Does symptom severity predict response to low-dose onabotulinumtoxinA for the treatment of urgency urinary incontinence?

OBJECTIVE: Intradetrusor onabotulinumtoxinA is a third-line treatment for urgency urinary incontinence (UUI) which is customarily reserved for severe disease. We sought to determine if symptom severity predicts the proportional response to onabotulinumtoxinA and whether low-dose injection may be an appropriate treatment for mild-moderate symptoms. STUDY DESIGN: This prospective cohort study compared patients with urgency urinary incontinence who were recruited from the Urogynecology Clinic with mild-moderate (2-9 episodes/3-day diary) and severe UUI (>9 episodes/3-day diary) symptoms. Twenty-eight subjects were treated (11 mild-moderate, 17 severe) with 50 units of intradetrusor onabotulinumtoxinA. Voiding diaries and validated questionnaires (UDI-6 and IIQ-7) were collected at baseline and one, six, and twelve months post-treatment. The primary outcome was the difference in percent reduction in UUI episodes per 3-day diary at one month. Secondary outcomes included differences in absolute reduction of UUI events, treatment success rate (defined as greater than 50% reduction in UUI episodes), changes in UDI-6 and IIQ-7 questionnaire scores, and rates of urinary retention, self-catheterization, and urinary tract infection. Normally distributed data are presented as means with standard deviations (SD) and groups were compared using the two sample t-test. Data that were not normally distributed are presented as medians with the interquartile range (IQR) and were compared using the Wilcoxon rank sum test. RESULTS: The mild-moderate group showed median improvement; 100% (IQR: 100%, 100%) and severe group; 81% (IQR: 35%, 100%), p < 0.019. Both had significant improvement in UUI episodes; the mild-moderate group decreased by four and the severe group by 15. No differences were noted in percent reduction between groups. There was no association between baseline severity and percent reduction in UUI episodes (rs = 0.127, p = 0.544); however, absolute reduction was highly correlated (rs = -0.821, p < 0.001). Treatment success was 90% in mild-moderate and 73% in the severe group (p = 0.615). Complications included urinary tract infections (25%) and intermittent catheterization (3.6%). CONCLUSIONS: Patients with both mild-moderate and severe symptoms showed a statistically significant improvement in UUI events from baseline to one month, but no difference between the groups in proportional improvement or treatment success.

Mild cough · wheezing · loud heart sounds · Dx?

A 25-year-old man, who was an active duty US Navy sailor, went to his ship's medical department complaining of a mild cough that he'd had for 2 days. He denied having any fevers, chills, night sweats, angina, or dyspnea. He said he hadn't experienced any exertional fatigue or difficulty completing the rigorous physical tasks of his occupation as an engineman on the ship. The patient had no medical or surgical history of significance, and he wasn't taking any medications or supplements. On exam, he was not in acute distress and his vital signs were within normal limits. Auscultation revealed mild wheezing throughout the upper lung fields and loud heart sounds throughout his chest that were audible even with gentle contact of the stethoscope diaphragm. He had no discernible murmurs, rubs, or gallops. In light of the unusually loud heart sounds heard on exam, we performed an electrocardiogram. The EKG revealed a normal sinus rhythm, slight right axis deviation indicated by tall R-waves in V1 (also suggestive of right ventricular hypertrophy), an incomplete right bundle branch block, and a crochetage sign (a notch in the R-waves of the inferior leads). A chest x-ray revealed a normal-sized heart and dilated pulmonary vasculature suggestive of pulmonary hypertension.

Intraoperative and postoperative gastrointestinal complications associated with laparoscopic sacrocolpopexy.

OBJECTIVE: This study aimed to quantify the risks of intraoperative and postoperative gastrointestinal (GI) complications associated with laparoscopic sacrocolpopexy and identify possible risk factors. METHODS: A total of 390 medical records were retrospectively reviewed for GI complications. Complications were classified as functional complications [ileus, small bowel obstruction (SBO), and prolonged nausea/emesis] or bowel injury. Nausea/emesis was considered prolonged if these symptoms resulted in a hospital stay of greater than 48 hours, or in readmission. RESULTS: Functional GI complications included 1 ileus, 3 SBOs, and 3 cases of prolonged nausea/emesis. The combined rate for ileus and SBO was 1.0% and the rate of prolonged nausea/emesis was 0.8%. Functional GI complications were associated with prior abdominal surgery (P = 0.048), but there were no differences in age, body mass index, estimated blood loss, or operative time.There were 3 small bowel and 2 rectal injuries for a bowel injury rate of 1.3%. Bowel injury was not associated with prior abdominal surgery (P = 0.071), age, body mass index, estimated blood loss, or operative time. The total reoperation rate for SBO or bowel injury was 0.8%. CONCLUSIONS: The rates of GI complications in laparoscopic sacrocolpopexy are low. Prior abdominal surgery was associated with an increased risk of functional GI complications, but not bowel injury. This information should assist surgeons with preoperative patient counseling.

Risk factors for mesh extrusion after prolapse surgery: a case-control study.

OBJECTIVES: To identify risk factors for mesh extrusion in women undergoing pelvic organ prolapse repair by abdominal sacral colpopexy (ASC) or vaginal mesh procedure (VMP). METHODS: A multicenter case-control study of patients who underwent ASC or VMP from 2006 to 2009 identified using diagnosis and procedure coding. Cases were defined as women who underwent eligible index procedure with synthetic mesh and had mesh visible through the vaginal epithelium at postoperative evaluation; controls were matched in an approximate 1:3 ratio by date and type of procedure. Two conditional logistic regression models were constructed to assess variables associated with mesh extrusion among women who underwent ASC and among women who underwent VMP. RESULTS: Eighty-four cases were identified (43 cases after ASC and 41 cases after VMP), and 252 patients were matched as controls (147 patients who underwent ASC and 105 patients who underwent VMP). Concomitant hysterectomy was positively associated with mesh extrusion) among women who underwent ASC (adjusted odds ratio, 3.18; 95% confidence interval, 1.27-7.93; P = 0.01) and VMP (adjusted odds ratio, 3.72, 95% confidence interval, 1.20-11.54; P = 0.02). Age, race, type of vaginal incision, menopausal status, medical comorbidities, and smoking were not significantly associated with extrusion in either group. CONCLUSIONS: Concomitant hysterectomy is a risk factor for mesh extrusion after ASC and VMPs. This information may be helpful during informed preoperative counseling and planning.

Effect of operative technique on mesh exposure in laparoscopic sacrocolpopexy.

OBJECTIVES: To determine if opening the vaginal cuff during laparoscopic sacrocolpopexy influences the rate of mesh exposure. METHODS: A total of 390 medical records were retrospectively reviewed for demographic information, operative technique, and relevant outcomes. RESULTS: Eleven mesh exposures (2.8%) and 14 suture extrusions (3.6%) were found, none involving visceral organs. Mesh exposure was more common when the vaginal cuff was opened, either during hysterectomy or when allowing transvaginal attachment of mesh in patients with a prior hysterectomy (4.9% vs 0.5%; relative risk [RR], 9.0, P = 0.012). In cases where concomitant hysterectomy was performed, a higher mesh exposure rate was seen in open-cuff hysterectomy (total vaginal hysterectomy/laparoscopically assisted vaginal hysterectomy) compared to supracervical hysterectomy (4.9% [9/185] vs 0% [0/92]; P = 0.032). Mesh exposure was more common when the mesh was sutured laparoscopically compared with transvaginally in patients undergoing open-cuff hysterectomy (14.3% [5/35] vs 2.7% [4/150]; RR, 5.4; P = 0.013). Permanent suture extrusion was significantly associated with laparoscopic versus transvaginal suturing of mesh (5.6% vs 0.6%; RR, 8.8; P = 0.010). Five patients underwent reoperation for mesh exposure, whereas most suture extrusions were asymptomatic; and all were managed nonsurgically. CONCLUSIONS: We found that preserving the integrity of the vaginal cuff led to a lower incidence of mesh exposure in patients undergoing laparoscopic sacrocolpopexy. When hysterectomy is indicated, a supracervical technique should be strongly considered as the mesh exposure rate was significantly lower. If removal of the cervix is indicated, the risk for mesh exposure remains low and should not preclude total hysterectomy, though transvaginal mesh attachment may be preferable.

Laparoscopic hysterectomy using various energy sources in swine: a histopathologic assessment.

OBJECTIVE: Analyze energy-induced damage to the swine vagina during laparoscopic hysterectomy. STUDY DESIGN: Laparoscopic colpotomy was performed in swine using ultrasonic, monopolar, and bipolar energy. Specimens (n = 22) from 13 swine were stained with hematoxylin and eosin and Masson's trichrome for energy-related damage. The distal scalpel-cut margin was used as reference. Energy induced damage was assessed by gynecologic and veterinary pathologists blinded to energy source. RESULTS: Injury was most apparent on Masson's trichrome, demonstrating clear injury demarcation, allowing consistent, quantitative damage measurements. Mean injury was 0 ± 0 µM (scalpel, n = 22), 782 ± 359 µM (ultrasonic, n = 7), 2016 ± 1423 µM (monopolar, n = 8), and 3011 ± 1239 µM (bipolar, n = 7). Using scalpel as the reference, all were significant (P < .001). CONCLUSION: All energy sources demonstrated tissue damage, with ultrasonic showing the least and bipolar the greatest. Further study of tissue damage relative to cuff closure at laparoscopic hysterectomy is warranted.

Randomized clinical trial evaluating the frequency of membrane sweeping with an unfavorable cervix at 39 weeks.

BACKGROUND: Despite the widely accepted use of membrane sweeping to prevent postmaturity pregnancies, the optimal frequency for this procedure has not been established. AIM: To determine if the frequency of membrane sweeping in women with an unfavorable cervix at term results in fewer labor inductions. METHODS: This was a randomized trial of women with an unfavorable cervix (Bishop's score of ≤4) at 39 weeks randomized into three groups: control, once-weekly membrane sweeping, and twice-weekly membrane sweeping. RESULTS: Between January 2005 and June 2008, 350 women were randomized into the study (groups: control [n = 116], once weekly [n = 117], and twice weekly [n = 117]). Randomization of Bishop's score was different between groups (P = 0.019), with 67%, 71%, and 83% of control, once-, and twice-weekly groups, respectively, having scores of 3-4. There was no difference in the unadjusted rate of labor induction between the groups (35% versus 27% versus 23%, P = 0.149), and after the adjustment for the randomization of Bishop's score (adjusted odds ratio [OR] = 0.73, 95% confidence interval [CI] 0.41-1.29 and OR = 0.65, 95% CI 0.36-1.18 for once- and twice-weekly groups, respectively). A Bishop's score of 3-4 at randomization was the only statistically significant factor that decreased the likelihood of induction at 41 weeks (OR = 0.42, 95% CI 0.25-0.69). CONCLUSION: Frequency of membrane sweeping does not influence the likelihood of remaining undelivered at 41 weeks of pregnancy. The Bishop's score at around 39 weeks is the important factor as a predictor of the duration of pregnancy, and further studies would be required to determine whether membrane sweeping influences pregnancy duration.

Anatomical and histological examination of the porcine vagina and supportive structures: in search of an ideal model for pelvic floor disorder evaluation and management.

OBJECTIVE: : The objective of the study was to examine the anatomy and histology of the swine vagina and adjacent supportive structures in comparison to human tissues to determine the potential utility of this model for pelvic floor disorder evaluation and management. METHODS: : This is a descriptive study of the gross anatomy and histology of the swine vagina, uterosacral ligament, cardinal ligament, and rectovaginal space. Tissue was collected from 6 different sites in each of the 6 animals, processed, and stained with hematoxylin-eosin, Masson trichrome, and van Gieson and evaluated by both gynecologic and veterinary pathologists. RESULTS: : Porcine tissues were similar to the human vagina and supporting structures. The origin, insertion, and course of the uterosacral and cardinal ligaments appeared similar to those in humans. Histologically, both the porcine and human vagina and rectum consist of a mucosal, muscular, and adventitial layers. The swine vaginal smooth muscle is arranged in an inner circular and outer longitudinal manner. Collagen, elastin, and smooth muscle were identified in 5 sites. Collagen was highest in the cardinal compared with the uterosacral ligament (P = 0.03), whereas elastin was highest in the uterosacral ligament. The vaginal epithelium measured approximately 40 µm at the vaginal cuff and 50 to 200 µm at anterior and posterior vagina. The swine vagina appeared thinner and contained less elastin. The rectovaginal region contained a smooth muscle layer leading to a thin adventitial layer. CONCLUSIONS: : The swine vagina and adjacent supportive structures appear to be grossly and histologically similar to human vaginal anatomy, and these similarities could lead to further investigation of the porcine model in the study of pelvic support and support disorders.

Use of physical therapy to augment dilator treatment for vaginal agenesis.

OBJECTIVE: : Dilator therapy has been used successfully for many years to treat vaginal agenesis. Our objective was to show how established physical therapy techniques can be used to augment dilator therapy. METHODS: : A 36-year-old woman desiring nonsurgical management of vaginal agenesis was instructed in the use of vaginal dilators by a pelvic-floor physical therapist. Manual stretching of the vaginal tissues was performed during office visits after application of heat and therapeutic ultrasound to the perineum. In addition, the patient's husband was taught how to perform the vaginal stretching at home in conjunction with dilator therapy. RESULTS: : The patient was able to attempt intercourse after 6 weeks of treatment and achieved full penetration by 9 weeks. At the completion of treatment, she scored 31.9 on the Female Sexual Function Index. The patient and her husband were very satisfied with the treatment approach, especially the encouragement and guidance received in physical therapy. CONCLUSIONS: : By using established physical therapy techniques in conjunction with dilator therapy, a faster time to intercourse may be achieved with high patient and spouse satisfaction. We recommend the involvement of a physical therapist specializing in the pelvic floor as an adjunct to standard dilator therapy in the treatment of vaginal agenesis.