Serious complication 1 year after sacrospinous ligament fixation

Myositis of the gluteal region caused by group A streptococci 1 year after a sacrospinous ligament fixation was recognised as a serious complication of this procedure. Most likely, the infection was spread to the gluteal region through a port d’entree caused by vaginal atrophy, via the non-resorbable sutures. The patient was treated successfully with antibiotics intravenous and local estrogens

Hysterectomy Does Not Cause Constipation

PURPOSE: This study was designed to evaluate the risk on development and persistence of constipation after hysterectomy. METHODS: We conducted a prospective, observational, multicenter study with three-year follow-up in 13 teaching and nonteaching hospitals in the Netherlands. A total of 413 females who underwent hysterectomy for benign disease other than symptomatic uterine prolapse were included. All patients underwent vaginal hysterectomy, subtotal abdominal hysterectomy, or total abdominal hysterectomy. A validated disease-specific quality-of-life questionnaire was completed before and three years after surgery to assess the presence of constipation. RESULTS: Of the 413 included patients, 344 (83 percent) responded at three-year follow-up. Constipation had developed in 7 of 309 patients (2 percent) without constipation before surgery and persisted in 16 of 35 patients (46 percent) with constipation before surgery. Preservation of the cervix seemed to be associated with an increased risk of the development of constipation (relative risk, 6.6; 95 percent confidence interval, 1.3-33.3; P=0.02). Statistically significant risk factors for the persistence of constipation could not be identified. CONCLUSIONS: Hysterectomy does not seem to cause constipation. In nearly half of the patients reporting constipation before hysterectomy, this symptom will disappear

Protocol for Physiotherapy OR Tvt Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence

<p>Abstract</p> <p>Background</p> <p>Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial.</p> <p>Methods/Design</p> <p>A multi-centre randomised controlled trial will be performed for women between 35 - 80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands</p> <p>Trial registration</p> <p>Nederlands trial register: NTR 1248</p

Predicting the development of stress urinary incontinence 3 years after hysterectomy

We aimed to develop a prediction rule to predict the individual risk to develop stress urinary incontinence (SUI) after hysterectomy. Prospective observational study with 3-year follow-up among women who underwent abdominal or vaginal hysterectomy for benign conditions, excluding vaginal prolapse, and who did not report SUI before surgery (n = 183). The presence of SUI was assessed using a validated questionnaire. Significant prognostic factors for de novo SUI were BMI (OR 1.1 per kg/m(2), 95% CI 1.0-1.2), younger age at time of hysterectomy (OR 0.9 per year, 95% CI 0.8-1.0) and vaginal hysterectomy (OR 2.3, 95% CI 1.0-5.2). Using these variables, we developed the following rule to predict the risk of developing SUI: 32 + BMI-age + (7.5 × route of surgery). We defined a prediction rule that can be used to counsel patients about their individual risk on developing SUI following hysterectom

Protocol for the CUPIDO trials; multicenter randomized controlled trials to assess the value of combining prolapse surgery and incontinence surgery in patients with genital prolapse and evident stress incontinence (CUPIDO I) and in patients with genital prolapse and occult stress incontinence (CUPIDO II)

Background: About 40% of all patients with genital prolapse report stress-incontinence. In about half of the 60% patients that do not report stress-incontinence, occult urinary stress-incontinence can be detected. In these patients stress-incontinence is masked due to kinking or compression of the urethra by the prolapse. In case surgical correction is indicated there are two strategies to manage patients with combined prolapse and (occult) stress incontinence. This strategy is either (i) a combination of prolapse surgery and stress-incontinence surgery or (ii) to correct the prolapse first and evaluate afterwards whether additional stress-incontinence surgery is indicated. The advantage of combining prolapse and stress-incontinence surgery is that only few patients report stress-incontinence following such combination. However, this combination has been associated with an increased risk on complications, of which the development of obstructive micturition symptoms, overactive bladder symptoms and bladder retention are the most important ones. Furthermore, combining two procedures may be unnecessary as performing only prolapse surgery may cure stress-incontinence In the randomized CUPIDO trials both strategies are compared in patients with prolapse and evident stress incontinence (CUPIDO I trial) and in patients with prolapse and occult stress incontinence (CUPIDO II trial). Methods/Design: The CUPIDO trials are two multicenter randomized controlled trials in which women with stress urinary incontinence (SUI) or occult stress urinary incontinence (OSUI) are randomized to prolapse surgery combined with anti incontinence surgery (concomitant surgery) or to prolapse surgery only. Patients with at least stage 2 POP are eligible, women with evident SUI are randomized in CUPIDO I. Patients without SUI are eligible for CUPIDO II and will have urodynamic evaluation or a standardized redression test. Women with OSUI are randomized, women without OSUI are followed up but not randomized. The primary outcome measure is absence of SUI twelve months after surgery. Furthermore, economic evaluations are conducted, and the effectiveness of urodynamic investigation is evaluated against a non-invasive way to determine SUI in women with POP. A total of 450 women will be included in the study

Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered

BACKGROUND: Stress urinary incontinence (SUI) is a common problem. In the Netherlands, yearly 64.000 new patients, of whom 96% are women, consult their general practitioner because of urinary incontinence. Approximately 7500 urodynamic evaluations and approximately 5000 operations for SUI are performed every year. In all major national and international guidelines from both gynaecological and urological scientific societies, it is advised to perform urodynamics prior to invasive treatment for SUI, but neither its effectiveness nor its cost-effectiveness has been assessed in a randomized setting. The Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) study evaluates the positive and negative effects with regard to outcome, as well as the costs of urodynamics, in women with symptoms of SUI in whom surgical treatment is considered. METHODS/DESIGN: A multicentre diagnostic cohort study will be performed with an embedded randomized controlled trial among women presenting with symptoms of (predominant) SUI. Urinary incontinence has to be demonstrated on clinical examination and/or voiding diary. Physiotherapy must have failed and surgical treatment needs to be under consideration. Patients will be excluded in case of previous incontinence surgery, in case of pelvic organ prolapse more than 1 centimeter beyond the hymen and/or in case of residual bladder volume of more than 150 milliliter on ultrasound or catheterisation. Patients with discordant findings between the diagnosis based on urodynamic investigation and the diagnosis based on their history, clinical examination and/or micturition diary will be randomized to operative therapy or individually tailored therapy based on all available information. Patients will be followed for two years after treatment by their attending urologist or gynaecologist, in combination with the completion of questionnaires. Six hundred female patients will be recruited for registration from approximately twenty-seven hospitals in the Netherlands. We aspect that one hundred and two women with discordant findings will be randomized. The primary outcome of this study is clinical improvement of incontinence as measured with the validated Dutch version of the Urinary Distress Inventory (UDI). Secondary outcomes of this study include costs, cure of incontinence as measured by voiding diary parameters, complications related to the intervention, re-interventions, and generic quality of life changes. TRIAL REGISTRATION: Clinical Trials NCT0081474

Does mode of hysterectomy influence micturition and defecation?

OBJECTIVE: Hysterectomy may affect bladder and bowel function. A retrospective study was performed to compare the prevalence of micturition and defecation symptoms between different modes of hysterectomy. METHODS: All pre-operatively asymptomatic patients, with uteral size < or =10 cm, who underwent hysterectomy between 1988 and 1997 were interviewed about the prevalence of micturition and defecation symptoms and the experienced physical and emotional limitations of these symptoms. Using logistic regression analysis, odds ratios (OR) were calculated for all symptoms of which the prevalence between modes of hysterectomy differed more than 10%. These odds ratios were adjusted for differences in other prognostic factors. RESULTS: Vaginal hysterectomy was performed on 68 patients, total abdominal hysterectomy on 109 patients and subtotal abdominal hysterectomy on 50 patients. An increased prevalence of urge incontinence (adjusted OR 1.5 (95% CI 0.8-3.1)) and feeling of incomplete evacuation (adjusted OR 1.9 (95% CI 1.0-4.0)) was observed among patients who had undergone vaginal hysterectomy as compared to patients who had undergone total abdominal hysterectomy. The prevalence of urge incontinence (adjusted OR 1.8 (95% CI 0.8-4.2)) and difficulty emptying the rectum (adjusted OR 1.8 (95% CI 0.7-4.4)) was higher among patients who had undergone vaginal hysterectomy than among patients who had undergone subtotal abdominal hysterectomy. Statistically significant odds ratios were not observed. Relevant differences in physical and emotional limitations related to micturition and defecation symptoms were not observed between groups. CONCLUSION: Our results suggest that technique of hysterectomy may influence the prevalence of micturition and defecation symptoms following hysterectom

Prediction of findings at defecography in patients with genital prolapse

OBJECTIVE: Defecography may be useful in pre-operative assessment of patients with genital prolapse. Defecography is an invasive and embarrassing procedure for patients and little effort has been made to optimalise selection criteria for defecography. This study investigated whether discrimination of high and low probability of abnormal defecography is possible based on the quantified findings from patient history, pelvic examination and a validated questionnaire. DESIGN: Prospective observational study. SETTING: Three teaching hospitals in The Netherlands. POPULATION: Eighty-two patients undergoing surgical correction of uterine prolapse Stages 2-4. METHODS: A history and pelvic examination were obtained from all patients. A validated questionnaire was used to assess the presence of defecation and micturition symptoms. Using multivariate logistic regression analyses with receiver operating characteristic curves, a diagnostic model to predict the presence of an abnormal defecography was systematically constructed and validated. MAIN OUTCOME MEASURE: Presence of abnormal finding at defecography. RESULTS: The most important predictors for abnormal defecography were prolapse of the posterior vaginal wall, history of abdominal or pelvic surgery and the presence of constipation. With these variables, a prediction rule could be constructed which predicted the prevalence of an abnormal defecography (area under curve = 0.73; 95% CI 0.61-0.83). CONCLUSIONS: This study shows that a diagnostic model based on findings obtained from a non-invasive workup can accurately predict the presence of an abnormal defecography. Such a model provides the possibility to tailor the request for defecography to the individual patien

Hysterectomy and sexual wellbeing: prospective observational study of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy

Objectives To compare the effects of vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy on sexual wellbeing. Design Prospective observational study over six months. Setting 13 teaching and non-teaching hospitals in the Netherlands. Participants 413 women who underwent hysterectomy for benign disease other than symptomatic prolapse of the uterus and endometriosis. Main outcome measures Reported sexual pleasure, sexual activity, and bothersome sexual problems. Results Sexual pleasure significantly improved in all patients, independent of the type of hysterectomy. The prevalence of one or more bothersome sexual problems six months after vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy was 43% (38/89), 41% (31/76), and 39% (57/145), respectively (χ(2) test, P = 0.88). Conclusion Sexual pleasure improves after vaginal hysterectomy, subtotal abdominal hysterectomy, and total abdominal hysterectomy. The persistence and development of bothersome problems during sexual activity were similar for all three techniques