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Background. To evaluate fertile women’s ability to recall the onset of stress incontinence. Methods. In a prospective cohort study 305 primiparae were interviewed after 1st delivery and again 5 years later using a tested questionnaire. In 83 women with stress incontinence 5 years after 1st delivery history of onset was compared with data from the initial questionnaire by grouping women with onset before 1st pregnancy, during 1st pregnancy, during 1st puerperium or after 1st puerperium. Results. Five years after 1st delivery only 26% recalled the onset of stress incontinence precisely. The statistical agreement for each of the four groups of women with different recall of onset varied with a Kappa from 0.02 to 0.38. Conclusion. Five years after 1st delivery stress incontinent women seem to recall the onset of the symptom imprecisely.

To evaluate the risk of developing long-lasting stress incontinence after first delivery, the authors interviewed all women who had their first delivery at Glostrup County Hospital in 1989 (N = 305). Within a few days of delivery and again 3 months later, the women were interviewed by phone using a questionnaire that incorporated the International Continence Society standards for stress incontinence. The questionnaire included questions about urinary incontinence symptoms provoked by physical exertion, frequency of symptoms, and social or hygienic problems caused by stress incontinence. Five years later all patients were mailed the same questionnaire with additional questions about obstetric history and treatment for stress incontinence. Two hundred seventy-eight of the initial population of 305 women (91%) returned the follow-up questionnaire and form the basis of the analysis. For comparison, the women were divided into three groups. The 166 women who had no initial stress incontinence before, during, or 3 months after the first pregnancy were assigned to group 0. Eighty women experienced onset of stress incontinence symptoms with the first pregnancy; they form group 1. Group 2 includes 19 women who reported stress incontinence symptoms persisting 3 months after first delivery. Multivariate logistic regression analysis of possible contributing factors, including length of second stage of delivery, episiotomy, use of vacuum extraction, and fetal weight, was performed for all groups. One hundred seventy-two of the 278 women had a second delivery during the 5-year interval. Eighteen of these were delivered by cesarean delivery. Vacuum extraction was necessary in seven women delivering vaginally. Five women had a sphincter rupture at second delivery; 1 woman had a spontaneous rupture with no episiotomy, and 4 women in the group of 25 who had mediolateral episiotomy also sustained a sphincter rupture. Minor perineal lesions requiring sutures occurred in 75 women. There was only one perineal lesion among eight women who had a third delivery during the 5-year follow-up. At the 5-year point, 83 women (30%) had stress incontinence. Seventeen (6%) reported daily symptoms, and 23 (8%) reported social or hygienic problems due to stress incontinence. The likelihood of developing stress incontinence in the 5 years after first delivery was 3.8 times greater for women in group 1 than for women in group 0. After multivariate logistic regression analysis, only episiotomy at first delivery had borderline significance in predicting the development of stress incontinence. Compared with group 0, the risk of developing stress incontinence was 4.5 times greater for women in group 2. The use of vacuum extraction during the first delivery was the only significant risk factor remaining after analysis. Nineteen percent of the women in group 0 developed stress incontinence in the 5-year study period. No significant predicting factors were found in multivariate analysis. Among all 278 women, retrospective bivariate analysis found that episiotomy at first delivery was the only significant predicting factor for the presence of stress incontinence at 5 years. The women in group 1 had a 42% chance of stress incontinence symptoms recurring by the 5-year follow-up. In comparison, 92% of the women in group 2, those with persistent symptoms, had stress incontinence at 5 years.

Background. The purpose of this study was to determine the long-term outcome after an appendectomy during pregnancy, especially focusing on fertility. Methods. The Danish National Registry of Patients identified 117 pregnant women who had had an appendectomy during the period 1980 to 1985. One hundred-and-one of these women answered a questionnaire designed to focus on long-term complications, including infertility, during a 4 to 9 year period after the appendectomy. More than a 2-year attempt to conceive was defined as infertility. Results. Of the 101 women 15 with a normal appendix had a new intraperitoneal operation due to different indications. Three of these women had intraperitoneal adhesions. In one patient, adhesions were located on the Fallopian Tube but the location did not influence fertility. Five of the 101 women complained of infertility as defined; all had a normal appendix and none had intraperitoneal surgery during the observation period. Two of these five women conceived later during the observation period; one had confounding female and male infertility factors and two were not examined. Conclusions. Appendectomy during pregnancy of a normal, inflamed or perforated appendix does not seem to cause clinically significant intraperitoneal adhesions or infertility later in life.

This study aimed to identify predictors of European men who self-reported being diagnosed with benign prostatic hyperplasia (DxBPH) compared to men with moderate-to-severe lower urinary tract symptoms [American Urological Association Symptom Index (AUA-SI) score ≥8] who did not self-report a BPH diagnosis (non-DxBPH).Data were taken from the 2010 European National Health and Wellness Survey; a cross-sectional, self-administered, Internet-based questionnaire. This analysis included males ≥40 years with DxBPH or without DxBPH, but with AUA-SI ≥8. Chi-square tests were used for categorical variables and independent samples t tests were used for continuous variables. Logistic regressions were conducted among all men ≥40 years to predict being DxBPH.About 1,638 DxBPH and 3,676 non-DxBPH men were included. The estimated prevalence of DxBPH and non-DxBPH was 8.53 and 19.13 %. Men with DxBPH were older than non-DxBPH males (mean age 66.1 and 58.3, P 0.001). The mean AUA-SI score was 11.3 for DxBPH and 13.2 for non-DxBPH. Being older (OR = 1.077), having a university education (OR = 1.252), having private health insurance (OR = 1.186), and specific health behaviors/attitudes [regular exercise (OR = 1.191), visiting a doctor within the previous 6 months (OR = 2.398), consulting with a medical professional when not feeling well (OR = 1.097), reporting having an attentive doctor (OR = 1.112)], and higher voiding symptoms (OR = 1.032) were significant predictors of DxBPH.Older men with higher education and access to care and more engagement in their healthcare were more likely to self-report being diagnosed.

Tadalafil significantly improves lower urinary tract symptoms suggestive of benign prostatic hyperplasia. We post hoc characterized changes in the maximum urinary flow rate using integrated data from 4 international, placebo controlled studies of tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia.After a 4-week placebo lead-in period 1,500 men were randomized to tadalafil 5 mg or placebo for 12 weeks. Data were analyzed using ANCOVA. Maximum urinary flow rate values were rank transformed for analysis.Baseline maximum urinary flow rate data were available on 1,371 men with a mean age of 63.1 years and end point data were available on 1,197. Tadalafil 5 mg significantly increased maximum urinary flow vs placebo (median 1.1 vs 0.4 ml per second, p = 0.003). At a baseline voided volume of 125 to less than 250 ml the median change in the maximum urinary flow rate was 0.9 and 1.2 ml per second (p = 0.142) in 731 patients, at a baseline of 250 to 450 ml the change was -0.3 and 0.7 ml per second (p = 0.011) in 428, and at a baseline of greater than 450 ml the change was -0.2 and 2.0 ml per second (p = 0.186) in 38 for placebo and tadalafil, respectively. The difference was 0.3, 1.0 and 2.2 ml per second, respectively. At a baseline maximum urinary flow rate of greater than 15 ml per second in 128 patients the median flow rate change was -2.1 and -0.8 ml per second (p = 0.246), at a maximum of 10 to 15 ml per second in 522 the change was 0.2 and 0.8 ml per second (p = 0.044), and at a maximum of less than 10 ml per second in 547 the change was 1.2 and 1.8 ml per second (p = 0.189) for placebo and tadalafil, respectively. Tadalafil improved I-PSS (International Prostate Symptom Score) voiding subscores significantly vs placebo across all baseline maximum urinary flow subgroups (each p0.001).This integrated analysis revealed a small but statistically significant median maximum urinary flow rate improvement for tadalafil vs placebo. The numerical difference in the maximum urinary flow change from baseline between tadalafil and placebo increased with increased voided volume.

Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction. We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction.Four separate analyses used integrated data from 4 randomized, double-blind, placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS (International Prostate Symptom Score) improvement was due to improvement in IIEF-EF (International Index of Erectile Function-Erectile Function domain score). Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms.A total of 1,496 men, of whom 77% had erectile dysfunction, received at least 1 dose of tadalafil 5 mg once daily or placebo. The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 (p0.0001) in total I-PSS vs -2.2 (p = 0.0007) for men without erectile dysfunction. The correlation between change from baseline in total I-PSS and IIEF-EF was weak (r(2) = 0.08, p0.0001). The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement (2.25) was derived from a direct treatment effect of 1.57 (70%, p0.001) and an indirect treatment effect of 0.67 (30% via IIEF-EF improvement, p0.001). Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct (92.5%, p0.001) vs indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement.Regardless of the analytical approach, self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia, supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction.

Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) commonly affect older men. There is limited epidemiology information on coexisting ED and BPH. This study assessed self-reported prevalence of ED with or without a diagnosis of BPH (ED/DxBPH versus ED only) in US men.Men ≥40 years old, who reported experiencing ED in the past 6 months with or without a diagnosis of BPH, were identified from the nationally representative 2011 US National Health and Wellness Survey (NHWS) - a cross-sectional, self-administered online survey. Unpaired t-tests were used to compare characteristics between ED-only and ED/DxBPH populations.The prevalence of ED only and ED/DxBPH was 24.6% and 4.9% (mean ages of 60 and 68 years, respectively). About two-thirds of those with ED only and ED/DxBPH reported speaking to their physician about ED. About 23% of either group reported currently using ED medication and 11.7% of men with ED only were prescribed ED medication by a urologist, compared to 31.1% with ED/DxBPH. Approximately 51.7% of men with ED/DxBPH were taking BPH medication. Overall, 37.3% of men with ED only and 74.6% with ED/DxBPH reported moderate-to-severe urinary symptoms on the American Urological Association-Symptom Index (AUA-SI ≥8).While self-reported ED is common, few men with ED in the US population report being diagnosed with BPH. The majority of ED only and ED/DxBPH men reported speaking to a physician about ED; however, few reported currently taking ED medication. A majority of men with ED/DxBPH reported an AUA-SI score ≥8, but only half reported taking BPH medications. Thus, although men are experiencing erectile or urinary symptoms, many remain untreated. A limitation of this study is that symptoms and diagnosis were self-reported and may not reflect how these conditions are diagnosed in a healthcare setting; however, patient self-report provides a unique perspective on the burden associated with these conditions.

To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH-LUTS) in men without erectile dysfunction (ED). To compare these with effects in men with ED.After a 4-week washout period and 4-week placebo run-in period, 1089 men without ED (n = 338) and with ED (n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs. In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH-LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality-of-life (IPSS-QoL) subscores. Safety was assessed using treatment-emergent adverse events. The treatment-by-ED-status interaction was used to assess efficacy differences between the with/without ED subgroups.Men without ED were similar in BPH-LUTS severity/previous therapy to men with ED. Tadalafil significantly reduced BPH-LUTS from baseline when compared with placebo in men without ED (IPSS -5.4 vs -3.3, P 0.01; IPSS voiding subscore -3.5 vs -2.0, P 0.01; IPSS storage subscore -1.9 vs -1.3, P 0.05). Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED (IPSS-QoL -1.0 vs -0.7, BII -1.4 vs -1.0; both P 0.05). Between-ED-subgroup interactions were not significant (all P 0.68). Tadalafil was safe and well tolerated.Tadalafil 5 mg once daily improved BPH-LUTS in men without ED by a magnitude similar to that observed in men with ED. The adverse event profile in men without ED was consistent with that observed in men with ED.

To gain further evidence on the efficacy, safety and tolerability of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil 5 mg (n = 306) or placebo (n = 304) for 12 weeks.A significantly greater improvement (P 0.001) in total International Prostate Symptom Score for the change from baseline (week 0) to study end-point (week 12) was observed for tadalafil (-6.0) versus placebo (-4.5). Significantly greater improvements (P 0.01) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo. Significantly greater improvements (P 0.05) in International Prostate Symptom Score voiding and storage subscores, and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo. Significantly greater improvements (P 0.001) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement. No new safety concerns were identified.These findings confirm the efficacy and safety profile of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH (LUTS/BPH), improvements in nocturia were not significant in individual studies. We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies. Data were integrated from four randomized, placebo-controlled, double-blind, 12-week registrational studies of tadalafil for LUTS/BPH. Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 (IPSS Q7). Efficacy results were analyzed using analysis of covariance. For the tadalafil 5 mg once daily (N = 752) and placebo (N = 748) groups, baseline characteristics were well balanced, and the overall severity of nocturia per mean IPSS Q7 was 2.3 ± 1.2. The mean treatment change was −0.4 with placebo and −0.5 with tadalafil; the least-squares mean (standard error) treatment difference was −0.2 (0.05), p = 0.002. For patients receiving placebo and tadalafil, respectively, the proportion with improved nocturnal frequency was 41.3 and 47.5 %, with no change was 44.8 and 41.0 %, and with worsening was 13.9 and 11.5 %. A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo; however, the treatment difference was small and not considered clinically meaningful. Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH.

To assess the efficacy and safety of tadalafil, a phosphodiesterase 5 (PDE5) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH), in population subgroups, using pooled data from 4 international, randomized, placebo-controlled studies in men with LUTS/BPH.The safety database included 1500 men randomized to tadalafil 5 mg once daily or placebo for 12 weeks. Changes in total International Prostate Symptom Score (IPSS), IPSS-quality of life index, and BPH impact index were examined overall, and changes in IPSS or adverse events (AEs) were examined across subgroups of interest. Treatment-group differences were assessed using analysis of covariance.Results of pooled data confirmed that tadalafil (N = 752) resulted in significant improvements from baseline vs placebo (N = 746) in IPSS (mean difference -2.3; P.001), and also in BPH impact index and IPSS-quality of life index (both P.001). Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity (IPSS20/≥20), age (≤65/65 years), recent previous use of α-blockers or PDE5 inhibitors, total testosterone level (300/≥300 ng/dL), or prostate-specific antigen predicted prostate volume (40/≥40 mL). [corrected] Rates of treatment emergent AEs were comparable between subgroups of baseline age (≤65/65 years), previous PDE5 inhibitor use, and the presence or absence of pre-existing diabetes, hypertension, or cardiovascular disease (including hypertension), but somewhat higher for recent previous α-blocker use.In these pooled data analyses, tadalafil 5 mg improved LUTS/BPH across subgroups of age, LUTS severity, testosterone levels, and prostate volume. Rates of AEs were similar across the subgroups assessed.

Context: Clinical trials of phosphodiesterase type 5 inhibitors (PDE5-Is) have consistently demonstrated a significant reduction in lower urinary tract symptoms (LUTS) and small urinary flow rate changes in men with benign prostatic hyperplasia (BPH). Objective: This review presents the proposed mechanisms of action of PDE5-Is in the treatment of BPH-LUTS focusing on the localization of PDE5 isoenzymes in the pelvic structures; smooth muscle relaxation in the bladder, prostate, and supporting vasculature; increased blood perfusion of the bladder and prostate; and modulation of sensory impulses from these organs. Evidence acquisition: Literature describing in vitro, preclinical, or clinical studies of pathologic processes contributing to LUTS or effects of PDE5 inhibition on the lower urinary tract (LUT) was selected for review. Evidence synthesis: We objectively assessed and summarized the published data focusing on articles published within the past 10 yr. Articles before the time cut-off were included if historically relevant. Conclusions: The PDE5 isoenzymes are highly expressed in the LUT including the bladder, prostate, and their supporting vasculature. In vitro assays have demonstrated PDE5-Is by regulating cyclic guanosine monophosphate (cGMP) degradation and enhancing the nitric oxide/cGMP signaling pathway to relax human smooth muscle strips from the prostate, bladder, and LUT arteries. In animals characterized by ischemia/ hypoxia of the genitourinary tract, treatment with PDE5-Is increases bladder and prostate tissue oxygenation. PDE5-Is have been shown to reduce nonvoiding contractions and bladder afferent nerve firing in decerebrate spinal cord–injured rats, and to reduce mechanosensitive afferent activities of both Ad- and C-fibers in an irritated or overextended bladder model.

To examine the efficacy and safety of tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily placebo (n=154), tadalafil 2.5 mg (n=151), tadalafil 5.0 mg (n=155) or tamsulosin 0.2 mg (active control, n=152) for 12 weeks.Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with tadalafil 2.5 mg (-4.8, P=0.003) and 5 mg (-4.7, P=0.004) versus placebo (-3.0). Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier (week 2) for tadalafil 5.0 mg than for tadalafil 2.5 mg (week 8). Significant improvements (P0.05) in both tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore, International Prostate Symptom Score Quality of Life, and for Patient and Clinician Global Impressions of Improvement. Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for tadalafil 5.0 mg (-1.7, P=0.021), but not tadalafil 2.5 mg (-1.5, P=0.072). No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo. Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates. Safety results were consistent with the known tadalafil and tamsulosin safety profiles.Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

To investigate the impact of the first pregnancy and delivery on the prevalence and types of urinary incontinence during pregnancy and 1 year after delivery.The study was a prospective cohort study with a control group. Primiparous women, who delivered in our department from June 2003 to July 2005, participated. The women filled out a questionnaire 2-3 days after the delivery and a new questionnaire after 1 year. The questionnaires comprised basic characteristics and symptoms of urinary incontinence. An attempted age-matched control group of nulliparous women was included, and filled out similar questionnaires. Prevalences and types of urinary incontinence, and a combined severity- and bother-score (ICIQ-SF score) among the incontinent women, were calculated and compared.The two groups differed significantly in age and most basic characteristics. During pregnancy, the prevalence of any type of urinary incontinence in the primiparous group was 32.1%, compared to 13.8% in the control group. Adjusted OR = 3.3 (95%CI = 2.4-4.4). One year after delivery, the prevalence in the primiparous group was 29.3%, compared to 16.6% in the control group. Adjusted OR = 2.5 (95%CI = 1.8-3.5). ICIQ-SF mean scores among the incontinent women varied insignificantly between 5.8 and 6.2.The prevalence of urinary incontinence during pregnancy was 3.3 times higher compared with a control group of nulliparous women. After 1 year, the difference was reduced, but still 2.5 times higher in the primiparous group. The symptoms and impact on quality of life seemed to be mild to moderate in both groups.

Background: Tadalafil is being investigated for the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH-LUTS). Objective: To assess efficacy, including onset, and safety of tadalafil on BPH-LUTS and the subject's and clinician's perception of changes in urinary symptoms. Design, setting, and participants: This randomized, double-blind, placebo-controlled, 12-week trial enrolled men >= 45 yr of age with BPH-LUTS for >6 mo, International Prostate Symptom Score (IPSS) >= 13, and maximum urine flow rate (Q(max)) >= 4 to

• To evaluate the 1-year safety of 5 mg of tadalafil once daily in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS); efficacy measures were included to evaluate the maintenance of efficacy after an additional year of treatment.• In total, 427 men who completed a 12-week, placebo-controlled, dose- finding study assessing once-daily tadalafil (2.5, 5, 10 or 20 mg) or placebo elected to continue into the open-label extension period. Safety and efficacy parameters were assessed after 1 month and every 3 months.• In total, 299 patients (69.9%) completed the 1-year, open-label extension period. Treatment-emergent adverse events (TEAEs) were reported by 57.6% of patients, with most TEAEs being mild (44%) or moderate (45%) in severity; the most common TEAEs (≥ 2%) were dyspepsia, gastro-oesophageal reflux disease, back pain, headache, sinusitis, hypertension and cough. Twenty-two patients (5.2%) discontinued as a result of AEs. During the open-label extension period, mean prostate-specific antigen increased from 1.6 ± 1.3 ng/mL to 1.8 ± 1.4 ng/mL. • Mean post-void residual volume was 61.1 ± 60.4 mL at study entry and 42.2 ± 64.1 mL after the open-label extension period. Changes in the total International Prostate Symptom Score (IPSS), IPSS irritative and obstructive subscores, IPSS health-related quality of life and BPH Impact Index were maintained after 1 year. In sexually-active patients with erectile dysfunction, improvements in the International Index of Erectile Function-Erectile Function domain were maintained after 1 year.• In men with BPH-LUTS, 5 mg of tadalafil once daily during 1 year of treatment was well tolerated and efficacy changes were maintained.

A total of 305 primiparae were questioned about their urinary symptoms before and during pregnancy, in the puerperium and 3 months after delivery. All symptoms appeared late in the first trimester and progressively worsened throughout pregnancy, reaching a maximum at term. In 7% (21/293) stress incontinence, and in 4% (12/293) urge incontinence began in the puerperium. Three months postpartum urinary symptoms in the form of frequency, urgency and urge incontinence had reached prepregnancy levels, while 9 of 88 women who developed stress incontinence during pregnancy and 6 of 21 who developed stress incontinence after delivery, respectively, still complained of this symptom. According to the definition of the International Continence Society only one woman had stress incontinence, while one had urge incontinence 3 months postpartum. None of the 2 women opted for treatment. It emerges that urinary symptoms occur as a natural consequence of pregnancy and delivery, and generally the symptoms disappear within 3 months postpartum. The risk of developing persistent symptoms seems to be relatively low in the primipara.

The PDE5 inhibitor tadalafil is investigation for the treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Several clinical studies of tadalafil and other PDE5 inhibitors have reported significant symptom reduction but limited urinary flow rate improvement. This manuscript reviews the published literature describing the pathophysiology of male LUTS, with an emphasis on mechanisms that may be modulated or improved by phosphodiesterase type 5 (PDE5) inhibition.Literature (through March 2010) was obtained via Medline searches and from the individual reviewers files. Articles were selected for review based on describing in vitro, preclinical, or clinical studies of pathological processes contributing to LUTS, or possible effects of PDE5 inhibition in the lower urinary tract.Major mechanisms contributing to LUTS include: reduced nitric oxide/cyclic guanosine monophosphate signaling; increased RhoA kinase pathway activity; autonomic overactivity; increased bladder afferent activity; and pelvic ischemia. Tadalafil and other PDE5 inhibitors have demonstrated beneficial effects on smooth muscle relaxation, smooth muscle and endothelial cell proliferation, nerve activity, and tissue perfusion that may impact LUTS in men.The pathophysiology of male LUTS is complex and not completely understood. LUTS may occur independently of BPH or secondary to BPH but in both cases involve obstructive or irritative mechanisms with substantial pathophysiological overlap. While the precise mechanism remains unclear, inhibition of PDE5 seems to have an effect on several pathways that may impact LUTS.

To evaluate short- and long-term safety and efficacy of duloxetine in women with predominant stress urinary incontinence (SUI).The study was a 6-week, double-blind, randomised, parallel, placebo-controlled study followed by an uncontrolled open-label extension (OLE) run in 342 study centres in 16 European countries. Women with predominant SUI were randomly assigned to placebo (n = 1380) or duloxetine 40 mg twice daily (n = 1378) for 6 weeks. Completers of the acute phase were enrolled in the OLE, which had a minimum duration of 6 weeks and ended, based on the approval status of duloxetine in the participating country.The primary outcome measure was the change in incontinence episode frequency (IEF) over 6 weeks. Secondary outcome measures were the long-term maintenance of effect on IEF and Patient Global Impression of Improvement (PGI-I), the short- and long-term impact on quality of life using the King's Health Questionnaire (KHQ), and the long-term safety of duloxetine.After 6 weeks, the decrease in weekly IEF was significantly greater with duloxetine treatment compared to placebo (-50.0 vs. -29.9%; p0.001). The percentage of responders (defined asor =50% decrease in IEF) was significantly higher with duloxetine treatment than with placebo (50.6 vs. 31.2%; p0.001). Duloxetine treatment was associated with improvements in weekly pad use (-31.4%), PGI-I ratings (63.6%), and KHQ score (-6.25) compared to placebo (-12.5%, 48.5% and -3.13, respectively, all p0.001). Treatment-emergent adverse events were significantly more common during duloxetine treatment (48.3%) than placebo (33.3%), (p0.001). Of the 2290 patients continuing into the OLE, 1165 (42.2%) completed the available duration, and 592 (21.5%) discontinued because of an adverse event (percentages relative to total randomised patients). Long-term efficacy in the OLE was assessed over a 72-week period and was maintained over that time. However, the results should be interpreted within the context that better responding patients are more likely to remain on duloxetine, while patients responding poorly are more likely to discontinue over time.Duloxetine seems to be an efficacious treatment with an acceptable safety profile for women with SUI. Achieved improvement is maintained over the longer term in those women who remain on therapy.

First pregnancy and delivery often result in urinary incontinence. The aim of this 12-year cohort study was to estimate the impact of incontinence and the need for treatment.A total of 305 women were questioned about lower urinary tract symptoms a few days, three months, five years and 12 years after their first delivery.A total of 242 women (79%) answered a questionnaire 12 years after their first delivery. Urinary incontinence increased significantly (p0.05) during the 12-year period to a total of 114 symptomatic women (47%); 25 of 102 women had stress incontinence (SI) and seven of 49 women had urge incontinence (UI) for at least 12 years. Three of 114 incontinent women (2.6%) had received treatment, while 162 women had exercised the pelvic floor the previous three months. None underwent SI surgery. Eighteen incontinent women wanted treatment; six of whom had SI alone and 12 of whom had both SI and UI. Among the 18 SI women ten had daily symptoms, while nine experienced social or hygienic inconvenience. Among the 86 incontinent women who did not want treatment, 51 had SI alone, 24 had both SI and UI, and 11 women had UI alone. Among the 75 SI women, five had daily symptoms, while ten experienced social or hygienic inconvenience.Urinary incontinence is prevalent 12 years after first delivery, though few receive treatment. Incontinence severity is associated with a desire for treatment.

Background: Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED). Objective: To evaluate the effects of once-daily tadalafil on erectile function in men with ED and BPH-LUTS. Design, setting, and participants: Post hoc analysis of a phase 2-3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH who reported being sexually active. In contrast to typical ED trials, no sexual activity threshold was required to participate. Interventions: Screening and 4-wk washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in period; then once-daily placebo or tadalafil 2.5, 5, 10, or 20 mg for 12 wk. Measurements: International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary flow rate (Q(max)), and postvoid residual volume (PVR). Analyses were performed in men who reported being sexually active with a female partner and who expected to remain so throughout the study. IIEF-EF data are presented for the BPH/ED population overall and for subgroups stratified by baseline age group, body mass index, BPH-LUTS severity, prostate-specific antigen, prior alpha-blocker use, and prior ED therapy. Results and limitations: Overall, 581 men were included (placebo, n = 115: tadalafil 2.5 mg, n = 113; tadalafil 5 mg, n = 117; tadalafil 10 mg, n = 120; tadalafil 20 mg, n = 116). IIEF-EF domain score improvements from baseline to end point with tadalafil were 5.4 (2.5 mg), 6.8 (5 mg), 7.9 (10 mg), and 8.2 (20 mg) versus 2.0 with placebo (least-squares means; all p values < 0.001). IIEF-EF domain score improvements were observed with tadalafil for all subgroup analyses, with no significant differences between subgroup or subgroup-by-treatment interaction terms. IPSS improvements from baseline to end point were significantly greater for all tadalafil doses versus placebo (all p values

Aim To expand our understanding of the clinical importance to patients with stress urinary incontinence (SUI) of reductions in incontinence episode frequency (IEF) that fall short of a complete cure. Methods We used an integrated database that included data from 1,913 women with SUI who were enrolled in four randomized, placebo-controlled pharmaceutical clinical trials and examined the relationship between various levels of reduction in IEF and minimally clinical important difference (MCID) levels established for the validated Incontinence Quality of Life (I-QOL) questionnaire. The first decile of IEF reduction to exceed the within-group MCID was considered to be the point at which the reduction in IEF first became clinically important. The between-group MCID was then used to determine when further reductions in incontinence represented clinically relevant incremental improvements for patients. Results Improvements in condition-specific quality of life were not clinically important until the fifth decile of IEF reduction, representing a reduction in IEF >40% to ≤50%. Patients appreciated incremental clinically important benefits when IEF reductions exceeded 70%, with progressive improvements in condition-specific quality of life with higher levels of IEF reduction. The difference between a >70% to ≤80% reduction and a >90% to ≤100% reduction was clinically important. Conclusion Reductions in IEF ≤40% do not appear to be clinically important for women with SUI. Patients appear to recognize important clinical value at reductions of approximately 50% and important incremental clinical value at reductions of approximately 75% and 90–100%. These thresholds may not apply to women seeking non-pharmaceutical treatments for SUI. Neurourol. Urodynam. 29:344–347, 2010. © 2009 Wiley-Liss, Inc.

Background This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI. Methods Taiwanese women with SUI were were randomly assigned to placebo (n = 61) or duloxetine 80 mg/day (n = 60) in this double-blind, 8-week, placebo-controlled study. Outcome variables included: incontinence episode frequency (IEF), Incontinence Quality of Life questionnaire (I-QOL) scores, and Patient Global Impression of Improvement rating (PGI-I). Results Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001). No treatment differences in I-QOL scores were significant. There were significant differences in PGI-I rating. Treatment-emergent adverse events (TEAEs) were experienced by more duloxetine-treated than placebo-treated women (80.0% vs 44.3%; P < .001). Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003). Conclusion Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI. Trial Registration ClinicalTrials.gov Identifier: NCT00475358

Objective Assess the impact of subsequent urinary incontinence risk factors in women with different urinary incontinence history. Study Design In a cohort study 232 women answered validated questions about urinary incontinence after the first delivery and 12 years later. Women who were continent during the first pregnancy or postpartum period (group 1) or who became incontinent during these periods (group 2) were identified. Results Urinary incontinence symptoms 12 years after the first delivery were reported by 32.6% (44/135) in group 1 and 66.0% (64/97) in group 2. Overweight and to a minor extent pelvic organ prolapse symptoms or heavy lifting at work was associated with higher relative risk of urinary incontinence in group 1 compared with group 2. Other risk factors such as age, breastfeeding 6 months or longer after both the first and second deliveries, bowel movements or urinary infections were not associated differentially with urinary incontinence in the 2 groups. Conclusion Subsequent risk factors had a more significant impact in women without initial urinary incontinence.

The safety and tolerability of duloxetine for major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and lower urinary tract disorders (LUTD) (including female stress urinary incontinence [SUI] and other LUTDs) has been established in individual clinical studies. The objective of this manuscript is to characterize the overall safety profile of duloxetine, regardless of indication, based on data from the duloxetine exposures integrated safety database.The duloxetine exposures integrated safety database was examined using pooled data from 23,983 patients randomized to receive duloxetine in 64 studies for MDD, GAD, DPNP, fibromyalgia, or LUTDs. Evaluated aspects of drug safety included treatment-emergent adverse events (TEAEs), adverse events leading to discontinuation, serious adverse events (SAEs), clinical laboratory tests, vital signs, and electrocardiograms.Common TEAEs included nausea, headache, dry mouth, insomnia, constipation, dizziness, fatigue, somnolence, diarrhea, and hyperhidrosis. Most TEAEs emerged early; the majority were mild to moderate in severity, and did not worsen. Overall, discontinuation rates due to AEs were 20.0%. SAEs occurred at a rate of 3.5% and no single event was predominant. Mean pulse increased by2 beats per minute. Mean increases in systolic and diastolic blood pressure were1 mmHg. Mean alanine transaminase and aspartate transaminase values increased by2 U/L.The safety profile for the molecule from the overall duloxetine exposures integrated safety database suggests that benign and common pharmacologic side effects occur with duloxetine treatment. Because these pooled analyses do not allow for statistical comparison to placebo or active comparator, and include data from five different studied indications, these data do not suggest causality for AEs, nor are they necessarily generalizable to each disease stated studied.

Objective To identify poor responders, we evaluated the impact of demographic characteristics and comorbidities on efficacy using an integrated database including data from four large randomized controlled trials. Duloxetine has been shown to be effective in women with stress urinary incontinence (SUI). Study design A total of 1913 women 22–83 years of age with predominant SUI (diagnosed using a validated clinical algorithm) were randomly assigned to receive placebo ( n =955) or duloxetine ( n =958) for 12 weeks. Efficacy outcome variables included a weekly incontinence episodes frequency (IEF) from patient-completed diaries, the Incontinence Quality-of-Life (I-QOL) questionnaire score, and a Patient Global Impression of Improvement rating. Subgroups selected a priori included: ethnicity, age, body mass index (BMI), chronic lung disease, hypoestrogenism, diabetes mellitus, and depression. For safety comparisons, adverse events were compared across age and ethnicity subgroups. Results Reduction in IEF was minimal and not significantly different between duloxetine and placebo in women with chronic lung disease. The decrease in IEF for women ≥65 years of age was slightly diminished for duloxetine and placebo groups, but the treatment differences were maintained. There was a significantly different I-QOL improvement by BMI subgroup, with greater increases in scores associated with a higher BMI (>28kg/m 2 ). There were no other notable subgroup impacts on efficacy. Conclusions With the possible exception of chronic lung disease, no characteristic was identified that predicted a lack of treatment response with duloxetine in the treatment of women with SUI. Elderly patients may experience lower response rates to duloxetine presumably due to age related changes in the lower urinary tract.

In women, stress urinary incontinence is a common problem that may lead to sexual dysfunction. We review the epidemiological data, the pathophysiology, and the risk factors for these two "closet" disorders, how they are related, how we can get patients to talk about them, and how the treatment of stress urinary incontinence may affect sexual dysfunction.

Urinary incontinence in the elderly is a significant health problem fraught with isolation, depression, and an increased risk of institutionalization and medical complications. Stress urinary incontinence (SUI), the complaint of involuntary loss of urine during effort or exertion or during sneezing or coughing, is the most common type of urinary incontinence. SUI can seriously degrade the quality of life for many active seniors, and has become an economic challenge for society. With the rapid increase in the active elderly worldwide, SUI is becoming a significant global problem. However, since only a fraction of women with SUI have consulted a physician, the clinical extent and public health impact of SUI are probably underestimated. The mounting social, medical, and economic problem of SUI in active elderly women as a rapidly growing segment of the population worldwide is reviewed. We evaluate the age-related changes of the lower urinary tract, examine risk factors, and suggest different treatment options shown to be effective in reducing SUI in this population.

Background: Mania is a rare but unwelcome side effect of treating depressed patients with antidepressants. This research sought to determine the risk of treatment-emergent mania or hypomania in women with stress urinary incontinence treated with duloxetine, a balanced dual serotonin-norepinephrine reuptake inhibitor currently under investigation for the treatment of both stress urinary incontinence and major depressive disorder. Method: Data were obtained from 4 double-blind, randomized, placebo-controlled studies involving 1913 women aged 22 to 83 years and 4 ongoing uncontrolled longer-term studies involving 1877 women aged 20 to 87 years. In all studies, women had the predominant symptom of stress urinary incontinence; in the active treatment arms, all women received duloxetine 80 mg/day. Women receiving antidepressants for major depressive disorder were excluded. In the placebo-controlled studies, 1 woman reported a history of bipolar disorder and 74 women reported a history of depression. In the uncontrolled longer-term studies, 1 woman reported a history of bipolar disorder and 69 reported a history of depression. Results: In the placebo-controlled trials, 1 woman treated with duloxetine reported euphoria, while 1 reported mania and 1 reported euphoria when on placebo. In the uncontrolled longer-term studies, 1 woman reported mania; 1, euphoria; and 4, elevated moods. No women discontinued the study due to treatment-emergent mood elevation. Conclusion: These data suggest that duloxetine does not induce mania or hypomania in women with stress urinary incontinence in this population, in which few women had a history of bipolar disorder or depression and women on antidepressants were excluded.

The objective was to characterize the safety of duloxetine for treatment of stress urinary incontinence (SUI) in women, using an integrated database generated from four published placebo-controlled clinical trials.The database included 1913 women randomized to duloxetine (N=958) or placebo (N=955), examining adverse events (AEs), serious adverse events (SAEs), vital signs, electrocardiograms, and laboratory analytes. AEs occurring initially or worsening during the double-blind treatment period were considered treatment-emergent (TEAE). Differences between duloxetine-treated and placebo-treated groups were compared statistically.Common TEAEs included: nausea (23.2%), dry mouth (13.4%), fatigue (12.7%), insomnia (12.6%), constipation (11.0%), headache (9.7%), dizziness (9.5%), somnolence (6.8%), and diarrhea (5.1%). Most TEAEs that emerged early were mild to moderate, rarely worsened, and resolved quickly. Overall AE discontinuation rates were 20.5% for duloxetine and 3.9% for placebo (P.001). Most discontinuations (83%) occurred within the first month of treatment. SAEs were uncommon and did not differ between treatments. Statistically significant, but clinically unimportant mean increases in heart rate (2.4 bpm) and systolic and diastolic blood pressure (or=2 mmHg) occurred. No arrhythmogenic potential was observed and any rare, transient, asymptomatic increases in hepatocellular enzymes normalized.Duloxetine was safe and tolerable, although transient AEs were not uncommon.

Stress urinary incontinence (SUI) is the accidental leakage of urine associated with physical activities such as running, jumping or lifting, or with sneezing and coughing. Worldwide, SUI is a highly prevalent condition, both in young and elderly women, and is a condition fraught with social isolation, loss of self-esteem and significant financial burden. Most women with SUI assume that it is an inevitable part of aging and "suffer in silence", relying on absorbent pads or lifestyle changes to cope with their condition.Unfortunately, for those who do seek medical treatment, the absence of effective and well tolerated pharmacological treatments for SUI limits the clinician's choices to behavioural modification, biofeedback and surgery. Many of the nonsurgical approaches have low success rates, particularly in the elderly and more severely afflicted. Although most continence surgeries have been reported to produce very high cure rates, many women are willing to live with their condition rather than undergo such invasive options. In an attempt to help these patients, some physicians prescribe off-label agents, including tricyclic antidepressants such as imipramine, alpha- and beta-adrenoceptor agonists, and estrogen replacement therapy. The use of these therapies has been limited by unpredictable results and adverse reactions. In addition, acetylcholine receptor antagonists are often prescribed for SUI, despite the fact that these medications have never been shown to be effective in this condition. This lack of a reliable pharmaceutical agent led to the development of duloxetine, a balanced dual reuptake inhibitor of serotonin and norepinephrine that is also being studied for the treatment of major depressive disorder. Based on in vivo data in animals, duloxetine is believed to increase the strength of urethral sphincter contractions and, thereby, prevent accidental urine leakage by increasing urethral closure forces. In clinical trials in women with SUI, duloxetine has demonstrated efficacy in reducing incontinence episodes and increasing the quality of life with no serious adverse effects. Nausea was the most common adverse event; however, in most patients it was reported early in treatment, mild-to-moderate in severity and transient. A medication such as duloxetine, if approved, would go a long way towards expanding the available treatment options for patients with SUI.

BACKGROUND: The efficacy and safety of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine at the recommended starting dose, have been demonstrated in the treatment of major depressive disorder (MDD) in men and women and in the treatment of stress urinary incontinence (SUI) in women. Since the mechanism of action of duloxetine in the treatment of SUI is believed to be related to enhanced urethral closure forces, it is important to clarify the risk of acute urinary retention. METHOD: The relationship between duloxetine and obstructive voiding symptoms was examined in 8 double-blind, 8- to 9-week, placebo-controlled studies and 1 open-label study in men and women treated for MDD with duloxetine 40 to 120 mg/day and in 4 double-blind, 12-week, placebo-controlled studies and 4 ongoing open-label studies in women treated for SUI with duloxetine 80 mg/day. RESULTS: In 378 men and 761 women with MDD treated in placebo-controlled trials, 0.4% (4/1139; 3 men and 1 woman) of those treated with active medication reported subjective urinary retention versus none (0/777) of those treated with placebo (p =.15). In 958 women with SUI treated with duloxetine in placebo-controlled trials, none reported subjective urinary retention. Overall, in the duloxetine placebo-controlled clinical studies in the treatment of MDD and SUI, obstructive voiding symptoms (reported either as subjective urinary retention or other obstructive voiding symptoms) occurred more often in patients receiving duloxetine (1.0%, 20/2097) than in patients receiving placebo (0.4%, 6/1732) (p

Stress urinary incontinence (SUI) is the involuntary loss of urine associated with physical activities such as running, jumping, or lifting, or with sneezing and coughing. For many patients it can be a very bothersome symptom, causing social isolation, loss of self-esteem, and increased expenses. Although there is currently no single medication approved worldwide for the treatment of SUI, a variety of off-label agents are often prescribed. This paper reviews the current pharmacological treatment options for SUI, describing the mechanism of action, efficacy, and possible adverse effects of each. A new centrally-acting compound with dual activity as a balanced serotonin and norepinephrine reuptake inhibitor, duloxetine, may offer a promising new approach for treatment.

Aim of the study To estimate the prevalence and 5-year incidence of lower urinary tract symptoms (LUTS) after the first delivery and to evaluate the impact of pregnancy per se and delivery per se on long-lasting symptoms. Materials and methods A longitudinal cohort study of 305 primiparae questioned a few days, 3 months, and 5 years after their delivery. The questionnaire used was tested and validated, and the questions were formulated according to the definitions of the International Continence Society (ICS). Maternal, obstetric, and neonatal data concerning every delivery and objective data concerning surgeries during the observation period were obtained from the records. From the sample of 278 women (91%) who responded 5 years after their first delivery, three subpopulations were defined: 1) women without initial LUTS before or during the first pregnancy or during the puerperal period, 2) women with onset of LUTS during the first pregnancy, and 3) women with onset of LUTS during the first puerperium. The risk of LUTS 5 years after the first delivery was examined using bivariate analyses. The obstetric variables in the bivariate tests with a significant association with long-lasting urinary incontinence were entered into a multivariate logistic regression. Results The prevalence of stress and urge incontinence 5 years after first delivery was 30% and 15%, respectively, whereas the 5-year incidence was 19% and 11%, respectively. The prevalence of urgency, diurnal frequency, and nocturia 5 years after the first delivery was 18%, 24%, and 2%, respectively, whereas the 5-year incidence was 15%, 20%, and 0.5%, respectively. The prevalence of all LUTS except nocturia increased significantly during the 5 years of observation. The risk of long-lasting stress and urge incontinence was related to the onset and duration of the symptom after the first pregnancy and delivery in a dose-response–like manner. Vacuum extraction at the first delivery was used significantly more often in the group of women with onset of stress incontinence during the first puerperium, whereas an episiotomy at the first delivery was performed significantly more often in the group of women with onset of stress incontinence in the 5 years of observation. The prevalence of urgency and diurnal frequency 5 years after the first delivery was not increased in women with symptom onset during the first pregnancy or puerperium compared with those without such symptoms. The frequency of nocturia 5 years after the first delivery was too low for statistical analysis. Conclusion The first pregnancy and delivery may result in stress and urge incontinence 5 years later. Women with stress and urge incontinence 3 months after the first delivery have a very high risk of long-lasting symptoms. An episiotomy or a vacuum extraction at the first delivery seems to increase the risk. Subsequent childbearing or surgery seems without significant contribution. Long-lasting urgency, diurnal frequency, or nocturia cannot be predicted from onset during the first pregnancy or puerperium. Neurourol. Urodynam. 21:2–29, 2002. © 2002 Wiley-Liss, Inc.

The aim of the study was to estimate the prevalence and 5-year incidence of lower urinary tract symptoms after the first delivery. A total of 278 primiparae were questioned about lower urinary tract symptoms after their first pregnancy and puerperium, and again 5 years later. The prevalence of such symptoms in the study population increased significantly during the 5 years of observation. The prevalence of stress or urge incontinence 5 years after first delivery was significantly higher in women with onset during the first pregnancy or 1st puerperium than in those without incontinence before or during that period. The prevalence of urgency or frequent voiding 5 years after first delivery was not increased in the women with onset during that time compared to those without such symptoms. Stress or urge incontinence during the first pregnancy and puerperium predicts an increased risk of having the symptom 5 years later. Urgency and diurnal frequent voiding cannot be predicted from onset during that period.

Objective: A review of the literature reveals contradictive conclusions regarding appendicitis during pregnancy due to the few patients included in previous reports. Methods: From 1980 to 1985, the Danish National Patient Registry identified the patients having the WHO codes Y60 (pregnancy), 54 000 (acute appendicitis) and the operation code 43 000 (appendectomy). Each patient's file was reviewed by the authors. Results: The ratio of appendicitis ( n =58) to appendectomy ( n =117) was 50%. The appendicitis group was significantly older (26.2 years) than the normal appendix group (23.8 years). Second trimester had the highest incidence of appendicitis, perforated appendicitis and normal appendix. No effect of tocolytic agents could be demonstrated. No maternal mortality. Obstetrical complications were few and appeared only in the group having a normal appendix and first after discharge. Conclusions: Pregnant women suspected of having appendicitis should be evaluated as non-pregnant women. Use of tocolytic agents is a matter of choice. Obstetrical complications are few and not related to the surgical trauma.