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.

The investigation and treatment of female pelvic floor dysfunction.

BACKGROUND: 25% of all women report involuntary loss of urine, and 7% may require treatment. METHODS: This review is based on a selection of pertinent literature, including guidelines and Cochrane reviews. RESULTS: The assessment of pelvic floor dysfunction in women begins with a basic evaluation that is followed by special diagnostic tests if indicated. The physician taking the clinical history should inquire about the patient's behavior, personality, social and other stressors, and eating and drinking habits, as well as any mental disorders that may be present, including anxiety disorders, depression, somatization disorders, and disorders of adaptation. Conservative treatment consists mainly of lifestyle changes, physiotherapy, and medication. Stress incontinence is most commonly treated with pelvic floor exercises, with a documented success rate of 56.1% vs. 6% without such treatment (relative risk 8.38, 95% confidence interval 3.67-19.07). If incontinence persists, surgery may be indicated ( implantation of suburethral tension-free slings, or colposuspension). Feedback and biofeedback training can be used to treat an overactive bladder. If these techniques and drug therapy are unsuccessful, botulinum toxin injections can be considered. CONCLUSION: Well-validated treatments for pelvic floor dysfunction are available. Psychosomatic factors must be taken into account and can have a major effect on treatment outcomes.

Change of steroid receptor expression in the posterior vaginal wall after local estrogen therapy.

Little is known about the reaction of the posterior vaginal wall influenced by steroid receptor expression. The aim of our study was to evaluate change of estrogen and progesterone receptor expression in the posterior vaginal wall after local estrogen therapy for vaginal prolapse surgery and to compare this expression with a group of untreated women of same age. Furthermore we examined the steroid receptor expression among untreated women in each period of life. In a prospective clinical study we examined staining intensity and ratio of positive cytoblasts in specimens of vaginal tissue sampled during posterior colporrhaphy and as control group specimens from autopsied corpses to proof the change in steroid receptor expression in treated women after local estrogen therapy compared to treatment-naive women of all ages. We compared 60 premenopausal female corpses to 43 postmenopausal female corpses and 80 postmenopausal women undergoing posterior colporrhaphy to 43 postmenopasusal female corpses. Estrogen-receptor alpha score was significantly higher in the intervention group in basal epithelium (p=0.004), stroma (p≤0.001) and connective tissue (p=0.005). Estrogen-receptor beta score was significantly higher in basal epithelium (p=0.048), progesterone-receptor score was significantly higher in the intervention group in stroma and connective tissue (p≤0.001) and in superficial epithelium (p=0.017). Local vaginal estrogen therapy leads to increase in estrogen-receptor alpha and progesterone-receptor expression of the posterior vaginal wall in postmenopausal women, while estrogen-receptor-beta-expression keeps nearly unchanged. This explains the fact that proliferation of the vaginal tissue is mediated by estrogen-receptor alpha and improves the condition for our prolapse surgery.

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).

Sexuality in German urogynecological patients and healthy controls: is there a difference with respect to the diagnosis?

OBJECTIVE: To evaluate sexual function among German urogynecological patients compared to a control group without urogynecological symptoms, using the validated German version of the Australian pelvic floor questionnaire. STUDY DESIGN: Retrospective study including 313 women divided into five subgroups: women with stress urinary incontinence (SUI), overactive bladder (OAB), mixed incontinence (MI), pelvic organ prolapse (POP) and healthy controls. The self-administered questionnaire is divided into three domains: bladder, pelvic organ prolapse, and sexual function. It also includes severity, bothersomeness and condition-specific quality of life. Only completely filled out questionnaires were included. The Mann-Whitney U-test was used as a non-parametric test to calculate significances for ordinal data. A p-value <.05 was taken as significant. RESULTS: 16/59 (27.1%) women in the control group were not sexually active compared to 19/60 (31.7%) in the SUI group, 51/98 (52.0%) in the mixed-incontinence group, 19/43 (44.2%) in the OAB group, and 24/53 (45.3%) in the prolapse group. Coital incontinence was present significantly more often in women with SUI (15/41, 36.6%) or mixed incontinence (20/44, 45.5%) than among the controls (1/49, 2.1%). Hence, concerning sexuality, women with urogynecological symptoms were all significantly more affected than the healthy controls. CONCLUSION: The German version of the Australian pelvic floor questionnaire is a feasible tool to evaluate not only symptoms of urinary incontinence and pelvic organ prolapse but also sexual dysfunction. A substantial proportion of our urogynecological patients suffer immensely from problems with their sexuality, and it is therefore our responsibility as physicians to provide assistance and improve our education in this field.

Clinical relevance of occult stress urinary incontinence (OSUI) following vaginal prolapse surgery: long-term follow-up.

INTRODUCTION AND HYPOTHESIS: Patients with genital prolapse and occult stress urinary incontinence (OSUI) are typically treated with prolapse surgery and anti-incontinence surgery based on either a one-step approach or a two-step approach. The aim of our study was to determine whether anti-incontinence surgery is necessary based on the occurrence of OSUI in a study cohort with a long follow-up period. METHODS: Prolapse surgery was performed using a vaginal approach. Preoperatively, a stress test, a pad test and an assessment of the urodynamics were performed with and without prolapse reduction. Over a follow-up period of 2-8 years, the patients with preoperative evidence of OSUI underwent urogynaecological examinations, stress tests and pad tests. RESULTS: Of 113 patients with preoperative evidence of OSUI, 57 (50.4 %) were followed up for an average of 5.7 years (range 2-8) after prolapse surgery. Of 57 patients, 16 (28.1 %) had objective and/or subjective stress urinary incontinence (SUI) during the follow-up period, but only 3 patients (5.3 %) required subsequent tension-free vaginal tape (TVT) surgery. In 17 of 57 patients (29.8 %), prolapse recurred. CONCLUSIONS: Despite the preoperative evidence of OSUI, the manifestation of SUI rarely occurs, with 28.1 % of patients experiencing SUI over long-term follow-up after vaginal prolapse surgery. Anti-incontinence surgery was necessary in only three cases (5.3 %). These results indicate that with the one-step approach, 54 of 57 patients (94.7 %) would have received prophylactic anti-incontinence surgery unnecessarily. In conclusion, we recommend the two-step approach in the management of vaginal prolapse surgery in patients with OSUI.

Anticholinergic therapy: do the patients take the pills prescribed?

PURPOSE: To evaluate how many patients with overactive bladder still take their prescribed medication at least 12 months later and to find out the reasons for discontinuation of the therapy. METHODS: Two hundred and ten patients who had received a prescription for anticholinergic medication were contacted by telephone 12-46 months later. RESULTS: Out of 210 eligible patients 132 (63%) could be contacted and gave consent to participate in the study. 38% of them still took their medication after at least 12 months. 17% were continent or much improved, 13% a little improved, 8% were not improved, although still taking their medication. 62% did not take the original medication any more. 10% had never started with the medication, 42% took the medication for 3 months and 8% for 4-12 months. 25% had changed to another anticholinergic drug. CONCLUSION: Anticholinergic therapy is often discontinued by patients and doctors. Patients with OAB therefore need counselling and follow-up in the long term to make sure that alternative treatment is offered if anticholinergic treatment does not work.

Is a dipstick test sufficient to exclude urinary tract infection in women with overactive bladder?

INTRODUCTION AND HYPOTHESIS: A dipstick test is recommended to screen for urinary tract infection in patients with overactive bladder (OAB). It was the aim of this study to test if a dipstick test is sufficient to identify patients with urinary tract infection attending a urological private practice because of OAB. METHODS: All patients who attended the practice because of OAB symptoms were routinely catheterized; a urine specimen was tested with dipstick, the spun sediment was examined microscopically, and the specimen was sent for microbiological examination. RESULTS: Two thousand two hundred fifty-two patients were examined. Of 1,754 patients with negative dipstick screening, 353 patients (20.1%) had growth of ≥10(3) colony forming units. The dipstick test had a sensitivity of 0.442 and a specificity of 0.865 for the correct identification of urinary tract infection. CONCLUSIONS: Dipstick screening is not sufficient to identify patients with urinary tract infection and symptoms of OAB.

What harm does a second delivery to the pelvic floor?

OBJECTIVE: To compare the pelvic floor function of primiparous women to women after a second delivery regarding symptoms of urinary and anal incontinence, anal sphincter ruptures and bladder-neck mobility. METHODS: A questionnaire evaluating symptoms of urinary and anal incontinence was used in nulliparous women before and 27 months after childbirth. Furthermore these symptoms were correlated with functional changes of the pelvic floor based on a careful gynecologic examination as well as perineal and endoanal ultrasound. RESULTS: 112 nulliparous women were included, 49 women returned for follow-up on average 27 months (SD 4.4 months) after the first delivery. 39 women (group A) had just one delivery, 10 women (group B ? 10/49) had had a second delivery. Apart from levator ani muscle strength, no significant difference between pelvic floor function of group A vs group B was demonstrable. Furthermore, we could show no significant difference for symptoms of urinary (11 (28.2%) vs. 5 (50.0%)) and anal incontinence (14 (35.9%) vs. 4 (40.0%)) between both groups. However, we found a lasting increase of stress urinary and anal incontinence as well as overactive bladder symptoms after one or more deliveries. The position of the bladder neck at rest was lower in both groups compared to the position before the first delivery and bladder neck mobility increased after one or more deliveries. DISCUSSION: Our study shows several statistically significant changes of the pelvic floor function even on average 27 months after delivery, but a subsequent delivery did not compromise the pelvic floor any further.

Prospective randomised multicentre trial with the birth trainer EPI-NO for the prevention of perineal trauma.

BACKGROUND: In several non-randomised trials training with EPI-NO increased the rate of intact perineum and decreased episiotomy rates, shortened the second stage of labour and lowered use of pain killers. AIMS: To verify the preliminary results with EPI-NO in a prospective randomised trial. METHODS: Randomised, single-blind multicentre trial in four university hospitals in Germany including 276 primigravidae. RESULTS: After training with EPI-NO we observed a significant increase in the incidence of intact perineum (37.4% vs 25.7%; P = 0.05) and a tendency towards lower episiotomy rates (41.9% vs 50.5%; P = 0.11). We found no significant differences between the two groups regarding incidence of perineal tears, duration of second stage of labour, use of pain relief and rate of vaginal infection. CONCLUSIONS: Training with EPI-NO increases significantly the likelihood of having an intact perineum and reduces the episiotomy rate.

Pregnant women after physical and sexual abuse in Germany.

BACKGROUND/AIMS: The aim of our study was to evaluate the prevalence of abuse among pregnant women in Germany attending our antenatal outpatient clinic and to observe whether a history of abuse had consequences for women's feelings about their pregnancy. METHODS: 455 women between the 35th and 42nd weeks of gestational age were included and were asked to fill out an anonymous questionnaire concerning their pregnancy, their actual psychological state, and their history of physical/sexual abuse. 600 questionnaires were distributed (return rate 75.8%), 70 women (10.4%) were excluded because of male companionship to ensure their safety in case that they were currently in an abusive relationship with the attending man. RESULTS: 88 women (19.3%) reported a history of sexual and/or physical abuse. Pregnant women after physical and/or sexual abuse significantly more frequently associate negative feelings with their pregnancy than nonabused women. The Hospital Anxiety Depression Scale (HADS) and the SCL-K-9 demonstrated significantly more negative feelings of depression and anxiety, strain, loneliness and less expectation of happiness for their future in abused women. CONCLUSION: Physical and sexual abuse are relevant problems among women in obstetric care that may complicate their pregnancies and make them feel more depressive.

Physical and sexual abuse in patients with overactive bladder: is there an association?

The known sequelae of sexual abuse include acute and chronic injury. The purpose of this study was to evaluate the association of overactive bladder symptoms (OABs) with a history of physical or sexual abuse. Two hundred and forty-three women who attended the gynaecological out-patient clinic or the urogynaecological clinic were recruited for our study. Based on their clinical examination, they were assigned to three groups of patients with either OAB or with stress urinary incontinence (SUI) without concomitant urgency symptoms (SUI), or without history of incontinence (control group). Afterwards, they completed an anonymous questionnaire about bladder function and physical/sexual violence. Significantly more women (30.6%, 26/85) with OAB had previously been physically or sexually abused than women with SUI (17.8%, 18/101) and of the control group (17.5%, 10/57). Our study showed that significantly more women with OAB report physical and sexual abuse than subjects with stress incontinence or no urinary complaints. Women with stress incontinence had the same rate of self-reported physical/sexual abuse as continent controls.

Doppler sonography of the uterine and the cubital arteries in normal pregnancies, preeclampsia and intrauterine growth restriction: evidence for a systemic vessel involvement.

AIMS: The decrease in uterine resistance during normal pregnancy is known to be related to invading trophoblast cells which derive from placental tissue. Uterine and peripheral resistance is elevated in preeclampsia. The aim of the present study was to prospectively examine uterine and peripheral resistance in pregnancies complicated by preeclampsia (PE), fetal intrauterine growth restriction (IUGR) and pregnancy induced hypertension (PIH). METHODS: Sixty-seven women with normal pregnancies, 17 with PE, 12 with IUGR underwent Doppler sonographic investigation of the uterine and the cubital arteries. The Pulsatility Index (PI) was calculated for each vessel. Statistical analysis was performed and a P-value <0.05 was considered significant. RESULTS: Patients with preeclampsia and IUGR showed a significant higher resistance at the placental (mean PI 1.267 and 1.063), nonplacental (mean PI 1.631 and 1.124) and cubital artery (mean PI 3,777 and 3.995) compared to the normal pregnancy group (mean PI 0.678; 0.859 and 2.95 respectively). Mean birth weight in the PE group was 1409 g, in the IUGR group 1649 g and 3419 g in the normal pregnancy group. CONCLUSIONS: Pregnancies with IUGR are associated with elevated peripheral resistance in the maternal arterial system as seen in pregnancies with preeclampsia. Our findings encourage to further investigate the maternal vascular system in high risk pregnancies.

Is the histomorphological concept of the female pelvic floor and its changes due to age and vaginal delivery correct?

AIMS: To compare the histomorphology of pelvic floor specimens of 94 female cadavers, ten male cadavers, and 24 female symptomatic patients who underwent pelvic floor surgery, and to evaluate the association of age, parity, and sex to myogenic and/or neurogenic changes to the levator ani muscle (LAM). METHODS: The pelvic floor was biopsied at the pubococcygeus, the iliococcygeus and the coccygeus muscle. After staining, signs for myogenic/neurogenic changes to the muscle were evaluated (fibrosis, variation in fiber diameter, centralization of nuclei, small angulated fibers, and type grouping). To identify the intact neuromuscular junction stainings with NCAM (neuronal cell adhesion molecule) and acetylcholinesterase (ACE) were used. RESULTS: A significant influence of age and parity on the histomorphological criteria of myogenic cell-damage was shown in this study. Although these criteria were found even in young nulliparous women, there was a significant increase in older or parous women with at least one vaginal delivery. We failed to demonstrate significant changes between the nulliparous LAM, the male LAM, and the LAM from women with prolapse and incontinence. None of the specimen showed any obvious evidence of neuropathy. CONCLUSIONS: We have evaluated histological criteria adapted from the examination of limb muscles in the LAM of nulliparous young women. "Myogenic changes" seem to be a normal finding in the LAM. The increase of these changes with aging and parity points to mechanical stress to the LAM as the most plausible causative factor. We propose that further studies using histomorphological techniques of the pelvic floor muscle in nulliparous and parous women should clarify the potential role of our histological findings.

Urinary and anal incontinence after vacuum delivery.

OBJECTIVES: To evaluate urinary and fecal incontinence symptoms, and occult anal sphincter defects in women after vacuum and spontaneous vaginal delivery. STUDY DESIGN: In a case-control study, 50 primiparous women delivered by vacuum extraction were compared to 50 women delivered spontaneously. Urinary and anal incontinence symptoms, pelvic floor muscle strength and sphincter defects on endoanal ultrasound were evaluated 6-24 weeks postpartum. RESULTS: New anal incontinence symptoms after childbirth were found in 30% of the vacuum group compared to 34% of the controls, new urinary incontinence symptoms in 28 and 42%, respectively (not significant). After excluding Grade III perineal tear, sonographic sphincter defects were found in 11 (27.5%) after vacuum delivery compared to 4 (10%) after spontaneous delivery (P<0.05, chi(2)-test). CONCLUSION: Anal and urinary incontinence symptoms are frequent after vaginal delivery. Vacuum delivery causes more sonographic sphincter defects but appears to cause no more harm to pelvic floor function than spontaneous vaginal delivery.

Prevalence of sexual abuse among women seeking gynecologic care in Germany.

OBJECTIVE: To estimate the prevalence of sexual abuse among patients seen for gynecologic care in Germany. METHODS: A short anonymous questionnaire was distributed to 1157 women attending a gynecologic outpatient clinic at a large urban teaching hospital. Data collected using the questionnaire included patient characteristics, sexual abuse history, and screening practices. Women who reported that they had been abused were asked if they had ever discussed the issue with their gynecologist. RESULTS: A total of 1075 questionnaires were returned, for a response rate of 92.9%. Almost half (n = 479 [44.6%]) of the women surveyed reported that they had been the subject of unwanted sexual attention. One fifth (n = 216 [20.1%]) had been forced to engage in sexual activities: 6.8% in childhood, 10.3% during adolescence, 6.4% as an adult, and 3.5% across more than one stage. Thirteen women (6%) reported having discussed the abuse with their gynecologist. Sixty-six (30.5%) were too afraid to raise the issue, and 119 (55.1%) stated it was not relevant to their care. Only one woman (0.5%) reported that her gynecologist had asked about sexual abuse. CONCLUSION: Despite the high prevalence of sexual abuse among women seeking gynecologic care, routine screening does not appear to be part of standardized practice.

Long-term efficacy of pelvic floor re-education with EMG-controlled biofeedback.

OBJECTIVE: To evaluate the long-term efficacy of pelvic floor re-education (PFR) with EMG-controlled biofeedback in the treatment of female genuine stress or mixed incontinence. STUDY DESIGN: Between 1995 and 1998, 36 women completed a pelvic floor muscle training with a biofeedback device for 3-6 months. A mean of 26 months later, a follow-up examination was performed. RESULTS: The prevalence of lower urinary tract symptoms decreased significantly immediately after the training but increased again at the long-term follow-up. Levator ani muscle strength improved after the treatment and remained significantly better for long-term follow-up. Immediately after the program, 25 (70%) women reported cure or improvement of stress incontinence. At the long-term follow-up, 17 (47%) reported the same result. CONCLUSIONS: About half of the patients after PFR with biofeedback are still improved or cured after 26 months. Women should be counseled about the long-term efficacy and about the necessity of maintaining training.