Pain and Quality of Life after Laparoscopic Excision of Endometriosis

Study ObjectiveTo evaluate the long-term impact of laparoscopic excision of endometriosis on quality of life through pain reduction as measured by the Endometriosis Health Profile-30 (EHP-30) in uterine-sparing (preservation of the uterus and at least 1 ovary) and nonuterine-sparing (removal of the uterus) surgery.DesignCohort study.SettingAcademic medical center.PatientsSixty-one women who had undergone laparoscopic excision of endometriosis for pelvic pain were enrolled in a tissue-procurement study.InterventionsPatients who had previously completed an EHP-30 preoperatively and at 4 weeks postoperatively were mailed a copy of the EHP-30 2.6 to 6.8 years after their index surgery.Measurements and Main ResultsThe primary outcome was quality of life as measured by changes in the EHP-30 scores before their index surgery and those measured weeks and years later. The secondary outcome was a comparison of the EHP-30 scores between patients who underwent excision of endometriosis alone and those who underwent excision of endometriosis with hysterectomy +/– oophorectomy. From 2011 to 2015, 61 women underwent laparoscopic excision of endometriosis for pelvic pain. Forty-six of the 61 patients completed the EHP-30 for a response rate of 75%. The patients demonstrated significant improvement in all 5 scales of the EHP-30 (pain, control and powerlessness, emotional well-being, social support, and self-image) at 4 weeks postoperatively (p <.001), which persisted for up to 6.8 years in follow-up (p <.001) when compared with their baseline scores. The improvement in EHP-30 scores did not differ by American Society for Reproductive Medicine staging or index surgery. Definitive surgery (total laparoscopic hysterectomy/bilateral salpingo-oophorectomy) was not associated with improved outcomes when compared with uterine-sparing surgery.ConclusionLaparoscopic excision of endometriosis offers improvement in all quality-of-life domains as measured by the EHP-30, including a reduction in pain, an effect that may persist for up to 6.8 years. These findings suggest that laparoscopic excision of endometriosis with uterine preservation can be considered as an option for discussion during counseling for treatment of endometriosis.     

Responsiveness of the Dutch Endometriosis Health Profile-30 (EHP-30) questionnaire

Objective

To evaluate the responsiveness to change and the minimal clinical important difference (MCID) of the Dutch Endometriosis Health Profile-30 (EHP-30) questionnaire.

Study design

Prospective cohort study among endometriosis patients attending the Radboud University Nijmegen Medical Centre and members of the Dutch endometriosis patient-support group. EHP-30 was measured at baseline and after 6 months. Changes in treatment were recorded, as well as the subjective change in symptoms. Effect sizes and index of responsiveness were evaluated as appropriate. The MCID was estimated with use of the change in scores in women reporting to feel ‘somewhat better’ after 6 months.

Results

228 women were included. Effect sizes varied from 0.1 to 0.5 in the complete group and from 0.3 to 1.1 in the group of women who reported improvement. Index of responsiveness ranged from 0.1 to 0.7 on the eleven dimensions of the questionnaire. MCID was 3.2–17.5 depending on the dimension.

Conclusions

The Dutch EHP-30 is sensitive to change and represents a useful tool in future research on the effect of endometriosis treatment on health status.     

Factors associated with postoperative recovery after laparoscopic and abdominal hysterectomy

Objectives

To determine whether the day-by-day recovery of general wellbeing was faster in women undergoing laparoscopic hysterectomy than in total abdominal hysterectomy and to analyse the association between stress coping and sick-leave and the day-by-day recovery measured as general wellbeing.

Study design

A randomised multicentre trial conducted in five hospitals in the South East of Sweden. Hundred and twenty-five women scheduled for hysterectomy for benign conditions were enrolled in the study and 117 women completed the study. Fifty-five women were randomised to abdominal hysterectomy and 62 to laparoscopic hysterectomy. Day-by-day recovery of general wellbeing was measured by a visual analogue scale 1 week preoperatively, 35 days postoperatively, and during 1 week 6 months postoperatively. Stress-coping capability was measured preoperatively using a specific psychometric measurement. Sick-leave was granted with an initial period of 14 days and prolonged on patient demand with 7 days periods.Effects of operating method and stress-coping ability on the day-by-day recovery adjusted for postoperative complications and analgesics were analysed by means of analysis of variance for repeated measurements.

Results

No significant difference was found in the day-by-day recovery of the general wellbeing between the operating methods. Stress-coping ability did significantly influence the day-by-day recovery of general wellbeing. Duration of sick-leave was associated with the occurrence of postoperative complications but not with stress-coping ability.

Conclusions

The day-by-day recovery of general wellbeing is not faster in laparoscopic hysterectomy than in abdominal hysterectomy. Women with high stress-coping abilities have a better outcome in general wellbeing than women with low stress-coping capacity. Identification of women with low stress-coping abilities and prevention of complications might be of benefit for improving postoperative wellbeing.     

Guidelines for the management of painful endometriosis

Objectives

To establish guidelines for the medical and surgical management of painful endometriosis.

Material and Methods

An exhaustive review on Medline and Cochrane Database between 1980 and 2006 was performed.

Results

GnRH agonists, progestins, continuous monophasic oral contraceptives and danazol have a suppressive effect on dysmenorrhoea, nonmenstrual pain and dyspareunia (grade A). Surgical treatment is effective in painful endometriosis (grade B). Complete surgical excision of deep endometriotic lesions with conservation of uterus and ovaries has a limited term efficacy on pain relief (grade C). A multidisciplinary approach is recommended (grade C). The use of the psychotherapy improves the management of chronic pain (grade A). There is a lack of information concerning the therapeutic strategy able to prevent recurrences. Whether endometriosis recurrences occur, medical treatment should be the first line approach (expert opinion). A hysterectomy with salpingo-oophorectomy and complete excision of the lesions is efficient in women with pain recurrence who no longer desire pregnancy (grade C).

Conclusion

Medical and surgical treatments have a limited term efficacy on painful endometriosis (grade A). The benefit/risk relationship, depending on secondary effect therapy, should be assessed on a case to case basis.     

Diameter of dominant leiomyoma is a possible determinant to predict coexistent endometriosis

Objective

To identify the frequency and assess risk factors for unexpected discovery of peritoneal endometriotic implants in patients who underwent myomectomy or hysterectomy for symptomatic uterine leiomyomas.

Study design

We retrospectively collected medical records of 829 patients with symptomatic leiomyomas in The University of Tokyo Hospital. All the patients underwent abdominal or laparoscopic surgeries between January 2001 and December 2010 and the presence or absence of endometriosis during surgery was analyzed. Possible determinant to predict coexistent endometriosis was statistically investigated.

Results

In total, 105 leiomyoma cases (12.7% in 829 patients) were diagnosed with endometriosis. Patients with small dominant leiomyomas were significantly complicated by peritoneal endometriotic implants (small leiomyomas were classified as <8 cm). The patients with both diagnoses were more likely to be infertile and at age 39 years or younger than those with leiomyoma alone.

Conclusions

Women undergoing myomectomy or hysterectomy with both endometriosis and leiomyomas have several different clinical features compared with women with only leiomyomas. The size of largest leiomyoma may provide an important clue for coexistent endometriosis. Women with substantial infertility despite a smaller leiomyomas burden may be more likely to have a surgical indication for concomitant endometriosis.     

Pure natural orifice transluminal endoscopic surgery (NOTES) involving peroral endoscopic salpingo-oophorectomy (POESY)

Objective

Natural orifice transluminal endoscopic surgery (NOTES) is a surgical approach that uses natural orifices to gain access to areas of the body. In the present article, we describe the first transgastric pure NOTES salpingo-oophorectomy, which we call peroral endoscopic salpingo-oophorectomy (POESY).

Methods

A woman with BRCA1 mutation presented for prophylactic bilateral salpingo-oophorectomy. We offered her the transgastric approach, having performed more than 25 transgastric appendectomies. After gastroscopic incision in the corpus wall, we advanced the gastroscope into the abdominal cavity. Salpingo-oophorectomy was performed with the help of an intrauterine manipulator and a transvaginally introduced 5-mm trocar. The posterior colpotomy was dilated and the specimens were extracted. The gastrotomy was closed with an over-the-scope clip, and the colpotomy with a running suture.

Results

The gastroscope provided excellent optical control and good tissue preparation. Prophylactic bilateral salpingo-oophorectomy was performed successfully via POESY. The patient recovered quickly and was discharged on the third day, with an uneventful follow-up.

Conclusion

The present case demonstrates the feasibility of transgastric access. The gastroscope provided excellent optical control and good tissue preparation. Therefore, we expect an increasing role of transgastric procedures for diseases in the pelvic region, particularly if new endoscopic platforms with better means of instrumentation and tissue management become available.     

Quality of life in patients with endometrial cancer treated with or without systematic lymphadenectomy

Objective

To compare the quality of life (QoL) of women affected by endometrial cancer treated with surgery with or without systematic lymphadenectomy.

Study design

Consecutive patients affected by stages I and II endometrial cancer and treated with surgery between 2008 and 2011 were selected. Eligible subjects were divided into two groups: Group A consisted of 36 patients who had hysterectomy plus bilateral salpingo-oophorectomy without lymphadenectomy; Group B consisted of 40 patients who had hysterectomy plus salpingo-oophorectomy plus pelvic and aortic lymphadenectomy. The EORTC Quality of Life Questionnaire-Cancer Module (QLQ-C30) and Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24) were administered to selected patients. All data were recorded and then analyzed using the scoring manual of the EORTC Quality of Life Group.

Results

Among symptom scales, only lymphedema gave a statistically significant difference among two groups, with a score of 10.64 ± 17.43 in Group A and 21.66 ± 24.51 in Group B (p = 0.0285). The p value obtained comparing the “Global Health Status” (items 29 and 30) in Group A and in Group B was not statistically significant.

Conclusion

Lymphadenectomy did not influence negatively global health status, but lymphadenectomy maintained its importance in determining a patient's prognosis and in tailoring adjuvant therapies. We therefore support its practice as part of the surgical procedure in patients affected by high risk endometrial cancer.     

Pronóstico y resultados en pacientes diagnosticadas de endometriosis a las que se les ha realizado por primera vez una cirugía conservadora por dolor o esterilidad

Objective

To analyze clinical outcomes in patients with suspected endometriosis undergoing conservative surgery. Pain reduction, pregnancy rates, and reinterventions were analyzed.

Material and methods

Patients with suspected endometriosis and symptoms of pain or infertility undergoing conservative surgery for the first time were included (n = 128). Exclusion criteria consisted of incomplete medical histories and interventions indicated for reasons other than pain or infertility.

Results

Surgery was indicated for pain in 70.3% and for infertility in 29.7%. A total of 32.5% of the patients had pain at the first postsurgical visit, 42.5% at 6 months and 58.3% at 1 year. Reintervention was performed in 11.29%. Among reinterventions for pain, there was a higher percentage of intestinal symptoms before surgery (P=.07), as well as episodes of abdominal pain requiring hospital care (P=.08); a higher proportion of these patients had pain in the first visit (P=.05) and at 1 year (P=.03) than patients not undergoing reintervention. Postsurgical medical treatment was less frequent in patients undergoing reintervention (P=.11). Among patients undergoing surgery for infertility, pregnancy was achieved in 65.8%.

Conclusions

Pain was less frequent in the first postsurgical visit than in subsequent visits. Among patients undergoing reintervention for pain, there was a higher percentage of intestinal symptoms and episodes of abdominal pain requiring hospital care prior to the intervention. Pain at the first visit and at 1 year are factors of poor prognosis for reintervention. Patients undergoing reintervention for pain less frequently required postsurgical medical treatment. More than half of patients with interfertility and endometriosis achieved spontaneous pregnancy after surgery.     

Prevalence of occult gynecologic malignancy at the time of risk reducing and nonprophylactic surgery in patients with Lynch syndrome

Objective

The primary aim of this study was to determine the prevalence of occult gynecologic malignancy at the time of risk reducing surgery in patients with Lynch Syndrome. A secondary aim was to determine the prevalence of occult gynecologic malignancy at the time of surgery for non-prophylactic indications in patients with Lynch Syndrome.

Methods

A retrospective review of an Inherited Colorectal Cancer Registry found 76 patients with Lynch syndrome (defined by a germline mutation in a DNA mismatch repair gene) or hereditary nonpolyposis colorectal cancer (HNPCC) (defined by Amsterdam criteria) who had undergone hysterectomy and/or salpingo-oophorectomy for a prophylactic or non-prophylactic indication. Indications for surgery and the prevalence of cancer at the time of each operation were reviewed.

Results

24 of 76 patients underwent prophylactic hysterectomy and/or bilateral salpingo-oophorectomy for Lynch syndrome or HNPCC. In 9 of these patients, a benign indication for surgery was also noted. 4 of 24 patients (17%, 95% CI = 5–38%) were noted to have cancer on final pathology. 20 of 76 patients (26%) undergoing operative management for any indication were noted to have occult malignancy on final pathology.

Conclusions

Patients should be counseled about the risks of finding gynecologic cancer at the time of prophylactic or non-prophylactic surgery for Lynch syndrome and HNPCC, and the potential need for additional surgery.     

Laparoscopic treatment of endometrial cancer: feasibility and results

Objective

The aim of this study was to compare laparoscopic and abdominal approach in the treatment of endometrial cancer in our department.

Study design

From January 1999 to November 2002, 77 patients underwent surgery for stages I–III endometrial cancer. The first group of 36 patients had abdominal hysterectomy as well as salpingo-oophorectomy, with or without lymphadenectomy. The remaining 41 patients received laparoscopic assisted vaginal hysterectomy as well as salpingo-oophorectomy, with or without lymphadenectomy.In this retrospective study, we have compared the surgical results, the short- and long-term morbidity and the outcome of the two patient groups.

Results

Body mass index (BMI) was significantly higher in the laparoscopic group (27.3 versus 24.6; p = 0.009). The average time for surgery was significantly longer for the laparoscopic group (143.6 min versus 109.7 min; p = 0.0001), but lymphadenectomy was performed in more patients (63.4% versus 25%; p = 0.001).Postoperative hospital stay was significantly longer in patients undergoing the abdominal approach (4.59 days versus 3.18 days; p < 0.0001). No blood transfusions were performed and the rates of complications were similar in the two groups. No differences were found in recurrence and survival rate.

Conclusions

In our experience, laparoscopic and abdominal surgery can achieve similar results in the treatment of endometrial cancer. In our series, even with the BMI and the number of lymphadenectomies being higher in the laparoscopic group, the rates of complications were similar in the two groups.     

Yolk sac tumours of the ovary: Evaluation of clinicopathological features and prognostic factors

Objective

To evaluate the clinicopathological prognostic features, factors and outcomes of chemotherapy in ovarian yolk sac tumours (YST).

Study design

We reviewed the medical records of 32 women with ovarian YST treated from 1990 to 2006 at two centres.

Results

The median follow-up was 36 months. The median age was 22 (range, 9–68). Two patients were postmenopausal. The most common symptoms at diagnosis included abdominal swelling or mass (72%) and abdominopelvic pain (62%). The location of the tumour was bilateral in 2 cases. Eight patients were in stage I, 4 patients in stage II, 17 patients in stage III, and 3 patients in stage IV. Eighteen patients underwent unilateral salpingo-oophorectomy, two bilateral salpingo-oophorectomy and two cystectomy, while 10 patients had total abdominal hysterectomy and two bilateral salpingo-oophorectomy. Of 32 patients who received postoperative chemotherapy, 27 were treated with a bleomycin/etoposide/cisplatin (BEP) regimen. Seventy-two percent of patients were alive at the last follow-up visit. Ten (31%) patients suffered from a recurrence of the disease with a median time to recurrence of 8 months (range, 6–28 months). The most common site of recurrence was the intra-abdominal space, with 8 patients. Only one patient who had recurrence could be salvaged. Fertility-sparing surgery was found at least as effective as radical surgery. While age, histology (mixed vs. pure), stage, tumour size, ascites, and marker levels were not found as prognostic factors, the presence of residual tumour (P = 0.014) and BEP chemotherapy (P = 0.016) were significant prognostic factors in univariate analysis.

Conclusions

In patients with ovarian YST, fertility-sparing surgery is as effective as radical surgery. Optimal cytoreductive surgery and standard BEP regimen are the most decisive prognostic factors. In these tumours, adjunctive therapeutic modalities to eradicate intra-abdominal disease and effective salvage therapy strategies are needed.     

Effect of a single preoperative dose of sublingual misoprostol on intraoperative blood loss during total abdominal hysterectomy

Objective

To investigate whether use of preoperative misoprostol can reduce blood loss during total abdominal hysterectomy (TAH).

Methods

In a randomized double-blind placebo-controlled trial at a tertiary care hospital in Kolkata, India, between March 2011 and April 2012, women (n = 132) undergoing TAH with or without bilateral salpingo-oophorectomy for symptomatic myomas were randomly allocated to receive either 400 μg of misoprostol or placebo 30 minutes before surgery. The primary outcome measure was intraoperative blood loss was. The secondary outcomes were postoperative drop in hemoglobin, need for blood transfusion, and incidence of adverse effects.

Results

The 2 groups were similar with regard to demographic and clinical characteristics. There was a significant reduction of blood loss during TAH after sublingual administration of misoprostol compared with placebo before surgery (356 mL vs 435 mL; P = 0.049). The mean postoperative hemoglobin concentration was higher (10.5 g/dL vs 9.5 g/dL; P < 0.001) and the postoperative drop in hemoglobin was smaller (1.1 g/dL vs 1.9 g/dL; P = 0.004) in the misoprostol group than in the placebo group. No significant adverse effects occurred in either group.

Conclusion

The results showed that a single dose of misoprostol administered before abdominal hysterectomy resulted in a significant reduction of blood loss with minimal adverse effects.Clinical Trial Registry India (www.ctri.nic.in): CTRI/2011/091/000216.     

Impact of alternative management policies on health-related quality of life in women with low-grade abnormal cervical cytology referred for colposcopy

Objective

To assess the health-related quality of life (HRQoL) over 30 months among women who received colposcopy following low-grade abnormal cervical cytology.

Design

751 women with low-grade abnormal cytology were seen for colposcopy. Of these, 350 additionally underwent either immediate treatment by large loop excision of the transformation zone (LLETZ) or investigation by punch biopsy followed by treatment of high-grade cervical intraepithelial neoplasia if present. The HRQoL of the women was assessed on seven separate occasions over 30 months by means of the EQ-5D instrument. Outcomes for women receiving colposcopy only, colposcopy with biopsy and colposcopy with LLETZ were compared.

Results

Women experienced modest short-term increases in HRQoL, statistically significant for the colposcopy only and biopsy groups but not for the LLETZ group. HRQoL in all three groups thereafter fell until 12 months following recruitment, significantly so for the LLETZ group. Changes in EQ-5D index score arose primarily from changes in severities in the “pain and discomfort” and “anxiety and depression” domains. Changes in the visual analogue scale (VAS) representations of quality of life corresponded closely to those of the index scores and most of the VAS scores themselves did not differ from VAS population norms. All inter-assessment changes in index scores were smaller than the minimum important difference for the instrument. Beyond 18 months from recruitment, HRQoL stabilised in all three groups.

Conclusion

Women referred to colposcopy following a low-grade abnormal smear test result experienced a short-term improvement in their health-related quality of life, but the long-term effect was insubstantial. HRQoL over the post-recruitment follow-up period did not vary by intervention.     

Inducción de endometriosis en rata Wistar,mediante autotransplante de fragmento uterino,sobre cicatriz previamente producida en el cuerno uterino izquierdo

Objective

To study the possibility of inducing internal or external endometriosis in Wistar rats through a new microsurgical model known as PGR 1.

Subjects and methods

Eleven Wistar rats underwent autologous transplantation of a uterine fragment over a deliberately created scar. After 8 weeks, a further intervention was carried out to inspect the abdominal cavity and take samples for pathological analysis.

Results

Macroscopic results consisted of adhesions mainly affecting the implant and yellow vesicles. Microscopic findings consisted of vesicles/cysts, inflammatory phenomena, neovascularization, and internal endometriosis in one animal

Conclusions

This new implant model could enhance our understanding of the mechanisms involved in the development of endometriosis, both internal and external.     

Infiltración de los ligamentos uterosacros con un anestésico local de larga duración en pacientes sometidas a histerectomía vaginal

Objective

To determine whether infiltration of the uterosacral ligaments with a long-acting anesthetic during vaginal hysterectomy reduces the use of other forms of postoperative analgesia with possible morbidity.

Subjects and methods

We performed a controlled, randomized, double-blind clinical trial with two groups of patients. In the study group (45 patients), 5 mL ropivacaine at 0.75% was injected in each uterosacral ligament during the intervention. Patients in the control group did not receive any paracervical injections. Postoperative pain was evaluated at 2:30, 3:30, 13:30, and 25:30 hours after initiation of anesthesia. When pain greater than 3 on the visual analogue scale was reported, epidural rescue analgesia was administered.

Results

No epidural rescue anesthesia was required in 68.9% of the study group compared with 43.6% in the control group (p = 0.027).

Conclusions

Infiltration of the uterosacral ligaments with a long-acting local anesthetic in patients undergoing vaginal hysterectomy reduces the need for rescue analgesia, which is expensive and has adverse effects.     

Predicting the success of vaginal surgery: a quantitative risk assessment model for future investigation

Objective

To introduce a model incorporating expected risks for a vaginal procedure based on objective measurements of a patient's characteristics and propose it as a potential tool to assist in the selection of candidates for vaginal surgery.

Study design

A quantitative model consisting of 13 clinical variables identified as risk factors in a prospective vaginal procedure was developed. Medical records of 315 women undergoing a set of routine gynecological surgeries via the vaginal, laparoscopic, and abdominal routes were obtained during January 2010 and November 2011. These surgeries included hysterectomy, myomectomy, bilateral or unilateral salpingo-oophorectomy and adnexal cystectomy. After that, each patient was scored according to the model. Sensitivity and specificity of the model were analyzed in one data set (cohort I) by receiver operating characteristic (ROC) curve and independently validated in a second data set (cohort II).

Results

175 patients were included in cohort I while the other 140 patients formed cohort II. The intra- and post-operative complication rates were 0.6% and 0%, respectively. A vaginal procedure was predicted with good accuracy (AUC = 0.852). The sensitivity was 86.0% and specificity was 72.0% at an optimal cut-off point of score = 3. The predication accuracy of this model was further validated in cohort II and reached as high as 85.7%. Furthermore, the score was significantly associated with the volume of estimated blood loss and the duration of operation time (P < 0.05).

Conclusion

Our quantitative risk assessment model predicts safe vaginal surgery with good accuracy. Predictive tools based on such a model could help surgeons to optimize patient selection and thus contribute to reducing costs while enhancing patients’ satisfaction. We invite other researchers to modify and validate the model in other populations.     

Vaginal cuff dehiscence after hysterectomy

Objective

To determine the incidence of vaginal cuff dehiscence (VCD) among women undergoing hysterectomy according to clinico-surgical factors including surgical route, and to describe patient characteristics associated with VCD.

Methods

In a retrospective study, the medical records of all women who underwent hysterectomy between January 2005 and March 2011 at a university teaching hospital in Seoul, Republic of Korea, were reviewed. The incidence of VCD was determined in relation to the following factors: patient age, hysterectomy route, indication for hysterectomy, and extent of resection (either simple or radical hysterectomy).

Results

Among 9973 hysterectomies, 37 (0.37%) cases of VCD were identified. The incidence of VCD was significantly higher after abdominal hysterectomy (0.6%) than after laparoscopic (0.2%) or vaginal (0.4%) hysterectomy (P = 0.016). Compared with laparoscopic approaches, abdominal hysterectomy was associated with a higher risk of VCD (odds ratio, 2.735; 95% confidence interval, 1.380–5.420). However, there was no significant difference in the incidence of VCD according to surgical indication or extent of resection.

Conclusion

Laparoscopic hysterectomy was found to be associated with a lower risk of VCD compared with abdominal hysterectomy. The lower risk is probably related to the different techniques used for colpotomy and cuff closure.     

Letrozole and norethisterone acetate in colorectal endometriosis

Objective

Up to now limited attention has been given to the medical treatment of bowel endometriosis. This study evaluates the efficacy of aromatase inhibitors and norethisterone acetate in treating pain and gastrointestinal symptoms caused by bowel endometriosis.

Study design

This prospective pilot study included six women with colorectal endometriosis; all women had intestinal nodules infiltrating at least the muscularis propria of the bowel and did not have a stenosis of the bowel lumen >60%; the patients suffered from pain and intestinal symptoms. The study subjects received letrozole (2.5 mg/day) and norethisterone acetate (2.5 mg/day) continuously for 6 months. The presence and intensity of symptoms were evaluated before starting the treatment, and after 3 and 6 months of treatment.

Results

The double-drug regimen improved pain, non-menstrual pelvic pain, deep dyspareunia, dyschezia, symptoms mimicking diarrhoea-predominant irritable bowel syndrome, intestinal cramping, abdominal bloating and passage of mucus in the stools, and 67% of the patients declared that the treatment improved their gastrointestinal symptoms.

Conclusions

The administration of letrozole and norethisterone acetate reduces pain and gastrointestinal symptoms of women with colorectal endometriosis, particularly when patients suffer from symptoms mimicking diarrhoea-predominant irritable bowel syndrome.     

Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix

BackgroundDyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL).AimWe evaluated the relationship of clinically meaningful improvements in dyspareunia with HRQoL changes among women with endometriosis.MethodsThis was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials. Women aged 18–49 years with moderate to severe endometriosis-associated pain were randomized to placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain. Dyspareunia was ranked 0–3 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly. A woman with a clinically meaningful dyspareunia response (dyspareunia responder) was defined as a woman with a reduction from the baseline in dyspareunia score greater than or equal to a predetermined cutoff while maintaining stable/decreased analgesic use.OutcomesDyspareunia response impact on EHP-30 scores was determined at 3 and 6 months using multivariate linear regression controlling for age, baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity.ResultsAnalysis included 1,368 women with a mean age of 32.2 years. Dyspareunia responders had significant improvements vs non-responders in all adjusted mean EHP-30 domain scores at months 3 and 6 (control and powerlessness: −17.8 and −18.5; emotional well-being: −10.0 and −10.4; pain: −15.3 and −15.7; self-image: −11.4 and −12.8; social support: −14.3 and −14.0; and sexual intercourse: −18.1 and −19.7; all P < .0001).Clinical ImplicationsDyspareunia improvements are associated with both personal and psychological benefits.Strengths & LimitationsThis study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results. As such, the findings may not be generalizable in a real-world setting. Although the perception of dyspareunia and its severity and the associated effect on HRQoL was subjective, the use of a large patient sample was used to minimize potential issues with this limitation.ConclusionClinically meaningful responses in dyspareunia are associated with improvements across multiple HRQoL domains among women with endometriosis.Agarwal SK, Soliman AM, Pokrzywinski RM, et al. Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix. J Sex Med 2020;17:2427–2433.