Comparing Single-Incision Midurethral Sling with Bulking Agents for Female Stress Urinary Incontinence: Rationale for a Non-Randomized Controlled Trial.

OBJECTIVES: Midurethral slings are considered the gold standard for the surgical treatment of stress urinary incontinence (SUI), with an efficacy up to 80%. Another therapeutic option is the use of bulking agents, which create an artificial mass in the urethral submucosa, with an efficacy varying from 64% to 74%. Although bulking agents have a lower risk of complications than midurethral sling surgery, they are mainly used in case a midurethral sling is not an option or if midurethral sling surgery failed to cure stress urinary incontinence. In this study, we offer all patients with SUI in secondary care a choice between a single-incision midurethral sling procedure and treatment with a bulking agent. We want to examine patient preference and patient satisfaction for both procedures. We expect that offering both interventions in combination with standardized counselling will result in high patient satisfaction. DESIGN: In this non-randomized controlled trial, 266 patients will be objectively counselled for both interventions, after which all patients will choose between single-incision midurethral slings and polyacrylamide hydrogel (PAHG), followed by the standard care procedure for women with SUI. PARTICIPANTS/MATERIALS, SETTING, METHODS: From January 1, 2021, onward, all consecutive adult patients (between 18 and 80 years of age) attending the outpatient gynaecology department with objectively confirmed, moderate to severe SUI will be eligible for enrolment in this non-randomized study. The primary outcome is patient satisfaction at 1 year, measured by the Patient Global Impression of Improvement; secondary outcomes are patient satisfaction at 3 months, objective and subjective cure at 3 months and 1 year, adverse events, post-operative pain, and cost-effectiveness. Differences in outcome measures will be assessed through logistic and linear regression analyses, both unadjusted and adjusted with covariate adjustment using the propensity score. RESULTS: No results are available yet. LIMITATIONS: The major disadvantage of this study design is the potential confounding bias. We intend to eliminate this bias by applying propensity scoring. CONCLUSION: By designing a non-randomized patient preference trial, we not only expect to demonstrate high patient satisfaction with both interventions but also provide insight into the possible role of PAHG-injections in the treatment of female SUI as a first-choice non-conservative treatment.

Evaluation of the long-term effect and complication rate of single-incision slings for female stress urinary incontinence.

OBJECTIVE: To evaluate the long-term outcomes of single-incision midurethral slings (SIMS) in real-life practice. STUDY DESIGN: This retrospective, single-arm, patient cohort study was performed in a large Dutch teaching hospital, including 397 consecutive women who underwent a SIMS-procedure between 2009 and 2018. Data were obtained through questionnaires and patient record study. Subjective improvement was the primary outcome, defined as a Patient Global Impression of Improvement (PGI-I) of '(very) much better'. Secondary outcomes were subjective cure rate (defined as a negative Urogenital Distress Inventory - item 4 'Do you experience involuntary urine leakage related to physical activity, coughing or sneezing?'), complication rate and sling failure (defined as the need for additional research or treatment for persisting stress urinary incontinence (SUI)). All data was analysed with a statistical significance level of 5%. RESULTS: The mean follow-up time was 54 months. All patients received SIMS (Ajust® or Altis®). Of all respondents, 75% reported a (very) much improved burden of disease. The subjective cure rate was 61%. In 93 patients a total of 120 complications were registered. In 10% of patients a sling failure was observed, 76% of these failures appeared in the first two years post-surgery. CONCLUSION: This study showed that, in real life practice, SIMS are both effective and safe over a long period of time.

A prospective observational cohort study of the Ajust® single incision sling performed under conscious sedation with local infiltration.

AIMS: To evaluate the adjustable single-incision sling (Ajust®) in the treatment of stress urinary incontinence (SUI), when placed under conscious sedation with local infiltration, using the cough test during surgery. METHODS: In this multicenter observational study, 90 women who had moderate to severe SUI, were asked to have the Ajust® procedure performed under sedation with local infiltration with levobupivacain. This allowed for a perioperative cough test to adjust the sling to the urethra till continence was reached. The primary outcome of the study was subjective cure of stress incontinence at 1 year follow up. Secondary objectives were objective and subjective improvement, complications during and after the procedure, and postoperative pain scores. These results were compared with the results of a historical control group of 96 patients who received their Ajust® under general or regional (spinal) anesthesia. RESULTS: At 6 weeks and 12 months, there were no statistical significant differences in the results for subjective cure (83.6% and 71.6% sedation group, 88.4% and 77.2% general/regional anesthesia group), objective cure (96% and 86.9% sedation group, 88.1% and 91.8% general/regional anesthesia group), de novo urgency (10.5% and 6.7% sedation group, 7.1% and 24.1% general/regional anesthesia group) and the patients global impression of improvement (96% and 89.2% sedation group, 91.4% and 84.4% general/regional anesthesia group). CONCLUSION: The performance of a cough test during the placement of an adjustable single-incision sling for the treatment of SUI does not affect the functional outcome, and is therefore not necessary.

Practice pattern variation in surgical management of pelvic organ prolapse and urinary incontinence in The Netherlands.

INTRODUCTION: Practice pattern variation (PPV) is the difference in care that cannot be explained by the underlying medical condition. The aim of this study was to describe PPV among Dutch gynecologists regarding treatment of pelvic organ prolapse (POP) and urinary incontinence (UI). MATERIALS AND METHODS: PPV was calculated from data of healthcare declaration codes of 2010. Data were provided by Vektis and Kiwa Carity. PPV for POP and UI in general was calculated per hospital and per region. Furthermore, PPV for transvaginal mesh and surgical treatment of uterine descent was assessed. RESULTS: PPV of surgical treatment for POP and UI in general was assessed for 91 hospitals. PPV for surgical treatment of uterine descent and transvaginal mesh placement was calculated for 88 hospitals. A high PPV per hospital and per region was found. In some hospitals, a hysterectomy was performed in all cases of uterovaginal prolapse, while in other hospitals, uterus-preserving techniques were mostly performed. A high PPV of transvaginal mesh placement was observed. CONCLUSION: In the small country of The Netherlands, we found a high PPV in surgical management of POP and UI with respect to the choice for surgical treatment and the type of surgery. This finding might be due to the absence of clearly defined guidelines. Studies with respect to conservative versus surgical treatment and the type of surgery are of need to establish evidence-based guidelines.

Microscopic diagnosis of vulvovaginal candidiasis in stained vaginal smears by Dutch general practitioners.

OBJECTIVE: To determine the accuracy of the microscopic diagnosis of vulvovaginal candidiasis (presence of [pseudo] hyphae and blastospores) in stained vaginal smears in clinical practice. STUDY DESIGN: General practitioners trained in diagnosing vulvovaginal candidiasis performed microscopy of 324 stained vaginal smears. These smears were sent to the pathologist for confirmation of the microscopic diagnosis of the clinician; cytologic diagnosis by the pathologist was considered the gold standard. RESULTS: In 104 of the 342 cases Candida was established by the pathologist. The clinicians made 24 false positive and 50 false negative diagnoses of Candida. Sensitivity and specificity of the microscopic diagnoses of the clinicians were 52% and 89%, respectively. The most frequent reason for a false positive diagnosis was presence of hairs, whereas the most frequent reason for a false negative diagnosis was understaining of the smear. CONCLUSION: This study shows that even in stained smears it is difficult for clinicians to recognize blastospores and (pseudo)hyphae. Efforts are clearly needed to improve the quality of the clinical diagnosis of vulvovaginal candidiasis.

Candida and dysbacteriosis: a cytologic, population-based study of 100,605 asymptomatic women concerning cervical carcinogenesis.

BACKGROUND: The objective of this study was to investigate whether the presence of vaginal Candida or dysbacteriosis predisposes women to an increased susceptibility for (pre)neoplasia over time. METHODS: A retrospective, longitudinal, cohort study was performed and was conducted in a population of 100,605 women, each of whom had 2 smears taken over a period of 12 years as part of the Dutch Cervical Screening Program. From these women, a cohort of 1439 women with Candida and a cohort of 5302 women with dysbacteriosis were selected as 2 separate study groups. The control cohort consisted of women who had completely normal cervical smears (n = 87,903 women). These groups were followed retrospectively over time. The odds ratios (OR) for squamous abnormalities in the follow-up smear for the women in these 3 cohorts were established. RESULTS: The dysbacteriotic cohort was significantly more likely to have low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL+) in their follow-up smear (OR, 1.85; 95% confidence interval [95% CI], 1.28-2.67 and OR, 2.00; 95% CI, 1.31-3.05, respectively) compared with women in the control group. In contrast, the Candida cohort had no significantly increased or decreased risk of developing SIL. The equivocal diagnosis 'atypical squamous cells of undetermined significance' was rendered significantly more often in the follow-up smear of both study cohorts (Candida cohort: OR, 1.42; 95% CI, 1.03-1.95; dysbacteriotic cohort: OR, 1.44; 95% CI, 1.22-1.71). CONCLUSIONS: The results from this study indicated that the presence of Candida vaginalis was not associated with an increased risk for SIL over time. In contrast, women with dysbacteriosis had a significantly increased risk of developing (pre)neoplastic changes. These findings should be taken into account in further research concerning predisposing factors for cervical carcinogenesis.