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.
Objective To investigate the prevalence of and factors associated with overactive bladder in middle‐aged women.
Design Cross sectional population‐based study.
Setting Southern Sweden and the ...Women's Health in the Lund Area study (WHILA 1995–2000) where 6917 (64% of the invited) women, 50–59 years old in 1995, participated.
Population From the WHILA study, 1500 women reporting troublesome urinary incontinence (INCONT‐1) and 1500 without incontinence (CONT‐1) were selected by computerised randomisation and received the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaire in January 2001.
Methods Overactive bladder was defined in two versions using the ICS definition of 2002 as either urgency alone (OAB‐1) or urgency combined with frequency more than eight times per day and/or nocturia twice or more per night (OAB‐2). Risk factors were analysed by multiple logistic regression analyses.
Main outcome measures Prevalence figures and odds ratios with corresponding 95% confidence intervals.
Results The prevalence of OAB‐1 was 46.9% in the INCONT‐1 and 16.7% in the CONT‐1 group, and that of OAB‐2 was 21.6% and 8.1%, respectively. Most urgency occurred in combination with stress incontinence (i.e. as mixed incontinence). The overlap between stress and urge symptoms increased with the frequency of stress incontinence episodes (P < 0.001). Metabolic risk factors were body mass index (BMI) ≥ 30 for OAB‐1, OAB‐2 and stress incontinence, positive metabolic screening for OAB‐1, family history of diabetes for OAB‐2 and elevation of BMI ≥ 25% since the age of 25 for stress incontinence. Stress incontinence was associated with the current use of hormonal replacement therapy.
Conclusions Overactive bladder and stress incontinence are intimately associated with each other. Both OAB and stress incontinence are associated with abnormal metabolic factors, mainly increased BMI.
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 wasfound.
Our aim was to compare the urethral pressure response pattern to pelvic floor muscle contractions in 20-27 years old, nulliparous continent women (n = 31) to that of continent (n = 28) and formerly ...untreated incontinent (n = 59) (53-63 years old) women. These women underwent urethral pressure measurements during rest and repeated pelvic muscle contractions. The response to the contractions was graded 0-4. The young continent women showed a mean urethral pressure response of 2.8, the middle-aged continent women 2.2 (NS vs young continent), and the incontinent women 1.5 (p < 0.05 vs middle-aged continent, p < 0.001 vs young continent). Urethral pressures during rest were significantly higher in the younger women than in both groups of middle-aged women. The decreased ability to increase urethral pressure on demand seen in middle-aged incontinent women compared to continent women of the same age as well as young women seems to be a consequence of a neuromuscular disorder rather than of age.
•The ideal material for the enhancement of prolapse surgery is yet to be found.•We examine the efficacy and safety of a porcine small intestinal submucosa graft.•Recurrence rates comparable to native ...tissue repairs are observed.•The complications profile is dominated by pain and urinary tract related symptoms.•There are no clear benefits from the use of this graft in prolapse surgery.
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™).
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.
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.
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.
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. 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. 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. 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.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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.
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.
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.
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.
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.
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.
Objective
To compare the 1–year (previously published) and 3–year objective and subjective cure rates, and complications, related to the use of a collagen‐coated transvaginal mesh for anterior ...vaginal wall prolapse against a conventional anterior repair.
Design
Randomised controlled study.
Setting
Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.
Population
A total of 138 women, of 55 years of age or older, admitted for stage ≥2 anterior vaginal wall prolapse.
Methods
The women scheduled for primary anterior vaginal wall prolapse surgery were randomised between conventional anterior colporrhaphy and surgery with a collagen‐coated prolene mesh. All patients were evaluated using the Pelvic Organ Prolapse Quantification (POP–Q) assessment before and after surgery. Symptoms related to pelvic organ prolapse were evaluated using the Pelvic Floor Impact Questionnaire (PFIQ–7) and the Pelvic Floor Distress Inventory (PFDI–20).
Main outcome measures
Objective cure, defined as POP–Q stage <2 prolapse at the 1‐ and 3–year follow‐ups. Furthermore, mesh exposure and dyspareunia were also recorded.
Results
In total, 138 patients (70 from the mesh group versus 68 from the conventional anterior colporrhaphy group) out of 160 (86.3%) participated in the 3–year follow‐up. POP–Q revealed an objective anatomic cure for 88.1 and 91.4%, respectively, in the mesh group at the 1‐ and 3–year follow‐ups, compared with 39.9 and 41.2% in the colporrhaphy group. No difference between the groups was observed regarding PFIQ–7, PFDI–20, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ–12) scores. The number of mesh exposures did not change during the study period and all exposures were minor.
Conclusion
Our study demonstrates that although the objective outcome was superior in the mesh group, the use of mesh had no impact on the subjective outcome.
Tweetable
POP–Q deteriorates after anterior prolapse surgery but remains stable in women with mesh implantation.
Tweetable
POP–Q deteriorates after anterior prolapse surgery but remains stable in women with mesh implantation.
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.
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.
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).
The presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time.
The Swedish Research Council for Health, Working Life and Welfare; Jan Hains Research Foundation; and Skane County Council's Research and Development Foundation.
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