Clean intermittent catheterization rates after initial and subsequent treatments with onabotulinumtoxinA for non-neurogenic overactive bladder in real-world clinical settings.

OBJECTIVE: Previous randomized controlled trials have reported a 6.1-6.9% incidence of clean intermittent catheterization (CIC) following treatment with onabotulinumtoxinA in non-neurogenic overactive bladder (OAB) patients who were inadequately managed by ≥1 anticholinergic. A multi-center retrospective chart review assessed the real-world rate of voiding dysfunction requiring catheterization. METHODS: Patients received onabotulinumtoxinA 100 U (approved dose) administered by experienced injectors between January 2013 and June 2015. Patients using CIC or an indwelling catheter for ≥24 hours for voiding dysfunction prior to onabotulinumtoxinA injections were excluded. The primary outcome was post-treatment CIC (lasting >24 hours; per individual physician's clinical judgment considering patient's voiding symptoms, post-void residual [PVR] urine volumes and patient bother). Potential baseline predictors of CIC (history of pelvic prolapse, cystocele, diabetes, PVR urine volume and age) were assessed using multivariable logistic regression. RESULTS: Overall, 299 patients received their first treatment with onabotulinumtoxinA 100 U. Mean age was 66.4 years; 98.3% were female. The incidence of CIC was 2.7% in the total study population after the first treatment with onabotulinumtoxinA. The de novo CIC rate in treatments 2 and 3 combined was similarly low (3.2%). None of the evaluated baseline characteristics were significant predictors of CIC initiation due to the low CIC incidence. CONCLUSIONS: This real-world study of non-neurogenic OAB patients treated with onabotulinumtoxinA suggests that the CIC rate is lower than the rates reported in previous studies. There were no significant correlations between baseline predictors and CIC initiation, although statistical significance may not have been reached because of the low incidence of CIC.

Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study.

OBJECTIVES: High-tone pelvic floor dysfunction (HTPFD) is a debilitating chronic pain disorder for many women with significant impact on their quality of life (QoL). Our objective was to determine the efficacy of electromyography-guided onabotulinumtoxinA (Botox; Allergan, Irvine, Calif) injections in treating patient's perception of pelvic pain and improving QoL measurement scores. METHODS: This is a prospective pilot open-label study of women with chronic pelvic pain and HTPFD who have failed conventional therapy between January 2011 and August 2013. Botox injections (up to 300 U) were done using needle electromyography guidance, from a transperineal approach, to localize spastic pelvic floor muscles (PFMs). Data were collected at baseline, 4, 8, 12, and 24 weeks after injections. This included demographics; Visual Analog Scale (VAS) scores for pain and dyspareunia; validated questionnaires for symptoms, QoL, and sexual function; Global Response Assessment scale for pelvic pain; digital examination of PFM for tone and tenderness; and vaginal manometry. Side effects were also recorded. RESULTS: Out of 28 women who enrolled in the study, 21 completed the 6-month follow-up and qualified for analysis. The mean (SD) age was 35.1 (9.4) years (range, 22-50 years), and the mean (SD) body mass index was 25 (4.4). Comorbidities included interstitial cystitis/bladder pain syndrome (42.9%) and vulvodynia (66.7%). Overall, 61.9% of subjects reported improvement on Global Response Assessment at 4 weeks and 80.9% at 8, 12, and 24 weeks post injection, compared with baseline. Of the subjects who were sexually active at baseline, 58.8% (10/17), 68.8% (11/16), 80% (12/15), and 83.3% (15/18) reported less dyspareunia at 4, 8, 12, and 24 weeks, respectively. Dyspareunia Visual Analog Scale score significantly improved at weeks 12 (5.6, P = 0.011) and 24 (5.4, P = 0.004) compared with baseline (7.8). Two of the 4 patients who avoided sexual activity at baseline secondary to dyspareunia resumed and tolerated intercourse after Botox. Sexual dysfunction as measured by the Female Sexual Distress Scale significantly improved at 8 weeks (27.6, P = 0.005), 12 weeks (27.9, P = 0.006), and 24 weeks (22.6, P < 0.001) compared with baseline (34.5). The Short-Form 12 Health Survey (SF-12) showed improved QoL in the physical composite score at all post injections visits (42.9, 44, 43.1, and 45.5 vs 40 at baseline; P < 0.05), and in the mental composite score at both 12 and 24 weeks (44.3 and 47.8 vs 38.5, P = 0.012). Vaginal manometry demonstrated significant decrease in resting pressures and in maximum contraction pressures at all follow-up visits (P < 0.05). Digital assessment of PFM (on a scale from 0 to 4) showed decreased tenderness on all visits (mean of 1.9, 1.7, 1.8, 1.9; P < 0.001) compared with baseline (2.8). Reported postinjection adverse effects included worsening of the following preexisting conditions: constipation (28.6%), stress urinary incontinence (4.8%), fecal incontinence (4.8%), and new onset stress urinary incontinence (4.8%). CONCLUSIONS: Electromyography-guided Botox injection into PFM could be beneficial for women with refractory HTPFD who have failed conservative therapy.

Risk factors for vaginal mesh exposure after mesh-augmented anterior repair: a retrospective cohort study.

OBJECTIVES: The aim of this study is to identify risk factors for vaginal mesh exposure after mesh-augmented repair of anterior prolapse. METHODS: We performed a retrospective cohort study of all patients who had mesh-augmented anterior repair by 1 surgeon between January 2007 and February 2012. Data were extracted from medical records. The primary outcome was the rate of anterior or apical vaginal mesh exposure. Both univariate and multivariate analyses were performed. RESULTS: A total of 201 subjects were included. The mean (SD) follow-up was 14.3 (12.4) months. All cases were done using a type 1 macroporous monofilament polypropylene mesh. The overall mesh exposure rate was 8.5% (17/201). Univariate analysis showed a statistically significant positive association between exposure rates and the following risk factors: lower body mass index (BMI) (P = 0.016), menopause in combination with the use of hormone replacement therapy (P = 0.023), midline sagittal vaginal incision (compared with distal transverse incision) (P = 0.026), concurrent total hysterectomy (P < 0.001), surgery time (P = 0.002), and worse apical prolapse at baseline (P = 0.007). After multivariate analysis using logistic regression, only BMI (P < 0.001) and concomitant total hysterectomy (odds ratio, 48; P < 0.001) remained relevant. The exposure rate was 23.5% (16/68) when concomitant hysterectomy was performed compared with 0.8% (1/133) when no hysterectomy was done. Exposure rates stratified by BMI class were 12.9% (8/62) for BMI less than 25 kg/m, 9.5% (8/84) for BMI of 25 to 29.9 kg/m, 3.1% (1/32) for BMI of 30 to 34.9 kg/m, and 0% (0/23) for BMI greater than or equal to 35 kg/m. CONCLUSIONS: Concomitant total hysterectomy is an independent risk factor for mesh exposure after mesh-augmented anterior repair, whereas BMI may negatively correlate with exposure rates.

Botulinum toxin for conditions of the female pelvis.

INTRODUCTION AND HYPOTHESIS: Botulinum toxin has recently been approved by the Food and Drug Administration (FDA) for the treatment of urinary incontinence associated with neurogenic detrusor overactivity. However, it has also been used off-label for a multitude of other conditions in the female pelvis, including urological, gynecological, and colorectal. This article reviews the most recent data regarding its efficacy and safety, and administration techniques for those conditions. METHODS: A literature review of the most relevant reports published between 1985 and 2012. RESULTS: Urinary incontinence related to neurogenic detrusor overactivity is currently the only approved indication in the female pelvis. Other supported off-label uses include: idiopathic detrusor overactivity, interstitial cystitis/bladder pain syndrome, detrusor sphincter dyssynergia, high-tone pelvic floor dysfunction, anal fissure, anismus, and functional anal pain. CONCLUSIONS: Botulinum toxin may effectively and safely be used in many conditions of the female pelvis. More high quality research is needed to better clarify its role in the therapeutic algorithm for those indications.

Sacral nerve stimulation during pregnancy: case report and review of the literature.

BACKGROUND: The use of sacral nerve stimulation during pregnancy is not recommended because of the unknown effects on the offspring. There is a paucity of literature on the subject. CASE: A 25-year-old woman who had a sacral nerve stimulator for severe interstitial cystitis/bladder pain syndrome had 2 successful pregnancies. Against medical advice, she kept the stimulator activated for symptom control during the pregnancies. The first child was later diagnosed with chronic motor tic disorder, and the second had a pilonidal sinus at birth. Whether this outcome is related to the neurostimulator is unknown. The efficacy of sacral nerve stimulation decreased after each pregnancy. CONCLUSION: The safety of sacral nerve stimulation in pregnancy has not been well established. Until further research is done, we recommend that women of reproductive age with a sacral nerve stimulator be advised about contraception and that the device should be deactivated before or as soon as pregnancy is confirmed.

Sacral neuromodulations for female lower urinary tract, pelvic floor, and bowel disorders.

PURPOSE OF REVIEW: In recent years, sacral neuromodulation (SNM) has been investigated for the treatment of various types of lower urinary tract and bowel dysfunctions. This review discusses recently published data related to the therapeutic applications of SNM in female lower urinary tract, pelvic floor, and bowel disorders. RECENT FINDINGS: SNM has been employed initially in the treatment of refractory idiopathic overactive bladder, urge urinary incontinence, and chronic nonobstructive urinary retention. Since then, several studies, including randomized and controlled trials, have confirmed the therapeutic effects of SNM in these disorders. The applications of SNM are now extended to the treatment of other female pelvic problems, such as fecal incontinence, chronic constipation, interstitial cystitis/painful bladder syndrome, sexual dysfunction, and neurogenic disorders, with similar promising results. SUMMARY: SNM is approved by the Food and Drug Administration for the treatment of idiopathic overactive bladder, urge urinary incontinence, and chronic nonobstructive urinary retention. SNM is not yet an approved method for the treatment of other pelvic disorders, but data supporting its benefit are emerging. The major advantage of SNM lies in its potential to treat the bladder, urethral sphincter, anal sphincters, and pelvic floor muscles simultaneously, which might result in better therapeutic effects.

Minimally invasive therapies for chronic pelvic pain syndrome.

Chronic pelvic pain syndrome (CPPS) is a common problem among men and women worldwide. It is a symptoms-complex term for interstitial cystitis/painful bladder syndrome in women and chronic prostatitis/chronic pelvic pain syndrome in men. Patients often present with a combination of lower urinary tract symptoms with pelvic pain and sexual dysfunction. No gold standard exists for diagnosis or treatment of CPPS. The diagnosis is often challenging and is determined by elimination. Multiple treatment modalities exist, ranging from physical therapy to surgery. We discuss minimally invasive therapies for treatment of this complex of symptoms. Although data suggest reasonable efficacy of several medications, multimodal therapy remains the mainstay of treatment. We review the following minimally invasive therapeutic modalities: dietary modifications, physical therapy, mind-body therapies, medical therapy, intravesical therapies, trigger point injections, botulinum toxin injections to the pelvic floor, and neuromodulation. We report data supporting their use and efficacy and highlight the limitations of each.

Urogenital complaints and female sexual dysfunction (part 1).

INTRODUCTION: Sexual dysfunction and dyspareunia are common complaints in women with urological disorders. AIM: To provide a comprehensive review of sexual dysfunction related to common hypersensitive/hyperactive urogenital disorders including interstitial cystitis/painful bladder syndrome (IC/PBS), overactive bladder (OAB) with and without incontinence, and high-tone pelvic floor muscle dysfunction and the appropriate treatment strategies. METHODS: A medical literature search using several related terms including sexual dysfunction, dyspareunia, IC/PBS, OAB, urinary incontinence pelvic floor dysfunction, and levator ani muscle spasm. MAIN OUTCOME MEASURES: Review of the medical literature to identify relation between sexual dysfunction and common urological disorders in women and to describe appropriate treatment strategies to improve the women's quality of life. RESULTS: A thorough review of sexual dysfunction in urological disorders and their related treatments modalities including: behavioral, pharmacological, and nonpharmacological therapies. CONCLUSIONS: Sexual dysfunction is a common, underestimated, and untreated complaint in women with urologic disorders. Identifying sexual complaints and treating the underlying etiologies can result in significant improvement in a woman's quality of life. This process requires a focused, multidisciplinary approach tailored to meet the needs of women with urogenital complaints.

Who's asking? Patients may under-report postoperative pain scores to nurses (or over-report to surgeons) following surgery of the female reproductive tract.

OBJECTIVE: To determine if postoperative pain reporting via standardised visual analogue scale (VAS) is affected by which member of the healthcare team collects the information. MATERIALS AND METHODS: A standardised ten-point VAS measured postsurgical pain level among patients (n = 60) undergoing laparotomy via Pfannenstiel incision. All study patients received the same patient-controlled analgesia and uniform post-operative orders were used. VAS data were gathered from patients by surgeons (MD) and nurses (RN) 6 h and 24 h after surgery; RNs and MDs independently recorded patients' VAS pain scores in variable order. RESULTS: When assessed 6 h after surgery, the average pain level reported by patients to RNs was significantly lower than that reported to MDs (3.3 +/- 2.8 vs. 4.0 +/- 2.4; P = 0.02). Average patient pain levels remained lower when reported to RNs 24 h post-operatively compared to that reported to MDs, although this difference was not significant (1.9 +/- 2.1 vs. 2.1 +/- 2.1; P = 0.39). Whenever post-surgical patients provided different VAS scores for pain level to RNs and MDs, the higher pain reading was always reported to the MD. CONCLUSION: This study identified important variances in subjective pain reporting by patients that appeared to be influenced by who sampled the data. We found patients gave lower VAS pain scores to RNs compared to MDs; the reverse pattern was never observed. Post-surgical patients may communicate pain information differently depending on who asks them, particularly in the early post-operative period. Accordingly, patient pain data gathered over time by a care team with a heterogeneous composition (i.e., RNs, MDs) may not be fully interchangeable. Patient projections of pain severity and/or intensity appear to vary as a function of who evaluates the patient.

Prospective randomized trial of iliohypogastric-ilioinguinal nerve block on post-operative morphine use after inpatient surgery of the female reproductive tract.

OBJECTIVE: To determine the impact of pre-operative and intra-operative ilioinguinal and iliohypogastric nerve block on post-operative analgesic utilization and length of stay (LOS). METHODS: We conducted a prospective randomized double-blind placebo controlled trial to assess effectiveness of ilioinguinal-iliohypogastric nerve block (IINB) on post-operative morphine consumption in female study patients (n = 60). Patients undergoing laparotomy via Pfannenstiel incision received injection of either 0.5% bupivacaine + 5 mcg/ml epinephrine for IINB (Group I, n = 28) or saline of equivalent volume given to the same site (Group II, n = 32). All injections were placed before the skin incision and after closure of rectus fascia via direct infiltration. Measured outcomes were post-operative morphine consumption (and associated side-effects), visual analogue pain scores, and hospital length of stay (LOS). RESULTS: No difference in morphine use was observed between the two groups (47.3 mg in Group I vs. 45.9 mg in Group II; p = 0.85). There was a trend toward lower pain scores after surgery in Group I, but this was not statistically significant. The mean time to initiate oral narcotics was also similar, 23.3 h in Group I and 22.8 h in Group II (p = 0.7). LOS was somewhat shorter in Group I compared to Group II, but this difference was not statistically significant (p = 0.8). Side-effects occurred with similar frequency in both study groups. CONCLUSION: In this population of patients undergoing inpatient surgery of the female reproductive tract, utilization of post-operative narcotics was not significantly influenced by IINB. Pain scores and LOS were also apparently unaffected by IINB, indicating a need for additional properly controlled prospective studies to identify alternative methods to optimize post-surgical pain management and reduce LOS.

Eosinophilia in a patient with cyclical vomiting: a case report.

BACKGROUND: Eosinophilic gastritis is related to eosinophilic gastroenteritis, varying only in regards to the extent of disease and small bowel involvement. Common symptoms reported are similar to our patient's including: abdominal pain, epigastric pain, anorexia, bloating, weight loss, diarrhea, ankle edema, dysphagia, melaena and postprandial nausea and vomiting. Microscopic features of eosinophilic infiltration usually occur in the lamina propria or submucosa with perivascular aggregates. The disease is likely mediated by eosinophils activated by various cytokines and chemokines. Therapy centers around the use of immunosuppressive agents and dietary therapy if food allergy is a factor. CASE PRESENTATION: The patient is a 31 year old Caucasian female with a past medical history significant for ulcerative colitis. She presented with recurrent bouts of vomiting, abdominal pain and chest discomfort of 11 months duration. The bouts of vomiting had been reoccurring every 7-10 days, with each episode lasting for 1-3 days. This was associated with extreme weakness and cachexia. Gastric biopsies revealed intense eosinophilic infiltration. The patient responded to glucocorticoids and azathioprine. The differential diagnosis and molecular pathogenesis of eosinophilic gastritis as well as the molecular effects of glucocorticoids in eosinophilic disorders are discussed. CONCLUSIONS: The patient responded to a combination of glucocorticosteroids and azathioprine with decreased eosinophilia and symptoms. It is likely that eosinophil-active cytokines such as interleukin-3 (IL-3), granulocyte macrophage colony stimulating factor (GM-CSF) and IL-5 play pivotal roles in this disease. Chemokines such as eotaxin may be involved in eosinophil recruitment. These mediators are downregulated or inhibited by the use of immunosuppressive medications.