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.

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.

Early secondary repair of labial tears, 1st and 2nd degree perineal lacerations and mediolateral episiotomies in a midwifery-led clinic. A retrospective evaluation of cases based on photo documentation.

OBJECTIVES: To examine whether early secondary repair of labial tears, 1st and 2nd degree perineal lacerations and episiotomies provided an anatomically acceptable result. STUDY DESIGN: A retrospective analysis of 126 women undergoing an early secondary repair of birth lacerations not involving the sphincter complex within 21 days postpartum. Patients were included from 1 January 2014 to 11 August 2017 at Aarhus University Hospital, Denmark. Photo documentation of the wound was available just before the early secondary repair and at the follow-up visit after the repair. Photos were evaluated by two trained Urogynaecological Consultants. MAIN OUTCOME MEASURES: Whether the anatomic result of the early secondary repair was acceptable based on photo documentation. RESULTS: Early secondary repair was performed by a specialised team of midwives in 94.4% and by doctors in 5.6% of the cases. In all, 72.2% were 2nd degree perineal lacerations. The most common indications for early secondary repair were wound dehiscence (55.3%) and suboptimal primary repair (34.1%). At the follow-up clinical examination seven days after the early secondary repair, the result was considered anatomically acceptable in 67.5% of the cases, not optimal in 22.2% and not possible to evaluate in 10.3% of the cases. In 7.9% of the cases, wound infection was suspected after the early secondary repair. CONCLUSIONS: Based on photo documentation, early secondary repair of birth lacerations not involving the sphincter complex provides an anatomically acceptable result in the majority of cases without risk of serious complications.

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.

Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study.

INTRODUCTION AND HYPOTHESIS: The objective was to assess safety and clinical outcomes in women operated on using the Uphold™ Lite Vaginal Support System. METHODS: We carried out a 1-year, multicenter, prospective, single cohort study of 207 women with symptomatic Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 apical pelvic organ prolapse, with or without concomitant anterior vaginal wall prolapse. Safety data were collected using a standardized questionnaire. Anatomical outcome was assessed by the POP-Q and subjective outcomes by the Pelvic Floor Distress Inventory after 2 months and 1 year using a one-way repeated measures analysis of variance. Pain was evaluated using a visual analog scale. RESULTS: The overall rate of serious complications was 4.3 % (9 out of 207 patients), including 3 patients with bladder perforations, 1 with bleeding >1,000 ml, 2 who had undergone re-operations with complete mesh removal because of pain, and 3 surgical interventions during follow-up because of mesh exposure. POP-Q stage ≤1 after 1 year was 94 % and subjective symptom relief was reported by 91 % of patients (p < 0.001). Pain after 2 months and 1 year was 60 % lower compared with the preoperative mean (p < 0.001). Minor complications occurred in 20 women (9.7 %) and were dominated by lower urinary tract dysfunction. No predisposing risk factors for complications were found. CONCLUSIONS: The Uphold™ Lite procedure in women with apical pelvic organ prolapse provided satisfactory restoration of vaginal topography and symptom relief. However, serious complication rates were largely comparable with those of other transvaginal mesh kits.

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.

A modified surgical technique for treatment of radiation-induced vesicovaginal fistulas.

OBJECTIVE: To present a modified surgical technique in the management of radiation-induced vesicovaginal fistulas. Radiation-induced vesicovaginal fistulas pose a great challenge to the treating surgeon owing to the fibrotic, poorly vascularized tissue in the area. Various techniques have been used to promote healing and prevent fistula recurrence, but most centers still recommend urinary diversion or more individualized management. MATERIALS AND METHODS: We used the left rectus abdominis muscle based on the deep inferior epigastric vessels as an interposition flap in 3 patients presenting with vesicovaginal fistulas 19, 28, and 34 years after radiotherapy for cervical cancer. The fistulas were isolated using an abdominal approach, and the distal half of the left rectus abdominis muscle was mobilized. Without closure of the 2 defects, the muscle was then interposed between the bladder and vagina, where it was fixed using single sutures around the edges of the 2 defects. The operations were performed by a team that included both a urologist and a plastic surgeon. RESULTS: All 3 patients underwent successful treatment. With a follow-up of 5-8 years, there has been no recurrence of symptoms. CONCLUSION: This modified surgical technique offers well-vascularized, nonirradiated tissue to be used as an interposition flap based on the inferior epigastric vessels in the management of radiation-induced vesicovaginal fistulas. The technique allows obstruction of the fistula without the need for closure of the mucosal defects in the bladder and vagina.

Anterior vaginal wall repair using local anaesthesia.

BACKGROUND: The purpose of the present study was to describe the possibility of surgical repair of anterior vaginal prolapse including amputation of the cervix using local anaesthesia. The description was made according to postoperative complication, recurrence rate, influence on urinary incontinence, and satisfaction of the patient. MATERIAL AND METHODS: Eighty-three women were consecutively operated in the anterior wall of the vagina using local anaesthesia and intravenously supplemented with propofol and fentanyl if needed, from January 1998 until September 2000 at a university clinic in Denmark. Operations executed by 16 different surgeons. Seventy patients were operated exclusively by anterior vaginal wall repair, 13 women were operated by other kinds of vaginal repair at the same time. All patients but one were interviewed by telephone. Ten patients reporting a sense of recurrence were called in for clinical examination. RESULTS: The median age was 64.5 years (range 37-85). The median follow-up period was 12.5 months (range 3-35). Median time of the operation was 25 min (range 10-60) including all patients, 20 min (range 10-60) for the patients solely operated in the anterior vaginal wall. The median time spent in hospital was 1 day (range 0-4). One patient was readmitted. Seven patients (8.4%) suffered from complications postoperatively including the patient readmitted, four of these patients were reoperated. By interview 10 women (12%) reported symptoms of prolapse again. By examination two women (2.4%) were diagnosed as recurrence, and were offered a new operation using local anaesthesia. The incontinence patterns before and after the operation are described. Seventy-nine women (95.2%) were totally satisfied with the type of anaesthesia, two women would not choose local anaesthesia for an eventually new operation, one patient did not know, and one patient was unsolved. CONCLUSIONS: The study illustrates an acceptable duration of the operation despite many different surgeons, a need of short time postoperative observation, low postoperative complication rate, low recurrence rate, and a high level of satisfaction reported by the patients. Surgical repair of anterior vaginal prolapse using local anaesthesia is described according to postoperative complication, recurrence rate, influence on urinary incontinence, and satisfaction of the patient. It is concluded that this way of handling anterior vaginal prolapse is suitable for all kinds of patients and in the out-patient clinic.