Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials.

BACKGROUND: Recruitment of participants is crucial to the success of any trial as it can have a major impact on study costs, the duration of the study itself, and, more critically, trial failure. Given that vulvodynia particularly affects young women, the use of social media and e-recruitment could prove efficient for enrollment. AIM: To compare the efficiency, effectiveness, and cost-effectiveness of three different recruitment methods. METHODS: The comparison data were collected as part of a bicentric randomized controlled trial evaluating the efficacy of physiotherapy in comparison with topical lidocaine in 212 women suffering from provoked vestibulodynia. The recruitment methods included: (i) conventional methods (eg, posters, leaflets, business cards, newspaper ads); (ii) health professional referrals, and (iii) e-recruitment (eg, Facebook ads and web initiatives). Women interested in participating were screened by telephone for eligibility criteria and were assessed by a gynecologist to confirm their diagnosis. Once included, structured interviews were undertaken to describe their baseline characteristics. MAIN OUTCOME MEASURES: The outcomes of this study were the recruitment efficiency (the number of patients screened/enrolled), recruitment effectiveness (the number of participants enrolled), cost-effectiveness (cost per enrolled participant), and retention rate, and baseline characteristics of participants were monitored for each method. RESULTS: The conventional methods (n = 101, 48%) were more effective as they allowed for greater enrollment of participants, followed by e-recruitment (n = 60, 28%) and health professional referrals (n = 33, 16%) (P < 0.007). Recruitment efficiency was found to be similar for e-recruitment and referrals (60/122 and 33/67, 49%, P = 0.055) but lower for conventional methods (101/314, 32%, P < 0.011). Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588). The average cost per enrolled participant was fairly similar for e-recruitment ($117) and conventional methods ($110) and lower for referrals ($60). CLINICAL IMPLICATIONS: Our results suggest that having a variety of recruitment methods is beneficial in promoting clinical trial recruitment without affecting participant characteristics and retention rates. STRENGTH & LIMITATIONS: Although recruitment methods were used concomitantly, this study gives an excellent insight into the advantages and limitations of recruitment methods owing to a large sample size. CONCLUSION: The study findings revealed that e-recruitment is a valuable recruitment method because of its comparable efficiency and cost-effectiveness to health professional referrals and conventional methods, respectively. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01455350. Benoit-Piau J, Dumoulin C, Carroll MS, et al. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med 2020;17:1304-1311.

Agreement between simple catheter method and 3D transperineal ultrasound for assessing urethral length measurement before stress urinary incontinence treatment.

AIMS: Optimal placement of periurethral material has an important role in treatment efficacy with stress urinary incontinence (SUI). The validity of methods for determining urethral length and the precise location of the mid-urethral complex for SUI treatment have been sparsely studied. The aim of this study was to investigate the agreement between urethral lengths measured with a catheter and by transperineal ultrasound. METHODS: Fifty-seven women with SUI or mixed urinary incontinence (MUI) with predominant stress symptoms were recruited. The urethral length was assessed with 3D transperineal ultrasound and measurements were taken offline from the postero-inferior margin of the pubic symphysis to the bladder neck. Then, it was measured with a foley catheter by another evaluator, blinded to the ultrasound data. The distance between the inflated balloon and the urethral meatus was considered. RESULTS: Thirty-three women (58%) had SUI and 24 (42%) had MUI. The mean urethral length evaluated with ultrasound and the catheter were 3.03 ± 0.34 cm and 3.02 ± 0.41 cm (P = 0.857), respectively. Agreement between the two methods as assessed by the intra-class correlation coefficient was 0.90 (CI0.82-0.94, P ≤ 0.001). Limits of agreement (Bland-Altman) were +0.46 to -0.45 cm, with a mean difference of -0.01 ± 0.23 cm. CONCLUSIONS: Findings of this study, reveal an excellent agreement between a simple catheter technique and ultrasound assessment for measuring urethral length, with a small mean bias and clinically acceptable limits of agreement. This provides relevant information in clinical practice for determining optimal placement of periurethral material or mid-urethral tape for SUI treatment.

High-Intensity Laser Therapy (HILT) as an Emerging Treatment for Vulvodynia and Chronic Musculoskeletal Pain Disorders: A Systematic Review of Treatment Efficacy.

High-intensity laser therapy (HILT) has been gaining popularity in the treatment of chronic musculoskeletal pain, including vulvodynia. The objective of this study was to critically appraise and synthesize the available evidence on the efficacy of HILT for reducing pain and improving function in vulvodynia and other chronic primary musculoskeletal pain conditions. Electronic databases and the grey literature were searched. Effects on pain intensity, function, and adverse events were assessed. One study investigating HILT in the treatment of vulvodynia and 13 studies on the treatment of chronic musculoskeletal pain were selected. The study assessing vulvodynia showed favorable results for reducing pain. Regarding chronic musculoskeletal pain, 12 out of the 13 studies selected consistently showed that HILT was more effective than the placebo/active comparator for reducing pain and improving function. The available effect sizes for pain showed large to huge effects. Similar effects were observed for function except for two studies showing moderate effects. The GRADE score was moderate. Conclusions: There are insufficient data to support the use of HILT in vulvodynia, but the promising results encourage further research. HILT appears to be effective in musculoskeletal pain conditions. More high-quality studies are needed to identify effective laser protocols.

Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia.

INTRODUCTION: Pelvic floor muscle physical therapy is recommended in clinical guidelines for women with provoked vestibulodynia (PVD). Including isolated or combined treatment modalities, physical therapy is viewed as an effective first-line intervention, yet no systematic review concerning the effectiveness of physical therapy has been conducted. AIM: To systematically appraise the current literature on the effectiveness of physical therapy modalities for decreasing pain during intercourse and improving sexual function in women with PVD. METHODS: A systematic literature search using PubMed, Scopus, CINHAL, and PEDro was conducted until October 2016. Moreover, a manual search from reference lists of included articles was performed. Ongoing trials also were reviewed using clinicaltrial.gov and ISRCTNregistry. Randomized controlled trials, prospective and retrospective cohorts, and case reports evaluating the effect of isolated or combined physical therapy modalities in women with PVD were included in the review. MAIN OUTCOME MEASURES: Main outcome measures were pain during intercourse, sexual function, and patient's perceived improvement. RESULTS: The literature search resulted in 43 eligible studies including 7 randomized controlled trials, 20 prospective studies, 5 retrospective studies, 6 case reports, and 6 study protocols. Most studies had a high risk of bias mainly associated with the lack of a comparison group. Another common bias was related to insufficient sample size, non-validated outcomes, non-standardized intervention, and use of other ongoing treatment. The vast majority of studies showed that physical therapy modalities such as biofeedback, dilators, electrical stimulation, education, multimodal physical therapy, and multidisciplinary approaches were effective for decreasing pain during intercourse and improving sexual function. CONCLUSION: The positive findings for the effectiveness of physical therapy modalities in women with PVD should be investigated further in robust and well-designed randomized controlled trials. Morin M, Carroll M-S, Bergeron S. Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia. Sex Med Rev 2017;5:295-322.