A randomized, double-blind, placebo-controlled trial of onabotulinumtoxin A trigger point injections for myofascial pelvic pain.

BACKGROUND: Pelvic pain is estimated to effect 15% of women, and onabotulinumtoxin A is used to treat a variety of pain disorders. However, the data on the use of onabotulinumtoxin A for the treatment of women with myofascial pelvic pain are limited. OBJECTIVE: The objective of the study was to compare the effect of onabotulinumtoxin A vs placebo injections to the pelvic floor muscles in women with myofascial pelvic pain. STUDY DESIGN: This was a double-blind, randomized, placebo-controlled trial in women with myofascial pelvic pain. Women ≥18 years were eligible if they reported pain ≥6 on a 10 point visual analog scale ≥50% of the time and had pain on palpation ≥6 on the visual analog scale in ≥1 of 6 pelvic floor muscle groups. Participants were randomly allocated to a pelvic floor injection of 200 units of onabotulinumtoxin A or 20 mL of saline. All participants started 8 weeks of physical therapy 4 weeks after the injection. Participants completed validated questionnaires at baseline, 2, 4, and 12 weeks after injection. At each visit, a urogynecologist who was blinded to treatment arm performed a clinical examination with palpation of the left and right sides of 6 pelvic floor muscle groups. The primary outcome was change in participant-reported pain on palpation of the most painful pelvic floor muscle at 2 weeks. Analyses were intention to treat. RESULTS: We consented 60 women. One participant was lost to follow-up after she was consented; therefore, we randomized 59 women. The groups had similar demographic and clinical characteristics. With regard to the primary outcome, there was no significant difference between the intervention and placebo groups in the change in participant-reported pain on palpation of the most painful pelvic floor muscle at 2 weeks. There were no significant differences in participant-reported pain on palpation for any muscle group at 4 or 12 weeks. At 4 and 12 weeks, participants in the intervention group reported greater declines in overall pelvic pain on the visual analog scale compared with the placebo group, although these differences were not statistically significant (both P = .16). Using the Patient Global Impression of Improvement index, participants in the intervention group were more likely to report their symptoms were improved at 4 and 12 weeks compared with the placebo group, although this difference was significant only at 4 weeks (P = .03 and P = .10, respectively). At 2 weeks, the placebo group had a significant improvement in the Pelvic Floor Distress Inventory score compared with the intervention group (P = .01); however, this difference did not persist at 4 (P = .19) or 12 weeks (P = .11). At 2 weeks, the most common adverse event was constipation in the intervention and placebo groups, with 10.1% reporting de novo constipation. This was followed by urinary incontinence in the intervention group (22%) and urinary tract infection (9%) in the placebo group. CONCLUSION: Pelvic floor onabotulinumtoxin A injections for myofascial pelvic pain were not more effective than saline injections at decreasing muscle pain on palpation. Despite this, participants who received onabotulinumtoxin A were more likely than those who received saline to report improvement, albeit not statistically significant, in their overall pelvic floor pain at 4 and 12 weeks.

Association between body mass index and pain following transobturator sling.

We aimed to prospectively evaluate the association between body mass index (BMI) and development of postoperative-onset pain in women undergoing transobturator midurethral sling procedures. We conducted a prospective, observational cohort study of women undergoing inside-to-out transobturator midurethral sling. At preoperative visit, height, weight, self-reported activity level and baseline pain were documented. At postoperative visits, patients indicated pain location and severity, procedure success, and satisfaction. We used log binomial regression to calculate risk ratios, controlling for potential confounders. For the 129 women included, median age was 50.0 years and BMI was 27.2 kg/m2. Adjusting for age and activity level, overweight and obese women had significantly increased risk of postoperative-onset pain compared to normal BMI women. Overweight women were at 1.70 (95%CI 1.05-2.75) times the risk compared to leaner counterparts, whereas obese women were at 1.76 times the risk (95%CI 1.04-2.89). Neither success nor satisfaction was associated with BMI. Impact statement Over three million midurethral slings have been placed worldwide for the treatment or prevention of stress urinary incontinence. The procedure has been studied in lean, overweight and obese populations, and found to have similar efficacy regardless of BMI. Similarly, the risks of midurethral sling have been well-documented, including the risk of pain after transobturator sling. Little attention has been given to whether this risk of postoperative pain varies based on patient BMI. Our previous work suggesting that leaner patients might be at increased risk of postoperative pain following transobturator sling was limited by the shortcomings of a retrospective study design. In this prospective study, we were able to adjust for age and activity level, finding that higher BMI women were at increased risk of postoperative pain, while reporting similar levels of satisfaction with the procedure. Future research is needed to find what differences in anatomy or physiology can explain this finding. From a clinical standpoint, thorough counselling of all patients but particularly those with elevated BMI, is required so that appropriate expectations regarding recovery can be set preoperatively.

Laparoscopic supracervical hysterectomy with transcervical morcellation and sacrocervicopexy for the treatment of uterine prolapse.

INTRODUCTION AND HYPOTHESIS: The objective is to describe our surgical approach for management of uterine prolapse using 5-mm skin incisions and transcervical morcellation. METHODS: This video presents a novel approach for laparoscopic supracervical hysterectomy, bilateral salpingectomy, and sacrocervicopexy using only 5-mm skin incisions and transcervical morcellation. The procedure begins with a laparoscopic supracervical hysterectomy with bilateral salpingectomy. A classic intrafascial supracervical hysterectomy (CISH) instrument is then used transvaginally to core the endocervical canal. A disposable morcellator is placed through the remaining cervix to morcellate the uterus and fallopian tubes. Following morcellation, the handle of the morcellator is removed, and it is used during the remainder of the surgery as an access cannula for the sacrocervicopexy. The polypropylene mesh is introduced through this cannula. It is secured to the anterior and posterior vaginal fascia with a suture that is also introduced through the transcervical port. At the conclusion of the surgery, a previously placed 0 Vicryl purse-string suture at the ectocervix is tied down as a cerclage around the cervix once the cannula is removed. CONCLUSIONS: The transcervical morcellation technique demonstrated in this video allows the surgeon to maintain 5-mm skin incisions and core the endocervical canal during a laparoscopic supracervical hysterectomy with sacrocervicopexy.

Effect of vaginal estrogen on pessary use.

INTRODUCTION AND HYPOTHESIS: Many providers recommend concurrent estrogen therapy with pessary use to limit complications; however, limited data exist to support this practice. We hypothesized that vaginal estrogen supplementation decreases incidence of pessary-related complications and discontinuation. METHODS: We performed a retrospective cohort study of women who underwent a pessary fitting from 1 January 2007 through 1 September 2013 at one institution; participants were identified by billing code and were eligible if they were postmenopausal and had at least 3 months of pessary use and 6 months of follow-up. All tests were two sided, and P values < 0.05 were considered statistically significant. RESULTS: Data from 199 women were included; 134 used vaginal estrogen and 65 did not. Women who used vaginal estrogen had a longer median follow-up time (29.5 months) compared with women who did not (15.4 months) and were more likely to have at least one pessary check (98.5 % vs 86.2 %, P < 0.001). Those in the estrogen group were less likely to discontinue using their pessary (30.6 % vs 58.5 %, P < 0.001) and less likely to develop increased vaginal discharge than women who did not [hazard ratio (HR) 0.31, 95 % confidence interval (CI) 0.17-0.58]. Vaginal estrogen was not protective against erosions (HR 0.93, 95 % CI 0.54-1.6) or vaginal bleeding (HR 0.78, 95 % CI 0.36-1.7). CONCLUSIONS: Women who used vaginal estrogen exhibited a higher incidence of continued pessary use and lower incidence of increased vaginal discharge than women who did not.

Use of a vessel loop to ensure tunnel patency during LeFort colpocleisis.

INTRODUCTION: The objective was to describe a novel method for maintaining bilateral channel patency for potential uterine drainage during LeFort colpocleisis. METHODS: This video presents a novel approach for ensuring bilateral channel patency during colpocleisis. An 88-year-old gravida 2 para 2 with stage 4 uterovaginal prolapse presented for definitive surgical management. She was no longer sexually active. After counseling on various treatment options, she elected to proceed with a LeFort colpocleisis. During the procedure, the vaginal epithelium is dissected off the underlying tissue with sharp dissection after infiltration with local anesthetic. After the epithelium is removed anteriorly and posteriorly, a blue vessel loop is placed across the cervix and within the lateral channels as they are created with a series of figure of eight stitches. Care is taken to suture around and not through the vessel loop. This is done on both sides. The anterior and posterior dissected surfaces of the vagina are then reapproximated to involute the vagina until the distal epithelial edges can be brought together. Once the vaginal epithelial edges are sewn, the vessel loop is easily pulled through, ensuring channel patency. CONCLUSIONS: The vessel loop technique demonstrated in this video allows the surgeon to ensure that the bilateral channels remain patent throughout the procedure.

Attitudes toward transvaginal mesh among patients in a urogynecology practice.

INTRODUCTION AND HYPOTHESIS: There has been increasing media attention regarding transvaginal mesh (TVM). We hypothesized that new urogynecology patients have limited knowledge and negative opinions of TVM. METHODS: An anonymous survey was distributed to all new patients presenting to the Mt Auburn Hospital urogynecology practice from 1 November 2012 to 31 January 2013. A total of 146 patients completed the questionnaire. The survey was designed to elicit information on participants' knowledge and opinions about TVM and knowledge about recent FDA safety communications. All statistical tests were two-sided, and P values <0.05 were considered statistically significant. RESULTS: Analyses were restricted to the 77 women who had either heard of TVM or were unsure if they had heard of TVM. A minority (32.5 %) of these women correctly defined TVM, and 33.8 % had a negative impression of TVM. Respondents obtained their information on TVM from the media (48.1 %), the Internet (24.7 %), family or friends (22.1 %), and health care providers (18.2 %). The majority (71.4 %) agreed that they needed more information about TVM before making any decisions about using it to treat their condition. Nearly one quarter of respondents (23.4 %) agreed that they would not want their doctor to use TVM on them for any reason. When asked about recent FDA communications, 27.3 % of patients correctly responded that the FDA had released a safety communication regarding TVM. CONCLUSIONS: The majority of participants had limited knowledge of TVM; however, only a minority had negative opinions. Given our findings, it is important that providers spend more time during the consent process explaining TVM and its risks and benefits as a treatment option.

Do Obstetrical Providers, Counsel Women About Postpartum Pelvic Floor Dysfunction?

OBJECTIVE: To assess prenatal counseling practices of obstetrics providers related to postpartum pelvic floor dysfunction at centers with integrated urogynecology services. STUDY DESIGN: A cross-sectional survey was distributed to obstetrical providers through urogynecology colleagues. The survey included questions about level of training as well as counseling practices related to common postpartum pelvic floor symptoms. All statistical tests were two-sided, and p values < 0.05 were considered statistically significant. RESULTS: A total of 192 surveys were received; 19 respondents did not perform their own prenatal counseling and were excluded. Among the remaining 173 respondents, 94 (56.3%) of those who answered the question reported never discussing postpartum urinary incontinence, and 73.7% reported never discussing postpartum fecal incontinence during prenatal counseling. Obstetrics and gynecology residents were significantly less likely than attending physicians to report discussing various pelvic floor dysfunction topics in prenatal counseling. Among those who reported not counseling women regarding pelvic floor dysfunction, the most common reason cited was lack of time (39.9%) followed by lack of sufficient information (30.1%). CONCLUSION: Prenatal counseling of pelvic floor dysfunction risk is lacking at all levels of obstetrical training. Limitations of time and information are the obstacles most often cited by providers.

The role of preoperative urodynamics in urogynecologic procedures.

Urodynamic studies refer to any tests that provide objective information about lower urinary tract function with the goal of evaluating bladder and urethral function. Pre-operative urodynamic testing is commonly performed prior to urogynecologic procedures for urinary incontinence and pelvic organ prolapse. Although the utility of preoperative urodynamics testing before urogynecologic procedures have been challenged in the literature, the preoperative utilization of urodynamic testing in women with complex voiding dysfunction or associated conditions such as prolapse or urethral diverticulum is still considered important for surgical planning and pre-operative counseling.

Is there a taxane-free interval that predicts response to taxanes as a later-line treatment of recurrent ovarian or primary peritoneal cancer?

OBJECTIVES: Taxanes have reported response rates of 20% to 40% in recurrent ovarian cancer (ROC) but are less well studied as a later-line treatment. We reviewed our experience with taxanes in ROC to determine (1) if a taxane-free interval is associated with response rates in women with ROC and (2) if the use of intervening therapy (IT) affects subsequent response rates to taxanes. METHODS: We retrospectively identified women who received first- or second-line platinum-taxane therapy and later received a single-agent taxane. Demographics, intervening regimens, and follow-up and survival data were collected. Responses were characterized by cancer antigen 125 levels based on the Gynecologic Cancer InterGroup serologic response definitions. RESULTS: We identified 46 women who met the eligibility criteria. The median age was 57 years (range, 39-78 years). The median interval between taxanes was 25.8 months (range, 2.9-85.5 months), with 10 (21%) of the women were treated 12 months or less from their last taxane and 37 (79%) treated more than 12 months. The median number of IT was 2 (range, 0-5). Forty patients (87%) received paclitaxel; 6 (13%) received docetaxel. All patients treated 12 months or less from their last taxane responded (P = 0.02). The number of IT was associated with a better response; all women (100%) treated who had no IT, 7 (54%) of 13 women with 1 to 2 ITs, and 7 (39%) of 18 women with 3 ITs or more responded. The overall survival was 13.4 months in responders versus 10.6 months in nonresponders (P = 0.27). CONCLUSIONS: Taxanes maintain an activity as a later-line agent, even with 3 or more intervening therapies. However, the highest responses were seen if taxanes were used within 12 months of the last platinum-based combination. The lack of an increased response with aprolonged taxane-free interval is likely related to the number of IT, consistent with the emergence of multidrug resistance.

Obliterative Versus Reconstructive Prolapse Repair for Women Older than 70: Is There an Optimal Approach?

OBJECTIVES: This study aimed to evaluate outcomes among women 70 years and older who underwent obliterative compared with reconstructive procedures for pelvic organ prolapse. METHODS: This was a retrospective cohort study of patients 70 years and older who underwent surgical prolapse repair at our institution from January 2004 through June 2010. Only patients with at least 4 weeks of follow-up were included. Patient characteristics and relevant pre, intra, and postoperative information were abstracted from medical records. Severity of postoperative complications was classified using the Dindo surgical classification system. RESULTS: We analyzed 143 (97.3%) patients. Fifty-four (37.8%) women underwent an obliterative procedure, whereas 89 (62.2%) underwent a reconstructive procedure. Twenty-eight (31.5%) women who had a reconstructive surgery met our criteria for recurrent prolapse compared with only 5 (9.3%) women in the obliterative group (P = 0.002).The incidence of intraoperative complication was 4.9%, and the incidence of any postoperative complication was 62.9%. Similar proportions of women who underwent each type of procedure experienced a postoperative complication. However, the severity of the complications differed between the groups (P = 0.02). In particular, 16.9% of women who had a reconstructive procedure experienced a grade III complication according to the Dindo scale compared with 13.0% of women who had an obliterative procedure. CONCLUSIONS: The majority of women 70 years and older do not have high-grade complications after pelvic organ prolapse repair, but women who undergo reconstructive procedures are more likely to experience high-grade complications and recurrent prolapse compared with women who undergo obliterative procedures.

Bladder Symptoms and Attitudes in an Ethnically Diverse Population.

OBJECTIVE: The aim of the study was to assess pelvic floor symptoms and attitudes in an ethnically diverse population. METHODS: We conducted a cross-sectional survey of women presenting to 2 community-based, ethnically diverse gynecology clinics. Before being seen by a provider, participants were asked to complete a questionnaire. RESULTS: A total of 312 women were included: 32.7% white, 50.3% African American, and 17.0% Hispanic. Other racial/ethnic groups were excluded secondary to small samples size. The median (interquartile range) age was 34.0 (27.0-44.0) years. The groups differed with respect to most demographic characteristics, such as income, education, and nation of origin. Nocturia and urinary frequency were the most commonly reported symptoms. African American respondents were more likely to report nocturia than white respondents (odds ratio, 2.4; 95% confidence interval, 1.2-4.8). Respondents' views of normal urinary function generally did not vary by race/ethnicity. However, Hispanic respondents were less likely than white respondents to agree that it is normal to leak urine after having children (odds ratio, 0.28; 95% confidence interval, 0.11-0.68). Among women who reported at least 1 symptom, 46.7% reported that at least 1 symptom bothered them, and this did not differ with respect to race/ethnicity (P ≥ 0.59). African American respondents were more likely than whites to report their urinary leakage to their doctors (P = 0.006). CONCLUSIONS: Our study demonstrates that with few exceptions, bladder symptoms and attitudes are similar among reproductive-age women of various racial/ethnic groups in a community setting.

Effect of Scopolamine Patch Use on Postoperative Voiding Function After Transobturator Slings.

OBJECTIVES: The aim of this study was to determine whether the use of a preoperative transdermal scopolamine (TDS) patch for postoperative nausea and vomiting prophylaxis affects the success of a voiding trial after a transobturator tape sling procedure. METHODS: This study is a retrospective cohort study of adult women who underwent a transobturator tape sling procedure without concomitant procedures from February 1, 2009 through August 1, 2010. The exposed group included all eligible women who received a preoperative TDS patch. For each exposed woman, we selected the next 2 consecutive eligible women who did not receive a TDS patch to be included in the unexposed group. The primary outcome was postoperative voiding trial failure. RESULTS: We identified 35 women who met eligibility criteria and used a preoperative TDS patch, and included 70 women who did not use a preoperative TDS. A significantly higher proportion of women in the TDS patch group (54.3%) failed their voiding trial than in the group that did not receive TDS (7.1%, P ≤ 0.001). A history of an incontinence procedure, older age, and higher body mass index strengthened the association between TDS patch and voiding trial failure. The adjusted model yielded a risk ratio for voiding trial failure of 13.8 (95% confidence interval, 5.2-36.5) for women who received TDS patch compared with those who did not. CONCLUSIONS: The results of this study demonstrate that use of TDS patches for postoperative nausea and vomiting prophylaxis may negatively affect the success of voiding trials after transobturator tape sling procedures.

Pelvic Floor Physical Therapy as Primary Treatment of Pelvic Floor Disorders With Urinary Urgency and Frequency-Predominant Symptoms.

OBJECTIVE: To assess the efficacy of pelvic floor physical therapy (PFPT) as primary treatment of urinary urgency and frequency symptoms METHODS: We conducted a prospective cohort study of women with urinary urgency and frequency symptoms. Participants underwent PFPT once or twice per week for 10 weeks. Symptom improvement was assessed by validated questionnaires (Pelvic Floor Distress Inventory-Short Form 20 and Patient Global Impression of Improvement), voiding diaries, and subjective measures. RESULTS: Fifty-seven participants enrolled; 21 (36.8%) withdrew or completed less than 5 weeks of PFPT. Thirty-one (54.4%) of the remaining 36 participants completed 10 weeks of PFPT. The mean age of the study group (n = 36) was 48.9 ± 15.0 years. The primary diagnoses were overactive bladder syndrome (n = 24, 66.7%) and painful bladder syndrome (n = 12, 33.3%). Women attended a median of 14.0 (interquartile range [IQR], 8.0-16.0) PFPT visits over a median of 11.9 weeks (IQR, 10.0-18.1). At baseline, the median Pelvic Floor Distress Inventory-Short Form 20 score was 79.2 (IQR, 53.1-122.9), and decreased to 50.0 (IQR, 25.0-88.5; P < 0.001) after PFPT; the urinary and prolapse symptom subscales both decreased significantly. Participants reported a decrease from a median of 10.0 voids per day to 8.0 (P < 0.001). On the Patient Global Impression of Improvement, 62.5% of women reported that they were "much better" or "very much better." CONCLUSIONS: The PFPT with myofasical release techniques improves urinary symptoms while avoiding medications and more invasive therapies. The high dropout rates suggest that motivation or logistic factors may play a significant role in the utilization and success of this treatment option.

Characterization of pain after inside-out transobturator midurethral sling.

OBJECTIVES: This study aimed to evaluate the prevalence, severity, duration, and location of pain after transobturator midurethral sling. METHODS: We evaluated patients who underwent inside-out transobturator sling from March 2011 through February 2013. Presence of pelvic girdle pain, its severity, and location were documented preoperatively and at 2- and 6-week postoperative visits. Pain severity was measured on a scale of 1 to 10, with 10 being the "worst imaginable" pain. RESULTS: Of the 130 women analyzed, the median age was 50.0 years (interquartile range, 44.0-62.0). Thirty-nine percent of women reported preoperative pain, mostly mild with a median score of 1.0 (1.0-5.0). The most common sites of postoperative-onset pain were the lateral leg, medial leg, groin, and low back. Women reporting preoperative pain were not more likely to report postoperative-onset pain than women without preoperative pain (P = 0.42). Twelve percent of women at 2 weeks and 0.8% at 6 weeks reported severe postoperative-onset pain. Women reporting postoperative-onset pain were equally likely to be satisfied with the procedure as those without pain at 2 (P = 0.76) and 6 (P = 0.74) weeks. CONCLUSIONS: Women undergoing transobturator sling commonly report preoperative pain. An expected postoperative increase in pain generally resolved by the sixth postoperative week. The lateral leg was the most common site of pain. Postoperative-onset pain was not associated with decreased patient satisfaction.