New TENSI+ Device for Transcutaneous Posterior Tibial Nerve Stimulation: A Prospective, Multicentre, Post-market Clinical Study.

BACKGROUND AND OBJECTIVE: Our aim was to report the first clinical trial of TENSI+, a new device for transcutaneous posterior tibial nerve stimulation (TNS) for treatment of overactive bladder (OAB). METHODS: A prospective, multicentre clinical trial was conducted in adults with OAB in seven French centres. The main exclusion criteria were prior percutaneous or transcutaneous TNS or invasive OAB treatment, current antimuscarinic use, 24-h polyuria, known bladder disease, postvoid residual volume >150 ml, and pelvic organ prolapse stage >2. Patients self-administered daily TTNS sessions of 20 min with TENSI+ at home after education by a specialized nurse. A bladder diary, Urinary Symptom Profile and OAB-q questionnaires, and Patient Global Impression of Improvement (PGI-I) scores were evaluated at baseline and 3 and 6 mo. The primary endpoint was efficacy, based on PGI-I and variations in bladder diary parameters. Success was defined as a PGI-I score ≤3 and any improvement ≥30% in bladder diary parameters. KEY FINDINGS AND LIMITATIONS: The study included 78 patients (13 males). Nine patients had neurological disease, 21 had previously tried antimuscarinics, and 41 had wet OAB at baseline. At 3 mo, 65/78 patients had a full analysis set. Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB-related endpoints were significantly improved, except bladder capacity and total voided volume per 24 h. At 6 mo, only five of 44 patients had interrupted their treatment. No factor predictive of success was identified. Two adverse events (pain at stimulation site and/or pelvic pain) were reported and spontaneously resolved without treatment interruption. CONCLUSIONS AND CLINICAL IMPLICATIONS: TENSI+ is a safe and effective TTNS treatment option for OAB management. PATIENT SUMMARY: TENSI+ is a new device for nerve stimulation in patients with overactive bladder. Patients use the device at home every day. In our short-term trial, TENSI+ use improved symptoms in 67% of patients. Further evaluation over a longer period of time is needed.

Perceived health status after mid-urethral sling revision in 287 women from the VIGI-MESH registry: A cross-sectional study.

OBJECTIVE: To evaluate the health status and recovery of women after mid-urethral sling (MUS) revision in response to complications. DESIGN: Cross-sectional study using a questionnaire sent to women from a registry. SETTING: Twenty-two French surgical centres. POPULATION: A total of 287 women from the VIGI-MESH registry responded, having undergone MUS revision for complications. METHODS: Our sample of women were compared against a representative set of French women taken from the Eurostat database. Multivariate analysis was performed to identify clinical predictors for successful MUS revision. A qualitative analysis was carried out on free-text comments. MAIN OUTCOME MEASURES: Health status, defined by the Minimum European Health Module, and recovery, assessed by Patient Global Impression of Improvement. RESULTS: The response rate was 76% (287/378), with 49% of the women (141/287, 95% CI 43%-55%) reporting good health status, which was 8 points lower than that expected from the comparator French set (57%, 95% CI 55%-58%). Overall, 53% (147/275, 95% CI 47%-59%) of the women reported feeling much better after MUS revision. Just over one-third (35%, 95/275, 95% CI 29%-40%) of respondents reported poor health with little or no improvement. Multivariate analysis showed that being operated on for pain at revision was associated with worse self-perceived health than being operated on for exposure (OR 0.6, 95% CI 0.14-0.95); women with pre-existing comorbidity reported a poorer health status following MUS revision (OR 0.22, 95% CI 0.13-0.38). CONCLUSIONS: Our results suggest that half of the women recovered good health status after MUS revision, whereas a proportion appeared to be seriously affected by an MUS complication despite the revision.

Diagnosis and management of complications following pelvic organ prolapse surgery using a synthetic mesh: French national guidelines for clinical practice.

Complications associated with pelvic organ prolapse (POP) surgery using a synthetic non-absorbable mesh are uncommon (<5%) but may be severe and may hugely diminish the quality of life of some women. In drawing up these multidisciplinary clinical practice recommendations, the French National Authority for Health (Haute Autorité de santé, HAS) conducted an exhaustive review of the literature concerning the diagnosis, prevention, and management of complications associated with POP surgery using a synthetic mesh. Each recommendation for practice was allocated a grade (A,B or C; or expert opinion (EO)), which depends on the level of evidence (clinical practice guidelines). PREOPERATIVE PATIENTS' INFORMATION: Each patient must be informed concerning the risks associated with POP surgery (EO). HEMORRHAGE, HEMATOMA: Vaginal infiltration using a vasoconstrictive solution is not recommended during POP surgery by the vaginal route (grade C). The placement of vaginal packing is not recommended following POP surgery by the vaginal route (grade C). During laparoscopic sacral colpopexy, when the promontory seems highly dangerous or when severe adhesions prevent access to the anterior vertebral ligament, alternative surgical techniques should be discussed per operatively, including colpopexy by lateral mesh laparoscopic suspension, uterosacral ligament suspension, open abdominal mesh surgery, or surgery by the vaginal route (EO). BLADDER INJURY: When a bladder injury is diagnosed, bladder repair by suturing is recommended, using a slow resorption suture thread, plus monitoring of the permeability of the ureters (before and after bladder repair) when the injury is located at the level of the trigone (EO). When a bladder injury is diagnosed, after bladder repair, a prosthetic mesh (polypropylene or polyester material) can be placed between the repaired bladder and the vagina, if the quality of the suturing is good. The recommended duration of bladder catheterization following bladder repair in this context of POP mesh surgery is from 5 to 10 days (EO). URETER INJURY: After ureteral repair, it is possible to continue sacral colpopexy and place the mesh if it is located away from the ureteral repair (EO). RECTAL INJURY: Regardless of the approach, when a rectal injury occurs, a posterior mesh should not be placed between the rectum and the vagina wall (EO). Concerning the anterior mesh, it is recommended to use a macroporous monofilament polypropylene mesh (EO). A polyester mesh is not recommended in this situation (EO). VAGINAL WALL INJURY: After vaginal wall repair, an anterior or a posterior microporous polypropylene mesh can be placed, if the quality of the repair is found to be satisfactory (EO). A polyester mesh should not be used after vaginal wall repair (EO). MESH INFECTION (ABSCESS, CELLULITIS, SPONDYLODISCITIS): Regardless of the surgical approach, intravenous antibiotic prophylaxis is recommended (aminopenicillin + beta-lactamase inhibitor: 30 min before skin incision +/- repeated after 2 h if surgery lasts longer) (EO). When spondylodiscitis is diagnosed following sacral colpopexy, treatment should be discussed by a multidisciplinary group, including especially spine specialists (rheumatologists, orthopedists, neurosurgeons) and infectious disease specialists (EO). When a pelvic abscess occurs following synthetic mesh sacral colpopexy, it is recommended to carry out complete mesh removal as soon as possible, combined with collection of intraoperative bacteriological samples, drainage of the collection and targeted antibiotic therapy (EO). Non-surgical conservative management with antibiotic therapy may be an option (EO) in certain conditions (absence of signs of sepsis, macroporous monofilament polypropylene type 1 mesh, prior microbiological documentation and multidisciplinary consultation for the choice of type and duration of antibiotic therapy), associated with close monitoring of the patient. BOWEL OCCLUSION RELATED TO NON-CLOSURE OF THE PERITONEUM: Peritoneal closure is recommended after placement of a synthetic mesh by the abdominal approach (EO). URINARY RETENTION: Preoperative urodynamics is recommended in women presenting with urinary symptoms (bladder outlet obstruction symptoms, overactive bladder syndrome or incontinence) (EO). It is recommended to remove the bladder catheter at the end of the procedure or within 48 h after POP surgery (grade B). Bladder emptying and post-void residual should be checked following POP surgery, before discharge (EO). When postoperative urine retention occurs after POP surgery, it is recommended to carry out indwelling catheterization and to prefer intermittent self-catheterization (EO). POSTOPERATIVE PAIN: Before POP surgery, the patient should be asked about risk factors for prolonged and chronic postoperative pain (pain sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Concerning the prevention of postoperative pain, it is recommended to carry out a pre-, per- and postoperative multimodal pain treatment (grade B). The use of ketamine intraoperatively is recommended for the prevention of chronic postoperative pelvic pain, especially for patients with risk factors (preoperative painful sensitization, allodynia, chronic pelvic or non-pelvic pain) (EO). Postoperative prescription of opioids should be limited in quantity and duration (grade C). When acute neuropathic pain (sciatalgia or pudendal neuralgia) resistant to level I and II analgesics occurs following sacrospinous fixation, a reintervention is recommended for suspension suture removal (EO). When chronic postoperative pain occurs after POP surgery, it is recommended to systematically seek arguments in favor of neuropathic pain with the DN4 questionnaire (EO). When chronic postoperative pelvic pain occurs after POP surgery, central sensitization should be identified since it requires a consultation in a chronic pain department (EO). Concerning myofascial pain syndrome (clinical pain condition associated with increased muscle tension caused by myofascial trigger points), when chronic postoperative pain occurs after POP surgery, it is recommended to examine the levator ani, piriformis and obturator internus muscles, so as to identify trigger points on the pathway of the synthetic mesh (EO). Pelvic floor muscle training with muscle relaxation is recommended when myofascial pain syndrome is associated with chronic postoperative pain following POP surgery (EO). After failure of pelvic floor muscle training (3 months), it is recommended to discuss surgical removal of the synthetic mesh, during a multidisciplinary discussion group meeting (EO). Partial removal of synthetic mesh is indicated when a trigger point is located on the pathway of the mesh (EO). Total removal of synthetic mesh should be discussed during a multidisciplinary discussion group meeting when diffuse (no trigger point) chronic postoperative pain occurs following POP surgery, with or without central sensitization or neuropathic pain syndromes (EO). POSTOPERATIVE DYSPAREUNIA: When de novo postoperative dyspareunia occurs after POP surgery, surgical removal of the mesh should be discussed (EO). VAGINAL MESH EXPOSURE: To reduce the risk of vaginal mesh exposure, when hysterectomy is required during sacral colpopexy, subtotal hysterectomy is recommended (grade C). When asymptomatic vaginal macroporous monofilament polypropylene mesh exposure occurs, systematic imaging is not recommended. When vaginal polyester mesh exposure occurs, pelvic +/- lumbar MRI (EO) should be used to look for an abscess or spondylodiscitis, given the greater risk of infection associated with this type of material. When asymptomatic vaginal mesh exposure of less than 1 cm2 occurs in a woman with no sexual intercourse, the patient should be offered observation (no treatment) or local estrogen therapy (EO). However, if the patient wishes, partial excision of the mesh can be offered. When asymptomatic vaginal mesh exposure of more than 1 cm2 occurs or if the woman has sexual intercourse, or if it is a polyester prosthesis, partial mesh excision, either immediately or after local estrogen therapy, should be offered (EO). When symptomatic vaginal mesh exposure occurs, but without infectious complications, surgical removal of the exposed part of the mesh by the vaginal route is recommended (EO), and not systematic complete excision of the mesh. Following sacral colpopexy, complete removal of the mesh (by laparoscopy or laparotomy) is only required in the presence of an abscess or spondylodiscitis (EO). When vaginal mesh exposure recurs after a first reoperation, the patient should be treated by an experienced team specialized in this type of complication (EO). SUTURE THREAD VAGINAL EXPOSURE: For women presenting with vaginal exposure to non-absorbable suture thread following POP surgery with mesh reinforcement, the suture thread should be removed by the vaginal route (EO). Removal of the surrounding mesh is only recommended when vaginal mesh exposure or associated abscess is diagnosed. BLADDER AND URETERAL MESH EXPOSURE: When bladder mesh exposure occurs, removal of the exposed part of the mesh is recommended (grade B). Both alternatives (total or partial mesh removal) should be discussed with the patient and should be debated during a multidisciplinary discussion group meeting (EO).

Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register.

BACKGROUND: Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

[Multidisciplinary meetings in pelvic floor disease in women: A national survey by the CUROPF among French urologists]. / Réunion de concertation pluridisciplinaire en pelvipérinéologie en France : résultats d'une enquête nationale du CUROPF auprès des urologues français.

INTRODUCTION: Multidisciplinary team meetings (MTMs) in the field of pelvic floor diseases in women tend to generalize, as they are required as mandatory before mid-urethral sling implantation or sacrocolpopexy by recent decrees published by the French health authorities. However, access to these meetings is variable in the French territory. The goal of the present study was to describe the existence and the settings of these kinds of meetings in France. MATERIEL AND METHODS: An on-line survey was conducted between June and July 2020 (stage 1) then between November 2021 and January 2022 (stage 2). A 15-item questionnaire was sent to all members of the Association française d'urologie (AFU). A descriptive analysis was conducted. RESULTS: Three hundred and twenty-two completed questionnaires were sent back during stage 1 and 158 during stage 2. Early 2022, 61.3% of respondents had access to a pelviperineology MTM, with important difference according to geographical areas. Main activity of MTMs was case discussion of complex situations (68% of meetings). At the end of 2021, 22% of the respondents declared willing to stop partially or totally their pelviperineology activity, given the new regulations set in place by the authorities. CONCLUSION: Despite being absolutely mandatory in current clinical practice, MTMs in pelvic floor disease have spread slowly. MTMs implementation was still insufficient in 2022, and variable on the French territory. Some urologists declare having no access to such resources and about 1 out of 5 were considering to voluntary stop of decrease significantly their activity in this difficult context.

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.

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse.

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan-Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien-Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively.

Transobturator Vaginal Tape in 10 Steps.

OBJECTIVE: Transvaginal tension-free vaginal tape-obturator (TVT-O) is an effective surgical treatment for stress urinary incontinence in women [1]. A correct preoperative urodynamic study has a role in obtaining the best results. However, some complications still occur during and after this surgical procedure. These complications cause a high burden for patients, who frequently have to receive other invasive treatments subsequently. The main objective of this video is the standardization and accurate description of this surgical procedure while adding some tips and tricks. DESIGN: Step-by-step description of the technique through a video. SETTING: A French tertiary care teaching hospital. INTERVENTIONS: `The local institutional review board was consulted and ruled that approval was not required. Patients cannot be identified and they signed a written consent to use video-recording for research, scientific and teaching purposes. We provided this video of TVT-O procedures to identify more delicate steps of this surgical procedure to clarify managing them successfully. We assessed 10 rational steps in the procedure to standardize it. This video presents clearly the standardization of this technique in 10 steps: (1) patient's ergonomy, (2) anesthetic infiltration, (3) single vaginal incision, (4) creation of the pathway for device placement, (5) placement of the device, (6) check flat position of the tape, (7) obtain the correct tension of the mesh, (8) cut both lateral arms of the tape emerging from the skin, (9) urinary drainage to exclude stenosis, and (10) suture vaginal mucosa and skin. CONCLUSION: Together with an appropriate preoperative study, the standardization of this surgical procedure and the application of tips and tricks suggested could make this technique easier to learn for beginners [2] and could help experienced surgeons in reducing, as much as possible, the most frequent complications as well [3].

What Is a Good Teaching Video? Results of an Online International Survey.

STUDY OBJECTIVE: To analyze surgeon views on criteria for a good teaching video with the aim of determining guidelines. DESIGN: An online international survey using a self-developed questionnaire. SETTING: A French university tertiary care hospital. PATIENTS: Three hundred eighty-eight participants answered an online questionnaire (154 women [40.53%] and 226 men [59.47%]). INTERVENTIONS: A questionnaire on the criteria for a good quality teaching surgery video was developed by our team and communicated via an online link. MEASUREMENTS AND MAIN RESULTS: The responses of 388 respondents were analyzed and highlighted the pedagogical benefits of teaching videos. The video duration may vary according to the type of media or surgical procedure but should not exceed 10 to 15 minutes for complex procedures. Providing information on the surgical setup (body mass index of the patient, Trendelenburg position degree, pressure of pneumoperitoneum, etc.) is essential. Surgical videos should be reviewed and divided into clearly defined steps with continued access to the entire nonmodified video for reviewers and be accessible on both educational and open platforms. Patient consent and relevant information should be made available. Reviews should include "bad procedure" videos, which are highly appreciated, especially by young surgeons. CONCLUSION: The many advantages of the video format, including availability and rising popularity, provide an opportunity to reinforce and complement current surgical teaching. To optimize use of this surgical teaching tool, standardization, updating, and ease of access of surgical videos should be promoted.

Minilaparoscopic Total Hysterectomy in Current Practice Feasibility and Benefits: A Unicentric, Randomized Controlled Trial.

STUDY OBJECTIVE: To investigate whether mini-instrumentation may be used for hysterectomy (HT) by all surgeons (assistants and seniors) without increasing the operative time or altering surgeon working conditions. DESIGN: A unicenter, randomized controlled, single blind, parallel, noninferiority trial comparing 2 surgical techniques. SETTING: A tertiary referral center. PATIENTS: Thirty-two patients undergoing HT for a benign gynecologic disease were enrolled in this study in our center between April 2, 2015, and June 1, 2018. Sixteen patients were randomized in group A and 16 patients in group B. INTERVENTIONS: HT with bilateral annexectomy or ovarian conservation using 3-mm instruments (group A) or conventional 5-mm instruments (group B). MEASUREMENTS AND MAIN RESULTS: Concerning the primary outcome, the operative time for the HT 3-mm group was 128 minutes (range, 122-150 minutes) versus 111 minutes (range, 92-143 minutes) for the HT 5-mm group (i.e., δ = 17 [90% confidence interval, -6 to 39]), with rejection of the noninferiority threshold at 35 minutes. Thirty-one percent of HTs initially performed using 3-mm instruments were completed with conventional instruments. HTs performed with mini-instruments required more concentration (p = .02) with surgeons reporting higher levels of frustration (p = .009) and sense of failure (p = .006). Patients tend to experience greater satisfaction regarding scars with a significant difference noted during the postoperative visit both for scar pain (1 vs 4 patients with moderate pain [30-50 mm on the Patient Scar Assessment Scale) in the HT 3-mm group and the HT 5-mm group, respectively) and scar firmness (p = .021; 3 vs 7 patients with moderate firmness [30-50 mm on the Patient Scar Assessment Scale] in the HT 3-mm group and the HT 5-mm group, respectively). CONCLUSION: Total minilaparoscopic HT appears inferior to standard laparoscopy in terms of operative time and surgeon working conditions; only the short-term cosmetic appearance was in favor of the 3-mm approach.

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.