Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire – IUGA Revised (PISQ-IR)

Background: To put statistically significant changes in patient reported outcome measurement (PROM) questionnaires into a clinical perspective, the concept of the minimal clinically important difference (MCID) can be used. Aim: To determine the MCID for the summary score for sexually active (SA) women of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), a validated instrument which assesses sexual functioning (SF) for patients suffering from a symptomatic pelvic floor disorder. Methods: Patients participating in a multicentre prospective cohort study comparing pessary therapy with surgery for a symptomatic pelvic organ prolapse (POP) filled in the PISQ-IR at baseline and 12 months’ follow-up. We used both an anchor-based as well as a distribution-based method to calculate the MCID for both treatment groups. The Patient Global Impression of Improvement (PGI-I) questionnaire and PISQ-IR question 19a about satisfaction with sexual functioning were used as anchors. For the distribution-based approach we used the effect size (ES). Outcomes: MCID for the SA summary score of the PISQ-IR. Results: Data of 243 women were used to calculate the MCID. In the pessary group, Kendall's tau-b correlation coefficients between the PISQ-IR summary score and both anchors were below the cut-off of 0.21, which implies the anchors cannot be used to calculate an MCID. In our surgery group, the PISQ-IR question 19a met the anchor criteria and 0.31 points increase in the PISQ-IR summary score was equal to an improvement of 1 point on question 19a about satisfaction with sexual functioning. Clinical implications: Future research on this subject should focus on clinical relevance of results rather than statistical significance only. Strengths & Limitations: Our main strength is the fact that we used both anchor-based and distribution-based methods to determine our MCID. Secondly, we set out to determine an MCID for both treatment groups separately, which relatively enhances the generalisability of our results. A limitation is that we were not able to estimate an MCID for the pessary group. Pruijssers B, van der Vaart L, Milani F, et al. Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire – IUGA Revised (PISQ-IR). J Sex Med 2021;18:1265–1270. Conclusion: We estimated the MCID for the PISQ-IR SA summary score to be 0.31 in our surgery group

A nationwide survey concerning practices in pessary use for pelvic organ prolapse in The Netherlands: identifying needs for further research

Introduction and hypothesis: To identify practice variation in management of patients with a vaginal pessary for pelvic organ prolapse (POP). Methods: A nationwide survey was sent to all Dutch gynecologists with a special interest in urogynecology. Results: The response rate was 59 %. Of the respondents, 13 % had a written protocol for pessary treatment in their department. Pessary treatment was proposed by 69 % of respondents as a treatment option. Counseling about side effects varied. All respondents provided information concerning the possibility of serious vaginal discharge. Concerning this side effect, 15 % of the respondents stated that it occurs in 5 – 20 % of patients, 27 % that it occurs in 20 – 40 % of patients, and 57 % that it occurs in more than 40 % of patients. Another item concerned counseling for the likelihood of vaginal blood loss. All respondents provided information concerning the possibility of vaginal blood loss. Concerning this side effect, 53 % of the respondents stated that it occurs in 5 – 20 % of patients, 33 % that it occurs in 20 – 40 %, and 14 % that it occurs in more than 40 % of patients. Follow-up after initial placement was done by 69 % of the respondents at 2 – 6 weeks, by 2 % at 8 weeks, and by 29 % at 12 weeks or more. Most (98 %) of the respondents extended the interval between visits when the patient had no complaints, and 96 % of the respondents reported that they routinely instruct patients about self-management. Conclusions: Pessaries are suggested as a treatment option by a majority of gynecologists, but practice varies widely. We consider that the variation in practice is due to a lack of available protocols and lack of evidence

Female Sexual Functioning in Women With a Symptomatic Pelvic Organ Prolapse; A Multicenter Prospective Comparative Study Between Pessary and Surgery

Background: Female pelvic organ prolapse (POP) has a negative effect on female sexual functioning and with an increasing life expectancy female sexual dysfunction caused by POP will be an arising global issue. Aim: Improvement in female sexual functioning, measured with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR), 24-months after pessary or surgery, for both sexually active (SA) and sexually inactive women (NSA) presenting with POP. Methods: A multicenter prospective comparative cohort study was conducted in 22 Dutch hospitals. Women referred with moderate to severe POP symptoms and POP stage ≥ 2 were included and chose either pessary therapy or surgical intervention. The PISQ-IR was filled in at baseline and 24-months, the delta of change was calculated and compared between both groups. Multivariate linear regression was performed to adjust for potential confounding factors in the association between the summary score of the PISQ-IR and therapy. Outcomes: Change in PISQ-IR between pessary and surgical intervention. Results: The delta of change at 24-months was calculated for 198 women in the pessary group and 129 women in the surgery group. SA women in the surgery group reported statistically significant more improvement on the condition-specific (-0.19 95%CI -0.35; -0.03, P = .02), and condition-impact (-0.48 95%CI -0.69; -0.28, P < .001) domains as well as on the summary score (-0.15 95%CI -0.23; -0.08, P < .001) as compared to the pessary group. No significant differences between pessary and surgery were found on the domains for NSA women. After controlling for potential baseline confounders, surgery still had a statistically significant effect on the summary score (B = 0.08; 95%CI interval 0.007–0.15, P = .03). Women having surgery had 2.62 times higher odds of changing from NSA to SA than pessary therapy. Clinical implications: SA women who clearly express that POP-related symptoms limit their sexual functioning should be counseled that surgery results in a more remarkable improvement. Strengths & Limitations: Our strengths include the large sample size, long-term follow-up, the use of the PISQ-IR as a validated outcome tool evaluating both SA and NSA women, and this study reflects real-life clinical practice that enhances the external validity of the findings. A limitation of our study is the considerable proportion of non-responders at 24-months follow-up. Conclusion: Sexual function in SA women with POP is superior in case surgery is performed as compared to pessary therapy. van der Vaart LR, Vollebregt A, Pruijssers B, et al. Female Sexual Functioning in Women With a Symptomatic Pelvic Organ Prolapse; A Multicenter Prospective Comparative Study Between Pessary and Surgery. J Sex Med 2022;19:270–279

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Objective To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective. Design Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up. Setting 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022. Participants 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital. Interventions Pessary therapy and surgery. Primary and secondary outcome measures The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of −10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires. Results For the PGI-I, the mean difference between pessary therapy and surgery was −0.05 (95% CI −0.14; 0.03) and −0.03 (95% CI −0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=−€1807, 95% CI −€2172; −€1446 and mean difference=−€1850, 95% CI −€2349; −€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives. Conclusions Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care

Polypropylene mesh in anterior vaginal prolapse surgery : Efficacy, safety and costs

Pelvic organ prolapse (POP) is a common condition from which millions of women suffer worldwide. In women with POP the vaginal wall or uterus protrudes or bulges outside the vagina. The prevalence of Dutch women with a symptomatic pelvic organ prolapse is 11%. In the Netherlands more than 13000 surgical procedures each year have been performed to correct POP. About 30% of women operated on POP will need a re-operation due to high recurrence rates after conventional surgical procedures by using native tissue. Owing to these high recurrence rates new techniques have been developed aiming on a better outcome. By using a vaginal mesh instead of native tissue the durability of the surgical repair can be augmented. The first results after vaginal POP surgery using mesh were promising. However, also concerns arose about the safety of these new procedures. Despite the lack of proper evidence to support their efficacy and safety, these techniques were rapidly introduced on the market. This lack of evidence prompted to start the research in this thesis. Since the majority of the recurrences after vaginal POP surgery occur in the anterior compartment of the vagina, the focus of the research in this thesis has been on the surgical correction of the anterior compartment. The risks and benefits of a vaginal polypropylene mesh kit with collagen coating in, (mainly) anterior, vaginal prolapse repair are studied. First, safety was studied in terms of preoperative handling of the mesh and infection. A routine and a more extensive sterility procedure were compared in a prospective study and it was concluded that the more extensive procedure provides no additional effect on the bacterial contamination of the mesh. The routine sterility procedure appears to be safe in combination with broad-spectrum antibiotic prophylaxis in vaginal POP surgery with mesh. Second, the results of an observational cohort study showed that trocar- guided transobturator mesh repair is effective in primary and recurrent repair with regards to both anatomical and functional outcomes. Third, the results of a randomized trial showed that primary cystocele repair using anterior mesh leads to significant better anatomical outcome compared to a repair using native tissue. However, despite these better anatomical results, similar improvement in urogenital symptoms and quality of life is observed. Both interventions appear to be safe, but after anterior mesh use a negative effect on sexual function, such as dyspareunia can be expected. Furthermore mesh use leads to higher costs compared to a native tissue repair. By taking these results into account, the use of vaginal trocar-guided transobturator mesh is not advocated in primary cystocele repair, in spite of being an anatomic effective and relative safe procedure. However, long term follow-up is necessary to demonstrate if anatomical recurrences after anterior colporrhaphy will subsequently become symptomatic with the need for re-operations. On the other hand, an increase in symptomatic de novo prolapse of the untreated compartment can occur after mesh repair, which also could result in new surgical intervention

Can we predict continued pessary use as primary treatment in women with symptomatic pelvic organ prolapse (POP)? A prospective cohort study

Introduction and hypothesis: The objective of this study was creating a prediction model for continued pessary use in patients with symptomatic pelvic organ prolapse (POP) and evaluating the percentage of continued pessary use after 12 months. Methods: We performed a prospective cohort study in patients with symptomatic POP stage ≥ 2. All patients received a pessary as primary treatment. Factors for continuation were identified from baseline characteristics and data from validated disease-specific quality of life (DSQOL) questionnaires. Univariate and multivariate analyses for predictors were performed and a prediction model was made. Improvement of POP was measured using the Patient Global Impression of Improvement (PGI-I) and DSQOL at 12 months' follow-up. Primary outcome was factors related to continued use. Secondary outcomes were the percentage continued pessary use after 12 months, improvement of complaints and DSQOL. Results: Two hundred ninety-one patients were included; 184 (63%) patients continued pessary use after 12 months. Factors related to continuation following the univariate analysis were age, sexual activity, POP-Q point c ≥ 0 and obstructive micturition. GH < 4 was not significant but added significantly to the prediction model. After multivariate analysis, age, point c ≥ 0 and GH < 4 cm remained predictors for continuation. The ROC showed an AUC of 0.65 (95% CI 0.58–0.71). PGI-I showed 83% perceived their prolapse complaints much or very much improved. Conclusions: Continued pessary use was found in 63%. Main predictors for continued pessary use were higher age, more prominent apical compartment prolapse (c ≥ 0) and a GH < 4 cm

A nationwide survey concerning practices in pessary use for pelvic organ prolapse in The Netherlands : identifying needs for further research

Introduction and hypothesis: To identify practice variation in management of patients with a vaginal pessary for pelvic organ prolapse (POP). Methods: A nationwide survey was sent to all Dutch gynecologists with a special interest in urogynecology. Results: The response rate was 59 %. Of the respondents, 13 % had a written protocol for pessary treatment in their department. Pessary treatment was proposed by 69 % of respondents as a treatment option. Counseling about side effects varied. All respondents provided information concerning the possibility of serious vaginal discharge. Concerning this side effect, 15 % of the respondents stated that it occurs in 5 – 20 % of patients, 27 % that it occurs in 20 – 40 % of patients, and 57 % that it occurs in more than 40 % of patients. Another item concerned counseling for the likelihood of vaginal blood loss. All respondents provided information concerning the possibility of vaginal blood loss. Concerning this side effect, 53 % of the respondents stated that it occurs in 5 – 20 % of patients, 33 % that it occurs in 20 – 40 %, and 14 % that it occurs in more than 40 % of patients. Follow-up after initial placement was done by 69 % of the respondents at 2 – 6 weeks, by 2 % at 8 weeks, and by 29 % at 12 weeks or more. Most (98 %) of the respondents extended the interval between visits when the patient had no complaints, and 96 % of the respondents reported that they routinely instruct patients about self-management. Conclusions: Pessaries are suggested as a treatment option by a majority of gynecologists, but practice varies widely. We consider that the variation in practice is due to a lack of available protocols and lack of evidence

Effect of pessary cleaning and optimal time interval for follow-up: a prospective cohort study

Introduction and hypothesis: The objective of this study was to determine the efficacy of routine follow-up visits for pessary cleaning, the effect of extended time intervals between visits and the proportion of patients being able to self-manage their pessary for pelvic organ prolapse (POP). Methods: We conducted a prospective cohort study in patients with a stage ≥II POP without previous POP surgery. All patients received a pessary as primary treatment. Our main outcome measure was a difference ≥2 in median visual analogue scale (VAS) scores (for pain, discharge, irritation) 1 week before and 1 week after cleaning. Measurements were performed after 3- and 9-month cleaning intervals. For the evaluation of the effect of cleaning, 132 patients (3 months’ follow-up) and 87 patients (12 months’ follow-up) were available for analysis. For the evaluation of the effect of the lengthening interval, 123 patients were available. Results: Self-management was performed in 45.2% of patients at 1 year. In 93.1% of patients, no differences were observed in pre-and post-cleaning VAS scores (effect of cleaning) on vaginal pain. Nor was there a difference in discharge (72.4%) or irritation 85.1% (p = 0.00). No differences were observed in pre-cleaning VAS scores for vaginal pain, discharge and irritation when the interval was lengthened from 3 to 9 months. No serious adverse events occurred. Conclusions: There is no proven benefit of regular follow-up visits to clean a pessary. Also, the length of the cleaning interval does not seem to matter