Changes in Stress Urinary Incontinence Symptoms after Pelvic Organ Prolapse Surgery: a Nationwide Cohort Study (FINPOP).

INTRODUCTION AND HYPOTHESIS: Various strategies are employed to manage stress urinary incontinence (SUI) during pelvic organ prolapse (POP) surgery. This study was aimed at facilitating shared decision-making by evaluating SUI symptom changes, staged SUI procedures, and their prognostic factors following POP surgery without concomitant SUI intervention. METHODS: We analyzed 2,677 POP surgeries from a population-based observational cohort, excluding patients with prior SUI surgery. The outcome measures were subjective SUI utilizing the Pelvic Floor Distress Inventory-20 questionnaire and number of subsequent SUI procedures. Multivariable linear models were applied to identify predictors of persistent SUI, procedures for persistent SUI, and de novo SUI. The primary assessment occurred at the 2-year follow-up. RESULTS: At baseline, 50% (1,329 out of 2,677) experienced SUI; 35% (354 out of 1,005) resolved, an additional 14% (140 out 1,005) improved, and 5.1% (67 out of 1,308) underwent a procedure for persistent SUI. De novo SUI symptoms developed in 20% (218 out of 1,087), with 3.2% (35 out of 1,087) reporting bothersome symptoms; 0.8% (11 out of 1,347) underwent a procedure for de novo SUI. High baseline symptom severity increased the risk of persistent SUI (adjusted odds ratio [aOR] 2.04, 95% confidence interval [CI] 1.65-2.53), whereas advanced preoperative apical prolapse decreased the risk (aOR 0.89, 95% CI 0.85-0.93). De novo SUI was more common with advancing age (aOR 1.03, 95% CI 1.01-1.05), baseline urgency urinary incontinence (aOR 1.21, 95% CI 1.06-1.38), and after transvaginal mesh surgery (aOR 1.93, 95% CI 1.24-3.00). It was not dependent on the compartment or preoperative degree of prolapse. CONCLUSIONS: In a pragmatic setting, POP surgery results in a low rate of subsequent SUI procedures.

Sexual Activity and Dyspareunia After Pelvic Organ Prolapse Surgery: A 5-Year Nationwide Follow-up Study.

Background: Even though surgery generally improves sexual function and alleviates dyspareunia related to pelvic organ prolapse (POP), knowledge of the long-term effects is scarce. Objective: To describe changes in sexual activity and dyspareunia rates after POP surgery and to identify potential risk factors for the occurrence of dyspareunia. Design setting and participants: This was a prospective longitudinal cohort study of women aged over 18 yr undergoing POP surgery in Finland during 2015. Out of 3515 participants, sexual activity and dyspareunia data were available at baseline, 6 mo, 2 yr, and 5 yr for 79%, 68%, 63%, and 57%, respectively. Intervention: Native tissue, transvaginal mesh, and abdominal mesh repair. Outcome measurements and statistical analysis: Rates of sexual activity and dyspareunia were assessed using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) at baseline and at 6 mo, 2 yr, and 5 yr after surgery. As a secondary outcome, risk factors for overall, persisting, and de novo dyspareunia were assessed using logistic regression models. Results and limitations: The proportion of sexually active women increased from 40.7% to 43% after surgery. Preoperative dyspareunia resolved in >50% of cases during the first 6 mo, irrespective of the surgical approach. De novo dyspareunia rates were low at all time points (1.9-3.1%). Several potential risk factors associated with preoperative and postoperative dyspareunia were identified: younger age, lower preoperative body mass index, lower prolapse stage at baseline, either pelvic pain or dyspareunia at baseline, prior surgery (stress urinary incontinence surgery, posterior colporrhaphy, POP surgery, hysterectomy), and posterior repair. Conclusions: Dyspareunia is significantly reduced after POP repair irrespective of the surgical approach. However, multiple factors seem to be associated with persisting and de novo symptoms, which should be considered in preoperative counseling. Patient summary: Our 5-year follow-up study demonstrates that surgery to repair pelvic organ prolapse (POP) in women improves sexual activity and reduces painful intercourse. Multiple factors, such as preoperative pain, previous POP surgery, and prolapse stage, may be associated with painful intercourse after surgery.

Pelvic organ prolapse surgery and overactive bladder symptoms-a population-based cohort (FINPOP).

INTRODUCTION AND HYPOTHESIS: It is unclear how compartment of pelvic organ prolapse (POP) impacts overactive bladder (OAB) symptom severity or improvement after POP surgery. We hypothesized that anterior and apical prolapse are more strongly associated with OAB symptoms than posterior compartment prolapse. METHODS: A total of 2933 POP surgeries from a prospective population-based cohort were divided into two groups: (1) anterior and/or apical compartment surgery (± posterior repair), N = 2091; (2) posterior repair only, N = 478. Urinary frequency and urgency urinary incontinence (UUI) were evaluated using PFDI-20 (bothersome symptom: score 3-4) at baseline, 6, and 24 months. Association between degree of POP in specific compartments and symptoms at baseline was estimated with generalized linear models and between compartment of surgery and symptom improvement with generalized estimating equations. RESULTS: At least one bothersome symptom was reported by 40% at baseline, 14% at 6, and 19% at 24 months. At baseline, urinary frequency was associated with degree of anterior and apical and UUI with anterior compartment prolapse. Women undergoing surgery for anterior/apical compartment started with worse symptoms and experienced greater improvement than women undergoing posterior compartment surgery. Bothersome frequency resolved in 82% after anterior/apical and in 63% after posterior compartment surgery. Bothersome UUI resolved in 75% after anterior/apical and in 61% after posterior compartment surgery. After surgery, symptom severity was comparable between groups. Bothersome de novo symptoms occurred in 1-3%. CONCLUSIONS: OAB symptoms are more strongly related to anterior and apical than to posterior compartment prolapse, but improvement is seen after surgery for any vaginal compartment.

Decreasing trend and changing indications of hysterectomy in Finland.

INTRODUCTION: Hysterectomy has been one of the most common surgical procedures in women in Finland. We studied the population-based trends of hysterectomy and its indications from 1986 to 2017. MATERIAL AND METHODS: A retrospective population-based cohort was created from the Care Register for Health Care by identifying women who had a hysterectomy from 1986 to 2017 and calculating the number of women from the Digital and Population Data Services Agency. We estimated the number and incidence of hysterectomy by period and age as well as by indication. We considered the primary diagnosis at the time of surgery as the indication of hysterectomy. RESULTS: The number of hysterectomies increased from 7492 procedures in 1986 to 12 404 procedures in 1998, and reduced substantially after that to 5971 procedures in 2017, the turning point being in 1999. The incidence rate of hysterectomy has decreased on average by 2.5% annually from 432.6 per 100 000 women in 1998-2001 to 224.5 per 100 000 women in 2014-2017. The median age at the time of hysterectomy has increased from 51 years in 1998-2001 to 55 years in 2014-2017. The cumulative burden of hysterectomy by age of 60 years has nearly halved from the first 4-year period (23%) to the last (12%). After 2010, the most common indication has been genital prolapse and incontinence, whereas earlier it was uterine fibroids. CONCLUSIONS: The number and incidence of hysterectomies have fluctuated during the observation period 1986-2017 and decreased considerably during the past 17 years in Finland. This is probably a result of the availability of hormonal and other conservative treatment options for bleeding disorders and uterine fibroids. As hysterectomy practically removes the risk for endometrial cancer, the change in hysterectomy incidence over time emphasizes the importance of correcting endometrial cancer incidence according to hysterectomy incidence.

Minimal important difference and patient acceptable symptom state for PFDI-20 and POPDI-6 in POP surgery.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) in pelvic organ prolapse (POP) surgery. METHODS: We used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified. RESULTS: The MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9-25.0 (median 24.2) points for PFDI-20 and 9.0-12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7-62.5 (median 60.0) for PFDI-20 and 16.7-17.7 (median 17.2) for POPDI-6. CONCLUSION: A mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state.

Complications of Pelvic Organ Prolapse Surgery in the 2015 Finnish Pelvic Organ Prolapse Surgery Survey Study.

OBJECTIVE: To describe the major complications of pelvic organ prolapse (POP) surgery in Finland. METHODS: The Finnish Pelvic Organ Prolapse Surgery Survey 2015 study is a prospective cohort of POP surgeries performed in Finland in 2015. Perioperative, postoperative, and late complications during 1 year of follow-up were compared among native tissue repair, transvaginal mesh, and abdominal mesh surgery. Major complications were assessed using the Clavien-Dindo grading system. Predictive factors for major complications were studied with logistic regression analysis. RESULTS: Within 1 year after POP surgery, 396 (11.2%) of 3,515 women had at least one complication: 10.9% after native tissue, 11.7% after transvaginal mesh, and 13.5% after abdominal mesh repair. The majority of complications occurred within 2 months after surgery and postoperative infection (4.3%) and bleeding or hematoma (2.6%) were the most frequent. The incidence of organ injuries was low. Mesh-augmented surgery was associated with significantly higher rates of bladder and bowel injuries than native tissue surgery. Complication-related reoperations occurred significantly more often after abdominal mesh repair than native tissue surgery (5.2% vs 1.8%, P=.001). Mesh-related complications were diagnosed more often after transvaginal mesh repair. The overall rate of major complications (Clavien-Dindo grades III-V) was 3.3%. Abdominal mesh surgery was associated with the highest rate of major adverse events (8.8% vs native tissue repair 2.6% and transvaginal mesh 4.9%). The incidence of Clavien-Dindo grade IV or V complications was rare (less than 0.6%). Mesh surgery (transvaginal mesh adjusted odds ratio [aOR] 2.23, 95% CI 1.31-3.80, and abdominal mesh aOR 3.02, 95% CI 1.67-5.46), longer operating time (aOR 2.84, 95% CI 1.78-4.53), prior POP surgery (aOR 1.68, 95% CI 1.00-2.81) and difficult surgery (aOR 2.75, 95% CI 1.63-4.62) were associated with an increased risk for occurrence of major complications. CONCLUSION: Serious adverse events were rare regardless of the operative approach. However, mesh-augmented surgery was associated with higher risk for major complications.

Agreement between patient global impression scale of improvement, pelvic floor distress inventory and 15D in measuring the outcome of pelvic organ prolapse surgery.

AIMS: To evaluate the correlation between three commonly used patient-reported outcome measures, two generic and one condition-specific instrument, in assessing the change in health-related quality of life following pelvic organ prolapse surgery. METHODS: The generic health-related quality of life measure 15-dimensional instrument (15D), Patient Global Impression of Improvement (PGI-I), and prolapse-specific Pelvic Floor Distress Inventory (PDFI-20) were used to assess the effectiveness of pelvic organ prolapse surgery in the national FINPOP study of 3535 surgeries (83% of all pelvic organ prolapse operations) performed in Finland in 2015. Spearman correlations between PGI-I, change in 15D and its dimensions and change in PFDI-20 and its subscales over a 2-year follow-up were investigated. The proportion of concordant ratings was also studied by investigating the proportion of women rated similarly (worse/no change/better/much better) by two instruments according to validated cutoffs. RESULTS: Among 2248 women for whom the 2-year change in all instruments could be measured, changes in PFDI-20 and 15D and its dimensions were weak (ρ < 0.2 for all except excretion; ρ = 0.39 and sexual activity; ρ = 0.27). PFDI-20 change (ρ = 0.39) and its subscales (ρ = 0.19-0.40, all P < .001) were more strongly correlated with PGI-I. The proportion of fully concordant ratings were higher for PFDI-20 and PGI-I (50.6%) than for PFDI-20 and 15D (33.0%). CONCLUSION: The weak correlations between 15D, PGI-I, and PDFI-20 observed in this study show that the quantified health gains are strongly dependent on the chosen patient-reported outcome measures. This demonstrates the importance of using condition-specific sensitive outcome measures in assessing the impact of surgical treatment in pelvic organ prolapse.

Pelvic organ prolapse surgery and quality of life-a nationwide cohort study.

BACKGROUND: Patient satisfaction and health-related quality of life are nowadays considered as the most important outcomes of pelvic organ prolapse treatment, and large, prospective clinical studies reporting the patient-reported surgical outcomes are needed. OBJECTIVE: To evaluate the effect of female pelvic organ prolapse surgery on health-related quality of life and patient satisfaction and to determine predictors of outcome. STUDY DESIGN: This prospective nationwide cohort study consisted of 3515 women undergoing surgery for pelvic organ prolapse in 2015. The outcomes were measured by validated health-related quality of life instruments (generic 15D, Pelvic Floor Distress Inventory-20, and Patient Global Impression of Improvement) at 6 months and 2 years postoperatively. The baseline predictors of outcomes were studied with logistic regression analysis. RESULTS: In total, 2528 (72%) women were eligible for analysis at 6 months and 2351 (67%) at 2 years. The mean change in the total 15D score suggested a clinically important improvement at 6 months but not at 2 years. However, an improvement in sexual activity, discomfort and symptoms, and excretion was observed during both follow-up assessments. Altogether, 77% and 72% of the participants reported a clinically significant improvement in Pelvic Floor Distress Inventory-20 at the 6-month and 2-year follow-ups, respectively. A total of 84% were satisfied with the outcome and 90% reported an improvement in comparison with the preoperative state with Patient Global Impression of Improvement-I. The strongest predictive factors for a favorable outcome were advanced apical prolapse (adjusted odds ratio, 2.06; 95% confidence interval, 1.58-2.70) and vaginal bulge (1.90, 1.30-2.80). Smoking was associated with an unfavorable outcome as measured by Patient Global Index of Improvement-I (1.69, 1.02-2.81). CONCLUSION: Pelvic organ prolapse surgery improved health-related quality of life in 7 of 10 patients over a 2-year follow-up period, and patient satisfaction was high. Apical prolapse beyond the hymen and vaginal bulge were the most consistent predictors for improvement. Our results suggest that patients should be encouraged to stop smoking to avoid an unfavorable outcome.

The relationship of defecation symptoms and posterior vaginal wall prolapse in women undergoing pelvic organ prolapse surgery.

BACKGROUND: Defecation symptoms are common among women with pelvic organ prolapse. However, the relationship between posterior vaginal wall prolapse and defecation symptoms remains debatable. Even though there is a plausible biomechanical rationale for posterior wall prolapse to cause obstructed defecation, previous studies have drawn contradictory conclusions regarding the association. OBJECTIVE: We aimed to examine the association between posterior vaginal wall prolapse and defecation symptoms by assessing the following: (1) does prevalence of defecation symptoms increase along with posterior wall prolapse severity, (2) is postoperative symptom improvement greater in women who underwent posterior compartment procedures in comparison with those who did not, and (3) is symptom improvement related to the symptom's correlation with the degree of prolapse? STUDY DESIGN: We used data from a nationwide longitudinal cohort study with 3515 women undergoing pelvic organ prolapse surgery. We measured the prevalence of 9 defecation symptoms at baseline and at 6 and 24 months after surgery using the short form of the Pelvic Floor Distress Inventory. Baseline degree of prolapse was categorized in stages as defined by the Pelvic Organ Prolapse Quantification System. The relationship between the degree of posterior wall prolapse and prevalence of bothersome defecation symptoms was studied with logistic regression and adjusted for patient characteristics and severity of anterior wall and apical prolapse. Generalized estimating equations were used to assess the longitudinal change in symptom prevalence in groups of participants with and without repair for posterior vaginal compartment. Correlations between symptom improvement and symptom dependency on the degree of prolapse was assessed by calculating Pearson's correlation coefficient. RESULTS: The stage of posterior wall prolapse (stage 2 vs stage 0) correlated with splinting, straining, incomplete evacuation, fecal incontinence of liquid stool, pain during defecation, fecal urgency, and anorectal prolapse (adjusted odds ratios, 2.7, 2.1, 2.0, 1.5, 2.1, 1.4, and 2.2, respectively; P ≤ .007 for all). Flatal incontinence and fecal incontinence of solid stool were not associated with the severity of posterior vaginal wall prolapse. Obstructed defecation symptoms (splinting, straining, and incomplete evacuation) improved more in women undergoing posterior compartment surgery compared with women undergoing repair for other compartments. The greatest improvement at follow-up was observed for those symptoms that showed strongest association with the degree of prolapse at baseline. CONCLUSION: Obstructed defecation symptoms are dependent on the posterior wall anatomy. Women presenting with posterior wall prolapse, and these symptoms can expect to improve after surgery. Other defecation symptoms also improve after pelvic organ prolapse surgery, but they are not as specific to posterior wall anatomy as obstructed defecation symptoms.

Methods of surgery for pelvic organ prolapse in a nationwide cohort (FINPOP 2015).

INTRODUCTION: The management of pelvic organ prolapse (POP) varies significantly between countries. The objective of this study was to describe the methods used for POP surgery in Finland and to identify the factors that affect clinicians' choice to use either a native tissue repair (NTR) or a mesh repair method. MATERIAL AND METHODS: This prospective cohort study included 3535 surgeries covering 83% of all POP operations performed in Finland in 2015. The operative details and patient characteristics, including the Pelvic Floor Distress Inventory (PFDI-20), were compared between three selected surgical methods: NTR, transvaginal mesh (TVM) and abdominal mesh (AM). The predictive factors for the use of mesh augmentation were also studied with logistic regression analysis. RESULTS: The most common method was NTR (n = 2855, 81%), followed by TVM (n = 429, 12%) and AM (n = 251, 7%). Approximately 92% of the patients who underwent primary prolapse surgery underwent NTR, and mesh surgery was used mainly for recurrent prolapse. The strongest predictor of mesh surgery was previous POP surgery for the same vaginal compartment (adjusted odds ratio [OR] = 56, 95% confidence interval [CI] = 38-84 for TVM; adjusted OR = 22, 95% CI = 14-34 for AM). Other predictive factors for mesh surgery were previous hysterectomy, healthcare district, severe bulge symptoms and advanced prolapse. TVM was associated with advanced anterior prolapse and older age. AM surgery was associated with advanced apical and/or posterior compartment prolapse. PFDI-20 scores were the highest in the AM group (108 vs 103 in the TVM group and 98 in the NTR group, P = 0.012), which indicates more bothersome symptoms than in the other groups. CONCLUSIONS: The Finnish practices follow international guidelines that advocate NTR as the principal surgical method for POP. Synthetic mesh augmentation was mainly used in patients with recurrent and advanced prolapse with severe symptoms. The variation in the rates of mesh augmentation for POP surgery in different hospitals implies a lack of sufficient evidence of the most suitable treatment method and indicates a need for national guidelines.

Robotic-Assisted Infrarenal Para-aortic Lymphadenectomy in Gynecological Cancers: Technique and Surgical Outcomes.

OBJECTIVE: Mini-invasive surgery has essentially replaced open laparotomy in surgery for endometrial and cervical carcinoma. Of the procedures needed for a complete staging, especially para-aortic lymphadenectomy (PALND) is challenging to perform. The present study was undertaken to investigate the technical and surgical outcomes of robotic-assisted PALND for gynecological cancers in the setting of a tertiary university hospital in Finland. METHODS: This was a retrospective chart review of 283 robotic-assisted para-aortic lymphadenectomies using the single-docking transperitoneal technique performed at the Department of Obstetrics and Gynecology of Tampere University Hospital, in 2009-2016. The primary outcome measure was the extent of the operation in terms of the height, that is, how often the level cranial to the inferior mesenteric artery (IMA) was achieved. The secondary outcome measures included operation time and surgical outcome. RESULTS: The majority of operations (n = 239 [84.4%]) were performed for endometrial carcinoma. The most common operation type was robotic-assisted hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy and PALND, which took a median of 3:38 hours or 218 minutes (range, 140-341 minutes) to perform. The high PALND (above the level of IMA) succeeded in 235 operations (83%). In the total cohort, the median number of para-aortic lymph nodes removed was 12 (range, 0-38), with a learning curve approximately more than 40 operations. Para-aortic lymph node metastases were found in 43 patients (15.2%). Seven conversions to laparotomy (2.5%) were done. The conversion and intraoperative complication rates were 2.5% and 3.5%, respectively, and postoperative complications was 18%, according to the classification of Clavien-Dindo. The median length of the postoperative hospital stay was 2 days (range, 1-8 days). CONCLUSIONS: Using the transperitoneal technique for PALND, the area between IMA and the renal veins can be reached in more than 80% of the operations, with a very low or 2.5% conversion rate.

Functional Outcome of Human Adipose Stem Cell Injections in Rat Anal Sphincter Acute Injury Model.

Anal incontinence is a devastating condition that significantly reduces the quality of life. Our aim was to evaluate the effect of human adipose stem cell (hASC) injections in a rat model for anal sphincter injury, which is the main cause of anal incontinence in humans. Furthermore, we tested if the efficacy of hASCs could be improved by combining them with polyacrylamide hydrogel carrier, Bulkamid. Human ASCs derived from a female donor were culture expanded in DMEM/F12 supplemented with human platelet lysate. Female virgin Sprague-Dawley rats were randomized into four groups (n = 14-15/group): hASCs in saline or Bulkamid (3 × 105 /60 µl) and saline or Bulkamid without cells. Anorectal manometry (ARM) was performed before anal sphincter injury, at two (n = 58) and at four weeks after (n = 33). Additionally, the anal sphincter tissue was examined by micro-computed tomography (µCT) and the histological parameters were compared between the groups. The median resting and peak pressure during spontaneous contraction measured by ARM were significantly higher in hASC treatment groups compared with the control groups without hASCs. There was no statistical difference in functional results between the hASC-carrier groups (saline vs. Bulkamid). No difference was detected in the sphincter muscle continuation between the groups in the histology and µCT analysis. More inflammation was discovered in the group receiving saline with hASC. The hASC injection therapy with both saline and Bulkamid is a promising nonsurgical treatment for acute anal sphincter injury. Traditional histology combined with the 3D µCT image data lends greater confidence in assessing muscle healing and continuity. Stem Cells Translational Medicine 2018;7:295-304.

Costs of Robotic-Assisted Versus Traditional Laparoscopy in Endometrial Cancer.

OBJECTIVES: The purpose of this study was to compare the costs of traditional laparoscopy and robotic-assisted laparoscopy in the treatment of endometrial cancer. METHODS AND MATERIALS: A total of 101 patients with endometrial cancer were randomized to the study and operated on starting from 2010 until 2013, at the Department of Obstetrics and Gynecology of Tampere University Hospital, Tampere, Finland. Costs were calculated based on internal accounting, hospital database, and purchase prices and were compared using intention-to-treat analysis. Main outcome measures were item costs and total costs related to the operation, including a 6-month postoperative follow-up. RESULTS: The total costs including late complications were 2160 &OV0556; higher in the robotic group (median for traditional 5823 &OV0556;, vs robot median 7983 &OV0556;, P < 0.001). The difference was due to higher costs for instruments and equipment as well as to more expensive operating room and postanesthesia care unit time. Traditional laparoscopy involved higher costs for operation personnel, general costs, medication used in the operation, and surgeon, although these costs were not substantial. There was no significant difference in in-patient stay, laboratory, radiology, blood products, or costs related to complications. CONCLUSIONS: According to this study, robotic-assisted laparoscopy is 37% more expensive than traditional laparoscopy in the treatment of endometrial cancer. The cost difference is mainly explained by amortization of the robot and its instrumentation.

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

BACKGROUND: Although several validated generic health-related quality of life instruments exist, disease-specific instruments are important as they are often more sensitive to changes in symptom severity. It is essential to validate the instruments in a new population and language before their use. The objective of the study was to translate into Finnish the short forms of three condition-specific questionnaires (PFDI-20, PFIQ-7 and PISQ-12) and to evaluate their psychometric properties in Finnish women with symptomatic pelvic organ prolapse. METHODS: A multistep translation method was used followed by an evaluation of validity and reliability in prolapse patients. Convergent and discriminant validity, internal consistency and reliability via test-retest were calculated. RESULTS: Sixty-three patients waiting for prolapse surgery filled the three questionnaires within two weeks. Response rate for each item was high in PFDI-20 and PISQ-12 (99.8 and 98.9% respectively). For PFIQ-7 response rate was only 60%. In PFIQ-7, six respondents (9.5%) reached the minimum value of zero showing floor effect. None of the instruments had ceiling effect. Based on the item-total correlations both PFIQ-7 and PFDI-20 had acceptable convergent validity, while the convergent validity of PISQ-12 was lower, r = 0.138-0.711. However, in this instrument only three questions (questions 6, 10 and 11) had r < 0.3 while others had r ≥ 0.380. In the test-retest analysis all the three instruments showed good reliability (ICC 0.75-0.92). Similarly, the internal consistency of the instruments, measured by Cronbach's α, was good (range 0.69-0.96) indicating high homogeneity. CONCLUSIONS: Finnish validated translation of the PFDI-20 and PISQ-12 have acceptable psychometric properties and can be used for both research purposes and clinical evaluation of pelvic organ prolapse symptoms. The Finnish version of PFIQ-7 displayed low response rate and some evidence of a floor effect, and thus its use is not recommended in its current form.

Robotic-assisted vs traditional laparoscopic surgery for endometrial cancer: a randomized controlled trial.

BACKGROUND: Previous studies comparing robotic-assisted laparoscopic surgery to traditional laparoscopic or open surgery in gynecologic oncology have been retrospective. To our knowledge, no prospective randomized trials have thus far been performed on endometrial cancer. OBJECTIVE: We sought to prospectively compare traditional and robotic-assisted laparoscopic surgery for endometrial cancer. STUDY DESIGN: This was a randomized controlled trial. From December 2010 through October 2013, 101 endometrial cancer patients were randomized to hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy either by robotic-assisted laparoscopic surgery or by traditional laparoscopy. The primary outcome measure was overall operation time. The secondary outcome measures included total time spent in the operating room, and surgical outcome (number of lymph nodes harvested, complications, and recovery). The study was powered to show at least a 25% difference in the operation time using 2-sided significance level of .05. The differences between the traditional laparoscopy and the robotic surgery groups were tested by Pearson χ2 test, Fisher exact test, or Mann-Whitney test. RESULTS: In all, 99 patients were eligible for analysis. The median operation time in the traditional laparoscopy group (n = 49) was 170 (range 126-259) minutes and in the robotic surgery group (n = 50) was 139 (range 86-197) minutes, respectively (P < .001). The total time spent in the operating room was shorter in the robotic surgery group (228 vs 197 minutes, P < .001). In the traditional laparoscopy group, there were 5 conversions to laparotomy vs none in the robotic surgery group (P = .027). There were no differences as to the number of lymph nodes removed, bleeding, or the length of postoperative hospital stay. Four (8%) vs no (0%) patients (P = .056) had intraoperative complications and 5 (10%) vs 11 (22%) (P = .111) had major postoperative complications in the traditional and robotic surgery groups, respectively. CONCLUSION: In patients with endometrial cancer, robotic-assisted laparoscopic surgery was faster to perform than traditional laparoscopy. Also total time spent in the operation room was shorter in the robotic surgery group and all conversions to laparotomy occurred in the traditional laparoscopy group. Otherwise, the surgical outcome was similar between the groups. Robotic surgery offers an effective and safe alternative in the surgical treatment of endometrial cancer.

Characterization of persistent pain after hysterectomy based on gynaecological and sensory examination.

BACKGROUND AND AIMS: Previous studies have shown that pelvic pain is common after hysterectomy. It is stated that only a minor part of that pain can be defined as persistent postsurgical pain. Our primary aim was to find out if the pelvic pain after hysterectomy may be classified as postsurgical. Secondary aims were to characterize the nature of the pain and its consequences on the health related quality of life. METHODS: We contacted the 56 women, who had reported having persistent pelvic pain six months after hysterectomy in a previously sent questionnaire. Sixteen women participated. Clinical examinations included gynaecological examination and clinical sensory testing. Patients also filled in quality of life (SF-36) and pain questionnaires. RESULTS: Ten out of sixteen patients still had pain at the time of examination. In nine patients, pain was regarded as persistent postsurgical pain and assessed probable neuropathic for five patients. There were declines in all scales of the SF-36 compared with the Finnish female population cohort. CONCLUSIONS: In this study persistent pelvic pain after vaginal or laparoscopic hysterectomy could be defined as persistent postsurgical pain in most cases and it was neuropathic in five out of nine patients. Pain had consequences on the health related quality of life. IMPLICATIONS: Because persistent postsurgical pain seems to be the main cause of pelvic pain after hysterectomy, the decision of surgery has to be considered carefully. The management of posthysterectomy pain should be based on the nature of pain and the possibility of neuropathic pain should be taken into account at an early postoperative stage.

Persistent posthysterectomy pain: A prospective, observational study.

BACKGROUND: There is a large variation in the prevalence of persistent postsurgical pain depending on the type of surgery. It is unclear how common persistent postsurgical pain is after vaginal or laparoscopic hysterectomy. OBJECTIVES: The objective of this study was to define the prevalence of persistent postsurgical pain 6 months after laparoscopic or vaginal hysterectomy for benign causes and to ascertain the intensity of the pain and its possible predictors. DESING: A prospective, observational study. SETTING: Pirkanmaa Hospital District between October 2008 and September 2013. PATIENTS: Two hundred and forty-two women who underwent laparoscopic (150) or vaginal (92) hysterectomy for benign causes and who also participated in our earlier studies concerning acute pain. INTERVENTIONS: A pain questionnaire and a prestamped return envelope were mailed to all women 6 months after surgery. If the questionnaire had not been returned within 4 weeks, a reminder was sent. Data regarding preoperative pain and acute postoperative pain were collected from the records of our earlier studies concerning acute pain. The patient characteristics and surgical outcomes were collected from the patients' medical records. MAIN OUTCOME MEASURE: The prevalence of persistent postsurgical pain 6 months after hysterectomy. RESULTS: The response rate was 94% (227 respondents). Twenty-seven (18.9%) of 143 patients who had no pain preoperatively had persistent pain after surgery. Overall, 26.0% of patients had persistent pelvic pain 6 months after surgery. On an 11-point numeric rating scale (NRS), most of the patients rated their average pain as mild (NRS 0 to 3) and only 6.9% rated their worst pain as severe (NRS 7 to 10). Smoking, acute postoperative pain at 4 h after surgery and a laparoscopic approach were significantly associated with persistent pain in a multivariable analysis. CONCLUSION: Persistent posthysterectomy pain is common, but pain is mild and does not interfere with daily activities for most of the patients 6 months after surgery. Smoking is the strongest predictor for persistent pain. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT 01537731.

Implementing robotic surgery to gynecologic oncology: the first 300 operations performed at a tertiary hospital.

OBJECTIVE: To investigate the initial experience with robotic-assisted laparoscopic surgery in gynecologic oncology. DESIGN: A retrospective survey. SETTING: Tertiary referral center. POPULATION: The first 300 patients operated on using robotic assistance at the Department of Obstetrics and Gynecology of Tampere University Hospital, from March 2009 through January 2013. METHODS: Retrospective patient chart review. MAIN OUTCOME MEASURES: The primary outcome measure was the learning curve events, and the complication and conversion rates were secondary outcome measures. RESULTS: The commonest type of operation was hysterectomy, bilateral salpingoophorectomy and pelvic lymphadenectomy (LH + BSO + PLND, n = 89), followed by the same procedure amended by para-aortic lymphadenectomy (PALND, n = 74), type II radical hysterectomy (n = 24), and PLND + PALND ± omentectomy (n = 15). A learning curve was most evident for LH + BSO + PLND: whereas the median operative time of all 89 operations was 167 min (range 403-104), it was 260 (range 403-135) and 153 (range 247-104) min in the case of the first and last 20 operations, respectively. The learning curve was short, or 10 procedures. A learning curve was also seen for the preoperative time in the operation room and for the number of lymph nodes harvested. The median blood loss during all 300 operations was 100 mL (range 5-3200). The median postoperative hospital stay was 1 day. The conversion rate was 4.0%, and the complication rate 19.3% (major in 9%). CONCLUSION: The learning curve of robotic-assisted laparoscopic surgery appears to be short, or 10 operations. Robotic-assisted procedures seem to offer a safe and useful alternative to traditional techniques.

Less postoperative pain after laparoscopic hysterectomy than after vaginal hysterectomy.

PURPOSE: To find out whether the severity of acute postoperative pain differs between laparoscopic (LH) or laparoscopically assisted vaginal hysterectomy (LAVH) and vaginal hysterectomy. METHODS: In a prospective, powered, non-randomized trial, the consumption of oxycodone and pain scores were evaluated in 164 women up to 20 h after VH or LH/LAVH. All hysterectomies were performed under standardized general anesthesia and the pain medication was similar in both groups. The primary endpoint was the cumulative oxycodone consumed. Main secondary endpoints were pain scores (numeric rating scale NRS), operative time and hospital stay. RESULTS: The patients in LH/LAHV group consumed less opioid than the patients in the vaginal group during the 20 h period after surgery. The difference was significant at time point 4 and 6 h. The oxycodone consumed at time point 4 h was 19.9 (95 % CI 18.1-21.7) mg in laparoscopic group and 22.8 (20.7-25.0) mg in vaginal group (p = 0.040) and at time point 6 h was 23.5 (21.5-25.6) mg in laparoscopic group and 27.4 (24.7-30.0) mg in vaginal group (p = 0.026). Pain scores were lower after laparoscopic approach and the difference was significant at time point 60 min after surgery (p = 0.026). CONCLUSION: In this study, LH was associated with reduced need of analgesics and lower acute postoperative pain scores than VH.