Treatment of apical vaginal prolapse with minimal mesh repair (Uphold): patient-reported long-term outcomes and mesh-related complications.

INTRODUCTION: To evaluate patient-reported outcomes and clinical findings after surgery for apical prolapse with the transvaginal Uphold mesh technique. Moreover, to evaluate the rate of mesh-related complications. MATERIAL AND METHODS: A historical cohort study of patients who underwent surgery from January 1, 2012 to April 30, 2019, at Aarhus University Hospital, Denmark. Pelvic examination and patient completion of questionnaires were performed in 2018-2019. Information on adverse events and reoperations was obtained from medical records. RESULTS: A total of 240 patients were operated on using the Uphold mesh, 89% due to recurrent prolapse. Follow-up was attended by 192 patients (80%). Median follow-up time was 30 months, interquartile range 19-52. During follow-up, 29 patients (15%) underwent reoperation due to prolapse and are considered failures. Among the remaining, patient satisfaction was high. Thus, average score for pelvic symptoms affecting daily life was 2, on a scale of 0-10, where 0 represents no symptoms. The Patient Global Impression of Improvement (PGI-I) had an average score of 6.4 (1: very much worse; 7 very much better). Preoperatively, 89.5% of the women had grade 2 or more apical prolapse, whereas at follow-up, this was only 6.1%. Perioperative heavy bleeding needing embolization was observed in one patient (0.5%). Two patients had serious constriction of the ureter and needed re-operation. Postoperative complications, primarily temporary voiding problems, were observed in 15 patients (8%). Complications during the follow-up period were registered in 23 patients (12%); eight of these were mesh erosions. Due to complications, 11 patients (6%) needed re-operation. CONCLUSIONS: The study confirms that the Uphold procedure in a centralized set-up is a procedure with high patient-reported satisfaction even in a population characterized by a high proportion of recurrent prolapse. Moreover, the procedure seems safe with acceptable complication rates.

Fast track sacrospinous ligament fixation: subjective and objective outcomes at 6 months.

BACKGROUND: Sacrospinous ligament fixation (SSLF) is a widely used vaginal procedure for correction of apical vaginal prolapse. The objective of this study was to evaluate subjective and objective outcomes of SSLF performed in a fast-track setting. METHODS: This was a prospective cohort study of sacrospinous ligament fixation performed using local anesthesia and light sedation in a fast-track setting at Aarhus University Hospital between April 2016 and December 2017. Objective signs of prolapse were assessed by gynecological examination preoperatively and at 6 months after the operation. Subjective symptoms were evaluated by questionnaires (the Pelvic Floor Distress Inventory (PFDI 20), and the Patient Global Impression of Improvement (PGI-I) supplemented with individual questions from the ICIQ-vaginal Symptoms (ICIQ-VS) and Sexual Questionnaire-IR (PISQ-12) questionnaires). RESULTS: One hundred and three women with a median age of 65 (36-84) years were included. Previous hysterectomy had been performed in 40% of the women, and 43% had a history of previous prolapse operations. At follow-up, 75% of the women had apical descent less than stage 2. However, 18% had anterior vaginal wall prolapse beyond the hymen, and 25% had recurrence of the apical prolapse stage 2 or more and were offered reoperation. Bladder and anal symptoms improved in most women after the operation, and the number of women reporting dyspareunia was halved. In the overall assessment by Patient Global Impression of Improvement (PGI-I) questionnaire, 76% reported improvement. No serious operative complications were reported, and 81% of the patients were discharged on the day of the surgery. CONCLUSION: In this cohort with a high rate of previous prolapse surgery, sacrospinous ligament fixation performed in a fast-track setting showed subjective and objective results comparable to the results of apical native tissue repair reported in the literature. Furthermore, the complication rate was low. Trial registration This study was notified to The Central Denmark Region Committees on Health Research Ethics on July 7, 2015, and was approved by The Danish Data Protection Agency (1-16-02-442-15). All methods were performed in accordance with the relevant guidelines and regulations. An informed consent for participation in the study and acceptance of using data for scientific purposes and publication was signed by all patients.

High Patient Satisfaction With Local Anesthesia and Light Sedation in a Novel Fast-Track Setup for Sacrospinous Fixation.

OBJECTIVES: Simple prolapse operations can be performed using local anesthesia. However, this has not been the case for advanced pelvic organ prolapse operations. The aim of this study was to investigate the patient-reported feasibility and acceptability of local anesthesia and light sedation for sacrospinous fixation (SSF). METHODS: This is a prospective observational study on 105 women who underwent SSF in a public outpatient setting from April 2016 to October 2017. They received infiltration anesthesia with mepivacaine or lidocaine together with a pudendal nerve block with Marcaine. Local anesthesia was supplemented by intravenous light sedation and pain reliever. A Local Anesthetic Intraoperative Experience Questionnaire was used to evaluate patient experience. RESULTS: One patient was converted to general anesthesia. Eighty-eight women answered the questionnaires. Ninety-nine percent defined themselves as satisfied or very satisfied with the anesthesia. Little or no pain during the operation was reported by 92% and 92% would choose the same type of anesthesia again. No adverse effect of the anesthetic procedure was observed. The median (range) admission time was 12 (4.5-48) hours, and 81% of the patients could be discharged on the day of surgery. At follow-up after 8 weeks and 6 months, no patients reported adverse events to the anesthesia. CONCLUSIONS: The SSF can be performed using local anesthesia and light sedation with high degree of patient satisfaction. These preliminary data indicate that the concept of ambulatory surgery might be implemented more widely if the use of local anesthesia is also applied to more advanced surgical procedures.

Recurrent apical prolapse after high uterosacral ligament suspension - in a heterogenous cohort characterised by a high prevalence of previous pelvic operations.

BACKGROUND: The apical prolapse is probably the most complex form of pelvic organ prolapse (POP). Adequate apical support is essential in the treatment of POP, as it contributes to the support in all vaginal compartments. This study aimed to evaluate the rate of symptomatic recurrent apical prolapse after high uterosacral ligament suspension (HUSLS), in a cohort of women characterised by a high prevalence of previous pelvic operations and a significant degree of prolapse. METHODS: This is a retrospective chart review of 95 women who underwent HUSLS for symptomatic apical prolapse from 2002 to 2009 at Aarhus University Hospital, Denmark. Of these women, 97% attended a six-month clinical control. Recurrence was defined as symptomatic vaginal vault prolapse stage 2 or more (according to the International Continence Society (ICS) quantification system). Medical charts were reviewed for a mean period of 7.2 years. Any new contacts due to prolapse were noted. RESULTS: Before the operation, 73% of the women were hysterectomised, and 52% had previous prolapse surgery. Stage 2 apical prolapse was reported in 71% of the women, whereas 26% had stage 3 or 4. At six-month follow-up, 19% of the women had recurrent symptomatic apical prolapse, and 9% of the women had symptomatic recurrent prolapse in other compartments 6 months after operation. In all, 35% of the women had a renewed prolapse operation during the long-term follow-up period. Perioperative adverse events were seen in 7%. Two women were re-operated due to postoperative complications. CONCLUSIONS: This retrospective study of 95 women with a significant degree of prolapse and a high prevalence of previous pelvic operations demonstrates that the rate of recurrent prolapse associated with HUSLS might be higher than originally described. In conclusion, HUSLS may not be the optimal first choice of operation in this group of patients.

Prospective evaluation of paravaginal defect repair with and without apical suspension: a 6-month postoperative follow-up with MRI, clinical examination, and questionnaires.

INTRODUCTION AND HYPOTHESIS: Paravaginal defect (PVD) has been suggested as one of the main contributors to the development of prolapse in the anterior vaginal wall (AVW). We aimed to evaluate the descent of pelvic organs, presence of vaginal H configuration, and pubococcygeus (PC) muscle defect by pelvic magnetic resonance imaging (MRI), together with subjective symptoms of prolapse, before and 6 months after PVD repair. We also aimed to evaluate risk factors of recurrence. METHODS: Fifty women with PVD diagnosed by gynecological examination and scheduled for vaginal PVD repair were planned for enrollment. Preoperatively and 6 months postoperatively, subjective symptoms were evaluated using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) together with MRI of the pelvis to evaluate defects in the PC muscle, vaginal shape, and pelvic organ descent. RESULTS: Forty-six women completed the study. Twenty had PVD repair alone, whereas 26 also had concomitant surgery performed. Prolapse grade, subjective symptoms, sexual problems, and quality of life (QoL) were significantly improved at follow-up. Missing vaginal H configuration was observed in 21 women before operation and was correlated with PC muscle defect. Recurrence rate was 39%, and significantly more women with recurrence had PC muscle defects and missing H configuration. CONCLUSION: Vaginal PVD repair alone or combined with concomitant surgery significantly reduces objective prolapse and subjective symptoms. We could not demonstrate MRI findings of missing H configuration to be a sign of PVD but, rather, a sign of defect in the PC muscle. Risk of recurrence is significantly higher in women with major PC muscle defects and missing H configuration.

Native-tissue repair of isolated primary rectocele compared with nonabsorbable mesh: patient-reported outcomes.

INTRODUCTION: We evaluated patient-reported outcomes and complications after treatment of isolated primary rectocele in routine health-care settings using native-tissue repair or nonabsorbable mesh. METHODS: We used prospective data from the Swedish National Register for Gynaecological Surgery and included 3988 women with a primary operation for rectocele between 2006 and 2014: 3908 women had native-tissue repair, 80 were operated with nonabsorbable mesh. No concurrent operations were performed. Pre- and perioperative data were collected from doctors and patients. Patient-reported outcomes were evaluated 2 and 12 months after the operation. Only validated questionnaires were used. RESULTS: One year after native-tissue repair, 77.8 % (76.4-79.6) felt they were cured, which was defined as never or hardly ever feeling genital protrusion; 74.0 % (72.2-75.7) were very satisfied or satisfied, and 84 % (82.8-85.9) reported improvement of symptoms. After mesh repair, 89.8 % (77.8-96.6) felt cured, 69.2 % (54.9-81.3) were very satisfied or satisfied, and 86.0 % (72.1-94.7) felt improvement. No significant differences were found between groups. Organ damage was found in 16 (0.4 %) patients in the native-tissue repair group compared with one (1.3 %) patient in the mesh group [odds ratio (OR) 3.08; 95 % confidence interval (CI) 0.07-20.30]. The rate of de novo dyspareunia after native-tissue repair was 33.1 % (30.4-35.8), comparable with that after mesh repair. The reoperation rate was 1.1 % (0.8-1.5) in both groups. CONCLUSION: Most patients were cured and satisfied after native-tissue repair of the posterior vaginal wall, and the patient-reported outcomes were comparable with results after mesh repair. The risk of serious complications and reoperation were comparable between groups.

Clinical risk factors and urodynamic predictors prior to surgical treatment for stress urinary incontinence: a narrative review.

INTRODUCTION AND HYPOTHESIS: Knowledge about clinical risk factors and the value of urodynamic testing is important to optimize treatment strategy and secure true informed consent. METHODS: We reviewed the relevant literature to clarify the evidence regarding clinical risk factors and the predictive value of urodynamic testing in patients with urinary incontinence, where surgery is considered. Because of the paucity of evidence based on randomized controlled trials, we conducted a narrative review of the published literature. RESULTS: Clinical risk factors in terms of mixed urinary incontinence, previous incontinence surgery, body mass index (BMI) ≥ 35, age ≥ 75, and presence of diabetes mellitus were significantly related to decreased outcome of incontinence surgery. Furthermore, noninvasive and invasive urodynamic parameters indicating detrusor overactivity, voiding difficulties, low urethral pressure, and bladder-neck immobility were related to poorer outcome of surgery. CONCLUSIONS: This study summarized the available evidence regarding preoperative clinical risk factors and urodynamic parameters indicating decreased or adverse outcome of surgery, and this report also provides clinical recommendations.

Operation for recurrent cystocele with anterior colporrhaphy or non-absorbable mesh: patient reported outcomes.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare patient reported outcomes and complications after repair of recurrent anterior vaginal wall prolapse in routine health care settings using standard anterior colporrhaphy or non-absorbable mesh. METHODS: The study is based on prospective data from the Swedish National Register for Gynaecological Surgery. 286 women were operated on for recurrent anterior vaginal wall prolapse in 2008-2010; 157 women had an anterior colporrhaphy and 129 were operated on with a non-absorbable mesh. Pre-, and perioperative data were collected from doctors and patients. Patient reported outcomes were evaluated 2 months and 12 months after the operation. RESULTS: After 12 months, the odds ratio (OR) of patient reported cure was 2.90 (1.34-6.31) after mesh implants compared with anterior colporrhaphy. Both patient- and doctor-reported complications were found more often in the mesh group. However, no differences in serious complications were found. Thus, an organ lesion was found in 2.3% after mesh implant compared with 2.5% after anterior colporrhaphy (p = 0.58). Two patients in the mesh group (1.2%) were re-operated compared with 1 patient (0.6%) in the anterior colporrhaphy group (p = 0.58). The infection rate was higher after mesh (8.5%) than after anterior colporrhaphy (2.5%; OR 3.19 ; 1.07-14.25). CONCLUSION: Implantation of synthetic mesh during operation for recurrent cystocele more than doubled the cure rate, whereas no differences in serious complications were found between the groups. However, mesh increased the risk of infection.

Regulation of insulin-like growth factor binding protein secretion by human granulosa luteal cells in a polycystic ovary-like environment.

OBJECTIVE: To determine the effect of androstenedione (A), insulin, and LH on secretion of insulin-like growth factor binding proteins (IGFBPs) from human granulosa luteal cells. DESIGN: Human granulosa cells were cultured for a total of 4 days in serum-free medium containing A (10(-6) mol/L), with or without insulin (100 microU/mL-800 microU/mL), LH (1 microU/mL-10 microg/L), and A (10(-5) mol/L). SETTING: Granulosa cells were obtained from IVF procedures. PATIENT(S): Women undergoing IVF for tubal disease. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Immunoassay and autoradiographs of Western ligand blotting detected IGFBP accumulations in the medium. RESULT(S): Cultured granulosa cells secreted IGFBP-1 through IGFBP-4. Insulin (100 microU/mL-800 microU/mL), LH (1 microg/L-10 microg/L), and A (10(-5) mol/L) caused a significant decrease in IGFBP-1 accumulation in the medium both alone and when added in combination. The release of IGFBP-2 and IGFBP-4 was significantly stimulated by insulin, whereas LH had no effect. Elevated levels of androgen (10(-5) mol/L) significantly stimulated the secretion of IGFBP-2, whereas the release of IGFBP-4 was reduced. CONCLUSION(S): These results demonstrate that androgen and insulin are important regulators of IGFBP release and that elevated levels of the two hormones may contribute to the altered IGFBP profile found in PCOS follicles, compared with the case of estrogen-dominant follicles.