Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study.

OBJECTIVE: To compare the 24-month efficacy of pessary or surgery as the primary treatment for symptomatic pelvic organ prolapse (POP). DESIGN: Multicentre prospective comparative cohort study. SETTING: Twenty-two Dutch hospitals. POPULATION: Women referred with symptomatic POP of stage ≥2 and moderate-to-severe POP symptoms. METHODS: The primary outcome was subjective improvement at the 24-month follow-up according to the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes included improvement in prolapse-related symptoms measured with the Pelvic Floor Distress Inventory (PFDI-20), improvement in subjective severeness of symptoms according to the Patient Global Impression of Severity (PGI-S) scale and crossover between therapies. The primary safety outcome was the occurrence of adverse events. MAIN OUTCOME MEASURE: PGI-I at 24 months. RESULTS: We included 539 women, with 335 women (62.2%) in the pessary arm and 204 women (37.8%) in the surgery arm. After 24 months, subjective improvement was reported by 134 women (83.8%) in the surgery group compared with 180 women (74.4%) in the pessary group (risk difference 9.4%, 95% CI 1.4-17.3%, P < 0.01). Seventy-nine women (23.6%) switched from pessary to surgery and 22 women (10.8%) in the surgery group underwent additional treatment. Both groups showed a significant reduction in bothersome POP symptoms (P ≤ 0.01) and a reduction in the perceived severity of symptoms (P ≤ 0.001) compared with the baseline. CONCLUSIONS: Significantly more women in the surgery group reported a subjective improvement after 24 months. Both therapies, however, showed a clinically significant improvement of prolapse symptoms. TWEETABLE ABSTRACT: Pessary treatment and vaginal surgery are both efficacious in reducing the presence and severity of prolapse symptoms, although the chance of significant improvement is higher following surgery.

Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy-a multicentre randomised controlled trial (LAVA trial).

OBJECTIVE: To investigate whether laparoscopic sacrohysteropexy (LSH) is non-inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse. DESIGN: Multicentre randomised controlled, non-blinded non-inferiority trial. SETTING: Five non-university teaching hospitals in the Netherlands, one university hospital in Belgium. POPULATION: 126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery. METHODS: Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%. MAIN OUTCOME MEASURES: Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life. RESULTS: Laparoscopic sacrohysteropexy was non-inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference -1.7%, 95% CI: -7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP. CONCLUSION: Laparoscopic sacrohysteropexy was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent. TWEETABLE ABSTRACT: Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short-term outcomes.

Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh.

OBJECTIVE: To compare anterior colporrhaphy with a trocar-guided transobturator mesh procedure (Avaulta(®) anterior). DESIGN: Randomised, controlled trial. SETTING: Three teaching hospitals. POPULATION: Women with a symptomatic cystocele at least stage II requiring primary surgical correction. METHODS: A total of 125 women were assessed at baseline and 1-year follow up. A sacrospinous hysteropexy or posterior colporrhaphy was performed when indicated. MAIN OUTCOME MEASURES: The primary outcome was the difference in anatomical cure (defined as Pelvic Organ Prolapse-Quantification

Acquired progressive hypotonia in infancy: consider compressive cervical myelopathy.

UNLABELLED: This case report presents a rare cause of progressive hypotonia due to a congenital bony defect of the atlas in a 2-month-old girl. The patient was initially referred to the paediatric department with feeding problems. Within days after admission she developed progressive hypotonia and showed decreased reflexes of the upper extremities. Magnetic resonance imaging showed compressive myelopathy at the level of vertebra C1. After laminectomy of the C1-vertebra the neurological symptoms resolved. CONCLUSION: Most anomalies of the vertebras are asymptomatic. Only symptomatic anomalies with compression and neurological symptoms need surgery.

How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery.

OBJECTIVE: To determine whether prolonged urinary bladder catheterisation after vaginal prolapse surgery is advantageous. DESIGN: Randomised controlled trial. SETTING: A large training hospital in the Netherlands. POPULATION: Patients undergoing anterior colporrhaphy. METHODS: One hundred patients were included. Patients were randomised into two groups. In one group (n= 50), a transurethral catheter was in place for four days post-operatively and removed on the fifth post-operative day. In the other group (n= 50), catheterisation was not prolonged and the catheter was removed the morning after surgery. Residual volumes after removal of the catheter were measured by ultrasound scanning. Where residual volumes of >200 mL were found the patient was recatheterised for three more days. Urinary cultures were taken before removal of the catheter. Six patients were excluded: four in the standard prolonged catheterisation group and two in the not prolonged catheterisation group. MAIN OUTCOME MEASURES: Need for recatheterisation, urinary tract infection, mean duration of catheterisation and hospital stay. RESULTS: Residual volumes exceeding 200 mL and need for recatheterisation occurred in 9% in the standard prolonged catheterisation group versus 40% of patients in the not prolonged catheterisation group (OR 0.15, 95% CI 0.045-0.47). Positive urine cultures were found in 40% of cases in the standard prolonged catheterisation group compared with 4% in the not prolonged catheterisation group (OR 15, 95% CI 3.2-68.6). Mean duration of catheterisation was 5.3 days in the standard prolonged catheterisation group and 2.3 days in the not prolonged catheterisation group (P < 0.001). Mean duration of hospitalisation was 7 days in the standard prolonged catheterisation group and 5.7 days in the not prolonged group (P < 0.001). CONCLUSION: The disadvantages of prolonged catheterisation outweigh the advantages, therefore, removal of the catheter on the morning after surgery may be preferable and longer term catheterisation should only be undertaken where there are specific indications.

Prepidil compared to Propess for cervical ripening.

OBJECTIVES: To compare the efficacy and safety of intracervical PGE(2) gel (Prepidil) with intravaginal PGE(2) insert (Propess) in cervical ripening and induction of labour. STUDY DESIGN: This was a retrospective analysis of patients with single pregnancies, intact membranes and a viable fetus who required cervical ripening. In the first half of 1998, all patients received Prepidil and in the first half of 1999 all patients received Propess. In both periods 50 consecutive files were retrieved and compared. RESULTS: The Prepidil and Propess group were similar in patient characteristics, indication for induction of labour and delivery outcome. Cervical ripening within 24 h was achieved in the Propess group in 80% as compared to 56% in the Prepidil group. The application-membrane rupture-interval was shorter in the Propess group compared to the Prepidil group (23.7 +/- 21.3 h versus 56.4 +/- 77.7 h, P = 0.009) as well as the application-delivery interval (29.8 +/- 22.0 h versus 62.0 +/- 78.8 h, P = 0.039). In the Propess group 62% delivered within 24 h compared to 28% in the Prepidil group. A smaller number of applications was observed in the Propess group (1.2 versus 1.8, P < 0.005). Both methods proved to be safe in cervical priming and no relevant differences in mode of delivery and outcome of labour were detected. None of the patients required an emergency caesarean section during the treatment with prostaglandines. CONCLUSIONS: Both prostaglandin E(2) agents are safe and effective in achieving cervical ripening; however the vaginal insert demonstrated a shorter application-delivery interval. The hospital stay was consequently shorter, contributing to cost effectiveness.

A study of PROforma, a development methodology for clinical procedures.

Knowledge engineering has shown that besides the general methodologies from software engineering it is useful to develop special purpose methodologies for knowledge based systems (KBS). PROforma is a newly developed methodology for a specific type of knowledge based systems. PROforma is intended for decision support systems and in particular for clinical procedures in the medical domain. This paper reports on an evaluation study of PROforma, and on the trade-off that is involved between general purpose and special purpose development methods in Knowledge Engineering and Medical AI. Our method for evaluating PROforma is based on re-engineering a realistic system in two methodologies: the new and special purpose KBS methodology PROforma and the widely accepted, and more general KBS methodology CommonKADS. The four most important results from our study are as follows. Firstly, PROforma has some strong points which are also strong related to requirements of medical reasoning. Secondly, PROforma has some weak points, but none of them are in any way related to the special purpose nature of PROforma. Thirdly, a more general method like CommonKADS works better in the analysis phase than the more special purpose method PROforma. Finally, to support a complementary use of the methodologies, we propose a mapping between their respective languages.