Acceptability, reliability, and validity of a vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia: a cross-sectional study.

BACKGROUND: Approximately half of people with endometriosis experience deep dyspareunia; however, there is no means of objective self-testing of endometriosis-associated deep dyspareunia. AIM: The aim of this study was to assess the acceptability, test-retest reliability, and validity of a vaginal insert for a self-assessment of endometriosis-associated deep dyspareunia. METHODS: Participants were recruited from a tertiary endometriosis center. Inclusion criteria were: 19 to 49 years of age, self-reported deep dyspareunia of ≥4 of 10, and surgically confirmed endometriosis. Participants completed 2 self-assessments using the vaginal insert to self-assess tenderness at the right and left pelvic floor, bladder, cervix-uterus, and posterior cul-de-sac (vaginal fornix). The participants recorded tenderness at each pelvic site and completed a questionnaire regarding the acceptability of the vaginal insert to assess deep dyspareunia. Test-retest reliability was assessed by correlating the tenderness scores between the 2 assessment dates. Over a 4-week period, the participants also recorded deep dyspareunia severity at each penetrative vaginal sex encounter. Validity was assessed by correlating vaginal insert tenderness to deep dyspareunia severity, and also to tenderness reported on a prior gynecologic pelvic examination. OUTCOMES: The main outcome measures were the acceptability index score, tenderness (0-10) at each pelvic site, and prospective deep dyspareunia scores (0-10) over 4 weeks. RESULTS: There were 19 participants (mean age 34 ± 7 years) who completed the study. The majority identified as female (94.7%), heterosexual (89.5%), and white (89.5%). The median acceptability index score was 0.72 (interquartile range, 0.66-0.81). For test-retest reliability, the intraclass correlation coefficients were 0.79 (P = .001) for the left pelvic floor, 0.82 (P < .001) for the right pelvic floor, 0.54 (P = .07) for the bladder, 0.89 (P < .001) for the cervix-uterus, and 0.77 (P = .003) for the cul-de-sac. The correlation between the highest self-assessed mean tenderness in each participant and self-reported deep dyspareunia over 4 weeks was r = 0.32, but correlations for each pelvic site varied significantly. Tenderness at each site on prior gynecologist pelvic exam was associated with higher self-assessed mean tenderness with the vaginal insert in each participant (effect sizes = 0.42-0.88). CLINICAL IMPLICATIONS: The vaginal insert is acceptable and reliable for the objective self-assessment of endometriosis-associated deep dyspareunia, with initial evidence of validity. STRENGTHS AND LIMITATIONS: A strength was the inclusion of participants who were avoiding sexual activity and a limitation was the small sample size. CONCLUSION: Future studies with larger sample sizes are required to further establish the validity of the vaginal insert for the self-assessment of endometriosis-associated deep dyspareunia.

Assessment of levator hiatal area using 3D/4D transperineal ultrasound in women with deep infiltrating endometriosis and superficial dyspareunia treated with pelvic floor muscle physiotherapy: randomized controlled trial.

OBJECTIVES: Deep infiltrating endometriosis (DIE) is associated with chronic pelvic pain, dyspareunia and pelvic floor muscle hypertonia. The primary aim of this study was to evaluate the effect of pelvic floor physiotherapy (PFP) on the area of levator ani hiatus during Valsalva maneuver, assessed using transperineal ultrasound, in women with DIE suffering from superficial dyspareunia. METHODS: This was a randomized controlled trial of 34 nulliparous women diagnosed with DIE and associated superficial dyspareunia. After an initial clinical examination, all patients underwent three-dimensional/four-dimensional (3D/4D) transperineal ultrasound to measure the levator hiatal area (LHA) at rest, on maximum pelvic floor muscle contraction and on maximum Valsalva maneuver, and were asked to rate their pain symptoms using a numerical rating scale (NRS). Eligible women were assigned randomly (1:1 ratio) to no intervention (control group, 17 women) or treatment with five individual sessions of PFP (study group, 17 women). Four months after the first examination, all women underwent a second evaluation of pain symptoms and LHA on transperineal ultrasound. The primary outcome measure was the percentage change in LHA on maximum Valsalva maneuver between the baseline and follow-up examinations. The percentage changes in pain symptoms between the two examinations, including superficial and deep dyspareunia, dysmenorrhea, chronic pelvic pain, dysuria and dyschezia, were also evaluated. RESULTS: Thirty women, comprising 17 in the study group and 13 in the control group, completed the study and were included in the analysis. The percentage change in LHA on maximum Valsalva maneuver between the two examinations was higher in the study group than in the control group (20.0 ± 24.8% vs -0.5 ± 3.3%; P = 0.02), indicating better pelvic floor muscle relaxation. After PFP treatment, the NRS score for superficial dyspareunia remained almost unchanged in the control group (median change in NRS (Δ-NRS), 0 (interquartile range (IQR), 0-0)) while a marked reduction was observed in the study group (median Δ-NRS, -3 (IQR, -4 to -2); P < 0.01). Moreover, there was a significant difference between the PFP and control groups with regards to the change in chronic pelvic pain (median Δ-NRS, 0 (IQR, -2 to 0) vs 0 (IQR, 0-1); P = 0.01). CONCLUSIONS: In women with DIE, PFP seems to result in increased LHA on Valsalva maneuver, as observed by 3D/4D transperineal ultrasound, leading to improved superficial dyspareunia, chronic pelvic pain and pelvic floor muscle relaxation. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study.

OBJECTIVE: The purpose of this study was to compare the abdominal sacral colpopexy and vaginal sacrospinous colpopexy in the treatment of vaginal vault prolapse. STUDY DESIGN: Ninety-five women with vaginal vault prolapse were allocated randomly to sacral colpopexy (47 women) or sacrospinous colpopexy (48 women). Primary outcome measurements include subjective, objective, and patient-determined success rates. Secondary outcomes include the impact on bowel, bladder, and sexual function, cost, and quality of life. RESULTS: Two years after the operation (range, 6-60 months), the subjective success rate was 94% in the abdominal and 91% in the vaginal group (P=.19). The objective success rate was 76% in the abdominal group and 69% in the vaginal group (P=.48). The abdominal approach was associated with a longer operating time, a slower return to activities of daily living, and a greater cost than the sacrospinous colpopexy (P<.01). Both surgeries significantly improved the patient's quality of life (P<.05). CONCLUSION: Abdominal sacral colpopexy and vaginal sacrospinous colpopexy are both highly effective in the treatment of vaginal vault prolapse.

Symptoms at pre- and postmenopause in rural and urban women from three States of Mexico.

OBJECTIVES: We studied the possible influence of modern cultural conditions on symptoms at menopause in three distant populations, comparing urban vs. rural women from three different States of Mexico: Guanajuato, Coahuila and Yucatán. In these groups we compared the age at menopause and symptoms at pre- and postmenopause. METHODS: A total of 7632 volunteers were selected from Guanajuato, Coahuila and Yucatán. In house visits, an oral questionnaire was applied to women 45-60 years old, non-pregnant or lactating, without hysterectomy, chronic illness, or hormone treatment. We collected general and personal data, clinical, somatometric variables, and symptoms: hot flashes, vaginal dryness, dispareunia, and diminished sexual interest. Depressive mood and anxiety were evaluated with the Hamilton-Bech-Rafaelsen Scale. RESULTS: The mean age at menopause was 48.0 years. A logistic regression identified the association of age at menopause with urban or rural residence, and the State of origin. Scores for depression and anxiety were lower in Yucatán, and they were higher in rural women. Hot flashes, vaginal dryness and the diminished sexual interest were increased at postmenopause. Hot flashes varied from 73 to 32%, and were associated with menopause, low schooling, rural residence, body mass index (BMI), and State of residence. Similar factors were associated with vaginal dryness, dispareunia, and loss of sexual interest. Depressive mood was associated with rural residence, State of residence, menopause, high BMI, smoking habit, age, and schooling. Anxiety was associated with menopause, rural residence, low schooling, high BMI, and age. The loss of sexual interest was associated with age, BMI, menopause and number of pregnancies. CONCLUSIONS: The frequencies of symptoms at menopause have similar ranges to other countries. Ethic and socio-cultural and environmental factors are involved in the appearance or symptoms.

Intralesional alpha interferon. Cost-effective therapy for vulvar vestibulitis syndrome.

The cost-effectiveness of two treatment strategies for vulvar vestibulitis syndrome (VVS) was compared. Our prospective study consisted of 55 patients with human papillomavirus (HPV)- and non-HPV-associated VVS of at least 6 months' duration treated with intralesional recombinant alpha interferon injections, followed by surgery for nonresponders and responders compared with a hypothetical model of surgery alone. The setting was a private-practice multispecialty center for vulvovaginal disorders. Improvement was defined by patients' subjective evaluation of change in the level of introital dyspareunia and the ability to have sexual relations and objective evidence of change in the degree of erythema and tenderness to touch within the vestibule. Statistical analyses of the overall probability of improvement, overall costs and the cost per patient treated were done. Twenty-seven (49%) of 55 patients treated with alpha interferon had substantial or partial improvement. Of the 28 (51%) who did not improve following alpha interferon, 19 elected to have surgery. Surgery resulted in substantial improvement in 84% of the patients and partial improvement in 11%. Statistical analysis comparing the group treated with alpha interferon (some of whom went to surgery with the hypothetical model of surgical treatment alone) showed significant cost-saving in the group first treated with alpha interferon. At the level of effectiveness achieved in this study, intralesional alpha interferon as a first choice in the treatment of VVS is cost-effective.