Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study.

OBJECTIVE: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up. DESIGN: Prospective, two-arm cohort study with 2-year follow-up. SETTING: International multicentre. POPULATION: Women with moderate to severe SUI. MAIN OUTCOME MEASURES: Primary outcome was subjective cure (Patient Global Impression of Improvement). SECONDARY OUTCOMES: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI-6), complications and re-interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D-5L, incremental cost-effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). RESULTS: In all, 131 PDMS-U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS-U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS-U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS-U and MUS surgery were €3567 and €6688. ICER for MUS surgery cost €15 598 per IIQ QALY and €37 408 per EQ-5D-5L QALY. With a willingness to pay (WTP) of €25 000, MUS has a 84% chance of being cost-effective using IIQ, whereas PDMS-U has a 99% chance of being cost-effective using EQ-5D-5L. CONCLUSION: MUS surgery is more cost-effective in realising improved disease-specific quality of life (QoL), while PDMS-U is more cost-effective in realising improved generic QoL.

Surgical management of pudendal nerve entrapment after sacrospinous ligament fixation.

OBJECTIVE: To analyse the efficacy of sacrospinous ligament (SSL) suture removal on the reduction of pain symptoms in the case of suspected pudendal nerve entrapment after sacrospinous ligament fixation (SSLF). DESIGN: Retrospective cohort study. SETTING: Tertiary referral centre, the Netherlands. POPULATION: A cohort of 21 women having their SSLF sutures removed because of SSLF-related pain symptoms. METHODS: Clinical record review. MAIN OUTCOME MEASURES: The primary outcome was reduction of pain after SSL suture removal. Secondary outcome measures were time interval between suture placement and suture removal, complete suture removal, adverse events and recurrence of pelvic organ prolapse (POP). RESULTS: A total of 21 women underwent SSL suture removal for severe and/or persistent pain, which was confirmed on clinical examination: 95% of the women (20/21) reported pain reduction after suture removal, and 57% reported complete pain relief. The time interval between suture placement and suture removal was at a median of 414 days (range 8-1855 days). Sutures could be completely removed in 86% of cases (18/21). One woman had excessive blood loss (520 ml) without blood transfusion. At 6-8 weeks after surgery, 10% of the women (2/21) had renewed symptomatic POP, stage ≥ 2, for which additional POP surgery was indicated. CONCLUSIONS: When performed by an experienced clinician, SSL suture removal is feasible and efficacious, with low morbidity. In addition, the risk of recurrent POP in the short term appeared to be low. TWEETABLE ABSTRACT: The surgical removal of sacrospinous ligament sutures is safe and efficacious for pain relief, even remote from initial placement.

Efficacy of surgical revision of mesh complications in prolapse and urinary incontinence surgery.

INTRODUCTION AND HYPOTHESIS: Women with mesh-related complications in prolapse (POP) and stress-urinary incontinence (SUI) surgery may benefit from operative mesh resection to alleviate symptoms. We hypothesized that mesh resection would alleviate symptoms and aimed to evaluate risks and benefits in these women. METHODS: We carried out a cross-sectional study. Primary outcome was improvement specified as better, unchanged or worsened symptoms after mesh revision surgery. Secondary outcomes were health-related quality of life (HrQol) scores of validated questionnaires, surgical characteristics and physical findings at follow-up visits. Descriptive data were reported with mean and medians. Associations were calculated with Spearman correlation coefficient and chi-square test to determine statistical differences between groups. RESULTS: Fifty-nine women who underwent mesh revision surgery between 2009 and 2016 were included. After a median follow-up of 1.7 (IQR: 1.1-2.4) years, 44 women (75%) reported improvement of symptoms. No significant surgical or patient characteristics were identified that could differentiate which patients did or did not experience cure or complications.A trend was observed to better HrQol scores in women who reported overall improvement after mesh revision surgery. Seventeen (29%) women needed a subsequent operation after mesh removal. CONCLUSIONS: This cross-sectional study shows that mesh revision surgery alleviates symptoms in 75% of women with mesh-related complications. Type of revision surgery and individual characteristics did not seem to matter to the individual chance of cure or complications. These data can facilitate the counseling of women considering mesh revision surgery.

Patients' satisfaction and safety of bulk injection therapy Urolastic for treatment of stress urinary incontinence: A cross-sectional study.

AIMS: Primary outcome was to evaluate patients' satisfaction after being treated with bulk injection therapy polydimethylsiloxane Urolastic (PDMS-U) for stress urinary incontinence (SUI). Secondary outcomes were: subjective cure, objective cure, severity of SUI symptoms, complications, reintervention rate, and disease-specific quality of life. Furthermore, to determine if outcomes worsened during time-after-treatment (time-frames: 0-12, 13-24, and ≥25 months). METHODS: In a cross-sectional design, patients treated with PDMS-U were recruited for hospital revisit. The primary outcome, patients' satisfaction, was assessed by the surgical satisfaction questionnaire. Subjective cure, objective cure, and severity of symptoms were assessed by the patients global impression of improvement, standardized cough stress test, and Sandvik severity scale, respectively. Medical charts and face-to-face interviews were used to determine complications and reinterventions. RESULTS: About 110 patients participated, 87 revisited the hospital. Median follow-up was 25 months (interquartile range: 14;35 months). Patients' satisfaction rate was 51%. Subjective and objective cure were respectively 46% and 47%. Most prevalent complications were: urinary retention (22%), pain (15%), and dyspareunia (15%). Exposure and erosion occurred in 7% and 5%, respectively. Reintervention rate of reinjection and excision of bulk material was 6% and 18.0%, respectively. Objective cure significantly worsened during time-after-treatment (P = < .05). CONCLUSIONS: About half of the patients being treated with PDMS-U were satisfied and subjectively cured 2 years after treatment, although the majority still experienced symptoms of SUI. Most complications were mild and transient, however, in 18% excision of bulk material was indicated for severe or persistent complications such as pain, exposure, or erosion.

Effects of mesh-related complications in vaginal surgery on quality of life.

INTRODUCTION AND HYPOTHESIS: Vaginal mesh surgery is subject of debate due to the impact of mesh-related complications on patient's lives. Not all of these complications are symptomatic. Restoration of the anatomy and improvement of pelvic floor function as a result may counter the experienced discomfort related to adverse events. We hypothesized that health-related quality of life (HR-QoL) is comparable in women after vaginal mesh surgery regardless of the presence or absence of a mesh-specific complication. METHODS: This was a cross-sectional study of 128 women who had vaginal mesh surgery in a Dutch university hospital between 2007 and 2012. HR-QoL was measured in women with and without mesh complications using standardized QoL questionnaires Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), Defecation Distress Inventory (DDI), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Complications were scored according to the International Urogynecological Association (IUGA) complication classification. Comparisons between groups were performed with Student's t test and analysis of variance (ANOVA) test. RESULTS: In 29 (23%) women, a mesh-related complication occurred. The domain scores of the UDI-6, DDI, IIQ, and PISQ showed no statistically significant differences between women with and without a mesh-related complication. A post hoc analysis showed similar HR-QoL for those in whom the complication had been resolved and those with persistent symptoms of the complication. CONCLUSION: Mesh surgery imposes specific complications. When counseling patients about the potential adverse events related to vaginal mesh surgery, it is important to inform them that mesh-related complications do not negatively affect QoL related to micturition, defecation, and sexual functioning.

Patients' perspectives on urethral bulk injection therapy and mid-urethral sling surgery for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to identify all treatment decision factors that determined the preference for peri-urethral bulk injection therapy (PBI) or mid-urethral sling (MUS) surgery in patients with primary stress urinary incontinence (SUI). Second, we explored what patients expect from treatment for SUI and whether patients would consider PBI as a primary treatment option. METHODS: In a qualitative design, 20 semi-structured, face-to-face interviews were conducted in women with primary SUI. Exclusion criteria were: previous PBI or MUS surgery; predominating urgency. Interviews were guided by three open-ended questions and a topic list. PBI treatment and MUS surgery were described in detail, and the efficacy was stated as 70% and 90%, respectively. Data saturation was reached when no new treatment decision factors were identified in three consecutive interviews. Interviews were audiotaped and fully transcribed. Thematic analysis by a coding process was done independently by two researchers. RESULTS: Sixteen procedural, personal, professional, social and external treatment decision factors were identified. Regarding expectations about treatment for SUI, women believed 'becoming dry' was wishful thinking. The majority of patients accepted a small degree of persistent urinary incontinence after treatment. Regardless of their treatment preference, patients indicated that women should be informed about PBI as a primary treatment option. CONCLUSION: Patients with primary SUI are open to PBI as an alternative treatment option even with lower cure rates compared with MUS surgery performed under general or spinal anesthesia. Patients indicated that women with primary SUI seeking treatment should be informed about PBI as a treatment option.

Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid-urethral sling surgery.

AIMS: To assess the efficacy and safety of peri-urethral bulking injections (PBI) with an innovative bulking material (PDMS-U) in women with stress-urinary incontinence (SUI) who are not optimal candidates for mid-urethral sling surgery. METHODS: A prospective study was performed in women with SUI who, for several reasons, have a relative contraindication for a mid-urethral sling procedure. These reasons include: (i) recurrent SUI after a prior SUI surgical procedure; (ii) a history of oncologic gynaecological surgery; (iii) a history of neurologic disease resulting in voiding problems; (iv) a maximal flow rate of less than 15 mL per second or; (v) women with a contraindication for surgery with general or regional anaesthesia. All women were treated with PBI consisting of PDMS-U, a bulking agent that polymerizes in situ. The primary outcome was subjective improvement, defined as "a little better" to "very much better" on the PGI-I. Secondary outcomes included objective cure, disease specific quality of life and adverse events. RESULTS: Subjective improvement was reported by 18 (90%) of the 20 included patients. The subjective cure rate was 56% and the objective cure rate was 65%. There was a statistically significant improvement of all domain scores of the UDI-6, IIQ-7, and PISQ-12 at 6 months follow up. Abnormal post voiding residual volume (>150 mL) was the most common adverse event (40%), but persisted in only one patient, based on the patient's preference for a catheter. CONCLUSIONS: PBI with PDMS-U is a viable treatment option in women with a relative contra-indication for mid-urethral sling surgery.

Septum resection for women of reproductive age with a septate uterus.

BACKGROUND: Women with a septate uterus are at increased risk for subfertility, recurrent miscarriage, and preterm birth. Restoration of the anatomy of the uterus by hysteroscopic septum resection is an established intervention. This treatment has been assessed mainly in retrospective cohort studies, which suggested a positive effect on pregnancy outcomes. The major flaw in these studies is the before/after design, which will always favour the tested intervention. OBJECTIVES: To determine whether hysteroscopic septum resection in women of reproductive age with a septate uterus improves live birth rates and to assess the safety of this procedure. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group Specialised Register (inception to May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL CRSO) (inception to May 2016), MEDLINE (1946 to May 2016), Embase (1974 to May 2016), PsycINFO (1806 to May 2016), and CINAHL database (1982 to May 2016). We also searched trial registers for ongoing and registered trials, reference lists, the Cochrane Library, unpublished dissertations and theses, conference abstracts, OpenGrey, LILACS, PubMed, and Google. SELECTION CRITERIA: We planned to include randomised controlled trials that assessed the effect on reproductive outcomes and the safety of hysteroscopic septum resection in women of reproductive age with a septate uterus. DATA COLLECTION AND ANALYSIS: If there had been studies to include, two review authors would have independently selected studies, assessed trial risk of bias, and extracted data. They would also have contacted study authors for additional information. MAIN RESULTS: As in the 2011 version of this review, we identified no randomised controlled trials for inclusion in this update. AUTHORS' CONCLUSIONS: Hysteroscopic septum resection in women of reproductive age with a septate uterus is performed worldwide to improve reproductive outcomes. At present, there is no evidence to support the surgical procedure in these women. Randomised controlled trials are urgently needed. Two trials are currently underway.

Reviewing Patients Following Mesh Repair; The Benefits.

BACKGROUND/AIMS: The use of synthetic mesh implants for vaginal prolapse surgery is still a subject of debate due to safety concerns. We aimed to explore long-term complications of all women treated with mesh surgery for pelvic organ prolapse (POP) in our centre. METHODS: This is a cross-sectional study of 188 women who underwent vaginal mesh surgery in a Dutch University Hospital between 2007 and 2012. The prevalence of mesh exposure, pain symptoms and patient satisfaction has been documented. RESULTS: Vaginal mesh surgery was performed in 188 women - in 147 (78%) because of recurrent POP. After a median follow-up of 40 months (range 12-76 months), 11 women (6%) had a symptomatic exposure of whom 8 women underwent surgery. Nine women (5%) had de novo pain following mesh surgery and in 3 women, (2%) this symptom was persistent despite treatment. Eighty-six percent of the responders were satisfied about their treatment. CONCLUSION: With this study, we showed that performing a total mesh recall is feasible. The prevalence of persisting symptomatic exposure and persisting pain symptoms was low in our population. Most of the complications we found were treatable. This is also reflected in the high overall satisfaction rate.

[Complications after vaginal mesh surgery]. / Complicaties na plaatsing van een vaginaal implantaat.

Pelvic organ prolapse (POP) is a common problem. There is a significant risk of recurrent POP after surgery. To reduce this risk vaginal meshes have been introduced. Mesh surgery has very specific complications that are not always recognised as most physicians are not aware of the symptoms. Possible solutions to these problems are not well known either. In this clinical lesson we describe two patients who developed complications following vaginal mesh surgery which had taken place several years after the index surgery. Although the symptoms were specific to vaginal mesh surgery, they were only recognised long after they had developed. Removal of the implant resolved the symptoms. Based on the complicated diagnosis and treatment of mesh-related complications we recommend that care for these patients should be centralised at a centre with a multidisciplinary team that has the surgical expertise to resolve the symptoms.