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.</p

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

Dutch women's attitudes towards hysterectomy and uterus preservation in surgical treatment of pelvic organ prolapse

Contains fulltext : 183838.pdf (publisher's version ) (Closed access

Long-term safety, objective and subjective outcomes of laparoscopic sacrocolpopexy without peritoneal closure

Contains fulltext : 221679.pdf (Publisher’s version ) (Closed access

Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study)

Contains fulltext : 202799.pdf (publisher's version ) (Open Access

Prognostic model on niche development after a first caesarean section:development and internal validation

Objective: To develop and internally validate a prognostic prediction model for development of a niche in the uterine scar after a first caesarean section (CS). Study design: Secondary analyses on data of a randomized controlled trial, performed in 32 hospitals in the Netherlands among women undergoing a first caesarean section. We used multivariable backward logistic regression. Missing data were handled using multiple imputation. Model performance was assessed by calibration and discrimination. Internal validation using bootstrapping techniques took place. The outcome was ‘development of a niche in the uterus’, defined as an indentation of = 2 mm in the myometrium. Results: We developed two models to predict niche development: in the total population and after elective CS. Patient related risk factors were: gestational age, twin pregnancy and smoking, and surgery related risk factors were double-layer closure and less surgical experience. Multiparity and Vicryl suture material were protective factors. The prediction model in women undergoing elective CS revealed similar results. After internal validation, Nagelkerke R2 ranged from 0.01 to 0.05 and was considered low; median area under the curve (AUC) ranged from 0.56 to 0.62, indicating failed to poor discriminative ability. Conclusions: The model cannot be used to accurately predict the development of a niche after a first CS. However, several factors seem to influence scar healing which indicates possibilities for future prevention such as surgical experience and suture material. The search for additional risk factors that play a role in development of a niche should be continued to improve the discriminative ability