Do Surgeons Anticipate Women's Hopes and Fears Associated with Prolapse Repair? A Qualitative Analysis in the PROSPERE Trial.

Women's preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women's hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women's hopes covered seven themes, and women's fears eleven. Women's hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women's fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women's expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman's expectations before pelvic-floor repair.

Perioperative morbi-mortality after pelvic organ prolapse surgery in a large French national database from gynecologist surgeons.

OBJECTIVE: To assess morbidity and mortality following pelvic organ prolapse surgery in France, irrespective of the surgical technique, using a broad national database. MATERIALS AND METHODS: This descriptive multicenter retrospective study was conducted using a database populated via an application run by a professional association. RESULTS: 286 gynecologists contributed data to the database. Of the 4322 surgeries analyzed, an abdominal approach was used in 975 of cases (22.5%), a vaginal approach in 3277 (75.9%), and a combined approach in 68 (1.6%). After one year, abdominal surgery was associated with higher rates of de novo urinary incontinence, constipation, and intestinal obstruction, whereas vaginal surgery was associated with higher rates of urinary retention, hematoma, de novo chronic pain, and vaginal mesh extrusion. There was no significant difference between the groups in the incidence of severe complications. After one year, vaginal mesh-augmented cystocele repair was associated with higher rates of de novo urinary incontinence, de novo chronic pain, and reoperation than native tissue repair. Mesh repair was also associated with higher rates of severe complications at one year. CONCLUSION: After pelvic organ prolapse surgery, the perioperative morbidity and mortality associated with transabdominal and transvaginal approaches are similar. However, transvaginal mesh repair is associated with greater perioperative morbidity than transvaginal native tissue repair.

Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial.

BACKGROUND: Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. OBJECTIVE: To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45-75 yr, without previous prolapse surgery. INTERVENTION: Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rate of surgical complications ≥grade II according to the modified Clavien-Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results. RESULTS AND LIMITATIONS: A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI -1.5 to 18]; p=0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p=0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI -0.4 to 13.3]; p=0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS). CONCLUSIONS: LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS. PATIENT SUMMARY: Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.

Ovarian thrombosis and uterine synechiae after arterial embolization for a late postpartum haemorrhage.

BACKGROUND: We report two unusual separate complications after uterine artery embolization for a late postpartum haemorrhage. This report appeared important to us in view of the apparent absence of any other publications on this topic. CASE PRESENTATION: We report the case of a 25-year-old woman, gravida 3, para 1, admitted for uterine bleeding 7 days after a spontaneous delivery at term, in our university hospital. A suction curettage and then, after persistent bleeding, uterine artery embolization were necessary. Immediately after the embolization, a bilateral ovarian thrombosis occurred, subsequently followed by amenorrhea, due to uterine synechiae, and depression. Hysteroscopic surgery was performed to remove the adhesions. A complete work-up for thrombophilia showed a heterozygous mutation of the factor V gene R506Q. The pathology examination found subinvolution of the placental bed. One month after treatment of the synechiae (and insertion of a copper IUD for contraception), the woman's menstrual cycle returned to normal. Her clinical examination 19 months later was normal. CONCLUSIONS: This case teaches us that one rare complication can hide another! It is important to consider the diagnosis of subinvolution of the placental bed in cases of late PPH and to know the complications associated with vascular artery embolization in order to provide the most rapid and least invasive treatment.

Effectiveness of Hyalobarrier and Seprafilm to prevent polypropylene mesh shrinkage: a macroscopic and histological experimental study.

INTRODUCTION AND HYPOTHESIS: Polypropylene (PP) mesh shrinkage represents a serious complication, as a significant cause of pain and recurrence of pelvic organ prolapse or ventral hernias, frequently requiring several surgical interventions. The retraction seems to be caused by the host, in response to the implantation, through the occurrence of periprosthetic adhesions and fibrosis. We hypothesized that avoiding the postoperative adhesions can prevent PP mesh shrinkage. METHODS: Sixty rats were randomly assigned to three groups. A standardized hernia defect was induced on the abdominal wall, which was repaired using an extraperitoneal PP mesh alone (group 1), with application of a hyaluronate carboxymethylcellulose-based bioresorbable membrane (Seprafilm, group 2), or an auto-cross-linked polysaccharide hyaluronan-based solution (Hyalobarrier gel, group 3). Eight weeks after the procedure, a repeat laparotomy was performed. After scoring the adhesion and measuring the mesh surface, a microscopic study of the prosthesis-host tissue interfaces was performed. RESULTS: Group 1 displayed a median shrinkage of 29% of the mesh. The Seprafilm group (p = 0.0238) and Hyalobarrier gel group (p = 0.0072) displayed a significantly smaller reduction of 19.12 and 17 %, respectively. Control group 1 displayed a significantly greater adhesion score (30.40) than the Seprafilm (11.67, p = 0.0028) and Hyalobarrier gel groups (11.19, p = 0.0013). The fibrosis was reduced in the Hyalobarrier gel group only. CONCLUSION: This experimental study revealed that Hyalobarrier gel and Seprafilm can prevent PP mesh shrinkage and postoperative adhesions. They might be integrated in a mesh size-saving strategy, which should preserve the quality and durability of the surgical repair and limit the postoperative pain.

Female urinary incontinence and intravaginal electrical stimulation: an observational prospective study.

OBJECTIVE: To assess the efficacy of intravaginal electrical stimulation in the management of female urinary incontinence. STUDY DESIGN: 359 Women with urinary incontinence (207 with stress incontinence [group A], 33 with urge incontinence [group B] and 119 with mixed urinary incontinence [group C]) were included in this multicenter prospective observational study. Patients were managed by home intravaginal electrical stimulation of the pelvic floor for 20-30 min per day, 5 days a week, for a period of 10 weeks. Identical clinical assessments were performed before and after pelvic floor rehabilitation, comprising a voiding diary and validated symptom and quality of life scores. RESULTS: Objective assessment demonstrated an overall cure rate of 63.5% (228/359): 65.7% (136/207) for group A, 57.6% (19/33) for group B, and 61.3% (73/119) for group C. The overall significant improvement rate was 15.6% (56/359): 14.6% (30/207) for group A, 24.2% (8/33) for group B and 15.1% (18/119) for group C. All domains of quality of life were significantly improved after pelvic floor muscle training (p<0.0001) with a patient satisfaction rate of 83.6%. Treatment was well tolerated with 1.4% (5/359) of patients describing pain at the highest stimulation intensities. No significant difference was observed between the various types of electrodes used (p<0.0001). CONCLUSION: The quantitative and qualitative efficacy in terms of social and psychological consequences and quality of life of home pelvic floor muscle training stimulators probably make this treatment modality one of the first-line treatments for female stress urinary incontinence.

75NC007 device for noninvasive stress urinary incontinence management in women: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Management of stress urinary incontinence (SUI) with intravaginal devices is an alternative to surgical management, but data of a high level of evidence remain scarce. Our goal was to assess efficacy, tolerance, and acceptability of the 75NC007 intravaginal device for SUI management. METHODS: A phase III, multicenter randomized controlled trial was conducted. After an initial washout period with no treatment, allowing baseline evaluation, women with SUI were randomly assigned to a treatment or control group (no treatment). The primary endpoint was the reduction of incontinence episode frequency (IEF), according to bladder diaries, as compared to baseline. Secondary endpoints were variation of the Urinary Symptom Profile (USP) score, of 24-h pad test, and of CONTILIFE questionnaire scores as compared to baseline. Intent-to-treat and per-protocol analyses were conducted. RESULTS: Fifty-five patients were enrolled and analyzed (26 controls and 29 treated). The mean relative variations of IEF, SUI USP subscore, and overactive bladder (OAB) USP subscore were more significant in the treatment group than in the control group (-31.7 ± 65.1 % vs -7.6 ± 24.5 %, p = 0.002, -2.4 ± 2.6 vs 0.2 ± 2.2, p = 0.004, and -1.5 ± 2.8 vs 0.2 ± 1.8, p = 0.016, respectively). The dysuria USP subscore was slightly decreased in the treatment group. CONTILIFE scores were slightly improved in the treatment group. Pad test variations were not different between groups. No serious adverse event was noted throughout the entire study. CONCLUSIONS: The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women.

Credentialing for transvaginal mesh placement--a case for "added qualification" in competency. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: A process of added qualification of transvaginal mesh (TVM) placement is desirable. METHODS: Through a physician-led partnership of specialty societies, centers of excellence, and industry, a core curriculum encompassing mesh/graft biology, technical skills, and safety can be coupled with current educational endeavors instructing surgeons in the use of TVM. A posttest process can verify a knowledge-based competency in mesh/graft safety. An auditing process after implementation would be optimal. RESULTS: We recommend implementation of a five-step process in order to accomplish these goals. CONCLUSIONS: It is hoped through these efforts, the ultimate goal of patient safety may be reached.

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical outcomes at 3 years following total transvaginal mesh (TVM) technique to treat vaginal prolapse. METHODS: Prospective, observational study in patients with prolapse ≥ stage II. Success was defined as POP-Q-stage 0-I and absence of surgical re-intervention for prolapse. Secondary outcome measures were: quality of life (QOL), prolapse-specific inventory (PSI), impact on sexual activity and complications. RESULTS: Ninety women underwent TVM repair, 72 a hysterectomy. Anatomical failure rate was 20.0% at 3 years. Three patients required re-intervention for prolapse. Improvements in QOL- and PSI-scores were observed at 1 and 3 years. Vaginal mesh extrusion occurred in 14.4% patients. After 3 years, 4.7% asymptomatic extrusions remained present. Of 61 sexually active women at baseline, a significant number of patients (41%) ceased sexual activity by 3 years; de novo dyspareunia was reported by 8.8%. One vesico-vaginal fistula resolved after surgery. CONCLUSION: Medium-term results demonstrate that the TVM technique provides a durable prolapse repair.

Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians.

Urinary incontinence is a frequent affliction in women and may be disabling and costly {LE1}. When consulting for urinary incontinence, it is recommended that circumstances, frequency and severity of leaks be specified {Grade B}. The cough test is recommended prior to surgery {Grade C}. Urodynamic investigations are not needed before lower urinary tract rehabilitation {Grade B}. A complete urodynamic investigation is recommended prior to surgery for urinary incontinence {Grade C}. In cases of pure stress urinary incontinence, urodynamic investigations are not essential prior to surgery provided the clinical assessment is fully comprehensive (standardised questionnaire, cough test, bladder diary, post-void residual volume) with concordant results {PC}. It is recommended to start treatment for stress incontinence with pelvic floor muscle training {Grade C}. Bladder training is recommended at first intention in cases with overactive bladder syndrome {Grade C}. For overweight patients, loss of weight improves stress incontinence {LE1}. For surgery, sub-urethral tape (retropubic or transobturator route) is the first-line recommended technique {Grade B}. Sub-urethral tape surgery involves intraoperative risks, postoperative risks and a risk of failure which must be the subject of prior information {Grade A}. Elective caesarean section and systematic episiotomy are not recommended methods of prevention for urinary incontinence {Grade B}. Pelvic floor muscle training is the treatment of first intention for pre- and postnatal urinary incontinence {Grade A}. Prior to any treatment for an elderly woman, it is recommended to screen for urinary infection using a test strip, ask for a bladder diary and measure post-void residual volume {Grade C}. It is recommended to carry out a cough test and look for occult incontinence prior to surgery for pelvic organ prolapse {Grade C}. It is recommended to carry out urodynamic investigations prior to pelvic organ prolapse surgery when there are urinary symptoms or occult urinary incontinence {Grade C}.

Surgery for pelvic organ prolapse.

OBJECTIVES: : Surgery for pelvic organ prolapse (POP) is common with increasing high-quality evidence to guide surgical practice. Yet many important basic questions remain, including the optimal timing for POP surgery, the optimal preoperative evaluation of urinary tract function, and the postoperative outcome assessment. This manuscript reviews traditional surgical approaches for POP. METHODS: : Formal and hand-searching of prolapse literature was conducted by the committee on Pelvic Organ Prolapse Surgery for the most recent International Consultation on Incontinence. The committee (authors) was composed of prolapse specialists from around the world. Consensus recommendations were made following literature abstraction. RESULTS: : Surgical correction of POP can be divided into 2 main categories as follows: reconstructive procedures to correct anterior and posterior wall defects and resuspend the vaginal apex or obliterative procedures to close off the vagina. Reconstructive surgery may use the vaginal route or the abdominal route. CONCLUSIONS: : In addition to recommendations within the report, the committee reaffirms that in planning surgery, the individual patient's risk for surgery, risk of recurrence, previous treatments, and surgical goals are all considered in deciding on obliterative versus reconstructive procedures, and in deciding whether the vaginal or the abdominal approach will be used for reconstructive repairs.

Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.

AIM: To study peri-surgical complications after cure of genital prolapse by vaginal route using interposition of synthetic prostheses Gynemesh Prolene Soft (Gynecare) following the Trans Vaginal Mesh (TVM) technique. METHODS: The present retrospective multicentered study comprised 684 patients who underwent surgery at seven French centers between October 2002 and December 2004. All patients had a genital prolapse >or=3 (C3/H3/E3/R3) according to International continence society (ICS) classification. According to each case, prosthetic interposition was total, or anterior only or posterior only. Patients were systematically seen 6 weeks, 3 months and 6 months after surgery. Multivaried statistical analysis followed a model of logistic regression applied to each post-surgical complication. RESULTS: The mean age of patients was 63.5 years (30-94). The mean follow-up period was 3.6 months. 84.3% of patients were post-menopause, 24.3% had hysterectomy, 16.7% previous cure of prolapse, and 11.1% cure of stress urinary incontinence (SUI). During the procedure, hysterectomy was combined in 50.3% of cases, cervix amputation in 1.5%, and cure of SUI in 40.9%. 15.8% were treated for a cystocele only. 14.8% had only a rectocele +/- elytrocele and 69.4% had a prolapse touching both compartments, anterior and posterior. In peri-surgical complications, (2%) were five bladder wounds (0.7%), one rectal wound (0.15%) and seven hemorrhages greater that 200 mL (1%). Among early post-surgical complications (during the first month after surgery) (2.8%) were two pelvic abscesses (0.29%), 13 pelvic hematomas (1.9%), one pelvic cellulitis (0.15%), two vesicovaginal fistulas and one rectovaginal fistula (0.15%). Among late post-surgical complications (33.6%) there were 77 granulomas or prosthetic expositions (11.3% [6.7% in the vaginal anterior wall, 2.1% in the vaginal posterior wall and 4.8% in the fornix]), 80 prosthetic retractions (11.7%), 36 relapse of prolapse (6.9%) and 37 SUI de novo (5.4%). Multivaried analysis shows that previous history of hysterectomy or placing of an isolated anterior prosthesis increase the risk of peri-surgical complication; preserved uterus and isolated posterior prosthesis lessen the risk of granulomas and prosthetic retractions; and association of a Richter's intervention increases the rate of prosthetic retractions. CONCLUSION: Cure of genital prolapse with synthetic prostheses interposed by vaginal route is now reliable and can be reproduced with a low rate of peri- and early post-surgical complications. However, our study shows a certain number of late post-surgical complications after insertion of strengthening synthetic vaginal implants (prosthetic expositions and prosthetic retractions). These retrospective results will soon be compared to a prospective study.

Is a breech presentation at term more frequent in women with a history of cesarean delivery?

OBJECTIVE: The purpose of this study was to determine whether breech presentation at term is more common among women with at least 1 previous cesarean delivery. STUDY DESIGN: This historic cohort study (n = 84,688) included women with a singleton term pregnancy and at least 1 previous delivery. Results were expressed as crude relative risks and adjusted odds ratios. RESULTS: While 2.46% of women had a fetus in breech presentation at term, 14.91% of women had had 1 or more previous cesareans. The relative risk of a breech presentation at term for women with a history of cesarean was 2.18 (95%CI: 1.98-2.39). It did not differ according to the number of previous cesareans. The logistic regression analysis took into account confounding factors including gestational age, maternal age, parity, birthweight, and oligohydramnios. The adjusted odds ratio was 2.12 (95%CI: 1.91-2.36). CONCLUSION: Women with previous cesarean deliveries have a risk of breech presentation at term twice that of women with previous vaginal deliveries.

The safety of the inside-out transobturator approach for transvaginal tape (TVT-O) treatment in stress urinary incontinence: French registry data on 984 women.

This study examines the safety of the inside-out transobturator approach for transvaginal tape (TVT-O, Gynaecare) treatment in stress urinary incontinence (SUI) in women based on a French registry of patients. A total of 984 women from 86 centres were enrolled in the study. Patients with predominant overactive bladder or significant pelvic organ prolapse were excluded from the study. Perioperative and post-operative complications were reported as well as urinary function at 4 and 12 weeks. Pain was assessed by the patients using a visual analog scale (VAS). The overall perioperative complication rate was 2.2%. The most commonly reported morbidities were vaginal wall perforation (1.3%) followed by haematoma (0.7%). Post-operative complication rate was 5.2%; the most common complication was residual pain (2.7%). The other complications of paravesical haematoma, urinary retention, vaginal erosion and re-intervention had an incidence of less than 1.0%. This study demonstrates that the transobturator transvaginal tape approach to the treatment of SUI is a safe procedure.

Prospective multicenter clinical trial of Uretex Sup for surgical treatment of stress urinary incontinence.

AIM: To evaluate in a prospective multicenter study the efficacy and safety of the suburethral support Uretex (Sofradim, Trevoux, France) delivered by a suprapubic approach in the treatment of female stress urinary incontinence. METHODS: Between March 2002 and March 2003, 57 patients were treated for stress urinary incontinence with Uretex. Preoperative evaluation included urodynamic examination and questionnaires (symptoms and quality of life, Contilife). Forty patients had pure stress urinary incontinence and 17 mixed urinary incontinence. No associated procedure was performed. The objective cure rate was evaluated by clinical examination and pad-test, and the subjective cure rate was assessed through questionnaires at 1, 3 and 12 months. RESULTS: The mean follow-up was 13 months (range 11-24 months). During follow up, chronic urinary retention requiring a tape section occurred in one patient, and in another patient a delay of vaginal healing was followed by a sling exposure and resection at 4 months. No infection or urethral erosion was reported. The objective cure rate was 96.2%, and the subjective cure rate was 79.2%; four patients reported low leakage on stress and nine patients complained of urge incontinence (four de novo and five persistent). CONCLUSION: The suprapubic Uretex Sup procedure is a safe and effective treatment for women with stress urinary incontinence.

Human choriocarcinoma cell line JEG-3 produces and secretes active retinoids from retinol.

Vitamin A (retinol) and its active derivatives (the retinoids) are essential for growth and development of the mammalian fetus. Maternally-derived retinol has to pass through the placenta to reach the developing fetus. Despite its apparent importance, little is known about placental metabolism of retinol, and particularly placental production and/or secretion of active retinoids. It has been previously considered that retinoids are recruited from the uterine environment to influence placental development and function during gestation. We have studied retinoid metabolism in the human choriocarcinoma cell line JEG-3 and demonstrate, for the first time, that active retinoids are produced endogenously by the JEG-3 cell line from retinol. These retinoids induce gene expression from a retinoic acid-responsive enhancer element reporter plasmid and modulate placental transglutaminase activity. Furthermore, retinoids are secreted from JEG-3, as shown by the activation of retinoic acid-responsive beta lacZ reporter cells grown in conditioned media. These results suggest that there could be an active role for trophoblast-derived retinoids during human development.