Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol.

BACKGROUND: Restoring community walking remains a highly valued goal for persons recovering from traumatic incomplete spinal cord injury (SCI). Recently, studies report that brief episodes of low-oxygen breathing (acute intermittent hypoxia, AIH) may serve as an effective plasticity-inducing primer that enhances the effects of walking therapy in persons with chronic (> 1 year) SCI. More persistent walking recovery may occur following repetitive (weeks) AIH treatment involving persons with more acute SCI, but this possibility remains unknown. Here we present our clinical trial protocol, designed to examine the distinct influences of repetitive AIH, with and without walking practice, on walking recovery in persons with sub-acute SCI (< 12 months) SCI. Our overarching hypothesis is that daily exposure (10 sessions, 2 weeks) to AIH will enhance walking recovery in ambulatory and non-ambulatory persons with subacute (< 12 months) SCI, presumably by harnessing endogenous mechanisms of plasticity that occur soon after injury. METHODS: To test our hypothesis, we are conducting a randomized, placebo-controlled clinical trial on 85 study participants who we stratify into two groups according to walking ability; those unable to walk (non-ambulatory group) and those able to walk (ambulatory group). The non-ambulatory group receives either daily AIH (15, 90s episodes at 10.0% O2 with 60s intervals at 20.9% O2) or daily SHAM (15, 90s episodes at 20.9% O2 with 60s intervals at 20.9% O2) intervention. The ambulatory group receives either 60-min walking practice (WALK), daily AIH + WALK, or daily SHAM+WALK intervention. Our primary outcome measures assess overground walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up & Go Test). For safety, we also measure levels of pain, spasticity, systemic hypertension, and autonomic dysreflexia. We record outcome measures at baseline, days 5 and 10, and follow-ups at 1 week, 1 month, 6 months, and 12 months post-treatment. DISCUSSION: The goal of this clinical trial is to reveal the extent to which daily AIH, alone or in combination with task-specific walking practice, safely promotes persistent recovery of walking in persons with traumatic, subacute SCI. Outcomes from this study may provide new insight into ways to enhance walking recovery in persons with SCI. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02632422 . Registered 16 December 2015.

Two techniques for assessing postoperative voiding function, a randomized trial.

INTRODUCTION AND HYPOTHESIS: Post-operative voiding dysfunction is common after sling placement and is assessed with a voiding trial (VT) before discharge. We hypothesized that an operating room (OR) initiated retrograde VT (OR-fill) would decrease time to discharge compared with a post-anesthesia care unit (PACU) initiated retrograde VT (PACU-fill). METHODS: This was a parallel non-blinded randomized trial, of women undergoing outpatient sling surgery at a university hospital. In the OR-fill group, fill was initiated after sling placement during cystoscopy by leaving fluid in the bladder. In the PACU-fill group, fill was initiated in the PACU. Pre-VT volumes were recorded and a PVR ≤ 100 mL defined a passed VT. The primary outcome was total PACU time, defined as arrival in PACU until discharge home. RESULTS: Thirty women were assigned to the OR-fill group and 29 to the PACU-fill group. Time from PACU arrival to VT was shorter in the OR-fill group (41.5 [31.0, 69.3] min vs 69.0 [44.0, 107.0] min, p = 0.03), but total PACU time in the groups was similar (125.0 [90.5, 180.5] min vs 131.5 [93.5, 178.0] min, p = 0.76). Bladder volume before VT was greater in the OR-fill group (557.3 ± 187.3 mL vs 433.0 ± 171.2 mL, p = 0.01). VT pass rates of the two groups were not significantly different (OR-fill 16.7% vs PACU-fill 24.1%, p = 0.48). CONCLUSIONS: OR-fill VT did not decrease total PACU time compared with PACU-fill VT. No overdistension was seen in either group; transient postoperative voiding dysfunction was common.

Implementation of a standardized digital rectal exam to improve the accuracy of rectocele diagnosis.

INTRODUCTION AND HYPOTHESIS: The standardized evaluation of posterior compartment prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system is limited. The primary objective of this study is to develop and validate the interexaminer reliability of a new system for assessing the posterior vaginal wall for the presence of a rectocele. METHODS: This was a cross-sectional study of women presenting to an academic urogynecology clinic. Subjects underwent a routine pelvic examination that included a standard POP-Q followed by two Standardized Digital Rectal Exams (SDRE) by two different providers, each blinded to the other's results. The SDRE measures the distance from the leading edge of a posterior bulge to the hymen with a finger in the distal rectum - first visually and then an actual measured distance using a marked cotton swab (Q-tip measurement). Correlations between examiners for the SDRE and the POP-Q were analyzed using Pearson's correlation coefficient (ρ). RESULTS: Eight attending and fellow urogynecologists examined 50 subjects. Mean age was 57.3 years, mean BMI 30.9 kg/m(2), with an overall median POP-Q stage 2 (range 0-3), and median posterior POP-Q stage 1 (range 0-3). Overall, 54 % of women had a noteworthy rectocele by typical digital rectal exam. Interexaminer correlations with SDRE for both the visual assessment (ρ = 0.697, p < 0.0001) and the Q-tip measurement (ρ = 0.767, p = p < 0.001) were strong. The intraexaminer visual assessment and the Q-tip measurement were highly correlated (ρ = 0.934, p = <0.001). CONCLUSION: This standardized rectal examination provides a consistent method for the reporting of distal rectoceles that can lend additional information to the POP-Q exam.

Short-term mesh exposure after robotic sacrocolpopexy with and without concomitant hysterectomy.

OBJECTIVES: The primary objective of this study was to compare the short-term rate of mesh exposure after a robotic sacrocolpopexy (RSCP) compared with those after RSCP with a concomitant hysterectomy. Secondary objectives included a comparison of mesh exposure from total hysterectomies (TH) versus supracervical hysterectomies (SCH) and determination of risk factors for mesh exposure. METHODS: This was a retrospective cohort study of women who underwent RSCP between January 2009 and December 2011 at one academic center. The primary outcome was mesh exposure at 6 weeks postoperation. Subjects were divided into two groups: those with concomitant hysterectomy and those with RSCP alone. The hysterectomy group was subdivided into TH versus SCH. Mesh exposures and mesh revision procedures were identified using International Classification of Diseases-9 and CPT codes, respectively, and confirmed by chart review. RESULTS: There were 230 eligible women who underwent RSCP during the study period and were followed up at a 6-week postoperative visit; 118 (51.7%) had RSCP only and 112 (48.7%) had a concomitant hysterectomy. Of those who underwent hysterectomy, 79 patients (70.5%) had TH and 33 (29.5%) had SCH. There were nine (3.9%) mesh exposures attributed to RSCP. The difference between the RSCP + hysterectomy group and the RSCP-only group was 2.7% versus 5.1% (P = 0.50). The 2.7% of mesh exposures in the hysterectomy group were associated with TH and none with SCH, but this difference was not significant (P = 0.55). CONCLUSIONS: Although mesh exposure with RSCP is low, serious morbidity can be associated with mesh use and appropriate preoperative counseling is critical.

Overlapping sphincteroplasty and posterior repair.

INTRODUCTION AND HYPOTHESIS: Knowledge of how to anatomically reconstruct extensive posterior-compartment defects is variable among gynecologists. The objective of this video is to demonstrate an effective technique of overlapping sphincteroplasty and posterior repair. METHODS: In this video, a scripted storyboard was constructed that outlines the key surgical steps of a comprehensive posterior compartment repair: (1) surgical incision that permits access to posterior compartment and perineal body, (2) dissection of the rectovaginal space up to the level of the cervix, (3) plication of the rectovaginal muscularis, (4) repair of internal and external anal sphincters, and (5) reconstruction of the perineal body. Using a combination of graphic illustrations and live video footage, tips on repair are highlighted. RESULTS: The goals at the end of repair are to: (1) have improved vaginal caliber, (2) increase rectal tone along the entire posterior vaginal wall, (3) have the posterior vaginal wall at a perpendicular plane to the perineal body, (4) reform the hymenal ring, and (5) not have an overly elongated perineal body. CONCLUSION: This video provides a step-by-step guide on how to perform an overlapping sphincteroplasty and posterior repair.

Randomized trial of a web-based tool for prolapse: impact on patient understanding and provider counseling.

INTRODUCTION AND HYPOTHESIS: Effective patient/provider communication is important to ensure patient understanding, safety, and satisfaction. Our hypothesis was that interactive patient/provider counseling using a web-based tool (iPad application) would have a greater impact on patient satisfaction with understanding prolapse symptoms compared with standard counseling (SC). METHODS: Women with complaints of seeing/sensing a vaginal bulge were enrolled in this randomized controlled trial. Participants completed pre- and postvisit Likert scale questionnaires on satisfaction with prolapse knowledge and related anxiety. After new patient histories and physical examinations, study participants were randomized to SC or SC with iPad. Ninety participants were required to detect a 30% difference in satisfaction with prolapse knowledge between the two groups. RESULTS: Ninety women were randomized to SC (n = 44) or SC with iPad (n = 46). At baseline, 47% of women were satisfied with their understanding of bulge symptoms (50% SC vs. 43.5% SC with iPad, p = 0.5). After counseling, 97% of women reported increased satisfaction with understanding of bulge symptoms (p < 0.0001), with no difference between groups [42/44 (95.5%) SC vs. 45/46 (97.8%) SC with iPad, p = 0.5]. Baseline anxiety was high: 70% (65.9% SC vs. 73.9% SC with iPad, p = 0.4). After counseling, anxiety decreased to 30% (p < 0.0001), with improvement in both groups (31.8% SC vs. 28.3% SC with iPad™, p = 0.7). Counseling times were similar between groups (9.5 min., SC vs. 8.9 min., SC with iPad, p = 0.4). CONCLUSIONS: Interactive counseling was associated with increased patient satisfaction with understanding bulge symptoms and decreased anxiety whether a web-based tool was used or not.

Venous thromboembolism in women undergoing pelvic reconstructive surgery with mechanical prophylaxis alone.

INTRODUCTION AND HYPOTHESIS: The objective of this study was determine the frequency of symptomatic perioperative venous thromboembolism (VTE) and risk factor(s) associated with VTE occurrence in women undergoing elective pelvic reconstructive surgery using only intermittent pneumatic compression (IPC) for VTE prophylaxis. METHODS: A multi-center case-cohort retrospective review was conducted at six clinical sites over a 66-month period. All sites utilize IPC as standard VTE prophylaxis for urogynecological surgery. VTE cases occurring during the same hospitalization and up to 6 weeks postoperatively were identified by ICD9 code query. Four controls were temporally matched to each case. Information collected included demographics, medical history, route of surgery, operative time, and intraoperative characteristics. Univariate and multivariate backward stepwise logistic regression analyses were performed to identify potential risk factors for VTE. RESULTS: Symptomatic perioperative VTE was diagnosed in 27 subjects from a cohort of 10,627 women who underwent elective urogynecological surgery (0.25 %). Univariate analysis identified surgical route (laparotomy vs others), type of surgery ("major" vs "minor"), history of gynecological cancer, surgery time, and patient age as risk factors for VTE (P < 0.05). Multivariate analysis identified increased frequency of VTE with laparotomy, age ≥ 70, and surgery duration ≥ 5 h. CONCLUSIONS: In our study cohort, the frequency of symptomatic perioperative VTE was low. Laparotomy, age ≥ 70 years, and surgery duration ≥ 5 h were associated with VTE occurrence.

Surgical privileging in gynecology: a Fellows' Pelvic Research Network study.

OBJECTIVES: This study aimed to describe the criteria used by US hospitals to grant surgical privileges for select gynecologic procedures and to compare the privileging processes between university-based and community-based hospitals. METHODS: We conducted a cross-sectional study from January 2011 to December 2012 that included institutions represented by Fellows' Pelvic Research Network members. A 5-page, anonymous survey was distributed to hospitals to determine the hospital criteria used for initial surgical privileges and for renewal of privileges for 13 gynecologic procedures. Information on training requirements, minimum number of supervised cases, and annual case number needed for maintenance was obtained. Criteria for privileging were described and compared between university-based and community-based hospitals. RESULTS: Of the 25 institutions that completed the surveys, 56% were university-based and 44% were community-based. Community hospitals differed significantly from university institutions with a larger portion of community hospitals requiring preceptorship for laparoscopic hysterectomy (70% vs 15%, P = 0.027), robotic hysterectomy (90% vs 25%, P = 0.012), robotic sacrocolpopexy (90% vs 20%, P = 0.009), and sacral neuromodulation (67% vs 0%, P = 0.004). CONCLUSIONS: Considerable variability exists in the criteria used by US hospitals for surgical privileging in gynecology. When compared to university centers, a higher proportion of community hospitals required preceptorship for minimally invasive hysterectomy, robotic sacrocolpopexy, and sacral neuromodulation.

Estimating the early impact of the FDA safety communication on the use of surgical mesh.

OBJECTIVES: To estimate the early impact of the July 2011 Food and Drug Administration Safety Communication on the practice patterns of gynecologic surgeons using surgical mesh to manage pelvic organ prolapse (POP) and stress urinary incontinence (SUI). METHODS: A cross-sectional study was performed by administering a mesh usage questionnaire to physician attendees at the opening session of the American Association of Gynecologic Laparoscopists Global Congress of Minimally Invasive Gynecology in November 2011. RESULTS: Of the 827 physicians attending the opening session of the conference, 281 (34%) completed the questionnaire, 202 (72%) of whom reported performing surgery for POP and/or SUI. The respondents were attending physicians (83.4%) with at least 10 years of experience (65.7%), 136 (71.1%) identifying themselves as General Gynecology, 29 (17.3%) as Urogynecology, 13 (7.1%) as Minimally Invasive Gynecologic Surgery, and 3 (1.8%) as Urology. When compared with generalists, specialists were more likely to use mesh for abdominal (86% vs 56.3%, P < 0.001) and vaginal (65.9% vs 37.2%, P = 0.001) POP repair. Specialists reported using mesh for the anterior compartment (50% vs 28.3%, P = 0.01) and the posterior compartment (36.4% vs 12.5%, P = 0.001), and total vaginal mesh kits (13.6% vs 1.7%, P = 0.005). Respondents reported an increase in mesh use for primary abdominal POP repair (82 vs 92, P = 0.013) and a decrease in mesh use for recurrent vaginal POP repair (99 vs 75, P < 0.001), with more surgeons opting against mesh for recurrent POP (49 vs 74, P < 0.001). For patient counseling, 53.7% reported changing their methods. CONCLUSIONS: In a self-selected sample of pelvic surgeons, we noted that the 2011 FDA Safety Communication had an impact, with changes in mesh usage and counseling patterns.

Outlet constipation 1 year after robotic sacrocolpopexy with and without concomitant posterior repair.

OBJECTIVES: The aim of this study was to estimate the rate of outlet constipation at 1 year after robotic sacrocolpopexy (RSCP) with and without a concomitant distal posterior repair (PR). We sought, first, to determine the rate of persistent outlet constipation and second, to determine de novo outlet constipation. METHODS: This was a cohort study of women who underwent RSCP alone versus RSCP + PR, at each surgeon's discretion, between November 2007 and February 2011 at an academic center. Specific questions in the Pelvic Floor Distress Inventory Short Form correlating to outlet constipation and its colorectal-anal subscale scores were compared between and within groups. Rates of posterior compartment reoperation were assessed. RESULTS: Of the 77 women who underwent RSCP, 21 (27%) had a concomitant distal PR. Overall, there was significant improvement in pelvic floor function and quality of life at 1 year after surgery (P = 0.01). Preoperatively, outlet constipation was present in 63.4% of those who underwent RSCP only and in 53.3% of those with concomitant PR. Postoperatively at 1 year, 56% of preoperative outlet constipation resolved and 44% persisted (P = 0.001), with no differences between groups (RSCP vs RSCP + PR). The rate of postoperative de novo outlet constipation was 13.6%. At 1 year after RSCP, 18.2% of patients had symptomatic posterior prolapse, with no difference between both groups (P = 0.746). Overall, 11.7% underwent a subsequent PR, none of whom underwent PR with the initial RSCP (P = 0.104). CONCLUSIONS: At 1 year after RSCP, there was a high rate of persistent outlet constipation and a moderate rate of de novo outlet constipation. Concomitant PR did not significantly affect these bowel symptoms.

Trainee performance at robotic console and benchmark operative times.

INTRODUCTION AND HYPOTHESIS: It is an ongoing challenge to maintain surgical efficiency while integrating trainee participation. We hypothesize that a program of graduated surgical responsibility for trainees does not hinder operative efficiency. METHODS: This was a retrospective cohort study of trainee performance times, collected prospectively in real time, for robotic cases performed at one university hospital between September 2008 and August 2011. The primary aim was to compare overall operative times between cases performed by trainees versus attendings. Secondary aims were to compare operative times for major portions of each operation by level of training and to establish benchmark operative times for trainees. RESULTS: During the study period, 98 cases had recorded trainee performance times. Total robot docked time was longer for trainees than for attendings (155 vs 132 min, p = 0.011), but mean performance times for hysterectomy (70 vs 59 min, p = 0.096) and sacrocolpopexy (76 vs 79 min, p = 0.545) were similar. Within the trainees, there was no correlation between surgical time and rank for each step of the procedures. Utilizing mean performance times for all trainees, benchmark operative times were established for each step of hysterectomy in minutes: right side (21), left side (21), bladder flap (10), colpotomy (15), and cuff closure (19); similarly, for sacrocolpopexy: sacral and peritoneal dissection (12), anterior cuff dissection (10), posterior cuff dissection (8), anterior mesh attachment (15), posterior mesh attachment (18), sacral mesh attachment (12), and peritoneal closure (9). CONCLUSION: In a program of graduated surgical responsibility, robotic operative efficiency was comparable when trainees were involved as console surgeons.

Evaluation of pelvic floor symptoms and sexual function in primiparous women who underwent operative vaginal delivery versus cesarean delivery for second-stage arrest.

OBJECTIVES: This study aimed to compare the prevalence and severity of pelvic floor symptoms and sexual function at 1 year postpartum in women who underwent either operative vaginal delivery (OVD) or cesarean delivery (CD) for second-stage arrest. METHODS: In this cohort study, women with second-stage arrest in their first pregnancy who delivered between January 2009 and May 2011 at 2 different institutions were identified by an obstetric database using International Classification of Diseases, Ninth Revision, codes. Validated questionnaires evaluating pelvic floor symptoms and sexual function were administered. Subjects were dichotomized into those who underwent an OVD or a CD. Additional analyses by intent-to-treat and stratification of vacuum versus forceps operative deliveries were performed. RESULTS: Of the 109 women who completed the 1-year postpartum symptom questionnaires, 53 (48.6%) had a successful OVD, 20 (18.3%) failed OVD and underwent CD, and 36 (33%) underwent CD only. There were no differences between those who had a successful OVD and those who underwent a CD in either pelvic floor function or sexual function, but bulge symptoms were more common in the OVD group (7.5% vs 0, P = 0.05). When analyzed by intent-to-treat (planned OVD vs planned CD), pelvic floor symptoms remained similar between groups. However, those in the planned CD group reported higher orgasm and overall sexual satisfaction scores. CONCLUSIONS: In this sample of primiparous women with second-stage arrest, mode of delivery did not significantly impact pelvic floor function 1 year after delivery, except for bulge symptoms in the OVD group and sexual satisfaction in the planned CD group.

Obstetric sphincter injury interacts with diarrhea and urgency to increase the risk of fecal incontinence in women with irritable bowel syndrome.

OBJECTIVES: This study aimed to confirm that fecal urgency and diarrhea are independent risk factors for fecal incontinence (FI), to identify obstetrical risk factors associated with FI in women with irritable bowel syndrome, and to determine whether obstetric anal sphincter injuries interact with diarrhea or urgency to explain the occurrence of FI. METHODS: The study is a supplement to a diary study of bowel symptoms in 164 female patients with irritable bowel syndrome. Subjects completed daily bowel symptom diaries for 90 consecutive days and rated each bowel movement for stool consistency and presence of urgency, pain, and FI. All female participants from the parent study were invited to complete a telephone-administered 33-item bowel symptom and obstetric history questionnaire, which included the fecal incontinence severity index. RESULTS: Of the 164 women in the parent study, 115 (70.1%) completed the interview. Seventy-four (45.1%) reported FI on their diary including 34 (29.6%) who reported at least 1 episode per month, 112 (97.4%) reported episodes of urgency, and 106 (92.2%) reported episodes of diarrhea. The mean fecal incontinence severity index score was 13.9 (9.7). On multivariable analysis, FI was significantly associated with parity (P = 0.007), operative abdominal delivery (P = 0.049), obstetrical sphincter lacerations (P = 0.007), fecal urgency (P = 0.005), diarrhea (P = 0.008), and hysterectomy (P = 0.004), but was not associated with episiotomy, pelvic organ prolapse, or urinary incontinence. The synergistic interactions of obstetric anal sphincter laceration with urgency (P = 0.002) and diarrhea (P = 0.004) were significant risk factors for FI. CONCLUSIONS: Fecal urgency and diarrhea are independent risk factors for FI, and they interact with obstetric anal sphincter laceration to amplify the risk of FI.

Effect of anticholinergic use for the treatment of overactive bladder on cognitive function in postmenopausal women.

BACKGROUND: Overactive bladder (OAB) is a common condition affecting the elderly. The mainstay of treatment for OAB is medical therapy with anticholinergics. However, adverse events have been reported with this class of drugs, including cognitive changes. OBJECTIVE: The objective of this study was to investigate the effect of an anticholinergic medication, trospium chloride, on cognitive function in postmenopausal women being treated for OAB. METHODS: This was a prospective cohort study conducted at a urogynaecology clinic at one academic medical centre from January to December 2010, with 12-week follow-up after medication initiation. Women aged 55 years or older seeking treatment for OAB and opting for anticholinergic therapy were recruited. Baseline cognitive function was assessed via the Hopkins Verbal Learning Test-Revised Form (HVLT-R) [and its five subscales], the Orientation, Memory & Concentration (OMC) short form, and the Mini-Cog evaluation. After initiation of trospium chloride extended release, cognitive function was reassessed at Day 1, Week 1, Week 4 and Week 12. Bladder function was assessed via three condition-specific quality-of-life questionnaires. Secondary outcomes included change in bladder symptoms, correlation between cognitive and bladder symptoms, and overall medication compliance. The main outcome measure was change in HVLT-R score at Week 4 after medication initiation, compared with baseline (pre-medication) score. RESULTS: Of 50 women enrolled, 35 completed the assessment. The average age was 70.4 years and 77.1% had previously taken anticholinergic medication for OAB. At enrollment 65.7% had severe overactive bladder and 71.4% had severe urge incontinence. Cognitive function showed an initial decline on Day 1 in HVLT-R total score (p = 0.037), HVLT-R Delayed Recognition subscale (p = 0.011) and HVLT-R Recognition Bias subscale (p = 0.01). At Week 1 the HVLT-R Learning subscale declined from baseline (p = 0.029). All HVLT-R scores normalized by Week 4. OMC remained stable throughout. The Mini-Cog nadired at a 90.9% pass rate at Week 4. OAB symptoms did not improve until Week 4, based on questionnaire scores (p < 0.05). CONCLUSION: Cognitive function exhibited early changes after initiation of trospium chloride but normalized within 4 weeks. Cognitive changes occurred weeks prior to OAB symptom improvement. Surveillance for cognitive changes with anticholinergic use should be part of OAB management.

Diagnostic accuracy of visual urethral mobility exam versus Q-Tip test: a randomized crossover trial.

OBJECTIVE: The objective of the study was to compare the diagnostic accuracy of a visual urethral mobility examination (VUME) with a Q-Tip test in the assessment of urethral hypermobility. STUDY DESIGN: Subjects were randomized to a VUME or Q-Tip test first, followed by the alternate assessment. Outcomes included hypermobile, not hypermobile, or indeterminate. Hypermobility was defined as 30° or greater from the horizontal. Pain perception and test preference were assessed. RESULTS: For the 54 subjects, 61.1% demonstrated hypermobility on VUME vs 72.2% on the Q-Tip test (P = .39). Assessment of hypermobility was correlated between the 2 tools (ρ = 0.47, P = .001). Positive and negative predictive value, sensitivity, and specificity for VUME were 88%, 56%, 78%, and 71%, respectively, with a Q-Tip test as the reference standard. Mean pain score on visual analog scale was 0.72 for VUME and 3.15 for Q-tip test (P < .001). VUME was preferred by 83% of subjects. CONCLUSION: VUME is a diagnostic alternative to the Q-Tip test for the assessment of urethral hypermobility and is preferred by subjects.