Popularity of endocrine endometriosis drugs and limited alternatives in the present and foreseeable future: A survey among 1420 affected women.

OBJECTIVES: Endocrine drugs represent an important cornerstone of endometriosis therapy. Pharmaceutical alternatives with similar efficacy remain out of sight in the near future. Aim of this study is to investigate attitudes and perceptions concerning endocrine therapies among affected women. STUDY DESIGN: An online survey was distributed via social media in Austria, Germany, and Switzerland. Primary endpoints were satisfaction, attitudes and perceptions towards endocrine endometriosis drugs and secondary outcomes differences regarding demographic variables. RESULTS: Of 1420 respondents, 63.5 % (n = 901) described their own attitude towards these drugs as rather negative. The most frequently reported unfavorable associations and experiences were sideeffects in general (85.5 %, n = 1181), change in libido (67.5 %, n = 932), hormone cycle disruptions (65.9 %, n = 910), and inefficiency at alleviating symptoms (38.2 %, n = 527). In total, 66.1 % (n = 935) were not satisfied with endocrine drugs for endometriosis. Age ≤ 30 years, living in a large city, and having an academic degree were significantly correlated to a more negative perception of these drugs and greater dissatisfaction with current endocrine endometriosis drugs. CONCLUSIONS: Among women with endometriosis - and particularly among those aged ≤30 years, being large-city residents, or holding an academic degree - there appears to be a relevant degree of rejection and wariness towards endocrine endometriosis drugs. Given the prevalence of endometriosis and the few pharmaceutical alternatives on the horizon, these data point a growing need for further research and development of non-hormonal drugs for the treatment of endometriosis.

Considering non-bladder aetiologies of overactive bladder: a functional neuroimaging study.

OBJECTIVES: To better understand the neuropathophysiology of overactive bladder (OAB) in women by characterising supraspinal activity in response to bladder distention and cold stimulation. SUBJECTS/PATIENTS AND METHODS: We recruited 24 female participants, 12 with OAB (median [interquartile range, IQR] age 40 [32-42] years) and 12 healthy controls (HCs) without lower urinary tract (LUT) symptoms (median [IQR] age 34 [28-44] years), and assessed LUT and cognitive function through neuro-urological examination, 3-day bladder diary, urodynamic investigation, and questionnaires. Functional magnetic resonance (MR) imaging using a 3-T scanner was performed in all participants during automated, repetitive bladder filling and draining (block design) with 100 mL body temperature (37 °C) saline using a MR-compatible and MR-synchronised infusion-drainage device until strong desire to void (HIGH-FILLING/DRAINING) and bladder filling with cold saline (4 °C, i.e. COLD). Whole-brain and region-of-interest analyses were conducted using Statistical Parametric Mapping, version 12. RESULTS: Significant between-group differences were found for 3-day bladder diary variables (i.e. voiding frequency/24 h, P < 0.001; voided volume/void, P = 0.04; and urinary incontinence [UI] episodes/24 h, P = 0.007), questionnaire scores (International Consultation on Incontinence Questionnaire-Female LUT symptoms [overall, filling, and UI scores, all P < 0.001]; the Overactive Bladder Questionnaire short form [symptoms and quality-of-life scores, both P < 0.001]; the Hospital Anxiety and Depression Scale [anxiety P = 0.004 and depression P = 0.003 scores]), as well as urodynamic variables (strong desire to void, P = 0.02; maximum cystometric capacity, P = 0.007; and presence of detrusor overactivity, P = 0.002). Age, weight and cognitive function (i.e. Mini-Mental State Examination, P = 1.0) were similar between groups (P > 0.05). In patients with OAB, the HIGH task elicited activity in the superior temporal gyrus, ventrolateral prefrontal cortex (VLPFC), and mid-cingulate cortex; and the COLD task elicited activity in the VLPFC, cerebellum, and basal ganglia. Compared to HCs, patients with OAB showed significantly stronger cerebellar activity during HIGH-FILLING and significantly less activity in the insula and VLPFC during HIGH-DRAINING. CONCLUSIONS: The present findings suggest a sensory processing and modulation deficiency in our OAB group, probably as part of their underlying pathophysiology, as they lacked activity in essential sensory processing areas, such as the insula. Instead, accessory areas, such as the cerebellum, showed significantly stronger activation compared to HCs, presumably supporting pelvic-floor motor activity to prevent UI. The novel findings of the present study provide physiological evidence of the necessity to consider non-bladder aetiologies of bladder symptoms.

Structured manual for MRI assessment of deep infiltrating endometriosis using the ENZIAN classification.

PURPOSE: Proposal of a systematic approach to assess Deep infiltrating endometriosis (DIE) through pelvic Magnetic resonance imaging (MRI) using the Enzian classification and examination of inter-rater agreement. METHODS: Three radiologists reviewed 23 MRI of patients with pelvic DIE at one tertiary referral center retrospectively and independently. Inclusion criteria were intraoperative confirmation of DIE and MR imaging according to ESUR (European Society of Urogenital Radiology) guidelines. Assessment of the anatomical pelvic compartments was performed using a manual based on the Enzian classification with step-by-step instructions using recommended planes and sequences presented here. Interrater agreement was measured using kappa statistics. RESULTS: According to the intraoperative site lesions in 53 anatomical compartments were present. Interrater agreement was best for compartments A (0.255) and FB (0.642). For FI (0.204) and B (0.146) it was slight, there was poor agreement for C (- 0.263), FA (- 0.022), and FO (- 0.030), respectively, and as for FU, no ureter infiltration was described. CONCLUSION: MRI as a noninvasive diagnostic tool offers essential advantages regarding classification and therapy planning for patients with DIE. However, its assessment is difficult and a more systematic approach is needed. Our proposed manual based on the Enzian classification is reproducible and could support radiologists and gynecologists.

[Recurrent Urogynecological Infections]. / Rezidivierende urogynäkologische Infektionen.

Recurrent Urogynecological Infections Abstract. Changes in the urogenital microbiome of the bladder, urethra, vagina and cervix can cause recurrent infections. We distinguish between obligate and facultative pathogens. In the case of facultative pathogens, treatment with antibiotic, antiviral or antifungal drugs should only be considered in cases with attributable symptoms. Sexually transmitted diseases (STD) manifest either urogenitally alone or in association with an ascending infection of the adnexa as a pelvic inflammatory disease. STD may be asymptomatic, as in cases of chlamydia, or may cause a high burden of symptoms, impairment of quality of life or infertility. The aim of this minireview is to give an overview of the pathogenicity of the different germs and their treatment.

[Female pelvic floor: anatomy and normal function]. / Beckenboden der Frau: Anatomie und normale Funktion.

Female pelvic floor: anatomy and normal function Abstract. In the course of evolution, the complex interaction of anatomical structures of the pelvic floor has led to bladder and bowel continence, sexual sensations and reproduction. All these functions and abilities play an important individual and social role, thanks to which higher interactions have become possible. For a better understanding of these functions, underlying anatomical concepts are essential. The knowledge gained through dissection of corpses in earlier centuries is now being expanded through modern imaging techniques and image processing. In the following article, we want to give readers an overview of the anatomically important structures and the functions of the pelvic floor.

[Etiology, Diagnosis, and Management of Female Bladder Outlet Obstruction]. / Blasenentleerungsstörungen bei der Frau ­ Ursachen, Diagnostik und Therapie.

Etiology, Diagnosis, and Management of Female Bladder Outlet Obstruction Abstract. Bladder outlet obstruction affects up to every fourth woman. This condition is causing difficulties to void. Patients complain about frequency, an urge to void, or they describe the feeling of post-void residual urine. Increased post-void residual urine or a pathological micturition pattern with increased pressure or pathological flow curves are suggestive for a bladder outlet obstruction. Common causes are genital organ prolapse, previous incontinence surgery, or dysfunctional voiding. Correspondingly, the underlying etiology is determining therapy: surgical correction of the pelvic organ prolapse usually eliminates the obstructive situation; a tightly placed incontinence sling should be loosened or incised, while dysfunctional disorders can be well addressed by pelvic floor rehabilitation.

The ENZIAN score as a preoperative MRI-based classification instrument for deep infiltrating endometriosis.

PURPOSE: Comparison of preoperative magnetic resonance imaging (MRI) with intraoperative findings in patients with deep infiltrating endometriosis (DIE) by means of the ENZIAN score. METHODS: This retrospective two-center study includes 63 patients with deep infiltrating endometriosis, who underwent surgery between 2012 and 2016 at both the University Hospital of Zurich and the Cantonal Hospital of Schaffhausen. Inclusion criteria were a preoperative pelvic MRI and intraoperative or bioptic confirmation of DIE. The preoperative MRI findings were compared with the intraoperative results by means of the ENZIAN score. Furthermore, the various MRI sequences were analyzed for their diagnostic value based on a Likert scale. RESULTS: Sensitivity and negative predictive values of MRI confirmed by surgery were 95.2% and 91.7% (lesions in the vaginal/rectovaginal space), 78.4% and 56% (uterosacral ligaments), 91.4% and 89.7% (rectum/sigmoid colon), 57.1% and 94.1% (myometrium), 85.7% and 98.3% (bladder), and 73.3% and 92.2% (intestine), respectively. T2 axial and sagittal MRI sequences in combination with a T1 sequence were diagnostically sufficient. CONCLUSIONS: The MRI-based ENZIAN score correlates well with the intraoperative findings, enabling a better planning of the surgical procedure for patients and physicians. However, considerable difficulty and a poorer comparability result from the variations in sequences used in the detection of this multifaceted disease. Therefore, a standardization of MRI protocols used in the detection of DIE will be a crucial step towards increased diagnostic validity and the ENZIAN score may be used as an anatomical land map and valuable communication tool between radiologists and gynecologists.

Measuring tissue displacement of the anterior vaginal wall using the novel aspiration technique in vivo.

Little is known about the mechanical properties of pelvic floor structures and their role in the course and treatment of pelvic organ prolapse (POP). We hypothesize that in vivo mechanical properties of the vaginal wall are related to the appearance of POP and pre-and post-operative states. We used a suction device for intravaginal application, the aspiration device, to evaluate two in vivo mechanical parameters of the anterior vaginal wall, the load dependent tissue displacement and the initial displacement, by image analysis in pre- and post-menopausal women with (POP) and without (control) cystocele (POP: pre-menopausal: N = 6, post-menopausal: N = 19, control: pre-menopausal: N = 17, post-menopausal: N = 6). Mechanical parameters in women with and without cystocele and pre- and post-operative parameters were compared. Statistically significant differences were observed between the two mechanical parameters in pre- and post-operative states (P = 0.04, P = 0.03), but not between the parameters for women with and without cystocele (P = 0.92, P = 0.75). The mechanical behavior of pelvic floor structures is influenced by factors such as POP, age or estrogenization that are apparent at different length scales, which cannot be separated by the aspiration based biomechanical measurements. When comparing pre- and post-operative states of the same patient, a firmer tissue response was observed after intervention.

Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial.

BACKGROUND: Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V). METHODS: In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794. FINDINGS: Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥105 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002). INTERPRETATION: This tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings. FUNDING: GlycoVaxyn, Janssen Vaccines.

Urinary incontinence and its association with functional physical and cognitive health among female nursing home residents in Switzerland.

BACKGROUND: Specific knowledge of urinary incontinence (UI) and its interrelation with physical and cognitive health is essential to working towards prevention of UI and to improving quality of treatment and care. The purpose of this study was to determine the association between UI and the activities of daily living (ADL) hierarchy scale, the cognitive performance scale (CPS) and comorbid conditions. METHODS: The cross-sectional retrospective analysis of 357 nursing homes in Switzerland was based on data of the Minimum Data Set of the Resident Assessment Instrument 2.0 (RAI-MDS). The analysis examined the effect of ADL hierarchy scale, CPS, joint motion and comorbidities on UI. Women ≥65 years were included (n = 44'811; January 2005 to September 2014) at the time of admission to a nursing home. Statistical analysis was done by means of descriptive statistics and logistic regression analysis. RESULTS: The prevalence of UI was 54.7%, the mean ADL hierarchy scale (± SD) 2.42 ± 3.26 (range = 0-6), the mean CPS 1.95 ± 1.67 (range = 0-6). There was a gradual increase in the odds ratio (OR) for UI depending on the ADL hierarchy scale, from the hierarchy scales of "supervised" to "total dependence" of 1.43 - 30.25. For CPS, the OR for UI from "borderline intact" to "very severe impairment" was 1.35 - 5.99. Considering the interaction between ADL and CPS, all ADL hierarchies remained significantly associated with UI, however for CPS this was the case only in the lower hierarchies. Of the 11 examined comorbid conditions, only diabetes mellitus (OR 1.19), dementia (OR 1.01) and arthrosis/arthritis (OR 1.53) were significantly associated with UI. CONCLUSION: The study indicated that impairment in ADL performance is strongly associated with UI, more than CPS performance and comorbidities. Physical more than cognitive training in order to improve or at least stabilize ADL performance could be a way to prevent or reduce the process of developing UI.

[Interstitial cystitis/bladder pain syndrome (IC/BPS)]. / Wenn die Blase brennt: interstitielle Zystitis/Bladder Pain Syndrome (IC/BPS).

Interstitial cystitis/bladder pain syndrome (BPS) is still an etiologically poorly understood chronic pain syndrome. BPS is a clinical diagnosis. The current treatment modalities are aimed at symptom relief because no cure is possible. Analgesics may be used at any point in treatment but preferably for short-term relief for flares or bladder pain. AUA has issued clinical practice guidelines with a stepwise approach. The first-line therapy begins with self-care and behavior modification. Physical therapy and oral medications such as amitriptyline, PPS, or antihistamines belong to the second-line therapy. Third-line therapy requires cystoscopy and hydrodistension, treatment of Hunner lesions, or intravesical use of e.g. DMSO. Neuromodulation is considered a fourth-line therapy in patients who have failed third-line treatments. Fifth-line therapies consist of intravesical injection of BoNT or oral cyclosporin A. Cystectomy is the sixth-line therapy and the treatment of last resort.

Label-free, three-dimensional multiphoton microscopy of the connective tissue in the anterior vaginal wall.

INTRODUCTION AND HYPOTHESIS: Multiphoton microscopy (MPM) is a nonlinear, high-resolution laser scanning technique and a powerful approach for analyzing the spatial architecture within tissues. To demonstrate the potential of this technique for studying the extracellular matrix of the pelvic organs, we aimed to establish protocols for the detection of collagen and elastin in the vagina and to compare the MPM density of these fibers to fibers detected using standard histological methods. METHODS: Samples of the anterior vaginal wall were obtained from nine patients undergoing a hysterectomy or cystocele repair. Samples were shock frozen, fixed with formaldehyde or Thiel's solution, or left untreated. Samples were imaged with MPM to quantify the amount of collagen and elastin via second harmonic generation and autofluorescence, respectively. In six patients, sample sections were also histologically stained and imaged with brightfield microscopy. The density of the fibers was quantified using the StereoInvestigator and Cavalieri software. RESULTS: With MPM, collagen and elastin could be visualized to a depth of 100 µm, and no overlap of signals was detected. The different tissue processing protocols used did not result in significantly different fiber counts after MPM. MPM-based fiber quantifications are comparable to those based on conventional histological stains. However, MPM provided superior resolution, particularly of collagen fibers. CONCLUSIONS: MPM is a robust, rapid, and label-free method that can be used to quantify the collagen and elastin content in thick specimens of the vagina. It is an excellent tool for future three-dimensional studies of the extracellular matrix in patients with pelvic organ prolapse.

Conjugates of cytochrome c and antennapedia peptide activate apoptosis and inhibit proliferation of HeLa cancer cells.

Polycationic cell-penetrating peptides (CPPs) deliver macromolecules into cells without losing the functional properties of the cargoed macromolecule. The aim of this study was to determine whether exogenous cytochrome c is delivered to HeLa cervical carcinoma cells by the CPP antennapedia (Antp) and activates apoptosis. HeLa cervical carcinoma cells were treated with conjugated Antp-SMCC-cytochrome c (cytochrome c chemically conjugated to Antp) or with non-conjugated Antp and cytochrome c. Sensitivity to the treatments was determined by the clonogenic assay (proliferation) and by immunoblot analysis (apoptosis activation). We report that conjugated Antp-SMCC-cytochrome c activated apoptosis in HeLa cells as demonstrated by poly (ADP-ribose) polymerase 1 (PARP-1) cleavage and inhibited their proliferation. The Antp-SMCC-cytochrome c-induced apoptosis was inhibited by z-VAD-fmk, a pan-caspase inhibitor peptide. Unconjugated Antp or cytochrome c demonstrated no inhibitory effect on survival and proliferation. Our results suggest that chemical coupling of cytochrome c to CPPs may present a possible strategy for delivering cytochrome c into cells and for activating apoptosis.

Pelvic floor muscle training for urinary incontinence: a comparison of outcomes in premenopausal versus postmenopausal women.

OBJECTIVES: Previous studies examining the effectiveness of pelvic floor muscle training (PFMT) for urinary incontinence in premenopausal and postmenopausal women have shown ambiguous results. The aim of this study was to compare subjective PFMT outcome in premenopausal versus postmenopausal women. METHODS: This is a retrospective study including premenopausal and postmenopausal women after PFMT for urodynamically proven stress urinary incontinence, mixed urinary incontinence, or urgency urinary incontinence from January 2003 to December 2008, with assessment of the need of an incontinence surgery in a follow-up time of least 24 months. Patients evaluated the change of their urinary incontinence on a 4-point Likert scale (1, no improvement; 2, slightly better; 3, no relevant incontinence; 4, excellent outcome; no incontinence at all) and their goal attainment on a 3-point Likert scale (1, less than expected; 2, as expected; and 3, more than expected). RESULTS: Successful outcome was reported by 59% of the premenopausal patients and 70% of the postmenopausal patients (P = 0.16), the attainment of the subjective goal by 68% and 81% (P = 0.09), and the need of an incontinence operation in a follow-up of 30 to 102 months by 15% and 14% (P = 1.0), respectively. None of the outcome parameters reached significance. CONCLUSIONS: In comparing premenopausal to postmenopausal women, we could not detect any statistically significant difference with regard to patients' satisfaction for the outcome of PFMT.

Developmental potential of human oocytes matured in vitro followed by vitrification and activation.

BACKGROUND: Oocyte in vitro maturation (IVM) and cryopreservation at the time of routine ovarian tissue freezing may be offered to cancer patients as an additional option for fertility preservation. This study aimed to investigate the developmental capacity of oocytes isolated from unstimulated ovaries. METHODS: Immature oocytes (n = 63) from seven consenting premenopausal patients were analysed. Oocytes were collected during routine laparoscopic examination with biopsy of an ovary (cystic adnexal mass, n = 3; cervical adenocarcinoma, n = 2) or oophorectomy (sex reassignment surgery, n = 2) without previous stimulation of the ovaries. The stage of the patient's menstrual cycle was not considered. Oocytes in all visible antral follicles were aspirated from ovaries, cultured in IVM medium and vitrified at the MII stage before being kept in liquid nitrogen for at least one month. After warming, oocytes were subjected to parthenogenetic activation by chemical stimulus. Their further development was recorded at intervals of 24 hours for up to 6 days of culture. RESULTS: 61.9% of oocytes matured in vitro within 48 hours. The survival rate after vitrification and warming was 61.5%. A total of 75% of surviving oocytes were able to respond to artificial activation, 44.4% of the parthenotes developed to early embryonic stage. However, only 1 in 18 (5.6%) of the resulting embryos reached blastocyst stage. CONCLUSIONS: Oocytes matured in vitro from unstimulated ovaries seem to have limited developmental potential after cryopreservation and artificial activation. Although the outcome of IVM for non-stimulated oocytes is poor, it is currently the only chance besides cryopreservation of ovarian tissue for women for whom ovarian stimulation is not possible due to life circumstances. Based on our preliminary results, we suggest that the use of cryopreserved ovaries for fertility preservation in women with cancer warrants further investigation.

Randomized, double-blind placebo-controlled trial with Bryophyllum pinnatum versus placebo for the treatment of overactive bladder in postmenopausal women.

INTRODUCTION: Overactive bladder syndrome (OAB) is a chronic disorder that often requires long-term treatment. There is a growing interest in new substances. In vitro experiments of Bryophyllum pinnatum (BP) on porcine bladder muscle have shown a muscle-relaxing effect. In this clinical trial we evaluated BP versus placebo regarding efficacy and safety. MATERIALS AND METHODS: Prospective, double-blind randomized, placebo-controlled study with 20 patients (10 BP, 10 placebo); medication over 8 weeks; dosage 3×2 capsules BP 50% (350 mg)/day or placebo (lactose). Primary aim: reduction of the micturition frequency/24h. Secondary aim: change in quality of life, alterations of parameters in the bladder diary and adverse events (AE). Statistical analysis was performed with IBM SPSS Statistics 20. The groups were compared using Fisher's exact test and the Mann-Whitney test; the visits using the Wilcoxon signed ranks test. RESULTS: Both groups did not differ significantly in demographical data. For the primary endpoint, a trend in the reduction of the micturition frequency/24h in the BP group was found: 9.5±2.2 before and 7.8±1.2 after BP versus 9.3±1.8 before and 9.1±1.6 after placebo, p=0.064. From visit 2 to visit 4, micturition frequency/24h improved in 8/10 patients in the BP group (p=0.037). In the placebo group, micturition frequency/24h improved in 5/9 patients (p=0.89). Improvement of the QoL did not differ between the two groups. The incidence of AE was similar in both groups, no SAE occurred. CONCLUSION: The successful safety outcome and positive trend for efficacy permits BP to be further evaluated as a favorable treatment option for OAB.

Twelve months effect on voiding function of retropubic compared with outside-in and inside-out transobturator midurethral slings.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to compare retropubic tension-free vaginal tape (TVT) with transobturator out-in TOT and in-out TVT-O for female stress urinary incontinence. Uroflow rate was primary; continence rates, quality of life (QoL) and complication pattern were secondary endpoints. METHODS: A prospective randomised trial with 2:1:1 randomisation at two Swiss teaching hospitals. Patients were followed up at 12 months. RESULTS: Eighty TVT, 40 transobturator tape (TOT) and 40 TVT-O were randomised. At 12 months, there was no difference in Qmax among the groups. Continence was comparable (≥ 89%). QoL was improved significantly in all groups (P < 0.05). Five vaginal tape exposures occurred (one TVT, four TOT, zero TVT-O; P = 0.028). Two percent (1/52) of sexually active patients after TVT, 17% (5/29) after TOT, but 0% (0/25) after TVT-O reported de novo female sexual dysfunction (P = 0.011). We considered this clinically important enough to stop enrolment. CONCLUSIONS: There was no difference for Qmax at 12 months between TVT, TOT and TVT-O. Female sexual dysfunction and tape exposure may be higher with a transobturator tape.