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Objective: To evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP)., Design: Randomised, double-blinded clinical trial (January 2020-April 2023)., Setting: This multicentre study was conducted at four hospitals in the Netherlands., Population and Sample: Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled., Methods: Participants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions., Main Outcomes and Measures: Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis., Results: A 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72-4.90, p = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32-2.80, p = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (p = 0.001)., Conclusion: The results from this study do not support the use of BTA injections in the management of CPP in women., (© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Objective: Pelvic organ prolapse is a common condition in women. Adequate timing of urinary catheter removal after vaginal prolapse surgery is essential to reduce post-operative morbidity. We compared midnight removal of the indwelling urinary catheter to removal next morning., Methods: We performed a retrospective cohort study among 266 women undergoing vaginal prolapse surgery, of whom 132 women had urinary catheter removal at midnight and 134 women morning after surgery. We compared the occurrence of urinary retention, time till first micturition, need for clean intermittent catherization and duration of hospital admission. Also, we assessed risk factors for the occurrence of retention., Results: Retention occurred less after midnight removal of the urinary catheter, compared to removal next morning (6.1 % versus 23.9 %, p < 0.001). Furthermore, the time till catheter removal and discharge from hospital were shorter and the need for clean intermittent catheterization during hospital admission was lower after midnight compared to next morning removal of the urinary catheter. We identified anterior colporrhaphy as a risk factor for retention., Conclusion: Our results suggest that early removal of the indwelling urinary catheter after vaginal prolapse surgery seems save with respect to urinary retention and leads to earlier mobilization and shorter hospital admission., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery., Methods: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist., Discussion: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017., (© 2021. The Author(s).)