Treatment and survival of Norwegian cattle after uterine prolapse.

BACKGROUND: Bovine uterine prolapse is a sporadic but life-threatening postpartum condition. The aims of this study were; (i) to determine which clinical findings determined the likelihood of treatment vs. culling, (ii) to identify the treatment methods currently employed by Norwegian veterinary surgeons and evaluate their effect on survival, (iii) to determine if clinical findings at the time of treatment could be used to determine prognosis. Practicing veterinary surgeons in Norway were contacted and asked to fill out a questionnaire on cases of bovine uterine prolapse they attended between February and October 2012. The questionnaires gathered data on signalment, clinical presentation, treatment, and outcome. These data were supplemented with culling data from the Norwegian Dairy and Beef Herd Recording Systems. The chi-squared test and logistic regression modelling was performed to identify likelihood of treatment and cox proportional hazard modelling was performed to identify the hazard of death after treatment. RESULTS: Data from 126 cases of bovine uterine prolapse were collected (78 beef and 48 dairy cows). Twenty-six cows (21%) were emergency slaughtered, or underwent euthanasia, without treatment. Of the remaining 100 cases amputation of the uterus was performed once and repositioning was performed in 99 cases. Survival data were missing from 2 of the cases that had undergone treatment leaving a study sample of 97 cases (64 beef and 33 dairy cows). Multivariable logistic regression analysis of the explanatory variables showed that beef cows were more likely to be treated than dairy cows (OR = 0.32, 95% CI 0.13 to 0.81, P = 0.017) and that cows with a significantly oedematous or traumatised uterus were less likely to be treated (OR = 0.26, 95% CI 0.10 to 0.67, P = 0.006). Treatment methods amongst Norwegian practitioners were broadly similar. In a multivariable model cows general clinical state at time of treatment was positively correlated with survival (HR = 0.29, 95% CI 0.29 to 0.73, P = 0.008) and a history of a vaginal prolapse prepartum increased the hazard of death (HR = 2.31, 95% CI 1.08 to 4.95, P = 0.031) in the first 30 days after treatment of a uterine prolapse. In the first 180 days after treatment only veterinary assessment of a cows' general clinical state was correlated with hazard of death (HR = 0.432, 95% CI 0.20 to 0.91, P = 0.046). CONCLUSIONS: This study shows that the production system and extent of uterine damage affect the likelihood of treatment, and that practitioners use similar treatment methods. A cows' general clinical state at time of treatment was positively correlated with survival, and a history of a vaginal prolapse prepartum increased the hazard of death in the first 30 days after treatment of a uterine prolapse.

Transvaginal repair of anterior vaginal wall prolapse with polyvinylidene fluoride (PVDF) mesh: an alternative for previously restricted materials?

INTRODUCTION AND HYPOTHESIS: To study the mid-term safety and functional outcomes of transvaginal anterior vaginal wall prolapse repair using polyvinylidene fluoride (PVDF) mesh (DynaMesh®-PR4) by the double trans-obturator technique (TOT). METHODS: Between 2015 and 2020, we prospectively included women with symptomatic high-stage anterior vaginal wall prolapse with or without uterine prolapse or stress urinary incontinence (SUI) in the study. The patients underwent transvaginal repair of the prolapse using PVDF mesh in two medical centers. We followed all patients for at least 12 months. We recorded the characteristics of vaginal and sexual symptoms, urinary incontinence, and prolapse stage pre- and postoperatively using International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF), and Pelvic Organ Prolapse Quantification (POP-Q) system, respectively. RESULTS: One hundred eight women were included in the final analysis with a mean follow-up time of 34.5 ± 18.6 months. The anatomical success was achieved in 103 (95.4%) patients. There was a significant improvement in patients' vaginal symptoms, urinary incontinence, and quality of life scores postoperatively (p < 0.0001). Only six patients (5.5%) had mesh extrusion, five of whom were managed successfully. The total rates of complications and de novo urinary symptoms were 21.3% and 7.4%, respectively. Significant pain was reported in 17 cases (15.7%). CONCLUSION: Our findings show that using PVDF mesh in the double TOT technique for anterior vaginal wall prolapse repair is a safe procedure with high anatomic and functional success rates and acceptable complication rates in mid-term follow-up.

Extending the limits of vaginal hysterectomy under local anesthesia and conscious sedation.

INTRODUCTION AND HYPOTHESIS: In this video we present the surgical management of a 58-year-old woman presenting with a large prolapsed myomatous uterus treated with vaginal hysterectomy (VH) and pelvic floor repair (PFR) (uterosacral ligament suspension and posterior colporraphy) under local anesthesia and conscious sedation. METHODS: The patient underwent VH and PFR by using an infiltration of a local anesthetic solution of lidocaine, ropivacaine and adrenaline in combination with intravenous (iv) conscious sedation. Debulking techniques, such as intramyometrial coring, uterine bisection, myomectomy and wedge resection, were used to facilitate VH. The final weight of the removed uterus was 870 g. RESULTS: This video demonstrates that performing a surgically challenging VH under local anesthesia is feasible. CONCLUSIONS: Vaginal uterine morcellation can be performed to debulk the enlarged uterus so that hysterectomy can be accomplished under local anesthesia. The use of local anesthesia may safely be offered as an alternative to patients undergoing a complex vaginal hysterectomy and reconstructive surgery.

An alternative technique in surgical correction of anterior compartment prolapse; Iliococcygeal fixation of the pubocervical fascia by native tissue repair.

AIM: To present 'bilateral iliococcygeal fixation of the pubocervical fascia' as an alternative vaginal surgical technique for anterior compartment repair with native tissue and the surgical outcomes of 30 cases. MATERIALS-METHODS: The consecutive 30 cases who admitted to urogynecology clinic with anterior vaginal prolapse/cystocele and underwent anterior compartment repair by bilateral iliococcgeal fixation of the pubocervical fascia by native tissue were included to the study. All cases attended to the postoperative follow-up visits at the sixth and the twelfth months. RESULTS: There were no major or minor intraoperative complications. Overall, in 28 (93.3 %) patients surgical success was achieved at the postoperative 12th month when it was defined as the maximum descent of the anterior segment was proximal to the hymen. During the study period, none of the patients requested or admitted for re-treatment for anterior compartment prolapse. Subjective cure that was assessed by the absence of bulge symptoms was achieved in 29 cases (96.7 %) at first year follow-up. Lower urinary tract symptoms (LUTS) were found to be significantly lower at the first-year postoperative visit compared to pre-operative evaluation. A clinically significant improvement in the quality of life parameters were also noted (mean PFIQ-7 scores = 8.5, 5.6 and 50.8, respectively). CONCLUSION: Bilateral iliococcygeal fixation of the pubocervical fascia seems to be effective in surgical correction of anterior vaginal prolapse according to our post-operative follow-up results. It is an easy to learn procedure with low complication rates and associated with high patient satisfaction.

Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial.

OBJECTIVE: To evaluate the effectiveness and success of uterus preserving sacrospinous hysteropexy as an alternative to vaginal hysterectomy with uterosacral ligament suspension in the surgical treatment of uterine prolapse five years after surgery. DESIGN: Observational follow-up of SAVE U (sacrospinous fixation versus vaginal hysterectomy in treatment of uterine prolapse ≥2) randomised controlled trial. SETTING: Four non-university teaching hospitals, the Netherlands. PARTICIPANTS: 204 of 208 healthy women in the initial trial (2009-12) with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery who had been randomised to sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. The women were followed annually for five years after surgery. This extended trial reports the results at five years. MAIN OUTCOME MEASURES: Prespecified primary outcome evaluated at five year follow-up was recurrent prolapse of the uterus or vaginal vault (apical compartment) stage 2 or higher evaluated by pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse. Secondary outcomes were overall anatomical failure (recurrent prolapse stage 2 or higher in apical, anterior, or posterior compartment), composite outcome of success (defined as no prolapse beyond the hymen, no bothersome bulge symptoms, and no repeat surgery or pessary use for recurrent prolapse), functional outcome, quality of life, repeat surgery, and sexual functioning. RESULTS: At five years, surgical failure of the apical compartment with bothersome bulge symptoms or repeat surgery occurred in one woman (1%) after sacrospinous hysteropexy compared with eight women (7.8%) after vaginal hysterectomy with uterosacral ligament suspension (difference-6.7%, 95% confidence interval -12.8% to-0.7%). A statistically significant difference was found in composite outcome of success between sacrospinous hysteropexy and vaginal hysterectomy (89/102 (87%) v 77/102 (76%). The other secondary outcomes did not differ. Time-to-event analysis at five years showed no differences between the interventions. CONCLUSIONS: At five year follow-up significantly less anatomical recurrences of the apical compartment with bothersome bulge symptoms or repeat surgery were found after sacrospinous hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension. After hysteropexy a higher proportion of women had a composite outcome of success. Time-to-event analysis showed no differences in outcomes between the procedures. TRIAL REGISTRATION: trialregister.nl NTR1866.

A randomized double-blind placebo-controlled trial on the effect of local analgesia on postoperative gluteal pain in patients undergoing sacrospinous ligament colpopexy.

BACKGROUND: The incidence of temporary gluteal pain after sacrospinous ligament colpopexy ranges from 6.1% to 15.3%. Gluteal pain may occur as a result of injury to S3 to S5 nerve roots that course over the mid-portion of the coccygeus-sacrospinous ligament complex at the time of suspension suture placement. There are no data on the use of injections to prevent postoperative pain from nerve entrapment at the time of suture placement. OBJECTIVE: The purpose of this study was to determine whether intraoperative local analgesia that is administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by patients postoperatively after sacrospinous ligament colpopexy. STUDY DESIGN: In a randomized double-blind placebo-controlled trial, women with vaginal apex prolapse who were undergoing surgical treatment with sacrospinous ligament colpopexy underwent intraoperative injection with either 0.25% bupivacaine or normal saline solution. Subjects completed visual analog pain scales (0-10) and the Activities Assessment Scale and recorded the use of pain medications over a 6-week period. The primary outcome was postoperative gluteal pain. A sample size of 50 subjects (25 in each arm) was planned to test the hypothesis that local analgesia administration will lessen postoperative pain compared with placebo. RESULTS: Between April 2014 and March 2016, 51 women were enrolled in the study, and 46 women underwent sacrospinous ligament colpopexy. On postoperative day 1, 90.2% of all subjects (n=41) reported gluteal pain. At weeks 1 and 2, 63.8% (n=29) and 44.1% (n=20) women reported pain; at weeks 4 and 6, 33.3% (n=15) and 26.9% (n=12) women continued to have some pain. On day 1, the mean score for gluteal pain was 3.7±2.9. By week 1, the score was 1.8±2.6; by week 6, the mean score was 0.1±0.3. There were no differences in pain scores for patients who had undergone injection with 0.25% bupivacaine and those who were injected with normal saline solution. Patients in the placebo group used significantly more nonsteroidal antiinflammatory drugs than the treatment group: adjusted odds ratio, 1.25; 95% confidence interval, 1.04-1.35; P=.01). By 6 weeks, 87.5% of patients had returned to their baseline "light" activity level. There was no difference in time to return to baseline between the groups. CONCLUSION: Intraoperative administration of local analgesia does not reduce patients' perceptions of postoperative gluteal pain after sacrospinous ligament colpopexy; however, it may reduce the need for pain medication after surgery.

Colpopexia al ligamento sacroespinoso con CapioTM; cirugía, resultados y evolución de pacientes / Sacroespinous ligament colpopexy with CapioTM; surgery patient outcomes and evolution

Introducción: El prolapso genital femenino altera significativamente la calidad de vida de la mujer. El prolapso apical es el segundo más frecuente después del defecto de pared anterior y la colposuspensión al ligamento sacroespinoso es una de las técnicas quirúrgicas descritas para su tratamiento. Objetivos: Determinar la factibilidad de la corrección del prolapso apical en pacientes sometidas a la colposuspensión al ligamento sacroespinoso, utilizando el dispositivo de captura de sutura CapioTM. Materiales y métodos: Análisis retrospectivo de pacientes intervenidas desde junio de 2015 a junio de 2016, en la unidad de piso pélvico del Hospital Luis Tisné Brousse, basándose principalmente en la evaluación del punto C del Prolpase Organ Pelvic Quatinfication (POP-Q). Resultados: Se intervinieron 15 pacientes, con edad promedio de 60,7 ± 6,8 años. Todas presentaron prolapso genital estadio III o IV. El seguimiento se realizó entre 3 y 13 meses después de la cirugía. Ninguna presentó complicaciones graves durante ni después de la cirugía y sólo una paciente recidivó. Conclusiones: La colposuspensión al ligamento sacroespinoso con CapioTM, es una técnica factible, segura y eficaz para el tratamiento del prolapso apical, sin embargo, es necesario mayor tiempo de seguimiento y estudios comparativos con otras técnicas de colposuspensión.

Introduction: Female genital prolapse significantly alter the quality of life of women. The apical prolapse is the second common defect after anterior wall and the colposuspension to sacrospinous ligament is one of the described surgical techniques for its treatment. Objective: To determine the feasibility of apical prolapse correction in patients undergoing sacrospinous colposuspension using the suture capture device CapioTM. Methods: Retrospective analysis of patients undergoing this surgery from June 2015 to June 2016, including an objective assessment focused mainly in the C point of Prolapse Organ Pelvic Quatinfication (POP-Q) and a subjective evaluation of the patient. Results: 15 patients, of which only 11 were able to complete follow-up, were included. The mean age of the patients at the time of surgery was 60.7 ± 6.8 years, and all were classified as prolapse stages III or IV. The evaluation was performed in average 6.75 ± 3.39 months after surgery, with a minimum of 3 and a maximum of 13 months. No patient had several complications during or after surgery and only one recurred. Conclusions: The colposuspension to sacrospinous ligament with CapioTM is a safe and effective alternative for the treatment of apical genital prolapse. However, a longer follow-up study is needed, in addition to comparative studies with other colposuspension techniques.

Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol).

BACKGROUND: Pelvic organ prolapse is a common health problem: the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19%. Pelvic organ prolapse has significant negative effects on a woman's quality of life. Worldwide, vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Therefore, we conducted the LAVA trial. METHODS: The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher. The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and general quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness. Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually till 60 months after surgery. Validated questionnaires will be used.Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and a non-inferiority margin of 10%, 62 patients are needed in each arm to prove the hypothesis with a 95% confidence interval. DISCUSSION: The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR4029.

[Sling suspension: a new technique of treating uterine prolapse].

OBJECTIVE: To report a novel surgical technique of laparoscopic extraperitoneal sling suspension for uterine prolapse and evaluate its efficacy. METHODS: A total of 21 consecutive patients of symptomatic uterovaginal prolapse with POP-Q (pelvic organ prolapse quantification system) stage ≥ 2 and aged 59 (42-76) years were enrolled for this procedure between September 2011 and December 2012. In brief, uterus was suspended to anterior abdominal wall fascia using an inelastic nonabsorable mesh extraperitoneally under laparoscopic guidance. The outcomes of interest included total operative duration, estimated blood loss, surgical length of stay POP-Q score change and quality of life questionnaire in pelvic floor distress inventor [PFDI-20] and pelvic floor impact questionnaire [PFIQ-7]. Follow-ups were scheduled at 1, 6 and 12 months and then annually. Comparisons were made between at preoperation and 6 and 12 months. The surgical success was defined as both subjective cure and significant improvement of POP-Q. RESULTS: This procedure was performed successfully in all patients. The estimated blood loss 10 (10-40) ml, operative duration 30 (25-90) minutes and postoperative hospital stay 1 (1-5) day. There were no major intraoperative or postoperative complications. The median follow-up was 20 (12-26) months. There were significant improvements in POP-Q measurements of Ba and C (P < 0.01) and quality-of-life scores (P < 0.01) at 6 and 12 months. The subjective cure rate was 100% and surgical success rate at 12 months 100%. CONCLUSION: This new sling suspension technique for uterine prolapse is safe, well-tolerated and effective so that it offers a simple alternative of laparoscopic uterine suspension.

Gluteal and posterior thigh pain in the postoperative period and the need for intervention after sacrospinous ligament colpopexy.

INTRODUCTION: Sacrospinous ligament (SSL) colpopexy is a transvaginal surgical option for the treatment of vaginal apex prolapse. The objective of this study was to determine the rate of gluteal and posterior thigh pain after SSL colpopexy using the Capio device in the immediate postoperative period, at the 6-week postoperative visit, and to determine the risk of needing intervention for this type of pain. METHODS: This was a retrospective cohort study of women who underwent SSL colpopexy with the Capio device for the treatment of vaginal apex prolapse between 2007 and 2012. The electronic inpatient and outpatient medical record was queried for demographic, intraoperative, and immediate and 6-week postoperative data. RESULTS: Two hundred forty-two subjects underwent SSL colpopexy with the Capio device for vaginal apex prolapse. Mean age and body mass index were 66 (10) years and 28.7 (5.4) kg/m, respectively. One hundred thirty-four (55.4%) subjects were found to have immediate gluteal or posterior thigh pain and 36 (15.3%) were found to have persistent pain at 6 weeks. Five (2.1%; 95% confidence interval, 0.8%-4.7%) subjects required intervention: physical therapy (3), trigger point injection (1), both (1), and no patients required reoperation. Concomitant midurethral sling placement was associated with pain at 6 weeks (P = 0.008). Need for intervention was associated with the number of sutures placed (2 or 3 vs 4; P = 0.03). Concomitant hysterectomy and approach to SSL colpopexy were not associated with gluteal or posterior thigh pain. CONCLUSIONS: The rate of immediate postoperative gluteal and posterior thigh pain is high in patients undergoing SSL colpopexy for vaginal apex prolapse; however, the rate of pain at 6 weeks is much lower, and the need for intervention is even lower.

Bowel preparation before vaginal prolapse surgery: a randomized controlled trial.

OBJECTIVE: To compare surgeons' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery. METHODS: In this single-blind, randomized trial, women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group. Surgeons were blinded to patient allocation. One day before surgery, mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas; the participants in the control group sustained a regular diet and nothing by mouth after midnight. The primary outcome was surgeons' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale (1, excellent; 4, poor). Secondary outcomes included participant satisfaction and bowel symptoms. The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol. RESULTS: Of the 150 women randomized (75 women to intervention and control group), 145 completed the study. No differences existed in the demographic, clinical, and intraoperative characteristics between groups (P>.05). Surgeons' intraoperative assessment rating was 85% "excellent or good" with bowel preparation compared with 90% for participants in the control group (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.21-1.61; P=.30). The bowel preparation group was less likely to report "complete" satisfaction compared with the participants in the control group (OR 0.11, 95% CI 0.04-0.35; P<.001). Abdominal fullness and cramping, fatigue, anal irritation, and hunger pains were greater in the bowel preparation group (all P<.01). CONCLUSION: Before reconstructive vaginal surgery, mechanical bowel preparation conferred no benefit regarding surgeons' intraoperative assessment of the operative field, reflected decreased patient satisfaction, and had increased abdominal symptoms. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01431040. LEVEL OF EVIDENCE: I.

Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT.

INTRODUCTION AND HYPOTHESIS: To compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009. The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery. Secondary endpoints consisted of functional results and mesh-related morbidity. RESULTS: One hundred and forty-seven patients were included, randomized and analyzed: 72 in the anterior colporrhaphy group and 75 in the mesh group. The anatomical success rate was significantly higher in the mesh group (89%) than in the colporrhaphy group (64%) (p = 0.0006). Anatomical and functional recurrence was also less frequent in the mesh group (31.3% vs 52.2%, p = 0.007). Two patients (2.8%) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence. No significant difference was noted regarding minor complications. An erosion rate of 9.5% was noted. De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group. An analysis of the quality of life questionnaires showed an overall improvement in both groups, with no statistical difference between them. Satisfaction rates were high in both groups (92% in the colporrhaphy group and 96% in the mesh group). CONCLUSION: Trans-obturator Ugytex mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy, but with small a increase in morbidity in the mesh group.

Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial).

BACKGROUND: Pelvic organ prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant negative influence on quality of life. Vaginal hysterectomy is currently the leading treatment method for patients with symptomatic uterine prolapse. Several studies have shown that sacrospinous fixation in case of uterine prolapse is a safe and effective alternative to vaginal hysterectomy. However, no large randomized trials with long-term follow-up have been performed to compare efficacy and quality of life between both techniques.The SAVE U trial is designed to compare sacrospinous fixation with vaginal hysterectomy in the treatment of uterine prolapse stage 2 or higher in terms of prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery and sexual functioning. METHODS/DESIGN: The SAVE U trial is a randomized controlled multi-center non-inferiority trial. The study compares sacrospinous fixation with vaginal hysterectomy in women with uterine prolapse stage 2 or higher. The primary outcome measure is recurrence of uterine prolapse defined as: uterine descent stage 2 or more assessed by pelvic organ prolapse quantification examination and prolapse complaints and/or redo surgery at 12 months follow-up. Secondary outcomes are subjective improvement in quality of life measured by generic (Short Form 36 and Euroqol 5D) and disease-specific (Urogenital Distress Inventory, Defecatory Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments, complications following surgery, hospital stay, post-operative recovery and sexual functioning (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and considering an upper-limit of 7% to be non-inferior (beta 0.2 and one sided alpha 0.025), 104 patients are needed per group. DISCUSSION: The SAVE U trial is a randomized multicenter trial that will provide evidence whether the efficacy of sacrospinous fixation is similar to vaginal hysterectomy in women with uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1866.

Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy.

INTRODUCTION AND HYPOTHESIS: This study seeks to compare the small intestine submucosa (SIS) graft with traditional colporrhaphy (TC) for surgical treatment of anterior vaginal prolapse. METHODS: Subjects were randomly assigned to SIS (n = 29) or to TC (n = 27) preoperatively and outcomes analyzed at 12 months postoperatively. The primary outcome was the absence of POP-Q stage >or= II prolapse, and secondary outcome was improvement in quality of life. Data were compared with independent samples or paired Student's t test. RESULTS: SIS group had 86.2% anatomic cure compared to 59.3% in TC (p = 0.03). SIS improved point Ba measurement significantly (-1.93 cm versus -1.37 cm, p = 0.02). Both operations significantly improved quality of life, although there were no differences between the groups. We observed a greater number of complications in the SIS group, with no infections or erosion. CONCLUSIONS: SIS repair improved point Ba significantly. However, there were no differences observed in quality of life between the techniques.

Successful use of botulinum toxin type a in the treatment of refractory postoperative dyspareunia.

BACKGROUND: Refractory dyspareunia presents a challenging therapeutic dilemma. CASE: A woman with defecatory dysfunction and dyspareunia presented with stage 2 prolapse. She underwent laparoscopic and vaginal pelvic floor reconstruction with excision of endometriosis. The patient experienced increased dyspareunia and de novo vaginismus postoperatively that were refractory to trigger point injections, physical therapy, and medical and surgical management. She underwent botulinum toxin type A injections into her levator ani muscles, which allowed her to have sexual intercourse again after 2 years of apareunia with no recurrence of pain for 12 months. CONCLUSION: Injecting botulinum toxin into the levator ani muscles shows promise for postoperative patients who develop vaginismus and do not respond to conservative therapy.

New concepts and trends in vaginal prolapse surgery.

Despite poor results in prolapse surgery, the operative procedures have basically remained unchanged for 100 years. It has been postulated that lifting restrictions and other measures of inactivation are crucial for the success. Even though most of what is done in prolapse repair is not evidence based, few have challenged the prevailing concepts. However, tradition-based policies are now being scrutinized and in accordance with other operations, time of hospitalization is sharply reduced at many institutions. The reintroduction of local anesthesia and sedation offers potential advantages compared to regional- or general anesthesia. Although augmentation by foreign material is not altogether a new concept, the introduction of commercial kits make mesh procedures more standardized, but not necessarily technically more easy to perform. As molecular biology provides more and more evidence about the importance of the quality of the connective tissue, it is conceivable that foreign material in prolapse repair is here to stay. In this period of time it is more essential than ever to scientifically document the results of the new concepts. In the Nordic countries, where the first registries were set up for Tensionfree Vaginal Tape (TVT), a cooperative effort among 53 institutions is under way to evaluate mesh repairs in prolapse surgery.

Corrosive-induced vesicovaginal fistula with procidentia: a rare occurrence.

Vesicovaginal fistula (VVF) has huge physical, psychological and, above all, social implications in a woman's life. It has always been a challenge for the urogynaecologic surgeons to manage VVF. VVF can be caused by unrelieved obstructed labour, pelvic surgery, malignancies, radiation therapy, infection and trauma. Here we report a case of VVF caused by the application of a mixture of chemicals in a female with longstanding pelvic organ prolapse. This occurrence is unique by virtue of aetiology and to the best of our knowledge is only the second of its kind reported till date. We have also explained the operative technique used to combine both the prolapse and the fistula repair into a single operation that achieved excellent functional results.

The effect of local anaesthetic infiltration on urethral function during the tension-free vaginal tape (TVT) procedure.

Different anaesthetic techniques are used for the tension-free vaginal tape (TVT) procedure. Using local anaesthetic and spinal techniques allows surgeons to adjust sling tension with the cough test. The aim of this study was to asses whether the periurethral infiltration of the local anaesthetic technique for TVT results in a significant alteration in urethral function. Twenty-five women who underwent a TVT procedure for stress incontinence were studied prospectively. Urethral function was assessed with the urethral retro-resistance pressure (URP) before and after the infiltration of local anaesthetic. Paired t tests were used to compare values. The mean URP value was 48.0 cm/H2O (SD, 18.4) before and 52.0 cm/H2O (SD, 34.5) after the periurethral infiltration of local anaesthetic. There was no statistical significance between the two groups (p = 0.37). Local anaesthetic does not alter urethral function, as measured by URP, allowing coughing to mimic non-anaesthetic conditions.

Graft interposition colpocleisis, perineorrhaphy, and tension-free sling for pelvic organ prolapse and stress urinary incontinence in elderly patients.

STUDY OBJECTIVE: We sought to describe the outcome of combined colpocleisis, perineorrhaphy, and tension-free sling procedure for advanced uterovaginal prolapse and stress urinary incontinence in patients who are elderly and medically compromised. DESIGN: Prospective analysis. SETTING: University hospital. PATIENTS: Thirty-nine women were enrolled. Median age of patients was 82 years (76-94 years). INTERVENTIONS: All patients had advanced uterovaginal prolapse with perineal relaxation and incontinence and each wore a large pessary. MEASUREMENTS AND MAIN RESULTS: Median estimated blood loss was 42 mL (range 10-65 mL), median operating time was 58 minutes (range 45-76 minutes), and median hospital stay was 8 hours (range 0-3 days). Thirty procedures were accomplished without general anesthesia. Le Fort colpocleisis was reinforced with excessive mesh strips from the sling by placing mesh between anterior and posterior vaginal walls at the time of closure. No intraoperative complications occurred and none had postoperative voiding difficulty or significant discomfort. One patient required hospitalization for cardiac arrhythmias and 3 others for observation purposes only. Median follow-up has been 24 months. Follow-up physical examinations were performed for postoperative evaluation. One patient required reoperation for minor posterior compartment prolapse and another has started to show some apical prolapse again. Neither patient had a perineorrhaphy at the time of initial procedure. Two patients required some graft excision as a result of exposure from the side without any loss of support or discomfort. In all, 37 patients (37 of 39) are extremely pleased with the prolapse repair and 35 patients (35 of 39) report significant improvement of stress incontinence. CONCLUSION: Concomitant severe pelvic organ relaxation and stress urinary incontinence can be surgically treated safely and rapidly using a tension-free sling and colpocleisis with perineorrhaphy under local anesthesia and sedation, thereby eliminating potential risks of general anesthesia and invasive surgery. A novel technique of graft interposition colpocleisis has been used.