Marie Ellström Engh

Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse

BACKGROUND The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. METHODS In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. RESULTS Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. CONCLUSIONS As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).

Trocar-guided transvaginal mesh repair of pelvic organ prolapse.

OBJECTIVE: To prospectively assess clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh. METHODS: This was a prospective multicenter cohort study performed throughout 26 clinics. Evaluation at baseline, 2 months, and 1 year after surgery included prolapse grading using the pelvic organ prolapse quantification system (POP-Q) and symptom assessment using the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6). For the purpose of this study, postoperative POP-Q stage 0–I was considered anatomic cure. RESULTS: Two-hundred sixty-one patients were included in the study; 232 (89%) attended the 1-year follow-up. Mean±standard deviation age at surgery was 66.3±9.4 years. Anatomic cure 1 year after surgery was observed in 96 of 121 women (79%) after anterior repair with mesh (P<.001), and 56 of 68 (82%) after posterior repair with mesh (P<.001). For combined anterior and posterior mesh repair, cure was 51 of 63 (81%) and 54 of 63 (86%) for the anterior and posterior compartment, respectively (P<.001 for both). Bladder and rectal perforations occurred in 9 of 252 patients (3.4%). Vaginal erosions, the majority mild to moderate, occurred in 26 of 232 cases (11%). Surgical intervention due to mesh exposure occurred in seven cases (2.8%). There were significant quality-of-life improvements in all domains of the IIQ-7. Despite significant improvements in UDI-6 scores, symptoms specific for stress urinary incontinence were not ameliorated. CONCLUSION: Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844 LEVEL OF EVIDENCE: II

Morphological Changes After Pelvic Floor Muscle Training Measured by 3-Dimensional Ultrasonography: A Randomized Controlled Trial

OBJECTIVE: To investigate morphological and functional changes after pelvic floor muscle training in women with pelvic organ prolapse. METHODS: This randomized controlled trial was conducted at a university hospital and a physical therapy clinic. One hundred nine women with pelvic organ prolapse stages I, II, and III were randomly allocated by a computer-generated random number system to pelvic floor muscle training (n=59) or control (n=50). Both groups received lifestyle advice and learned to contract the pelvic floor muscles before and during increases in intraabdominal pressure. In addition the pelvic floor muscle training group did individual strength training with a physical therapist and daily home exercise for 6 months. Primary outcome measures were pelvic floor muscle (pubovisceral muscle) thickness, levator hiatus area, pubovisceral muscle length at rest and Valsalva, and resting position of bladder and rectum, measured by three-dimensional ultrasonography. RESULTS: Seventy-nine percent of women in the pelvic floor muscle training group adhered to at least 80% of the training protocol. Compared with women in the control group, women in the pelvic floor muscle training group increased muscle thickness (difference between groups: 1.9 mm, 95% confidence interval [CI] 1.1–2.7, P<.001), decreased hiatal area (1.8 cm2, 95% CI 0.4–3.1, P=.026), shortened muscle length (6.1 mm, 95% CI 1.5–10.7, P=.007), and elevated the position of the bladder (4.3 mm, 95% CI 2.1–6.5, P<.000) and rectum (6.7 mm, 95% CI 2.2–11.8, P=.007). Additionally, they reduced the hiatal area and muscle length at maximum Valsalva indicating increased pelvic floor muscle stiffness. CONCLUSION: Supervised pelvic floor muscle training can increase muscle volume, close the levator hiatus, shorten muscle length, and elevate the resting position of the bladder and rectum. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, NCT00271297. LEVEL OF EVIDENCE: I

Improving quality by introducing enhanced recovery after surgery in a gynaecological department: consequences for ward nursing practice

Introduction: Enhanced Recovery After Surgery (ERAS) is a perioperative treatment protocol that can improve individual recovery. This allows patients to leave hospital earlier, implying a cost reduction. The programme seems to spread slowly. ERAS was introduced at the Department of Obstetrics and Gynaecology at Akershus University Hospital in 2005. The objective of this study was to monitor changes in the workload and work environment of the ward nursing staff when ERAS was introduced at the department. Methods: A pre-postintervention prospective design was used. Triangulated data were collected immediately before introduction (Phase 1), soon after (Phase 2), and 1 year after introduction (Phase 3). Data sources in all phases were registrations of time spent caring for individual patients during their stay, personnel survey responses and verbal interviews with informants from different staff groups. Patients were included consecutively, the aim being to include a minimum of 40 per phase. Results: Time registration showed that during the observation period, there was a 28% reduction in mean length of stay (−1.3 days, 95% CI −1.63 to −0.97, p<0.001) and 39% reduction in total time used in nursing activities per stay (−162 min, 95% CI −239.3 to −84.4, p<0.001). The personnel survey had a 100% response rate and presented few changes other than decreasing workload. The interview data from four informants described a successful change. Conclusion: The findings confirmed the successful introduction of ERAS in the gynaecological department of a large university hospital. The experiences we made indicate that the expected gains of implementing ERAS are achieved without compromising the workload or work environment of ward nursing staff.

Test–retest reliability of pelvic floor muscle contraction measured by 4D ultrasound†‡

The aim of the present study was to evaluate test‐retest measurements of functional aspects of pelvic floor muscle (PFM) contraction using four dimensional (4D) ultrasound.

Validation of three-dimensional perineal ultrasound and magnetic resonance imaging measurements of the pubovisceral muscle at rest

To compare biometric measurements of the pubovisceral muscle during rest, measured using transperineal three‐dimensional (3D) ultrasound and magnetic resonance imaging (MRI).

Constriction of the levator hiatus during instruction of pelvic floor or transversus abdominis contraction: a 4D ultrasound study

A new theory claims that the pelvic floor muscles (PFM) can be trained via the transversus abdominis (TrA). The aim of the present study was to compare the effect of instruction of PFM and TrA contraction on constriction of the levator hiatus, using 4D perineal ultrasonography. Thirteen women with pelvic organ prolapse participated in the study. Perineal ultrasound in standing position was used to assess constriction of the levator hiatus. Analyses were conducted off-line with measurements in the axial plane of minimal hiatal dimensions. The reduction of all the hiatal dimensions was significantly greater during PFM than TrA contraction. All patients had a reduction of the levator hiatus area during PFM contraction (mean reduction 24.0%; range 6.1–49.2%). In two patients, there was an increase of the levator hiatus area during TrA contraction. Instruction of PFM contraction is more effective than TrA contraction.

A randomized trial comparing changes in sexual health and psychological well-being after subtotal and total hysterectomies

Objective. To evaluate changes in sexual health and psychological well‐being one year after subtotal and total hysterectomies. Design. Prospective randomized controlled trial. Material and methods. One hundred and thirty‐two premenopausal patients scheduled for hysterectomy without planned oophorectomy for benign disorders and without a history of cervical dysplasia or symptomatic prolapse were randomized to total (n = 66) or subtotal hysterectomy (n = 66). The McCoy Female Sexuality Questionnaire was used to evaluate changes in sexual health and the Psychological General Well‐Being index was used to evaluate changes in psychological well‐being. Differences in outcome before and one year after the hysterectomy were calculated for each individual, and changes compared between the groups. Results. Women who had subtotal hysterectomy (SH) reported a significantly greater positive change in frequency of orgasm and sexual pleasure as compared with women who had total hysterectomy (TH) (mean values ± standard deviation (SD), orgasm: SH: 0.4 ± 1.1; TH: ‐0.2 ± 0.9, p = 0.012, sexual enjoyment: SH 0.3 ± 1.5; TH: ‐0.3 ± 1.3, p = 0.039). There was a significantly greater general health gain for the women who underwent subtotal hysterectomy as compared with total hysterectomy (mean values ± SD SH: 1.2 ± 2.3; TH: 0.3 ± 1.6, p = 0.03). The total score did not show a difference. Conclusions. Women undergoing subtotal hysterectomy experience a greater positive change in the frequency of orgasm and extent of sexual pleasure after surgery than women undergoing total hysterectomy, but the results must be interpreted with caution.

Postpartum pelvic floor muscle training and urinary incontinence: a randomized controlled trial.

OBJECTIVE: To evaluate whether postpartum pelvic floor muscle training decrease prevalence of any urinary incontinence (UI) in primiparous women with and without UI at inclusion (mixed population) and further to perform stratified analyses on women with and without major levator ani muscle defects. METHODS: A two-armed assessor-blinded randomized controlled trial including primiparous women 6 weeks after vaginal delivery was conducted. Participants were stratified on major levator ani muscle defects, verified by transperineal ultrasonography, and thereafter randomly allocated to training or control. All participants were taught to contract the pelvic floor muscles. The control participants received no further intervention, whereas training participants attended a weekly supervised pelvic floor muscle training class and performed daily home exercise for 16 weeks. Primary outcome was self-reported UI analyzed by relative risk. RESULTS: We included 175 women, 55 with major levator ani muscle defects and 120 without. Prevalence of UI at baseline was 39.1% in the training group (n=87) and 50% among those in the control group (n=88). Fifteen women (8.6%) were lost to follow-up. At 6 months after delivery (postintervention), 34.5% and 38.6% reported UI in the training and control groups, respectively. Relative risk analysis of UI gave a nonsignificant effect size of 0.89 (95% confidence interval [CI] 0.60–1.32). Results were similar for the stratum with and without major levator ani muscle defects, 0.89 (95% CI 0.51–1.56) and 0.90 (95% CI 0.53–1.52), respectively. CONCLUSIONS: Postpartum pelvic floor training did not decrease UI prevalence 6 months after delivery in primiparous women. Stratified analysis on women with and without major levator ani muscle defects showed similar nonsignificant results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01069484. LEVEL OF EVIDENCE: I

Impact of childbirth and mode of delivery on vaginal resting pressure and on pelvic floor muscle strength and endurance.

OBJECTIVE We sought to study impact of delivery mode on vaginal resting pressure (VRP) and on pelvic floor muscle (PFM) strength and endurance, and whether these measurements differed in women with and without urinary incontinence. STUDY DESIGN We conducted a cohort study following 277 nulliparous women from midpregnancy to 6 weeks postpartum. Manometer was used for PFM measurements; differences were analyzed by t test (within groups) and analysis of variance (between groups). RESULTS Only VRP changed significantly (10% reduction, P = .001) after emergency cesarean section. After normal and instrumental vaginal delivery, VRP was reduced by 29% and 30%; PFM strength by 54% and 66%; and endurance by 53% and 65%, respectively. Significant differences for all PFM measures (P < .001) were found when comparing cesarean vs normal and instrumental vaginal delivery, respectively. Urinary continent women at both time points had significantly higher PFM strength and endurance than incontinent counterparts (P < .05). CONCLUSION Pronounced reductions in VRP and in PFM strength and endurance were found after vaginal delivery. Continent women were stronger than incontinent counterparts.