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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).)

Introduction and Hypothesis: Pelvic floor muscle function plays an important role in female sexual functioning. Smaller genital hiatal dimensions have been associated with sexual dysfunction, mainly dyspareunia. On the other hand, trauma of the levator ani muscle sustained during childbirth is associated with increased genital hiatus, which potentially can affect sexual functioning by causing vaginal laxity. This study aims to determine the association between levator hiatal dimensions and female sexual dysfunction after first vaginal delivery., Methods: This is a secondary analysis of a prospective observational study. Two hundred four women who had a first, spontaneous vaginal delivery at term between 2012 and 2015 were recruited at a minimum of 6 months postpartum. Thirteen pregnant women were excluded. We analyzed the association of total PISQ-12 score, as well as individual sexual complaints (desire, arousal, orgasm and dyspareunia), with levator hiatal dimensions at rest, with maximum Valsalva and during pelvic floor muscle contraction as measured by 4D transperineal ultrasound. Statistical analysis was performed using linear regression analysis and Mann-Whitney U test., Results: One hundred ninety-one women were evaluated at a median of 11 months postpartum. There was no significant association between total PISQ-12 score and levator hiatal dimensions. Looking at individual sexual complaints, women with dyspareunia had significantly smaller levator hiatal area and anterior-posterior diameter on maximum Valsalva. By using multivariate logistic regression analysis however we found dyspareunia was not independently associated with levator hiatal dimensions., Conclusions: After first vaginal delivery sexual dysfunction is not associated with levator hiatal dimensions as measured by 4D transperineal ultrasound.

Objective: Postpartum urinary retention is a frequent complication after childbirth. It is usually a temporary condition. However, unrecognised urinary retention can lead to considerable morbidity due to bladder over distention, detrusor atony and long term voiding dysfunction. In our clinic we noticed an overestimation of post void residual measured with the BladderScan ® in comparison with catheterization in women one week after delivery., Study Design: We included 25 women in this prospective pilot study. These women had a urinary retention over 1000 ml within 4-5 h postpartum. Conform our local protocol, an indwelling catheter was inserted for one week. After removal of the indwelling catheter, a micturition trial was conducted. The post void residual was first measured with BladderScan ® (BVI 3000), directly followed by clean intermittent catheterization which is the golden standard at this moment., Results: There was a significant mean difference in post void residual measurements with the BladderScan ® and catheterization of 312 ml (95% CI 220-404 ml) (p < 0.001). According to our post void residual definition of 200 ml, the sensitivity and specificity of the BladderScan ® was respectively 100% and 17.6%. The positive predictive value was 36%., Conclusion: The BladderScan ® (BVI 3000) is a non-reliable instrument to measure post void residual one week postpartum. For now clean intermittent catherization remains the golden standard.

Background: Pelvic organ prolapse is a common health problem in women and has a negative influence on quality of life. A major cause of pelvic organ prolapse is levator injury., Objective: The objective of the study was to evaluate the association of mediolateral episiotomy with levator injury (levator avulsion, ballooning, or combined) and urogynecological complaints., Study Design: A prospective observational cohort study was performed in 204 primiparous women with a spontaneous vaginal delivery without anal sphincter tear in a general hospital between 2012 and 2015. One hundred three of these women had had a mediolateral episiotomy. Validated urogynecological questionnaires and transperineal 3-dimensional/4-dimensional ultrasound were completed after delivery. Outcome measures were levator avulsion, ballooning (hiatal area of more than 25 cm 2 ), and urogynecological questionnaire scores. Statistical analysis was performed using univariate and multiple logistic regression analysis., Results: The median time at investigation after vaginal delivery was 13 months (range 6-33). Levator injury (avulsion, ballooning, or combined) was identified in 35 of the 103 women who had undergone mediolateral episiotomy (40.0%) and 33 of the 101 women without episiotomy (32.7%) (P = .69). No differences were found in the incidence of levator avulsion 27 (26.7%) vs 23 (22.8%) (P = .53) or in levator ballooning (20 [19.4%] vs 23 [22.8%] (P = .58) between both groups. There was an association between longer duration of the second stage of labor and the incidence of levator avulsion (odds ratio, 1.24 [95% confidence interval, 1.01-1.52]). Nonocciput anterior fetal position increased the risk of levator ballooning and levator injury (odds ratio, 10.19 [95% confidence interval, 1.89-54.91] and odds ratio, 12.16 [95% confidence interval, 1.41-104.38], respectively). No differences in urogynecological complaints were found., Conclusion: Mediolateral episiotomy is not associated with the occurrence of levator injury or urogynecological complaints in women with a spontaneous vaginal delivery who did not obtain an anal sphincter injury. Levator injury was associated with a prolonged second stage of labor and a nonocciput anterior fetal position., (Copyright © 2018. Published by Elsevier Inc.)