Role of lateral suspension for the treatment of pelvic organ prolapse: a Delphi survey of expert panel.

INTRODUCTION AND HYPOTHESIS: Lateral suspension is an abdominal prosthetic surgical procedure used to correct apical prolapse. The procedure involves the placement of a T-shaped mesh on the anterior vaginal wall and on the isthmus or uterine cervix that is suspended laterally and posteriorly to the abdominal wall. Since its description in the late 90s, modifications of the technique have been described. So far, no consensus on the correct indications, safety, advantages, and disadvantages of this emerging procedure has been reached. METHODS: A modified Delphi process was used to build consensus within a group of 21 international surgeons who are experts in the performance of laparoscopic lateral suspension (LLS). The process was held with a first online round, where the experts expressed their level of agreement on 64 statements on indications, technical features, and other aspects of LLS. A subsequent re-discussion of statements where a threshold of agreement was not reached was held in presence. RESULTS: The Delphi process allowed the identification of several aspects of LLS that represented areas of agreement by the experts. The experts agreed that LLS is a safe and effective technique to correct apical and anterior prolapse. The experts highlighted several key technical aspects of the procedure, including clinical indications and surgical steps. CONCLUSIONS: This Delphi consensus provides valuable guidance and criteria for the use of LLS in the treatment of pelvic organ prolapse, based on expert opinion by large volume surgeons' experts in the performance of this innovative procedure.

Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

AIMS: To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. METHODS: A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). RESULTS: Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. CONCLUSIONS: At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare.

Outcome of sonography-based minimally invasive surgery for deep infiltrating endometriosis of the ureter and urinary bladder - a retrospective cohort study.

INTRODUCTION: The aim of this study was to evaluate the accuracy of transvaginal sonography for preoperative detection of bladder endometriosis and surgical outcomes regarding fertility and pain symptoms of women with urinary tract endometriosis. MATERIAL AND METHODS: Retrospective cohort study of consecutive patients with urinary tract endometriosis undergoing laparoscopic partial cystectomy and/or ureterolysis/decompression, ureteric resection and end-to-end anastomosis or ureteroneocystostomy for ureteral stenosis and hydronephrosis. RESULTS: Of 207 patients with deep infiltrating endometriosis, 50 exhibited urinary tract endometriosis, comprising 30 patients with bladder endometriosis and 23 women with solitary or additional hydronephrosis. Sensitivity, specificity, positive and negative predictive value, positive/negative likelihood ratios and test accuracy for transvaginal sonography detecting bladder endometriosis were 93%, 99%, 97%, 99%, 155.5, 0.07 and 98.6% respectively. All women with bladder endometriosis underwent partial cystectomy. In cases of hydronephrosis, 14 conservative ureterolysis/decompressions, six ureteral resection anastomoses and three ureteroneocystostomies were performed. Duration of surgery was 205 min (range 89-365 min), average blood loss was 1.6 g/dL (range 0.3-4.6 g/dL) and hospital stay on average 8 days (range 2-16 days). The conversion rate was 4%. We observed five grade III complications. After a median follow up of 23 months, there was a decrease in dysmenorrhea (7.6-1.6; p < 0.001), dyspareunia (3.0-0.9, p < 0.001) and dysuria (3.3-0.2; p < 0.003), and an increase in quality of life (3.3-8.1; p < 0.001). The overall clinical pregnancy rate was 46% and life birth rate 18%. CONCLUSIONS: Laparoscopic surgery for urinary tract endometriosis is effective for treatment of hydronephrosis, reduction of pain symptoms and may improve fertility. Transvaginal sonography is highly accurate for presurgical detection of bladder involvement.

Ten-Year Followup after Tension-Free Vaginal Tape-Obturator Procedure for Stress Urinary Incontinence.

PURPOSE: Suburethral tapes are a standard surgical treatment for stress urinary incontinence. The aim of the study was to evaluate subjective and objective cure rates 10 years after a tension-free vaginal tape-obturator procedure. MATERIALS AND METHODS: All 124 patients who underwent the tension-free vaginal tape-obturator procedure at a total of 2 centers in 2004 and 2005 were invited for followup. Objective cure was defined as a negative cough stress test at 300 ml. Subjects completed KHQ (King's Health Questionnaire), IOQ (Incontinence Outcome Questionnaire), FSFI (Female Sexual Function Index Questionnaire) and PGI-I (Patient Global Impression of Improvement). RESULTS: Overall, 55 of 112 women (49%) who were alive were available for clinical examination and 71 (63%) completed the questionnaires. The objective cure rate in the 55 women examined clinically was 69%, 22% were not cured and 9% (5) had undergone reoperation for recurrent or persistent stress urinary incontinence. Treatment was counted as having failed in these 5 women for study purposes. Subjective cure was reported by 45 of 71 women (64%). Three patients (5%) had vaginal tape extrusion at the time of clinical examination. Extrusion in all of them was small and asymptomatic, and did not require treatment for a cumulative extrusion rate of 7%. Six women (9%) had undergone reoperation for tension-free vaginal tape-obturator associated complications and 18 (26%) experienced de novo overactive bladder. CONCLUSIONS: Subjective and objective cure rates 10 years after the tension-free vaginal tape-obturator procedure were 69% and 64%, respectively. The vaginal extrusion rate in this study was slightly higher than in other series but major long-term complications appeared to be rare.

Learning curve for the detection of pouch of Douglas obliteration and deep infiltrating endometriosis of the rectum.

STUDY QUESTION: How long does it take to be proficient in diagnosing pouch of Douglas (POD) obliteration and deep infiltrating endometriosis (DIE) of the rectum with transvaginal sonography (TVS)? SUMMARY ANSWER: Sonographers familiar with the general use of TVS are expected to be proficient in the diagnosis of endometriosis nodules of the rectum and the detection of POD obliteration using the 'sliding sign' after ∼40 examinations, performed in a referral clinic for pelvic pain. WHAT IS ALREADY KNOWN: With rectal DIE, the reasons for the obvious diagnostic problems are complex. Menstrual pain or cramps are still considered to be 'normal' and do not provide a reason for patients and even health-care providers to seek expert help. Furthermore, the performance of TVS for diagnosing pelvic endometriosis has been shown to be accurate only in experienced hands. STUDY DESIGN, SIZE AND DURATION: This prospective study included 121 selected patients with suspected endometriosis. PARTICIPANTS/MATERIALS, SETTING, METHODS: Symptomatic patients, referred to a pelvic pain clinic, were examined by an expert sonographer (E.S.) and consecutively by two trainees (T1/2). MAIN RESULTS AND THE ROLE OF CHANCE: The learning curve using the cumulative sum shows that the trainees, listed as T1/T2, reached the predefined level of proficiency in detecting bowel nodules after examining 42 and 37 patients, for T1 and T2, respectively. The prevalence rate of bowel nodules demonstrated by the ES was 21%. The sensitivity, specificity, positive and negative predictive values (PPV, NPV) as well as the accuracy for TVS of T1 and T2 in comparison with the results of ES were 72 and 89, 96 and 95, 87 and 80, 90 and 98, and 89 and 94%, respectively. The prevalence rate of POD obliteration, as demonstrated by a negative sliding sign, was 27%. The trainees reached the predefined level of proficiency after examining 42 and 33 patients, for T1 and T2, respectively. The sensitivity, specificity, PPV, NPV as well as the accuracy of TVS for T1 and T2 in comparison with the results of the ES were 83 and 89, 95 and 95, 91 and 80, 90 and 98, and 91 and 94%, respectively. LIMITATIONS, REASONS FOR CAUTION: We performed this analysis in a tertiary referral centre with a high number of advanced cases of DIE, not reflecting a standard population. WIDER IMPLICATION OF THE FINDINGS: Integrated in TVS training courses, typical sonographic video clips for DIE of the rectum, including the use of disease-specific signs, could help to improve diagnostic accuracy in DIE and shorten diagnostic delays. STUDY FUNDING/COMPETING INTERESTS: No funding was received for this study. None of the authors has any competing interests.

Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial.

BACKGROUND: We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women. STUDY DESIGN: The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O. RESULTS: A total of 480 patients (85%) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87% of patients after TVT and in 84% after TVT-O; 64% and 59% of patients, respectively, reported no pad use, and 88% of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings' Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications. CONCLUSIONS: Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).

Correction: Sonographic sling position and cure rate 10-years after TVT- O procedure.

[This corrects the article DOI: 10.1371/journal.pone.0209668.].

Transobturator tapes for stress urinary incontinence: Results of the Austrian registry.

OBJECTIVE: We established a voluntary registry to collect data on the perioperative course of transobturator tape operations for stress incontinence. STUDY DESIGN: Forty-seven centers completed a 1-page, 15-item questionnaire per procedure. RESULTS: Data on a total of 2543 operations with 11 different tape systems were collected. Intraoperative complications were noted for 120 procedures (4.7%). These included 85 cases of increased bleeding (3.3%), 10 vaginal perforations (0.4%), 10 bladder perforations (0.4%), and 2 urethral perforations. Reoperations attributable to the tape procedure were reported for 57 patients (24 tapes cut or loosened for voiding dysfunction, 11 vaginal erosions, 7 abscesses with erosions). One patient was reoperated at 14 days for a retropubic hematoma. There were no reports of bowel or major vessel injuries or mortality. Significant postoperative pain was reported for 12 patients (0.5%), although this was not specifically asked for in the questionnaire. CONCLUSION: Significant complications with transobturator tapes are uncommon. Bladder perforations occurred more frequently with outside-in than with inside-out techniques. Vaginal erosions, abscesses, and pain may be more common with transobturator than with retropubic tapes, and this may be due to the structure of the tapes rather than to the route of passage.

When sex is not on fire: a prospective multicentre study evaluating the short-term effects of radical resection of endometriosis on quality of sex life and dyspareunia.

OBJECTIVE: The aim of the current study was to evaluate the effect of surgical removal of endometriosis on dyspareunia, sexual function, quality of sex life and interpersonal relationships. STUDY DESIGN: A questionnaire-based multicentre prospective study was conducted in six tertiary referral centres in Austria and Germany. Ninety-six patients with histologically proven endometriosis and dyspareunia were included. Before surgery and averagely 10 months postoperatively (range 9-12 months), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to screen women's sexuality. Additionally, we evaluated psychological parameters and pain intensity during/after sexual intercourse via a self-administered questionnaire. RESULTS: Pain scores measured via NAS during/after intercourse decreased significantly after surgery. Frequencies of interrupted sexual intercourse, feelings of guilt towards the partner, being afraid of pain before/during sexual intercourse and feelings of being a burden for the relationship also decreased significantly in patients with peritoneal endometriosis and deep infiltrating endometriosis. Interestingly, sexually related personal distress did not improve in women with peritoneal endometriosis/vaginal resection, but improved in cases of deep infiltrating endometriosis (DIE). CONCLUSION: Radical laparoscopic excision of endometriosis offers an effective treatment option and offers a significant improvement in dyspareunia and quality of sex life.

Bleeding complications with the tension-free vaginal tape operation.

OBJECTIVE: This study was undertaken to analyze bleeding problems with tension-free vaginal tape (TVT) operations in a national registry. STUDY DESIGN: We studied patients for whom increased intraoperative bleeding or reoperation for bleeding/hematoma with TVT operation were reported to the registry. RESULTS: Bleeding problems were reported for 151 of 5578 (2.7%) TVT operations. Increased intraoperative bleeding was reported for 106 (1.9%) and reoperation (or conversion) in 45 (0.8%) patients (both in 5 patients). Increased intraoperative bleeding was managed conservatively in 103 patients (95%). Overall, 45 (0.8%) patients required reintervention for bleeding or hematoma. The reinterventions comprised 34 laparotomies, 4 transvaginal evacuations of hematomas, 3 revisions for bleeding from a suprapubic catheter site, and 2 revisions of the vaginal incision (details unclear in 1 patient). Bleeding was considered arterial in 12% (including 1 external iliac artery injury and 1 obturator artery injury) and venous or unknown in 88%. Of reoperated patients, 39% were reoperated within 24 hours, 20% within 2 to 10 days, and 41% within 11 to 56 days after TVT placement. Overall, 19 patients received blood transfusions (range, 1-10 units). There were no deaths from bleeding complications. CONCLUSION: Bleeding complications were reported with less than 3% of 5578 TVT operations. Most cases of increased intraoperative bleeding were managed conservatively; 0.8% of patients required conversion or reoperation.

Effects of surgical excision of endometriosis regarding quality of life and psychological well-being: a review.

The aim of the present work is to give a critical and detailed reflection on the effects of surgical resection of deep infiltrating endometriosis regarding reduction of symptoms, psychological well-being and quality of life. The current evidence strongly supports the effectiveness of radical laparoscopic resection in relieving endometriosis-associated symptoms and enhancing psychological well-being. In addition, studies suggest a general improvement of quality of life, however, further studies are needed to support this observation.

Increased C282Y heterozygosity in gestational diabetes.

BACKGROUND: Hereditary hemochromatosis is an autosomal recessive disorder of iron metabolism that is characterized by excess accumulation of iron in various organs and often leads to diabetes mellitus (DM). To study whether mutations in the hemochromatosis gene (HFE) could be a risk factor for the development of gestational diabetes mellitus (GDM), the prevalence of HFE mutations in patients with GDM was compared to that of healthy pregnant controls. METHODS: GDM was diagnosed in 208 of 2,421 pregnant woman screened between the 24th and 28th week of gestation over a period of 18 months. Patients and 170 matched control subjects were screened for the HFE gene mutations C282Y and H63D. RESULTS: In North and Central European GDM patients, the allele frequency of the C282Y mutation (7.7%) was higher than in pregnant controls (2.9%; p = 0.04), while the frequency of the H63D mutation was not different (p = 0.45). Three patients with GDM were homozygous for H63D (3.1%), 1 patient was homozygous for C282Y (1.0%), 2 patients were compound heterozygous (2.0%) and 26 were heterozygous [11 C282Y (11.2%) and 15 H63D (15.3%)]. C282Y and H63D allele frequencies were not different between controls and GDM patients of Southern European or non-European origin. Irrespective of the HFE-mutation status, serum ferritin levels were increased in patients with GDM compared to healthy pregnant controls (p = 0.01), while transferrin saturation was similar in both groups. CONCLUSIONS: In North and Central European patients with GDM, the C282Y allele frequency is higher than in healthy pregnant women, suggesting a genetic susceptibility to the development of GDM.