prostate cancers (3 %), 2 Ewing sarcomas (3 %), and 1 each of liposarcoma, esophagus, rectum, hepatocellular carcinoma, vulva, ovarian and testicular cancer. In 15 cases, a cancer of unknown primary was diagnosed. In 28 cases the metastasis was the initial sign of the malignant disease. Skeletal metastasis occurred in 37 cases and a soft tissue metastasis in 36 patients. CONCLUSION: The different primaries seem to metastasize in different frequencies to the head and neck area. The relatively common prostate cancer rarely seems to produce metastases in the head and neck area compared to cancers arising in the kidneys. In case of a malignant tumour of unknown primary, osseous metastases most often are caused by breast or lung cancer or renal cell carcinoma. Soft tissue metastases are most often caused by breast cancer.

Adjuvant treatment decisions for patients with endometrial cancer in Germany: results of the nationwide AGO pattern of care studies from the years 2013, 2009 and 2006.

PURPOSE: In 2013, 2009 and 2006, the Arbeitsgemeinschaft Gynäkologische Onkologie evaluated the therapeutic approaches for endometrial carcinoma and the adherence to their guideline in Germany. Here, the adjuvant treatment decisions were presented. METHODS: A questionnaire was developed and sent to all 682 German gynecological departments in 2013 (775 in 2009 and 500 in 2006, respectively). The results of the questionnaires were compared with the recommendations of the guideline and with each other using Fisher's exact test. RESULTS: Responses were available in 40.0 % in 2013, 33.3 % in 2009 and 35.8 % in 2006. Participants recommended external beam radiotherapy (EBRT) in 13 out of 16 requested stages and vaginal brachytherapy (VBT) in only 10 out of 16 requested stages as suggested by the guideline. Comparing the results of 2013 with 2009, less participants used EBRT and VBT in 7 out of 16 and in 6 out of 16 requested stages, respectively. Conversely, more participants offered adjuvant chemotherapy (CT) in 2013 (90.4 %) compared to 61.9 % in 2009 (p < 0.001) and 48.8 % in 2006 (p < 0.001), respectively. However, the stage-adjusted recommendations of CT were not in line with the guideline in 11 out of 15 requested stages. In total, 77.3 % of the participants use a multiple drug schedule with a platinum and a taxane compound. CONCLUSIONS: The results suggest non-adherence to the guideline concerning the stage-adjusted use of VBT and CT in endometrial carcinoma. These findings emphasize great uncertainties and the need of more clarifying trials. Furthermore, a shift from radiotherapy toward CT is observable.

Changes in sexual function and quality of life after single-incision mid-urethral sling for treatment of female stress urinary incontinence.

OBJECTIVES: To evaluate the effectiveness and assess the changes in sexual function and quality of life after placement of a single-incision sling for the treatment of female stress urinary incontinence. STUDY DESIGN: A prospective study of women diagnosed with stress urinary incontinence. The single-incision sling was implanted and patients were followed postoperatively for 6 months. The postoperative rate of continence, complications, changes in sexual function, and patient-reported quality of life were evaluated. Female Sexual Function in sexually active patients was evaluated before and after the single-incision sling procedure using the Female Sexual Function Index. From January 2009 to November 2011, 73 patients were enrolled and underwent the procedure to implant the MiniArc® or Ajust® single-incision sling. RESULTS: Overall, 93.2% of the patients who successfully received a single-incision sling demonstrated total restoration of continence (83.6%) or improved continence (9.6%) at the 6-month postoperative visit. Improvements were seen in the quality of life scores related to global bladder feeling (87.7%) and the Female Sexual Function Index (preoperative score 23.86±5.67 vs postoperative score 27.25±4.66 [P<0.0001]). CONCLUSION: Single-incision sling treatment for stress urinary incontinence led to improvements in continence and sexual function at 6 months of postoperative follow-up.

Complications following the use of alloplastic materials in urogynecological surgery.

STUDY DESIGN: 118 patients, who were admitted from 2005 to 2008 to our department due to complications following mesh implantation, were included in a retrospective survey. We investigated patient symptoms, findings and subsequent patient management. There was a re-evaluation of symptoms in a follow-up eight weeks after the revision procedure. Data from our urogynecological file archive were used. RESULTS: The main complaints were de novo urgency, pain and recurrent urinary tract infections. The main findings were mesh erosion and infections including abscess formations and osteomyelitis. Before being admitted to our department, 42 patients (35.6%) had already undergone at least one intervention. Surgery to overcome complications was performed in our unit after an average time of 27 months. In most cases, mesh removal was necessary. CONCLUSIONS: Surgeons need to be aware of potential mesh complications, which should be managed in referral centres as soon as symptoms arise and should be documented in registers. There is a need for more prospective randomised studies on complications arising from surgery.

Mesh complications following prolapse surgery: management and outcome.

OBJECTIVE: This is a description of complications following prolapse surgery with the use of alloplastic materials, the management and outcome. STUDY DESIGN: 54 women have been referred to Mainz, urogynecology referral center due to complications following mesh-augmented prolapse surgery. RESULTS: The complaints who lead to the admission are expressed by the new terminology and standardized classification for complications arising directly from the insertion of prostheses and grafts in female pelvic floor surgery [1]. Pain (66.7%), mesh erosion (55.6%) and vaginal discharge (48.1%) were the most frequent complaints. Revision was performed after a median time of 27.2 months post mesh implantation. Nine patients underwent limited excision of the mesh, 49 had a vaginal revision with wide mesh removal and 10 had a laparotomy with wide mesh removal. After 3 months 48 patients had a follow-up, 25 could have been relieved from their complaints. CONCLUSION: Although the incidence is low, complications after prolapse repair with mesh use are difficult to prevent, affect quality of life and often require a new surgical intervention, which should be performed by an experienced and competent surgeon.

The effect of hormonal status on the expression of estrogen and progesterone receptor in vaginal wall and periurethral tissue in urogynecological patients.

OBJECTIVE: Our objective was to study the expression of estrogen receptor (ER) isoforms ER alpha (α) and ER beta (ß) and of progesterone receptor (PR) in the vaginal wall and in periurethral tissue of women who underwent urogynecological surgical treatment with reference to estrogen status. STUDY DESIGN: The study included 89 patients undergoing vaginal surgery for urogynecological conditions. Patients' history and clinical data including estrogen status and body mass index (BMI) were evaluated. Biopsies from the vaginal wall and from periurethral tissue were obtained during surgery. The expression of ER α and ß and of PR in vaginal wall and periurethral tissue was measured by RT-PCR. RESULTS: Nine patients were premenopausal. Eighty women were menopausal, of whom 21 were taking estrogen/progestin replacement therapy (HRT), 20 used local estrogen, and 39 had no endocrine treatment. Neither BMI nor age had any influence on the expression of ER and PR. Menopausal women showed a higher amount of PR expression in vaginal tissue than premenopausal women. Women with no endocrine treatment showed a lower amount of ER ß expression in vaginal tissue. CONCLUSION: Steroid receptors are expressed in periurethral and vaginal tissue. The receptor expression varies with hormonal changes only in vaginal tissue. Vaginal tissue seems to be more sensitive to estrogen than periurethral tissue.

Isolation of fibroblasts for coating of meshes for reconstructive surgery: differences between mesh types.

AIMS: An extensive colonization of surgical meshes with autologous fibroblasts may reduce complications. Therefore, we aimed to establish a technique that allows isolation and propagation of fibroblasts from vaginal biopsies. Using these cells we tested the applicability of several clinically applied meshes for fibroblast coating. MATERIALS & METHODS: Fibroblasts were isolated from vaginal tissue after digestion with collagenase. Characterization was performed by immunostaining for cytokeratin 5, 6 and 14, smooth muscle actin and vimentin. A semiquantitative technique was applied to determine the degree of mesh coating 5 h and 5 weeks after seeding of fibroblasts. Seven meshes of different mesh types have been tested. RESULTS: Cells with a fibroblast-like morphology have been isolated from vaginal tissue and could be propagated for at least 12 passages, resulting in a total number of 1.2 x 10(7) cells. Immunostaining showed that cells were positive for the mesenchymal cell marker vimentin and negative for smooth muscle actin, as well as the epithelial cell markers cytokeratin 5, 6 and 14, supporting their classification as fibroblasts. Clear differences in fibroblast colonization between the seven tested mesh types have been observed. Polypropylene mesh Obtape showed an acceptable covering with fibroblasts. The best coating was obtained for xenograft-based meshes, but under cell-culture conditions the mesh showed signs of decomposition. CONCLUSION: We have established a technique that allows isolation and propagation of vaginal fibroblasts. The result of vaginal fibroblast colonization of allograft-based meshes strongly depends on the mesh type, whereby the best coating could be achieved for a polypropylene mesh.