First dose of misoprostol administration at home or in hospital for medical abortion between 12-22 gestational weeks in Sweden (PRIMA): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Medical abortion after 12 gestational weeks often requires a stay in hospital. We hypothesised that administering the first misoprostol dose at home could increase day-care procedures as compared with overnight care procedures, shorten inpatient stays, and improve patient satisfaction. METHODS: This multicentre, open-label, randomised controlled trial was done at six hospitals in Sweden. Participants were pregnant people aged 18 years and older who were undergoing medical abortion at 85-153 days of pregnancy. Randomisation was done in blocks 1:1 to mifepristone administered in-clinic followed by home administration or hospital administration of the first dose of misoprostol. Allocation was done by opening of opaque allocation envelopes. Due to the nature of the intervention, masking was not feasible. Between 24-48 h after mifepristone 200 mg, the participants administered 800 µg of misoprostol either at home 2 h before admission to hospital or in hospital. The primary outcome was the proportion of day-care procedures (defined as abortion completed in <9 h). The intention-to-treat analysis included all participants randomly assigned to receive the study drug and who had known results for the primary outcome. Individuals who received any treatment were included in the safety analyses. This trial is registered at ClinicalTrials.gov, NTC03600857, and EudraCT, 2018-000964-27. FINDINGS: Between Jan 8, 2019, and Dec 21, 2022, 457 participants were randomly assigned to treatment groups. In the intention-to-treat-population, 220 participants were assigned to the home group and 215 to the hospital group. In the home group, 156 (71%) of 220 participants completed the abortion as day-care patients, compared with 99 (46%) of 215 in the hospital group (difference 24·9%, 95% CI 15·4-34·3; p<0·0001). In total, 97 (22%) of 444 participants in the safety analysis had an adverse event. Seven (2%) of 444 participants aborted after mifepristone only. Two (1%) of 220 in the home group aborted after the first dose of misoprostol, before hospital admission. INTERPRETATION: Home administration of misoprostol significantly increases the proportion of day-care procedures in medical abortion after 12 gestational weeks, offering a safe and effective alternative to in-clinic protocols. FUNDING: Region Västra Götaland, Hjalmar Svensson's Fund, the Gothenburg Society of Medicine, Karolinska Institutet-Region Stockholm, and The Swedish Research Council.

Placement of an intrauterine device within 48 hours after second-trimester medical abortion: a randomized controlled trial.

BACKGROUND: International guidelines recommend placement of intrauterine devices immediately after second-trimester medical abortion, but evidence concerning the optimal time for intrauterine device placement is lacking from clinical trials. OBJECTIVE: This study aimed to investigate effectiveness, safety, and acceptability of intrauterine device placement within 48 hours, compared with placement at 2 to 4 weeks after second-trimester medical abortion. We hypothesized that intrauterine device placement within 48 hours would be superior compared with placement at 2 to 4 weeks after the abortion, in terms of the proportion of intrauterine device use after 6 months, with maintained safety and acceptability. STUDY DESIGN: In this open-label, randomized, controlled, superiority trial, we recruited participants at 8 abortion clinics in Sweden. Eligible participants were aged ≥18 years, requesting medical abortion with gestation ≥85 days, and opting for use of a postabortion intrauterine device. Participants were randomized (1:1) to intrauterine device placement either within 48 hours of complete abortion (intervention) or after 2 to 4 weeks (control). Our primary outcome was self-reported use of an intrauterine device after 6 months. Secondary outcomes included expulsion rates, pain at placement, adverse events and complications, acceptability, and subsequent pregnancies and abortions. Differences in nonnormal continuous variables were analyzed with the Mann-Whitney U test, and differences in dichotomous variables with the chi-square or Fisher exact tests. A P value <.05 was considered statistically significant. Group differences are presented by modified intention-to-treat and per-protocol analyses. RESULTS: Between January 2019 and June 2022, we enrolled 179 participants, of whom 90 were assigned to the intervention and 89 to the control arm. Enrollment was prematurely stopped after an interim analysis exceeded a predefined intrauterine device expulsion rate of 20%. According to modified intention-to-treat analysis, use of intrauterine device after 6 months was 50.7% (34/67) in the intervention group vs 71.6% (48/67) in the control group (proportion difference, 20.9%; 95% confidence interval, 4.4%-35.9%; P=.02). The intrauterine device expulsion rate was 30.1% (22/73) in the intervention group vs 2.9% (2/70; P<.001) in the control group. Other adverse events were rare and patient acceptability was high in both groups. CONCLUSION: Intrauterine device placement within 48 hours after second-trimester medical abortion was nonsuperior in terms of the proportion of intrauterine device use after 6 months when compared with placement after 2 to 4 weeks. Placement within 48 hours after second-trimester abortion can be used in selected individuals after counseling on expulsion risk.

Dyspareunia and pelvic pain: comparison of mid-urethral sling methods 10 years after insertion.

INTRODUCTION AND HYPOTHESIS: The mid-urethral sling (MUS) has been used for more than 30 years to cure stress urinary incontinence. The objective of this study was to assess whether surgical technique affects the outcome after more than ten years, regarding dyspareunia and pelvic pain. METHODS: In this longitudinal cohort study we used the Swedish National Quality Register of Gynecological Surgery to identify women who underwent MUS surgery in the period 2006-2010. Out of 4348 eligible women, 2555 (59%) responded to the questionnaire sent out in 2020-2021. The two main surgical techniques, the retropubic and the obturatoric approach, were represented by 1562 and 859 women respectively. The Urogenital Distress Inventory-6 (UDI-6) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), as well as general questions concerning the MUS surgery, were sent out to the study population. Dyspareunia and pelvic pain were defined as primary outcomes. Secondary outcomes included PISQ-12, general satisfaction, and self-reported problems due to sling insertion. RESULTS: A total of 2421 women were included in the analysis. Among these, 71% responded to questions regarding dyspareunia and 77% responded to questions regarding pelvic pain. In a multivariate logistic regression analysis of the primary outcomes, we found no difference in reported dyspareunia (15% vs 17%, odds ratio (OR) 1.1, 95% CI 0.8-1.5) or in reported pelvic pain (17% vs 18%, OR 1.0, 95% CI 0.8-1.3) between the retropubic and obturatoric techniques among study responders. CONCLUSION: Dyspareunia and pelvic pain 10-14 years after insertion of a MUS do not differ with respect to surgical technique.

Postpartum perineal pain and its association with sub-classified second-degree tears and perineal trauma-A follow-up of a randomized controlled trial.

INTRODUCTION: Postnatal perineal pain is prevalent following childbirth and can impact women both physically and emotionally. The aim of the study was to study the effect of collegial midwifery assistance on perineal pain and pain medication 1 month after birth and to investigate the associations between the type of tear and perineal pain, satisfaction with healing, and resumption of intercourse. MATERIAL AND METHODS: A follow-up questionnaire was sent 1 month postpartum to women with a first spontaneous vaginal birth participating in a randomized controlled trial (Oneplus trial). Data were collected from December 2019 to May 2020. Differences in perineal pain between women attended by one or two midwives were analyzed according to intention-to-treat using bivariate analyses. Associations between the type of tear and perineal pain, satisfaction with healing, and resumption of sexual intercourse were investigated using univariable and multivariable logistic regression. The category no tear/first-degree tear was compared separately to each of the other tear categories. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03770962. RESULTS: Out of 2233 women, 1762 responded within 30-60 days postpartum. Of women in the no tear/first-degree tear category, 27.7% reported perineal pain during the past week, in contrast to women with OASI, where 64.2% reported perineal pain. Women with OASI experienced the highest odds of perineal pain (aOR 4.51, 95% CI 2.72-7.47) compared to those with no tear/first-degree tear, followed by women with major second-degree tears (aOR 1.87, 95% CI 1.45-2.41), women with an episiotomy (aOR 1.78, 95% CI 1.11-2.87), and those with minor second-degree tears (aOR 1.43, 95% CI 1.06-1.94). Women with episiotomy reported the highest odds ratios for dissatisfaction with tear healing (aOR 3.48, 95% CI 1.92-6.31). No significant differences in perineal pain and pain medication were observed between women allocated to collegial midwifery assistance and those allocated to standard care. CONCLUSIONS: Women with OASI reported the highest odds of perineal pain 30-60 days after birth compared to women with no tear or first-degree tear, followed by women with major second-degree tears. Women subjected to an episiotomy reported highest odds ratios of dissatisfaction with tear healing.

The effect of two midwives during the second stage of labour to reduce severe perineal trauma (Oneplus): a multicentre, randomised controlled trial in Sweden.

BACKGROUND: Severe perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife. METHODS: In this multicentre, randomised, controlled parallel group, unmasked trial done at five obstetric units in Sweden, women were randomly assigned to be assisted by either one or two midwives in late second stage. Nulliparous women and women planning the first vaginal birth after caesarean section who were age 18-47 years were randomly assigned to an intervention when reaching the second stage of labour. Further inclusion criteria were gestational week 37+0, carrying a singleton live fetus in vertex presentation, and proficiency in either Swedish, English, Arabic, or Farsi. Exclusion criteria were a multiple pregnancy, intrauterine fetal demise, a planned caesarean section, or women who were less than 37 weeks pregnant. Randomisation to the intervention group of two midwives or standard care group of one midwife (1:1) was done using a computer-based program and treatment groups were allocated by use of sealed opaque envelopes. All women and midwives were aware of the group assignment, but the statistician from Clinical Studies Forum South, who did the analyses, was masked to group assignment. Midwives were instructed to implement existing prevention models and the second midwife was to assist on instruction of the primary midwife, when asked. Midwives were also instructed to complete case report forms detailing assistance techniques and perineal trauma prevention techniques. The primary outcome was the proportion of women who had SPT, for which odds ratios (ORs) and 95% CIs were calculated, and logistic regression was done to adjust for study site. All analyses were done according to intention to treat. The trial is registered with ClinicalTrials.gov, NCT0377096. FINDINGS: Between Dec 10, 2018, and March 21, 2020, 8866 women were assessed for eligibility, and 4264 met the inclusion criteria and agreed to participate. 3776 (88·5%) of 4264 women were randomly assigned to an intervention after reaching the second stage of labour. 1892 women were assigned to collegial assistance (two midwives) during the second stage of labour and 1884 women were assigned to standard care (one midwife). 13 women in each group did not meet the inclusion criteria and were excluded. After further exclusions, 1546 women spontaneously gave birth in the intervention group and 1513 in the standard care group. 1546 women in the intervention group and 1513 in the standard care group were included in the intention-to-treat analysis of the primary outcome. There was a significant reduction in SPT in the intervention group (3·9% [61 of 1546] vs 5·7% [86 of 1513]; adjusted OR 0·69 (0·49-0·97). INTERPRETATION: The presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time. FUNDING: The Swedish Research Council for Health, Working Life and Welfare; Jan Hains Research Foundation; and Skane County Council's Research and Development Foundation.

Retropubic slings are more efficient than transobturator at 10-year follow-up: a Swedish register-based study.

INTRODUCTION AND HYPOTHESIS: Long-term performance of mid-urethral slings (MUS) and potential differences between the retropubic and the transobturator technique for insertion are scarcely studied. This study aims to evaluate the efficacy and safety 10 years after surgery and compare the two main surgical techniques used. METHODS: Women who underwent surgery with a MUS between 2006 and 2010 were identified using the Swedish National Quality Register of Gynecological Surgery and were invited 10 years after the operation to answer questionnaires regarding urinary incontinence and its impact on quality-of-life parameters (UDI-6, IIQ-7) and impression of improvement, as well as questions regarding possible sling-related complications and reoperation. RESULTS: The subjective cure rate reported by 2421 participating women was 63.3%. Improvement was reported by 79.2% of the participants. Women in the retropubic group reported higher cure rates, lower urgency urinary incontinence rates and lower UDI-6 scores. No difference was shown between the two methods regarding complications, reoperation due to complications or IIQ-7 scores. Persisting sling-related symptoms were reported by 17.7% of the participants, most commonly urinary retention. Mesh exposure was reported by 2.0%, reoperation because of the tape by 5.6% and repeated operation for incontinence by 6.9%, significantly more in the transobturator group (9.1% vs. 5.6%). Preoperative urinary retention was a strong predictor for impaired efficacy and safety at 10 years. CONCLUSIONS: Mid-urethral slings demonstrate good results for the treatment of stress urinary incontinence and tolerable complication profiles in a 10-year perspective. The retropubic approach displays higher efficacy than the transobturator, with no difference regarding safety.

Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective was to compare the effect of antibiotics versus no antibiotics prophylaxis per-operatively on the frequency of urinary tract infection (UTI) following mid-urethral sling application to treat stress or mixed urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women were included from eight centers in three countries. Women were aged under 60 years and had objectively verified stress urinary incontinence. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either antibiotics or no antibiotics. UTI was defined in accordance with the Centers for Disease Control (CDC) criteria for symptomatic UTI. Women were followed up at 3, 12, and 36 months. This was part of a trial comparing subjective cure rate in relation to application of Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings. RESULTS: The main outcome was to evaluate if per-operative antibiotics had any impact on UTI following sling surgery. In total, 305 women were randomized (158 [52%] to antibiotics and 147 [48%] to no antibiotics). Demographic data disclosed no differences between the two groups. The trial did not show any difference between the two groups regarding the frequency of postoperative UTI. Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs. Per-operative antibiotics had no influence on the frequency of mesh erosions or any other complication. CONCLUSIONS: Our trial does not suggest any beneficial effect of per-operative antibiotics on the risk of post-operative UTIs.

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. RESULTS: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. CONCLUSIONS: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial.

INTRODUCTION: The primary aim of this study was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS). The secondary aim was to report pain perception and complications at the one-year follow up. MATERIAL AND METHODS: The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary incontinence were included. All women were randomized to SIMS (Ajust® ; n = 155) or SMUS (TVT, TVT-O or TOT; n = 150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using ICIQ-SF, PISQ-12 and PGI-S and PGI-I. Objective cure was defined as no leakage during a stress test and subjective cure defined as no leakage stated in the bladder diary or no indication of urinary leakage in the ICIQ-SF. Furthermore, mesh exposure and dyspareunia were recorded. RESULTS: In total, 280 women [141 (91%) in the SIMS and 139 (94%) in the SMUS groups] participated in the one-year follow up. No difference between the groups was observed regarding objective and subjective outcomes. VAS score disclosed a lower postoperative pain perception in the SIMS group than in the SMUS group. CONCLUSIONS: Ajust® appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period.

Informed consent to midwifery practices and interventions during the second stage of labor-An observational study within the Oneplus trial.

OBJECTIVES: To study informed consent to midwifery practices and interventions during the second stage of labor and to investigate the association between informed consent and experiences of these practices and interventions and women's experiences of the second stage of labor. METHODS: This study uses an observational design with data from a follow-up questionnaire sent to women one month after giving birth spontaneously in the Oneplus trial, a study aimed at evaluating collegial midwifery assistance to reduce severe perineal trauma. The trial was conducted between 2018-2020 at five Swedish maternity wards and trial registered at clinicaltrials.gov, no NCT03770962. The follow-up questionnaire contained questions about experiences of the second stage of labor, practices and interventions used and whether the women had provided informed consent. Evaluated practices and interventions were the use of warm compresses held at the perineum, manual perineal protection, vaginal examinations, perineal massage, levator pressure, intermittent catheterization of the bladder, fundal pressure, and episiotomy. Associations between informed consent and women's experiences were assessed by univariate and multivariable logistic regression. FINDINGS: Of the 3049 women participating in the trial, 2849 consented to receive the questionnaire. Informed consent was reported by less than one in five women and was associated with feelings of being safe, strong, and in control. Informed consent was further associated with more positive experiences of clinical practices and interventions, and with less discomfort and pain from interventions involving physical penetration of the genital area. CONCLUSION: The findings indicate that informed consent during the second stage is associated with feelings of safety and of being in control. With less than one in five women reporting informed consent to all practices and interventions performed by midwives, the results emphasize the need for further action to enhance midwives' knowledge and motivation in obtaining informed consent prior to performance of interventions.

Impact of collegial midwifery assistance during second stage of labour on women's experience: a follow-up from the Swedish Oneplus randomised controlled trial.

OBJECTIVE: To compare experiences of the second stage of labour in women randomised to assistance by one or by two midwives to reduce severe perineal trauma (SPT). DESIGN: Analysis of a secondary outcome within the Swedish Oneplus multicentre randomised trial. SETTING: Five obstetric units in Sweden between December 2018 and March 2020. PARTICIPANTS: Inclusion criteria in the Oneplus trial were women opting for their first vaginal birth from gestational week 37+0 with a singleton pregnancy and a live fetus in the vertex presentation. Further inclusion criteria were language proficiency in Swedish, English, Arabic or Farsi. Exclusion criteria were multiple pregnancies, intrauterine fetal demise and planned caesarean section. Of the 3059 women who had a spontaneous vaginal birth, 2831 women had consented to participate in the follow-up questionnaire. INTERVENTIONS: Women were randomly assigned (1:1) to assistance by two midwives (intervention group) or one midwife (standard care) when reaching the second stage of labour. OUTCOME MEASURES: Data were analysed by intention to treat. Comparisons between intervention and standard care regarding experiences of the second stage of labour were evaluated with items rated on Likert scales. The Student's t-test was used to calculate mean differences with 95% CIs. RESULTS: In total 2221 (78.5%) women responded to the questionnaire. There were no statistically significant differences regarding women's experiences of being in control, feelings of vulnerability or pain. Women randomised to be assisted by two midwives agreed to a lesser extent that they could handle the situation during the second stage (mean 3.18 vs 3.26, 95% CI 0.01 to 0.15). Conducted subgroup analyses revealed that this result originated from one of the study sites. CONCLUSIONS: The intervention's lack of impact on the experience of the second stage is of importance considering the reduction in SPT when being assisted by two midwives. TRIAL REGISTRATION NUMBER: NCT03770962.

One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. RESULTS: No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p < 0.0001). CONCLUSION: The TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

Women's experiences of the second stage of labour.

BACKGROUND: The second stage of labour is generally considered as an intensive part of labour. Despite this, knowledge about women's experiences of the second stage of labour is scant. AIM: To explore experiences of the second stage of labour in women with spontaneous vaginal birth. METHODS: This is a qualitative study where twenty-one women with a spontaneous birth at term, were interviewed four to ten weeks after birth. Data were analysed using qualitative thematic analysis based on descriptive phenomenology. The participating women had experienced a vaginal birth; some for the first time, having previously given birth by caesarean section and some with a previous vaginal birth. FINDINGS: Three themes emerged: "An experience of upheaval" which represents the women's experiences of intensity, power and pain during the second stage of labour. "The importance of trusting relationships" signifies the meaning of women's relationships during the second stage of labour. "Becoming a mother" which is characterised by feelings of accomplishment and the experience of the final moments of birth. CONCLUSION: During the second stage of labour women experienced overwhelming sensations which made evident the importance of trusting relationships with those involved in the birth. The women were in a transformative state between pregnancy and motherhood where experiences of being involved and being provided with information and guidance were all considered crucial. Continuous support should be offered to women during the second stage of labour.

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. RESULTS: No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001). CONCLUSIONS: In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

Validation of the Swedish short forms of the Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).

OBJECTIVE: To psychometrically evaluate the Swedish translations of the short forms of the Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). DESIGN AND SETTING: Cross-sectional design, University hospital. SAMPLE: Forty-four patients awaiting prolapse surgery. METHODS: The dual-panel translation method followed by an evaluation of validity and reliability in prolapse patients. MAIN OUTCOME MEASURES: Construct, convergent and discriminant validity, reliability via test-retest and internal consistency. RESULTS: Item response rates were high (range 95.5-100%) for PFIQ-7 and PFDI-20. The corrected item-total correlations showed acceptable construct validity for PFIQ-7 (r=0.338-0.826) but low for PFDI-20 (r=0.116-0.581) and PISQ-12 (r=0.024-0.735). Acceptable convergent validity was found in all three instruments, with a negative correlation with the SF-12. There were no floor or ceiling effects in the three instruments. In the test-retest analysis, intraclass correlation coefficients were significant (r=0.888-0.943). Cronbach's α varied between 0.57 and 0.94. CONCLUSION: This is the first validated translation of the PFIQ-7, PFDI-20 and PISQ-12 in Swedish. All three instruments indicated acceptable psychometric properties.

Efficacy and safety of pelvic organ prolapse surgery with porcine small intestinal submucosa graft implantation.

OBJECTIVE: The ideal implant material for the surgical repair of pelvic organ prolapse in women is yet to be found. This retrospective study aims to evaluate a porcine small intestinal submucosa (SIS) graft (Surgisis™). STUDY DESIGN: We reviewed the medical records of women that were operated upon for pelvic organ prolapse using implantation of SIS graft and we examined the short-term complications and recurrence rates. RESULTS: A total of 155 surgical procedures were reviewed. SIS graft was placed in the anterior, posterior and middle compartments in 93 (60%), 71 (45.8%) and 13 (8.4%) cases, respectively. At three-month follow-up, 22.6% of anterior graft repairs displayed anatomical recurrence (POP-Q stage ≥ 2), compared to 4.8% of posterior and none of the middle compartment graft repairs. During the three postoperative months, 56% of the women were recorded with complications, mostly urinary retention (19%) and pain (12%). The incidence of grade III complications was 5.3%. Persistent complications at three months were observed in 28% of all cases. Logistic regression analysis showed that previous prolapse surgery at the same compartment was a significant predictor for recurrence of prolapse after SIS graft application, whereas lower age, smoking and longer duration of surgery were significant predictors for the development of complications. Younger women had higher risk of developing pain postoperatively. CONCLUSION: Pain and urinary tract symptoms hold a central position in the complications profile of SIS graft-augmented prolapse surgery. The relatively high recurrence rates do not suggest a clear benefit from SIS graft use.

A serious bleeding complication with injury of the corona mortis with the TVT-Secur procedure.

We report a serious complication following a TVT-Secur procedure due to injury of the corona mortis requiring a surgical intervention for removal of 1 l of clotted blood from the space of Retzius. The corona mortis is an anomaly of the vessel combining the obturator and epigastric arteries passing over the superior pubic ramus, well known to hernia and orthopedic surgeons but probably less well known to gynecological surgeons.

The relation between urinary incontinence and steroid hormone levels in perimenopausal women. A report from the Women's Health in the Lund Area (WHILA) study.

OBJECTIVE: To outline possible associations between urinary incontinence (UI) and serum levels of steroid hormones in middle-aged women. DESIGN AND SETTING: Community-based observational study. SAMPLE: All women aged 50-59 living in the Lund area by December 1995 were invited to a screening procedure. Sixty-four percent (n = 6,917) attended the screening that included physical and laboratory examinations and questionnaires. METHODS: Serum levels of cortisol, testosterone, androstendione, SHBG (sex hormone-binding globulin), and estradiol were analyzed and the 2,221 (32%) women who reported urinary leakage causing a social or hygienic problem were compared to those who denied incontinence. MAIN OUTCOME MEASURE: Possible differences in serum levels of steroid hormones in continent and incontinent women. RESULTS: There were no significant differences between continent and incontinent women regarding serum levels of cortisol, testosterone, androstendione, or testosterone + androstendione combined. Serum estradiol adjusted for body mass index, parity, smoking, and hysterectomy was significantly higher in incontinent women (87.1 +/- 138.4 pmol/l vs. 78.0 +/- 118.5 pmol/l, p = 0.005), whereas the ratio estradiol/SHBG was not. These differences persisted when the group of women not on hormonal treatment was analyzed. CONCLUSIONS: UI in middle-aged women seems related to higher serum estradiol levels. This corroborates with studies showing a higher incidence and/or prevalence of UI in women on hormone therapy. No association between UI and serum levels of cortisol, testosterone, or androstendione was found.