For women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.).
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 ¼ 50), a transurethral catheter was in place for four days post-operatively and removed on the fifth postoperative day. In the other group (n ¼ 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.
Objective To compare anterior colporrhaphy with a trocar-guided transobturator mesh procedure (Avaulta Ò 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 ProlapseQuantification
ImportancePelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase.ObjectiveTo investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.Design, Setting, and ParticipantsThe PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022.InterventionsTwo hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery.Main Outcomes and MeasuresThe primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured.ResultsAmong 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, −6.1% [1-sided 95% CI, −12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, −13.1% [1-sided 95% CI, −23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery.Conclusions and RelevanceAmong patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery.Trial RegistrationNetherlands Trial Register Identifier: NTR4883
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.
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