Roxana Geoffrion

Technical Update on Pessary Use

OBJECTIVE To review the use, care, and fitting of pessaries. OPTIONS Pessaries are an option for women presenting with prolapse and/or urinary incontinence. OUTCOMES Pessaries can be successfully fitted in the majority of women with excellent satisfaction rates and minimal complications. EVIDENCE PubMed and Medline were searched for articles published in English to September 2010, using the key words pessary, prolapse, incontinence, fitting, and complications. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis, and articles were incorporated in the guideline to May 2012. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES The quality of evidence was rated with use of the criteria described by the Canadian Task Force on Preventive Health Care. Recommendations for practice were ranked according to the method described by the Task Force (Table 1). BENEFITS, HARMS, AND COSTS Women may choose a pessary for management of their prolapse and/or stress incontinence rather than opt for surgery. Major complications have been seen only with neglected pessaries. Minor complications such as vaginal discharge, odour, and erosions can usually be successfully treated. SUMMARY STATEMENTS AND RECOMMENDATION: Summary Statements 1. Most women can be successfully fitted with a pessary when they present with prolapse. (II-2) 2. Complications of pessary use are usually minor, and vaginal discharge is the most common complaint. (II-3) 3. Vaginal erosions can be treated with removal of the pessary and optional vaginal estrogen supplementation. (II-2) 4. Satisfaction rates with pessary use are very high. (II-2) Recommendation 1. Pessaries should be considered in all women presenting with symptomatic prolapse and/or urinary stress incontinence. (II-1A).

Treatments for Overactive Bladder: Focus on Pharmacotherapy

OBJECTIVE To provide guidelines for pharmacotherapy to treat overactive bladder syndrome (OAB). OPTIONS Pharmacotherapy for OAB includes anticholinergic (antimuscarinic) drugs and vaginal estrogen. Both oral and transdermal anticholinergic preparations are available. OUTCOMES To provide understanding of current available evidence concerning safety and clinical efficacy of pharmacotherapy for OAB; to guide selection of anticholinergic therapy based on individual patient characteristics. EVIDENCE The Cochrane Library and Medline were searched for articles published from 1950 to the present related to individual anticholinergic drugs. Review articles on management of refractory OAB were also examined. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to 2010. VALUES The quality of evidence is rated and recommendations are made using the criteria described by the Canadian Task Force on Preventive Health Care (Table 1). BENEFITS, HARMS, AND COSTS Anticholinergics are the mainstay of pharmacotherapy for OAB. EVIDENCE for their efficacy is mostly derived from short-term phase III randomized drug trials. Placebo response is strong, and long-term follow-up and patient subjective outcome data are lacking. Care providers need to be well acquainted with the side effects of anticholinergics and select therapy based on individual patient parameters. Recommendations 1. Behavioural management protocols and functional electrical stimulation should be offered in the spectrum of effective primary treatments for overactive bladder syndrome. (I-A) 2. Oral oxybutynin, immediate and extended release, as well as transdermal oxybutynin, may be offered as treatment for overactive bladder syndrome, as they are associated with significant objective clinical improvement at 12 weeks. (I-A) Oxybutynin immediate release has superior cost-effectiveness but more side effects than other anticholinergics. (I-A) Adverse events associated with transdermal oxybutynin are fewer than with oral oxybutynin. (I-A) 3. Tolterodine, immediate and extended release, may be offered as treatment for overactive bladder syndrome, as it is associated with significant objective clinical improvement at 12 weeks. (I-A) 4. Trospium, immediate and extended release, may be offered as treatment for overactive bladder syndrome as it is associated with significant clinical improvement at 12 weeks. (I-A) Trospium is an adequate anticholinergic choice for overactive bladder syndrome patients with pre-existing cognitive impairment (II-B) and for overactive bladder syndrome patients taking concurrent CYP450 inhibitors. (III-B) 5. Solifenacin may be offered as treatment for overactive bladder syndrome, as it is associated with significant objective clinical improvement at 12 weeks. (I-A) Solifenacin may be an adequate anticholinergic choice for elderly overactive bladder syndrome patients or patients with pre-existing cognitive dysfunction. (I-B) 6. Darifenacin may be offered as treatment for overactive bladder syndrome, as it is associated with significant objective clinical improvement at 12 weeks. (I-A) Darifenacin is an adequate anticholinergic choice for overactive bladder syndrome patients with pre-existing cardiac concerns or cognitive dysfunction. (I-B) 7. Overactive bladder syndrome patients should be offered a choice between bladder training, functional electric stimulation, and anticholinergic therapy, as there is no difference in cure rates. Combination therapy does not have a clear advantage over one therapy alone. (I-A) 8. The choice of anticholinergic therapy should be guided by individual patient comorbidities, as objective efficacy of anticholinergic drugs is similar. (I-A) Dose escalation does not improve objective parameters and causes more anticholinergic adverse effects. It is, however, associated with improved subjective outcomes. (I-A) To decrease side effects, switching to a lower dose or using an extended release formulation or a transdermal delivery mechanism should be considered. (I-A) 9. Education on treatment efficacy, realistic expectations, and length of treatment should be offered to patients upon initiation of anticholinergic therapy, as continuation rates for anticholinergic therapy are low. (III-B) 10. Oral or transdermal estrogen supplementation should not be recommended for treatment of overactive bladder syndrome as its effects are comparable to placebo. (I-E) Vaginal estrogen can be suggested for subjective improvements in overactive bladder syndrome symptoms. (III-B) 11. Intravesical botulinum toxin injection and sacral nerve and posterior tibial nerve stimulation are clinically effective options for patients with overactive bladder syndrome unresponsive to conservative options, anticholinergics, or vaginal estrogen. (I-A).

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1‐year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35–80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2–4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ –TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention‐to‐treat analysis was used with logistic regression adjusting for baseline differences. RESULTS: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One‐year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1‐year cure rates and high satisfaction.

Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair

OBJECTIVE To review the evidence relating to obstetrical anal sphincter injuries (OASIS) with respect to diagnosis, repair techniques and outcomes. To formulate recommendations as to patient counselling regarding route of delivery for subsequent pregnancy after OASIS. OPTIONS Obstetrical care providers caring for women with OASIS have the option of repairing the anal sphincter using end-to-end or overlapping techniques. They may also be involved in counselling women with prior OASIS regarding the route of delivery for future pregnancies. OUTCOMES The outcome measured is anal continence following primary OASIS repair and after subsequent childbirth. EVIDENCE Published literature was retrieved through searches of Medline, EMBASE, and The Cochrane Library in May 2011 using appropriate controlled vocabulary (e.g., anal canal, obstetrics, obstetric labour complication, pregnancy complication, treatment outcome, surgery, quality of life) and key words (obstetrical anal sphincter injur*, anus sphincter, anus injury, delivery, obstetrical care, surgery, suturing method, overlap, end-to-end, feces incontinence). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to September 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). BENEFITS, HARMS, AND COSTS Benefits from implementation of these guidelines include: improved diagnosis of OASIS, optimal functional outcomes following repair, and evidence-based counselling of women for future childbirth.

Training Surgical Residents: The Current Canadian Perspective

BACKGROUND Numerous constraints may limit the practical experience of surgical residents. Current research supports a need for structured curricula, skills acquisition, and feedback outside the operating room (OR) and formal assessment of technical skills. We examined the current state of surgical skill teaching and evaluation for Canadian residents across surgical specialties. METHODS One hundred twenty-three surveys were mailed to surgical residency program directors of all 17 Canadian medical schools. Nine surgical specialties were identified. Program demographics, details of surgical skill teaching methods, and several surgical skill assessment modalities used from admission to graduation were surveyed. Obstetrics and Gynecology (ObGyn) survey results were compared with other surgical specialties. RESULTS Seventy surveys (57%) from 15 medical schools (88%) were returned. All specialties were represented in responses. ObGyn residents had fewer surgical training months per year than other residents (4.9 versus 8.5 months; p = 0.001). The most common teaching method was didactic lectures (86%; 95% confidence interval [CI], 75%-93%) for all programs. Inanimate and/or animate skills laboratories and didactic lectures were equally used by 90% (95% CI, 55%-100%) of ObGyn programs. Virtual reality simulators for procedure-specific surgical skills ranked low at 30% (95% CI, 7%-65%) use in ObGyn programs. Most programs had a dedicated space to teach and practice skills outside the OR. Assessment, feedback, and determination of surgical competence were most commonly performed via subjective evaluation by surgical mentors. Forty percent of ObGyn programs versus 76% of other programs used a local program-specific surgical training curriculum (p = 0.054). Most program directors who did not have access to a standard training curriculum wished to have one implemented. CONCLUSIONS Lectures and subjective evaluations are the most common educational tools in Canadian surgical residencies. Despite the availability of validated surgical teaching and evaluation tools remote from the OR, standard training curricula are not the norm in Canadian ObGyn residency programs.

Clinical characteristics associated with unsuccessful pessary fitting outcomes.

Objectives To identify clinical characteristics and quality of life/symptom questionnaire scores associated with unsuccessful vaginal pessary trials in the treatment of pelvic organ prolapse (POP). Methods This was a retrospective study of pessary fittings between 2006 and 2012 at our tertiary care urogynecology unit. One hundred one patients with symptomatic POP filled out detailed history and validated pelvic floor quality-of-life and symptom questionnaires at baseline. They were examined and POP was staged. After discussion of treatment options, they agreed to attempt a trial of pessary (TOP). Unsuccessful TOP was defined as an inability to continue pessary use beyond 4 weeks from initial fitting. Stepwise logistic regression analysis was performed to build a prediction model for the odds of unsuccessful TOP. Results The main reason for unsuccessful TOP was patient discomfort. Multivariate stepwise logistic regression showed that age 65 or younger (odds ratio [OR], 3.13; P = 0.042), smoking history (OR, 3.42; P = 0.049), genital hiatus/total vaginal length ratio greater than 0.8 (OR, 6.70; P = 0.042), and lower POP Quantification overall stage (OR, 2.84; P = 0.017) were associated with increased likelihood of unsuccessful TOP. Other variables such as sexual activity and concurrent urinary or POP symptoms did not affect the outcome. Conclusions Several clinical characteristics influenced the likelihood of unsuccessful TOP. These may be taken into account for clinical counseling. Pessaries remain a good treatment option, as many clinical variables did not seem to influence the success of fittings.

Abdominal sacral hysteropexy: a pilot study comparing sacral hysteropexy to sacral colpopexy with hysterectomy.

Objectives Treatment of pelvic prolapse with uterine conservation using the sacral hysteropexy may be associated with less patient morbidity but has uncertain subjective and objective outcomes. We sought to compare abdominal sacral hysteropexy (ASH) with sacral colpopexy/total abdominal hysterectomy (ASC/TAH). Methods This is an ambispective (retrospective/prospective) cohort pilot study comparing ASH to ASC/TAH. The primary outcome was global impression of improvement. Secondary outcomes were based on validated quality-of-life questionnaires and surgical complications. Results Eighteen ASHs were compared to 9 ASC/TAHs after a mean follow-up of 19 months. Whereas subjective outcomes did not differ, anterior failure (55%) and subsequent uterine pathology (22%) were higher in the ASH cohort. Graft erosion occurred in 33% of the ASC/TAH group. Conclusions The ASH offers advantages and disadvantages that warrant further investigation with a prospective study.

Does bilateral sacrospinous fixation with synthetic mesh recreate nulliparous pelvic anatomy? An MRI evaluation.

Objectives The aim of this study was to determine whether the bilateral sacrospinous vault fixation (BSSVF) with synthetic, polypropylene mesh arms restores the nulliparous anatomic relationships of the vaginal vault in women with and without uterus using magnetic resonance imaging (MRI). Methods This was a prospective case series of women with symptomatic pelvic organ prolapse (POP) who, after BSSVF, underwent a pelvic MRI (1–13 months postoperatively). Postsurgical pelvic distances were measured from MRI scans and compared with measurements from a group of 11 nulliparous women with adequate pelvic support who underwent MRI in a previous study. Our primary outcome measure was the difference in average distance from the vault to the ischial spine among women after BSSVF when compared with the average nulliparous distances. The secondary outcome measures were the difference in average distance from the posterior fornix to the sacrum and the change in apical POP quantification parameters 6 weeks after surgery. Results Ten women underwent MRI post-BSSVF—4 women with and 6 women without uterine preservation. In the BSSVF group, similar to the nulliparous group measurements, the average distance between the vaginal apex and the spine was 5.2 cm (SD, 0.8) (95% confidence interval, −0.6 to 0.5; P = 0.92). There was an anterior-inferior displacement of the line between the vaginal apex and the sacrum in women who underwent BSSVF. The posterior fornix was 7.4 cm (SD, 1.2) from the second sacral vertebra versus 5.6 cm (SD, 1.5) in women without POP (P < 0.01). Adequate clinical resolution of apical prolapse was confirmed in all women 6 weeks post-BSSVF. Conclusions The BSSVF with synthetic mesh restores the anatomy between the vagina and the ischial spines. Clinical studies are underway to compare BSSVF with standard techniques of vaginal vault prolapse repair.

Vaginal paravaginal repair with porcine small intestine submucosa: midterm outcomes.

Objective: This study aimed to determine the midterm efficacy of porcine small intestine submucosa for paravaginal repairs of anterior vaginal prolapse. Methods: One hundred five women underwent repairs between 2003 and 2006 and met our inclusion criteria. Women were invited to return for a pelvic examination and to fill out validated questionnaires. Objective failure was defined as anterior prolapse recurrence at or beyond the hymen. Results: Fifty-nine women (56%) were available for follow-up. Median age of patients was 60 years (range, 26-80 years) and 83% had a parity of 2 or more. Ninety-seven percent of patients had a preoperative prolapse stage of 2 or more. Follow-up ranged from 1 to 5 years (median, 27.5 months; interquartile range, 14.5). The most common postoperative complication was transient voiding dysfunction (23.7%). Objective cure rate was 68.8%. A positive change in bladder, vaginal, and bowel symptoms (a little better, much better, or very much better) was reported by 69.5%, 59.3%, and 25.5% of women, respectively. Thirty-one women (52.5%) were sexually active at postoperative follow-up. Only 4 women (6.8%) were not sexually active because of pelvic symptoms. Dyspareunia was reported by 8.3% of the 48 women who returned for a clinic follow-up. Twenty-four women (40.7%) were not sexually active postoperatively, for reasons unrelated to their surgeries. Conclusions: Vaginal paravaginal repair using porcine xenograft is a safe procedure whose long-term efficacy needs further evaluation through prospective trials.

Bilateral Sacrospinous Vault Fixation With Tailored Synthetic Mesh Arms: Clinical Outcomes at One Year

OBJECTIVES Bilateral sacrospinous fixation with tailored mesh arms (bSSVF) uses polypropylene mesh to suspend the vault to the sacrospinous ligaments bilaterally with minimal tension, recreating nulliparous midline anatomy. It can be used with uterine conservation. Our primary objective was to determine objective cure rate at one year following bSSVF compared with a control group undergoing abdominal sacrocolpopexy (ASC). Secondary objectives were to compare symptoms, quality of life, sexual function, pain, and global satisfaction before and after surgery and between bSSVF and ASC groups at one year. METHODS This prospective cohort study enrolled patients with symptomatic prolapse who chose to undergo bSSVF or ASC. Baseline demographics were obtained. Prolapse quantification, validated symptom questionnaire scores, and McGill pain scores were obtained at baseline, six weeks, and one-year postoperatively. Global satisfaction was recorded. The primary outcome measure was the difference in cure rate (vault stage ≤ 1) between groups. RESULTS Fifty patients were recruited: 30 underwent bSSVF and 17 ASC. Forty-three patients were available for one-year follow-up. Baseline data were similar. There was no difference in vault stage between bSSVF and ASC groups at one year. Five women who underwent bSSVF had cervical elongation, and four of these were classified as POP recurrence. Women who underwent bSSVF had more anterior recurrences but fewer postoperative complications, shorter hospital stay, and less use of narcotics than controls. Questionnaire scores were similar at one year. All respondents felt subjective improvement after either surgical procedure. CONCLUSIONS Objective and subjective cure rates are comparable after bSSVF and ASC. Hysteropexy may cause cervical elongation that merits further research.