The tension-free vaginal tape operation: Is the inexperienced surgeon a risk factor? Learning curve and Swedish quality reference.

INTRODUCTION: To reduce the risk of avoidable damage to the patient when training surgeons, one must predefine what standards to achieve, as well as supervise and monitor trainees' performance. The aim of this study is to establish a quality reference, to devise comprehensive tension-free vaginal tape (TVT) learning curves and to compare trainees' results to our quality reference. MATERIAL AND METHODS: Using the Swedish National Quality Register for Gynecologic Surgery, we devised TVT learning curves for all Swedish TVT trainees from 2009 to 2017, covering their first 50 operations. These outcomes were compared with the results of Sweden's most experienced TVT surgeons for 14 quality variables. RESULTS: In all, 163 trainees performed 2804 operations and 40 experienced surgeons performed 3482 operations. For our primary outcomes - perioperative bladder perforations and urinary continence after 1 year - as well as re-admission, re-operation and days to all daily living activities, there was no statistically significant difference between trainees and experienced surgeons at any time. For the first 10 trainee operations only, there were small differences in favor of the experienced surgeons: patient-reported minor complications after discharge (14% vs 18.4%, P = .002), 1-year patient-reported improvement (95.9% vs 91.8%, P < .000), and patient satisfaction (90.9% vs 86.2%, P = .002). For both trainee operations 1-10 and 11-50, compared with experienced surgeons, operation time (33.8 vs 22.2 min, P < .000; 28.3 vs 22.2 min, P < .000) and hospital stay time (0.16 vs 0.06 days, P < .001; 0.1 vs 0.06 days, P < .001) were longer, perioperative blood loss was higher (27.7 vs 24.4 mL, P = .001; 26.5 vs 24.4 mL, P = .004), and patient-reported catheterization within 8 weeks was higher (3.9% vs 1.8%, P < .000; 2.5% vs 1.8%, P = .001). One-year voiding difficulties for trainee patients (operations 1-10:14.2%, P = .260; operations 11-50:14.5%, P = .126) were comparable to the experienced surgeons (12.4%). CONCLUSIONS: There is a learning curve for several secondary outcomes but the small effect size makes it improbable that the difference has clinical significance. Our national Swedish results show that it is possible to train new TVT surgeons without exposing patients to noteworthy extra risk and achieve results which are equivalent to the most experienced Swedish surgeons.

Smoking cessation prior to gynecological surgery-A registry-based randomized trial.

INTRODUCTION: Smoking cessation, both pre- and postoperatively, is important to reduce complications associated with surgery. Identifying feasible and effective means of alerting the patient before surgery to the importance of perioperative smoking cessation is a challenge to healthcare systems. MATERIAL AND METHODS: A randomized registry-based trial using the web-version of the Swedish national quality register for gynecological surgery, GynOp, was performed (ClinicalTrials.gov NCT03942146). Current smokers scheduled for gynecological surgery were randomly assigned before surgery to group 1 (control group, no specific information), group 2 (web-based written information), group 3 (information to doctor that the woman was a smoker and should be recommended smoking cessation or group 4 (a combination of groups 2 and 3). Perioperative smoking habits were evaluated in a postoperative questionnaire 2 months after surgery. The treatment effect was estimated to be a 15% reduction in the number of smokers at the time of surgery. Thus, 94 women in each group were required, in total 376 women, using a one-sided test with an alpha level of 0.001 and a statistical power of 80%. RESULTS: Participants (n = 1427) were recruited between 5 November 2015 and 6 December 2017. A total of 1137 smokers responded to the follow-up questionnaire (80%), with 486 women declining to participate, leaving 651 women eligible for analysis. Women who received both web-based information prior to surgery and information from a doctor, reported smoking cessation more often from 1 to 3 weeks preoperatively (Odds ratio [OR] 1.8, 95% confidence interval [CI] 1.0-3.3) and 1 to 3 weeks after surgery (OR 1.9, 95% CI 1.1-3.3) compared with the control group who received no specific information. CONCLUSIONS: A combination of written information in the health declaration and a recommendation from a doctor regarding smoking cessation may be associated with higher odds of smoking cessation at 1-3 weeks pre- and postoperatively.

A Swedish population-based evaluation of benign hysterectomy, comparing minimally invasive and abdominal surgery.

OBJECTIVE: The aim was to evaluate surgical routes for benign hysterectomy in a Swedish population, including abdominal and minimally invasive surgery. STUDY DESIGN: Prospectively collected data from the Swedish National GynOp Registry 2009-2015: 13 806 hysterectomy cases were included: abdominal (AH, n = 7485), vaginal (VH, n = 3767), conventional laparoscopic (LH, n = 1539) and robotically-assisted (RAH, n = 1015). RESULTS: The VH group had the shortest operation time at 75 min, AH 97 min and RAH 104 min. LH was longest at 127 min (p < 0.005). The mean estimated blood loss was higher in the AH group (250 ml) compared to all minimally invasive surgery (MIS, 65-172 ml); p < 0.005). Conversion rates were 10% for LH, 4.8% for VH and 1.6% for RAH (p < 0.005). Hospitalization and patient-reported time to normal activities of daily living (ADL) were longer for AH compared to MIS (p < 0.005). Time to return to work was eight days longer in the AH group (35 days) compared with the MIS groups (p < 0.005). Complications were fewest in the VH group at 5.4% compared with AH 7.6% and RAH 8.7% (both p < 0.001), but did not significantly differ from the LH group at 6.6%. Overall patient satisfaction was reported to be 86-94% one year after surgery. CONCLUSION: Women operated on for benign hysterectomy with minimally invasive methods in Sweden 2009-2015 had reduced length of hospitalization, as well as time to resuming normal ADL and return to work, compared to AH. Postoperative outcome measures were improved by minimally invasive methods and MIS should preferably be used.

Factors influencing the outcome of surgery for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) surgery is a common gynecological procedure. Our aim was to assess the influence of obesity and other risk factors on the outcome of anterior and posterior colporrhaphy with and without mesh. METHODS: Data were retrieved from the Swedish National Register for Gynecological Surgery on 18,554 women undergoing primary and repeat POP surgery without concomitant urinary incontinence (UI) surgery between 2006 and 2015. Multivariate logistic regression analyses were used to identify independent risk factors for a sensation of a vaginal bulge, de novo UI, and residual UI 1 year after surgery. RESULTS: The overall subjective cure rate 1 year after surgery was 80% (with mesh 86.4% vs 77.3% without mesh, p < 0.001). The complication rate was low, but was more frequent in repeat surgery that were mainly mesh related. The use of mesh was also associated with more frequent de novo UI, but patient satisfaction and cure rates were higher compared with surgery without mesh. Preoperative sensation of a vaginal bulge, severe postoperative complications, anterior colporrhaphy, prior hysterectomy, postoperative infections, local anesthesia, and body mass index (BMI) ≥30 were risk factors for sensation of a vaginal bulge 1 year postsurgery. Obesity had no effect on complication rates but was associated increased urinary incontinence (UI) after primary surgery. Obesity had no influence on cure or voiding status in women undergoing repeat surgery. CONCLUSIONS: Obesity had an impact on the sensation of a vaginal bulge and the presence of UI after primary surgery but not on complications.

Factors influencing the incidence and remission of urinary incontinence after hysterectomy.

BACKGROUND: Studies on the influence of body mass index, smoking, and mode of delivery on the occurrence of urinary incontinence after hysterectomy are required to provide women with information about how these factors influence continence after a hysterectomy. OBJECTIVE: The aim was to assess the impact of lifestyle factors such as body mass index, smoking, and delivery mode (vaginal/cesarean) on the incidence and remission of urinary incontinence after hysterectomy. STUDY DESIGN: This was a cohort study based on pre-, per-, and postoperative (1 year) data retrieved from the Swedish National Register for Gynecological Surgery on 16,182 hysterectomies performed because of a benign indication between 2006 and 2013. Multivariable logistic regression analyses were used to identify independent risk factors for de novo urinary incontinence and postoperative remission of urinary incontinence, presented as adjusted odds ratios with 95% confidence intervals. RESULTS: De novo urinary incontinence was reported by 8.5%, remission of urinary incontinence by 13.3%, and residual urinary incontinence by 16.1% after the hysterectomy. A body mass index ≥30 kg/m2 (odds ratio, 1.63, 95% confidence interval, 1.37-1.94), having undergone a vaginal delivery (odds ratio, 1.40, 95% confidence interval, 1.14-1.86), the presence of daily urge without incontinence prior to surgery (odds ratio, 1.77, 95% confidence interval, 1.47-2.13), and a uterine weight <500 g (odds ratio, 2.46, 95% confidence interval, 1.96-3.09) were associated with an increased risk of de novo urinary incontinence. A uterine weight >300 g (odds ratio, 1.98, 95% confidence interval, 1.69-2.33), body mass index <25 kg/m2 (odds ratio, 1.22, 95% confidence interval, 1.01-1.47), prolapse (odds ratio, 2.25, 95% confidence interval, 1.60-3.18), or fibroids (odds ratio, 1.33, 95% confidence interval, 1.09-1.62) as indication for surgery and the absence of daily urge without incontinence preoperatively (odds ratio, 1.51, 95% confidence interval, 1.29-1.76) were associated with an increased remission of urinary incontinence. Vaginal compared with abdominal hysterectomy was associated with a decreased remission of urinary incontinence (odds ratio, 0.70, 95% confidence interval, 0.57-0.87). There was no effect of age or smoking or a difference between total and subtotal hysterectomy with regard to de novo urinary incontinence or remission of urinary incontinence after the hysterectomy. Residual urinary incontinence and de novo urinary incontinence significantly reduced satisfaction with surgery 1 year postoperatively compared with women without urinary incontinence. CONCLUSION: Vaginal delivery, obesity, and daily urge symptoms without incontinence prior to surgery increased de novo urinary incontinence and had a negative influence on the rate of remission of urinary incontinence after hysterectomy, which in turn influenced patients' satisfaction with surgery.

Influence of the modifiable life-style factors body mass index and smoking on the outcome of hysterectomy.

INTRODUCTION: The aim of this study was to study the impact of body mass index (BMI) and smoking on the outcome of hysterectomy and whether effects of these factors vary between abdominal, laparoscopic and vaginal hysterectomy. MATERIAL AND METHODS: Pre-, per- and postoperative (8 weeks) data were retrieved from the Swedish National Register for Gynecological Surgery on 28 537 hysterectomies performed because of a benign indication between 2004 and 2013. Multivariable logistic regression analyses were used to identify independent factors affecting the rate of complications, presented as adjusted odds ratios (adjOR) with 95% confidence intervals (CI). RESULTS: Overweight and obesity had the strongest impact on complications in the abdominal hysterectomy group. In women with a BMI ≥ 30 an increased adjOR could be seen for bleeding >1000 mL (2.90; 95% CI 2.23-3.77), peroperative complications (1.54; 95% CI 1.26-1.88), operation time >120 min (2.67; 95% CI 2.33-3.03), postoperative complications (1.21; 95% CI 1.08-1.34) and postoperative infections (1.73; 95% CI 1.50-1.99). With vaginal hysterectomy, the effect of BMI ≥ 30 could be seen in relation to excessive bleeding >500 mL (1.63; 95% CI 1.22-2.17) and operative time >120 min (2.00; 95% CI 1.60-2.50). With laparoscopic hysterectomy (LH), a BMI ≥ 30 had a higher adjOR for prolonged surgery (1.71; 95% CI 1.30-2.26). Smokers had an increased risk of postoperative infection in the abdominal hysterectomy (1.23; 95% CI 1.07-1.40) and vaginal hysterectomy groups (1.21; 95% CI 1.02-1.43) but not in the LH group. CONCLUSIONS: Body mass index and smoking had a negative effect with all hysterectomy approaches but to a lesser extent in vaginal and laparoscopic hysterectomies. This should be taken into consideration in advance of surgery to improve outcome.

The influence of the modifiable life-style factors body mass index and smoking on the outcome of mid-urethral sling procedures for female urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The aim of this observational study was to investigate the influence of body mass index (BMI) smoking and age on the cure rate, rate of complications and patient satisfaction with mid-urethral sling (MUS) procedures. METHODS: Pre-, peri- and postoperative (8 weeks and 1 year) data were retrieved from the Swedish National Register for Gynecological Surgery of MUS procedures (retropubic procedures, n = 4,539; transobturator procedures, n =1,769) performed between January 2006 and December 2011. Multiple logistic regression analyses were performed between the outcome variables and BMI and smoking, presented as adjusted odds ratios (adjOR) with 95 % confidence interval (CI). RESULTS: Subjective 1-year cure rate was 87.4 % for all MUS procedures (88.3 % with the retropubic technique and 85.2 % with the transobturator technique (p = 0.002). Preoperative daily urinary leakage and urgency were more common with increasing BMI, but surgery reduced symptoms in all BMI groups. Lower cure rate was seen in women with a BMI >30 (0.49; CI 0.33-0.73), in diabetics (0.50; CI 0.35-0.74) and women aged > 80 years (0.18; CI 0.06-0.51). Perioperative complications were more common in the retropubic group (4.7 % vs 2.3 % in the transobturator group, p=0.001) and in women with BMI < 25. Smoking did not influence any of the outcome variables. CONCLUSIONS: The overall 1-year cure rate for MUS procedures was 87 %, but was negatively influenced by BMI >30, diabetes and age > 80 years. Perioperative complications were more common with the retropubic procedure than with the transobturator technique, and in women with a BMI < 25. Smoking did not impact on any of the studied outcome variables.

Female urinary incontinence: patient-reported outcomes 1 year after midurethral sling operations.

INTRODUCTION AND HYPOTHESIS: Although midurethral slings have become standard surgical methods to treat stress urinary incontinence (SUI), little is known about women who still have urinary incontinence (UI) after surgery. This study assesses and compares the patient-reported outcome 12 months after tension-free vaginal tape (TVT), tension-free vaginal tape-obturator (TVT-O), and transobturator tape (TOT), with a special focus on women who still have urinary leakage postoperatively. METHODS: This study analyzed preoperative and 12-month postoperative data from 3,334 women registered in the Swedish National Quality Register for Gynecological Surgery. RESULTS: Among the women operated with TVT (n = 2,059), TVT-O (n = 797), and TOT (n = 478), 67 %, 62 %, and 61 %, respectively, were very satisfied with the result at the 1-year follow-up. There was a significantly higher chance of becoming continent after TVT compared with TOT. In total, 977 women (29 %) still had some form of urinary leakage postoperatively. Among the postoperatively incontinent women who expressed a negative impact of UI on family, social, work, and sexual life preoperatively, considerably fewer reported a negative impact in all domains after surgery. Of those in the postoperatively incontinent group who had coital incontinence preoperatively, 63 % reported a cure of coital incontinence. CONCLUSIONS: The proportion of women very satisfied with the result of the operation did not differ between the three groups. TVT had a higher SUI cure rate than did TOT. Despite urinary leakage 1-year postoperatively, half of the women were satisfied with the result of the operation.

How do urinary incontinence and urgency affect women's sexual life?

OBJECTIVE: To investigate the impact of urinary incontinence and urgency on women's sexual life and the prevalence of urinary leakage during sexual activity. A further aim was to explore factors affecting sexual desire and satisfaction with sexual life. DESIGN: A semi-structured questionnaire study. SETTING AND SAMPLE: Sexually active women (n=147) aged 18-74years with urinary incontinence and urgency were recruited from four outpatient clinics. METHODS: The women completed questionnaires concerning medical history, psychosocial situation, partner relationship and sexual life, and answered the Bristol Female Lower Urinary Tract Symptoms questionnaire. All underwent clinical evaluation. MAIN OUTCOME MEASURES: Prevalence of urinary leakage during sexual activity, factors affecting sexual desire and sexual satisfaction. RESULTS: The vast majority considered sexuality to be important in their lives. One-third of the women had urinary leakage during sexual activity. Half reported that sexual life was more or less spoiled due to their urinary incontinence or urgency and they were worried about having urinary leakage during intercourse, and almost two-thirds worried about odor and felt unattractive. The women's dissatisfaction with sexual life was strongly correlated to unsatisfying psychological health, orgasmic disability and worry about urinary leakage during intercourse. Insufficient vaginal lubrication, unsatisfying psychological health and their partners' ill health were significantly correlated with decreased sexual desire. CONCLUSIONS: Urinary incontinence and urgency have a negative impact on women's sexual life. Thus, a dialogue about sexual function in women with urinary symptoms should become an integral component in clinical management.

Impact of female urinary incontinence and urgency on women's and their partners' sexual life.

AIMS: To assess the impact of female urinary incontinence (UI) and urgency on women's and their partners' sexual life in sexually active couples and to elucidate the concordance of answers within couples. METHODS: Women aged 18-74 years with UI and/or urgency (n = 206) were consecutively recruited from four outpatient clinics. Those with a partner (n = 170) completed a questionnaire regarding relationship and sexual life and gave a similar questionnaire to him. The present paper focuses on 99 couples with an active sexual life. RESULTS: Twenty-two percent of the men and 43% of the women stated that the female urinary symptoms impaired their sexual life. Forty-nine percent of the women expressed worries about having urinary leakage during sexual activity, but most of their men, 94%, did not. Twenty-three percent of the men and 39% of the women responded that the woman leaked urine during sexual activity. The majority, 84%, of women considered this a problem, but 65% of their partners did not. Except for this disparity, the rest of the answers were significant concordant within the couples. CONCLUSIONS: Female UI and urgency negatively affected sexual life in almost half of the women and in every fifth partner. A need for information and advice concerning sexual issues due to the woman's urinary disorder was found in one fifth of the couples. The majority of women with urinary leakage during sexual activities considered this as a problem, but most of their partners did not. Overall, the concordance of the answers within the couples was high.