Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial.

BACKGROUND: Provoked vestibulodynia is the most common subtype of chronic vulvar pain. This highly prevalent and debilitating condition is characterized by acute recurrent pain located at the entry of the vagina in response to pressure application or attempted vaginal penetration. Although physical therapy is advocated as a first-line treatment for provoked vestibulodynia, evidence supporting its efficacy is scarce. OBJECTIVE: The purpose of this study was to establish the efficacy of multimodal physical therapy compared with topical lidocaine, a frequently used first-line treatment. STUDY DESIGN: We conducted a multicenter, parallel-group, randomized clinical trial in women diagnosed as having provoked vestibulodynia recruited from the community and 4 Canadian university hospitals. Women were randomly assigned (1:1) to receive either weekly sessions of physical therapy or overnight topical lidocaine (5% ointment) for 10 weeks. Randomization was stratified by center using random permuted blocks from a computer-generated list managed by an independent individual. Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy, and dilation. Assessments were conducted at baseline, posttreatment, and 6-month follow-up. Outcome assessors, investigators, and data analysts were masked to allocation. The primary outcome was pain intensity during intercourse evaluated with the numeric rating scale (0-10). Secondary outcomes included pain quality (McGill-Melzack Pain Questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (numeric rating scale of 0-10), and participants' impression of change (Patient Global Impression of Change). Intention-to-treat analyses were conducted using piecewise linear-growth models. RESULTS: Among 212 women who were recruited and randomized, 201 (95%) completed the posttreatment assessment and 195 (92%) completed the 6-month follow-up. Multimodal physical therapy was more effective than lidocaine for reducing pain intensity during intercourse (between-group pre-post slope difference, P<.001; mean group postdifference, 1.8; 95% confidence interval, 1.2-2.3), and results were maintained at 6-month follow-up (mean group difference, 1.8; 95% confidence interval, 1.2-2.5). The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction, and participants' impression of change) at posttreatment and 6-month follow-up. Moreover, the changes observed after physical therapy were shown to be clinically meaningful. Regarding participants' impression of change, 79% of women in the physical therapy group reported being very much or much improved compared with 39% in the lidocaine group (P<.001). CONCLUSION: The findings provide strong evidence that physical therapy is effective for pain, sexual function, and sexual distress and support its recommendation as the first-line treatment of choice for provoked vestibulodynia.

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.

Incitation à participer à une campagne de dépistage du cancer du col de l'utérus : expérience d'un centre de soins tertiaires au Canada.

OBJECTIVES: The main objective of this study was to determine the most cost-effective communications strategy for National Cervical Cancer Awareness Week. The secondary objectives were to identify the reasons women were not screened by their primary care provider and to determine the number of abnormal cytology results obtained as a result of the awareness week screening. METHODOLOGY: As part of an evaluation of the quality of care, we reviewed the medical records of all patients who underwent cervical cancer screening at a Québec teaching hospital during National Cervical Cancer Awareness Week. RESULTS: A total of 202 women underwent screening during the national awareness week, held in October 2018. For 180 of the women, we were able to identify the communications strategies that led them to get screened and to obtain information on their follow-up care with their primary health care provider. No-cost marketing channels (including Facebook, the hospital website, and a news report and interview) led to 66 women (36.7%) participating, making these channels the most cost-effective. While 59% of the women had a family physician, 41% of them reported that their family physician did not perform pelvic exams. Abnormal cytology results were reported for 2.8% of the women. CONCLUSION: No-cost communications channels were the most effective for raising awareness. The majority of participants had a family physician. Efforts to raise awareness of cervical cancer must continue in order to increase screening rates. In addition, strategies must be put in place to improve access to Pap tests.

Efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia.

BACKGROUND: Provoked vestibulodynia is a highly prevalent condition characterized by acute recurrent pain located at the vaginal entrance in response to pressure application or attempted vaginal penetration. Despite a wide variety of treatments offered to women with provoked vestibulodynia, a high proportion of women are refractory to conventional treatment. Transcranial direct-current stimulation is a noninvasive brain stimulation technique that has been shown effective for improving various chronic pain conditions. Growing evidence suggests that the central nervous system could play a key role in provoked vestibulodynia. Targeting the central nervous system could therefore be a promising treatment for women with provoked vestibulodynia. OBJECTIVE: The purpose of this study was to evaluate and compare the efficacy of active and sham transcranial direct-current stimulation in reducing pain intensity during intercourse in patients with provoked vestibulodynia. STUDY DESIGN: We conducted a triple-blind, parallel-group, randomized controlled trial. Women aged 17-45 years diagnosed with provoked vestibulodynia by a gynecologist using a validated protocol were randomized to 10 sessions of either active transcranial direct-current stimulation (intensity = 2 mA) or 10 sessions of sham transcranial direct-current stimulation, over a 2-week period. Both active and sham transcranial direct-current stimulation were applied for 20 minutes, with the anode positioned over the primary motor cortex, and the cathode over the contralateral supraorbital area. Outcome measures were collected at baseline, 2 weeks after treatment, and at 3-month follow-up by an evaluator blinded to group assignment. The primary objective was to assess pain intensity during intercourse, using a numerical rating scale. Secondary outcomes focused on sexual function and distress, vestibular sensitivity, psychological distress, treatment satisfaction, and patient impression of change. Statistical analyses were conducted on the intention-to-treat basis, and treatment effects were evaluated using a mixed linear model for repeated measures. RESULTS: A total of 40 patients were randomly assigned to receive either active (n = 20) or sham (n = 20) transcranial direct-current stimulation treatments from November 2014 through February 2016. Baseline characteristics were similar between the active and sham transcranial direct-current stimulation groups. In full compliance with the study protocol, every participant followed all courses of the study treatment, including assessments at 2-week and 3-month follow-up. Pain during sexual intercourse was not significantly different between active and sham treatment groups 2 weeks after treatment (P = .84) and at follow-up (P = .09). Mean baseline and 2-week assessment pain intensity were, respectively, 6.8 (95% confidence interval, 5.9-7.7) and 5.6 (95% confidence interval, 4.7-6.5) for active transcranial direct-current stimulation (P = .03) vs 7.5 (95% confidence interval, 6.6-8.4) and 5.7 (95% confidence interval, 4.8-6.6) for sham transcranial direct-current stimulation (P = .001). Nonsignificant differences between the 2 groups were also found in their sexual function and distress after treatment (P > .20) and at follow-up (P > .10). Overall, at 2-week assessment 68% assigned to active transcranial direct-current stimulation reported being very much, much, or slightly improved compared to 65% assigned to sham transcranial direct-current stimulation (P = .82), and still comparable at follow-up: 42% vs 65%, respectively (P = .15). CONCLUSION: Findings suggest that active transcranial direct-current stimulation is not more effective than sham transcranial direct-current stimulation for reducing pain in women with provoked vestibulodynia. Likewise, no significant effects were found on sexual function, vestibular sensitivity, or psychological distress.

Effect of endometrial ablation on premenstrual symptoms.

STUDY OBJECTIVE: To evaluate the effect of endometrial ablation on 6 premenstrual symptoms for up to 1 year after treatment. DESIGN: Prospective cohort of 59 women awaiting endometrial ablation (Canadian Task Force classification II-2). SETTING: University tertiary care hospital. PATIENTS: Adult women of childbearing age awaiting endometrial ablation for heavy menstrual bleeding were recruited through the gynecology clinic of the Centre Hospitalier Universitaire de Sherbrooke. Fifty-nine patients were recruited, of whom 9 were excluded. Women were eligible to participate after an initial self-evaluation of ≥ 3 out of 10 for at least 1 premenstrual symptom. INTERVENTIONS: Women underwent endometrial ablation using the microwave, impedance-controlled, or rollerball technique. MEASUREMENTS AND MAIN RESULTS: Women had to fill out 2 surveys at 3 time points: before surgery, 4 months after surgery, and 12 months after surgery. The first survey consisted of visual analog scales for self-evaluation of 6 premenstrual symptoms (i.e., irritability, agitation/anxiety, depression/sadness, headache, swelling/bloating, and breast tenderness), and the second evaluated the heaviness of menstrual bleeding. The severity of all 6 symptoms decreased significantly (p < .025) up to 1 year after endometrial ablation. The greatest improvement was seen in swelling/bloating, with mean decreases of 4.1 on a scale of 10 at the 4-month follow-up and 3.1 at the 12-month follow-up. Women who reported the most severe symptoms before surgery appeared to have greater improvement compared with women with milder symptoms. Significant improvements were nevertheless observed in the mild severity subgroup for 4 of the 6 symptoms studied (i.e., irritability, depression, swelling/bloating, and breast tenderness). CONCLUSION: Women reported significant improvement for the 6 premenstrual symptoms for up to 1 year following an endometrial ablation for heavy menstrual bleeding. The improvement of these symptoms appears to be linked to the efficacy of the procedure.

Requesting cesareans without medical indications: an option being considered by young canadian women.

BACKGROUND: Cesarean delivery on maternal request is a worldwide growing phenomenon. The goal of this study was to describe young nulliparous women's attitudes about cesarean delivery on maternal request. METHODS: A total of 140 nulliparous women in Canada aged between 18 and 24years and attending school from the vocational (n=53), college (n=61), and university (n=18) levels (n=8 other) participated in the survey. The self-administered questionnaire consisted of 23 open-ended questions. The outcome measure was the participant's attitude toward cesarean delivery on maternal request. Descriptive, bivariate, and multiple regression analyses were performed. RESULTS: Many of the respondents (63%) had previously heard about cesarean delivery on maternal request, and of these women 28.6 percent had a favorable attitude toward the procedure. Sociodemographic variables were not associated with participants' attitudes toward cesarean delivery on maternal request except for place of residence and type of professional preferred for pregnancy care. Thinking that vaginal birth was more painful than cesarean delivery (p=0.012) and had more consequences for the mother (p<0.001) were related to a positive attitude toward cesarean delivery on maternal request. A positive attitude by peers was also associated with participants' favorable attitude toward cesarean delivery on maternal request (p<0.001). The overall predictive success of the model was 66.5 percent. CONCLUSIONS: Young women are spreading the word about cesarean delivery on maternal request and may influence one another about their preferred delivery method. During prenatal visits practitioners need to address women's fear of vaginal birth and its consequences for the mother, counseling, and women's understanding of the consequences of cesarean delivery. This study supports the urgent need to systematically document cesarean delivery on maternal request as a medical procedure and to study its prevalence and related factors.

Pain Characteristics, Fear-avoidance Variables, and Pelvic Floor Function as Predictors of Treatment Response to Physical Therapy in Women With Provoked Vestibulodynia.

OBJECTIVE: The aim was to investigate whether pretreatment pain characteristics, psychological variables, and pelvic floor muscle (PFM) function predict the response to physical therapy (PT) in women with provoked vestibulodynia (PVD). MATERIALS AND METHODS: One hundred-five women diagnosed with PVD underwent 10 weekly sessions of individual PT comprising education, PFM exercises with biofeedback, manual therapy, and dilators. Treatment outcomes were evaluated at pretreatment, post-treatment, and 6-month follow-up and included pain intensity (numerical rating scale 0 to 10) and sexual function (Female Sexual Function Scale). Multilevel analyses were used to examine the potential predictors of response over time including pain characteristics (PVD subtype, pain duration), psychological variables (fear of pain, pain catastrophizing), and PFM function assessed with a dynamometric speculum (tone, flexibility, and strength). RESULTS: PVD subtype and PFM tone were significant predictors of greater treatment response for pain intensity reduction. Secondary PVD (ie, pain developed after a period of pain-free intercourse) and lower PFM tone at baseline were both associated with greater reduction in pain intensity after PT and at follow-up. Among the psychological variables, fear of pain was the only significant predictor of better treatment response when assessed through improvement in sexual function, where higher fear of pain at baseline was associated with greater improvement after PT. DISCUSSION: This study identified PVD secondary subtype, lower PFM tone, and higher fear of pain as significant predictors of better treatment response to PT in women with PVD.

Transcranial direct current stimulation for provoked vestibulodynia: What roles do psychosexual factors play in treatment response?

There is growing evidence that provoked vestibulodynia (PVD), a frequent and debilitating condition, is characterized by central sensitization. This study aimed to examine predictive factors of transcranial direct current stimulation (tDCS) efficacy in this chronic pain population. Exploratory analysis derived from a randomized controlled trial was performed to assess predictors of pain reduction among 39 women with PVD who received 10 daily sessions of either active or sham tDCS. Clinical characteristics (e.g. pain intensity, duration and pain sensitivity) and psychosexual factors (e.g. pain catastrophizing, pain-related fear, anxiety, depressive symptoms and vaginal penetration cognitions) were assessed at baseline and used to predict tDCS response at 3-month follow-up. Analysis revealed that higher depressive symptoms and lower negative self-image cognitions were significant predictors of pain reduction at follow-up and accounted for 62.3% of the variance in the active tDCS group. Higher genital incompatibility cognitions were related to poorer response, regardless of treatment group. These findings suggest that women with PVD presenting higher depressive symptoms and lower levels of negative self-image cognitions could derive greater benefits from tDCS. These results suggest that tDCS could be effective in a subgroup of women with PVD - a possibility worth exploring with future prospective larger studies.

Valerian Root in Treating Sleep Problems and Associated Disorders-A Systematic Review and Meta-Analysis.

Sleep problems are widely prevalent and associated with various comorbidities including anxiety. Valerian (Valeriana officinalis L.) is a popular herbal medicine used as a sleep aid, however the outcomes of previous clinical studies are inconsistent. This study was conducted to update and re-evaluate the available data in order to understand the reason behind the inconsistent outcomes and to provide a broader view of the use of valerian for associated disorders. PubMed, ScienceDirect, and Cochrane Library were searched to retrieve publications relevant to the effectiveness of valerian as a treatment of sleep problems and associated disorders. A total of 60 studies (n=6,894) were included in this review, and meta-analyses were performed to evaluate the effectiveness to improve subjective sleep quality (10 studies, n=1,065) and to reduce anxiety (8 studies, n=535). Results suggested that inconsistent outcomes were possibly due to the variable quality of herbal extracts and that more reliable effects could be expected from the whole root/rhizome. In addition, therapeutic benefits could be optimized when it was combined with appropriate herbal partners. There were no severe adverse events associated with valerian intake in subjects aged between 7 and 80 years. In conclusion, valerian could be a safe and effective herb to promote sleep and prevent associated disorders. However, due to the presence of multiple active constituents and relatively unstable nature of some of the active constituents, it may be necessary to revise the quality control processes, including standardization methods and shelf life.

Fear-avoidance and Pelvic Floor Muscle Function are Associated With Pain Intensity in Women With Vulvodynia.

OBJECTIVE: To investigate the association between fear-avoidance variables, pelvic floor muscle (PFM) function, pain intensity in women with provoked vestibulodynia (PVD), as well as the moderator effect of partner support. MATERIALS AND METHODS: A sample of 173 women diagnosed with PVD participated in the study. Fear-avoidance variables were assessed with validated self-administered questionnaires: pain catastrophizing (Pain Catastrophizing Scale), pain-related fear (Pain Anxiety Symptoms Scale), and partner support (Partner Support Questionnaire). Pain intensity was evaluated using a numerical rating scale. PFM function, including maximal strength, speed of contraction, flexibility, and muscle tone, was evaluated with a dynamometric speculum. RESULTS: Pain catastrophizing was significantly associated with pain intensity (ß=0.310, P<0.001), partner support (ß=0.194, P=0.004), and PFM flexibility (ß=-0.255, P<0.001). Fear-avoidance, PFM variables, and partner support explained 28.3% of the variance in pain during intercourse (P<0.001). The addition of PFM was of particular interest as it explained a significant addition of 9% of the variance in pain intensity. Partner support was found to moderate the association between pain intensity and catastrophizing. Among women with high partner support, catastrophizing was not significantly related to pain (b=0.150, P=0.142). When partner support was low, catastrophizing was significantly related to pain (b=0.068, P<0.001). DISCUSSION: Findings of this study support that the symptomatology of PVD can be explained partly by fear-avoidance variables and PFM function. This study supports the significant role of PFM function and its importance in the pathophysiology of PVD. It also sheds light on the role of partner support and its moderating effect on pain catastrophizing.

Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial.

BACKGROUND: Provoked vestibulodynia is the most common form of vulvodynia. Despite its high prevalence and deleterious sexual, conjugal, and psychological repercussions, effective evidence-based interventions for provoked vestibulodynia remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Growing evidence suggests that the central nervous system (CNS) could play a key role in provoked vestibulodynia; thus, treatment targeting the CNS, rather than localized dysfunctions, may be beneficial for women suffering from provoked vestibulodynia. In this study, we aim to build on the promising results of a previous case report and evaluate whether transcranial direct-current stimulation, a non-invasive brain stimulation technique targeting the CNS, could be an effective treatment option for women with provoked vestibulodynia. METHODS/DESIGN: This single-center, triple-blind, parallel group, randomized, controlled trial aims to compare the efficacy of transcranial direct-current stimulation with sham transcranial direct-current stimulation in women with provoked vestibulodynia. Forty women diagnosed with provoked vestibulodynia by a gynecologist, following a standardized treatment protocol, are randomized to either active transcranial direct-current stimulation treatment for ten sessions of 20 minutes at an intensity of 2 mA or sham transcranial direct-current stimulation over a 2-week period. Outcome measures are collected at baseline, 2 weeks after treatment and at 3-month follow-up. The primary outcome is pain during intercourse, assessed with a numerical rating scale. Secondary measurements focus on the sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction, and the patient's global impression of change. DISCUSSION: To our knowledge, this study is the first randomized controlled trial to examine the efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia. Findings from this trial are expected to provide significant information about a promising intervention targeting the centralization of pain in women with provoked vestibulodynia. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02543593 . Registered on September 4, 2015.

Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods.

Provoked vestibulodynia (PVD) is a highly prevalent and debilitating condition yet its management relies mainly on non-empirically validated interventions. Among the many causes of PVD, there is growing evidence that pelvic floor muscle (PFM) dysfunctions play an important role in its pathophysiology. Multimodal physiotherapy, which addresses these dysfunctions, is judged by experts to be highly effective and is recommended as a first-line treatment. However, the effectiveness of this promising intervention has been evaluated through only two small uncontrolled trials. The proposed bi-center, single-blind, parallel group, randomized controlled trial (RCT) aims to evaluate the efficacy of multimodal physiotherapy and compare it to a frequently used first-line treatment, topical overnight application of lidocaine, in women with PVD. A total of 212 women diagnosed with PVD according to a standardized protocol were eligible for the study and were randomly assigned to either multimodal physiotherapy or lidocaine treatment for 10weeks. The primary outcome measure is pain during intercourse (assessed with a numerical rating scale). Secondary measures include sexual function, pain quality, psychological factors (including pain catastrophizing, anxiety, depression and fear of pain), PFM morphology and function, and patients' global impression of change. Assessments are made at baseline, post-treatment and at the 6-month follow-up. This manuscript presents and discusses the rationale, design and methodology of the first RCT investigating physiotherapy in comparison to a commonly prescribed first-line treatment, overnight topical lidocaine, for women with PVD.

The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women.

BACKGROUND: Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes. METHODS/DESIGN: Obese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women. DISCUSSION: This study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information will be relevant for decision-makers and health care professionals, and should be generalizable to North American fertility clinics. TRIAL REGISTRATION: ClinicalTrials.gov NCT01483612. Registered 25 November 2011.

Cervical ripening using vaginal misoprostol before hysteroscopy: a double-blind randomized trial.

STUDY OBJECTIVE: The aim of this study was to evaluate the use of vaginal misoprostol to decrease both the force required to dilate the cervix and the pain experienced during a hysteroscopy. DESIGN: Randomized clinical trial (RCT) (Canadian Task Force classification I). SETTING: University hospital gynecology clinic. PATIENTS: A total of 101 patients needing a diagnostic hysteroscopy. Fifty patients were randomized to the misoprostol group and 51 to the placebo group. Patient characteristics were similar in the 2 groups. INTERVENTIONS: Self-administration of 400 microg of vaginal misoprostol or vaginal placebo 12 to 24 hours before a hysteroscopy. MEASUREMENTS AND MAIN RESULTS: The force needed to dilate the cervix was assessed by a tonometer, and pain was measured by a visual analog scale. The force to dilate the cervix to 6mm was significantly less in the misoprostol group (5.0 vs 7.5N, p=.02). Pain-related measurements after dilatation of the cervix to 6mm were significantly reduced in the misoprostol group (42.1 vs 57.2, p=.004). The main side effect reported with the use of the drug was pelvic cramping. CONCLUSION: The use of 400 microg of vaginal misoprostol 12 to 24 hours before hysteroscopy reduces the pain and the force needed to dilate the cervix, with only mild side effects.