Pulsed Radiofrequency of Pudendal Nerve for Treatment in Patients with Pudendal Neuralgia. A Case Series with Long-Term Follow-Up.

Pudendal neuralgia (PN) is an impairing neuropathic disorder, affecting both men and women, involving a severe burning and sharp pain along the course of the pudendal nerve. Treatment is often insufficient, and options are limited. Pulsed radiofrequency (PRF) is a technique which might be useful in therapy. This case series aims to determine the effectiveness of PRF in patients with PN in the context of evaluation of care. Between 2010 and 2016, all female patients of University Medical Center Utrecht diagnosed with PN who experience insufficient pain relief after common treatment were offered PRF. Patient Global Impression of Improvement (PGI-I) scores were assessed at 3-month follow-up and at long-term follow-up (median 4 years). PGI-I scores were recorded to evaluate our quality of care. Twenty patients with PN consented to undergo PRF. We lost one patient in follow-up. Seventy-nine percent of the patients described their condition as "(very) much better" at 3-month follow-up. At long-term follow-up, 89% of the patients described their condition as "(very) much better." No serious side effects were observed. In conclusion, PRF is a successful treatment option in patients not responding to standard treatment options, including pudendal nerve blocks. PRF of the pudendal nerve can be used for PN to provide relief in patients' chronic pelvic pain.

A prospective observational cohort study of the Ajust® single incision sling performed under conscious sedation with local infiltration.

AIMS: To evaluate the adjustable single-incision sling (Ajust®) in the treatment of stress urinary incontinence (SUI), when placed under conscious sedation with local infiltration, using the cough test during surgery. METHODS: In this multicenter observational study, 90 women who had moderate to severe SUI, were asked to have the Ajust® procedure performed under sedation with local infiltration with levobupivacain. This allowed for a perioperative cough test to adjust the sling to the urethra till continence was reached. The primary outcome of the study was subjective cure of stress incontinence at 1 year follow up. Secondary objectives were objective and subjective improvement, complications during and after the procedure, and postoperative pain scores. These results were compared with the results of a historical control group of 96 patients who received their Ajust® under general or regional (spinal) anesthesia. RESULTS: At 6 weeks and 12 months, there were no statistical significant differences in the results for subjective cure (83.6% and 71.6% sedation group, 88.4% and 77.2% general/regional anesthesia group), objective cure (96% and 86.9% sedation group, 88.1% and 91.8% general/regional anesthesia group), de novo urgency (10.5% and 6.7% sedation group, 7.1% and 24.1% general/regional anesthesia group) and the patients global impression of improvement (96% and 89.2% sedation group, 91.4% and 84.4% general/regional anesthesia group). CONCLUSION: The performance of a cough test during the placement of an adjustable single-incision sling for the treatment of SUI does not affect the functional outcome, and is therefore not necessary.

Method and reliability of measuring midurethral area and echogenicity, and changes during and after pregnancy.

INTRODUCTION AND HYPOTHESIS: Internal closure of the urethral sphincter is one of the mechanisms in maintaining continence. Little is known about changes in the urethral sphincter during pregnancy. We designed this study to develop a reliable method to measure the area and mean echogenicity of the midurethra during and after pregnancy and to assess changes over time. METHODS: Two observers independently segmented the urethra as follows: in the sagittal plane, the urethra was positioned vertically, the marker was placed in the middle section of the lumen of the urethra, and eight tomographic US images of 2.5 -mm slices were obtained. The central image was selected, and area and mean echogenicity were calculated automatically. Intra- and interobserver reliability were determined by intraclass correlation coefficients (ICC) and their 95% confidence intervals (CI). Two hundred and eighty women underwent TPUS at 12 weeks and 36 weeks of gestation and 6 months postpartum, and 3D/4D transperineal ultrasound (TPUS) images of 40 pregnant nulliparous women were used for the reliability study. Paired t tests were used to assess changes in echogenicity and area. RESULTS: The ICC for measuring the area was substantial, at 0.77 and for measuring mean echogenicity was almost perfect, at 0.86. In the total study group (n = 280), midurethral area and mean echogenicity were significantly lower 6 months after delivery compared with 12 and 36 weeks of gestation. CONCLUSIONS: Our protocol for measuring area and mean echogenicity of the midurethra is reliable. This study indicates that structural changes in the midurethraoccur during pregnancy.

Mean echogenicity and area of puborectalis muscle in women with stress urinary incontinence during pregnancy and after delivery.

INTRODUCTION AND HYPOTHESIS: Pregnancy and childbirth are risk factors for the development of stress urinary incontinence (SUI). Urinary continence depends on normal urethral support, which is provided by normal levator ani muscle function. Our objective was to compare mean echogenicity and the area of the puborectalis muscle between women with and those without SUI during and after their first pregnancy. METHODS: We examined 280 nulliparous women at a gestational age of 12 weeks, 36 weeks, and 6 months after delivery. They filled out the validated Urogenital Distress Inventory and underwent perineal ultrasounds. SUI was considered present if the woman answered positively to the question "do you experience urine leakage related to physical activity, coughing, or sneezing?" Mean echogenicity of the puborectalis muscle (MEP) and puborectalis muscle area (PMA) were calculated. The MEP and PMA during pregnancy and after delivery in women with and without SUI were compared using independent Student's t test. RESULTS: After delivery the MEP was higher in women with SUI if the pelvic floor was at rest or in contraction, with effect sizes of 0.30 and 0.31 respectively. No difference was found in the area of the puborectalis muscle between women with and those without SUI. CONCLUSIONS: Women with SUI after delivery had a statistically significant higher mean echogenicity of the puborectalis muscle compared with non-SUI women when the pelvic floor was at rest and in contraction; the effect sizes were small. This higher MEP is indicative of a relatively higher intramuscular extracellular matrix component and could represent diminished contractile function.

Changes in the mean echogenicity and area of the puborectalis muscle during pregnancy and postpartum.

INTRODUCTION AND HYPOTHESIS: Three-dimensional (3D) and four-dimensional (4D) volume transperineal ultrasound imaging is increasingly used to assess changes in the dimensions of the pelvic floor during pregnancy and after delivery. Little is known with regard to the area of the puborectalis muscle and its structural changes. Echogenicity measurement, a parameter that provides information on the structure of muscles, is increasingly used in orthopaedics and neuromuscular disease evaluation. This study is aimed at assessing the changes in the mean echogenicity of the puborectalis muscle (MEP) and the puborectalis muscle area (PMA) during first pregnancy and after childbirth. METHODS: The MEP and PMA of 254 women during first pregnancy were measured at 12 and 36 weeks' gestation and 6 months postpartum. To determine the effect of child-birth on MEP and PMA, the results at 6 months postpartum were separately analysed for vaginal deliveries, operative vaginal deliveries (ventouse) and caesarean section deliveries. Mean differences in MEP and PMA were analysed using ANOVA statistics. RESULTS: The MEP at 6 months postpartum was, independent of manoeuvre, significantly (p < 0.001) lower than MEP values during pregnancy. After caesarean delivery, the PMA was significantly smaller at maximum pelvic floor contraction than PMA after vaginal delivery (p = 0.003) or operative vaginal delivery (p = 0.002). CONCLUSION: Our study indicates that structural changes in the puborectalis muscle during and after pregnancy, as measured by MEP, occur and can be analysed. In addition, the mode of delivery affects the area of the puborectalis during contraction after delivery. For true volume analysis, as part of an assessment of contractility of the puborectalis muscle we will need 3D volume analysis.

Mid-term clinical efficacy of a volumetric magnetic resonance-guided high-intensity focused ultrasound technique for treatment of symptomatic uterine fibroids.

OBJECTIVE: To assess the mid-term efficacy of magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) using a volumetric ablation technique for treating uterine fibroids. METHODS: Forty-six premenopausal women with 58 symptomatic uterine fibroids were prospectively included for MR-HIFU. After treatment, CE-MRI allowed measurement of the non-perfused volume (NPV) ratio, defined as the non-enhancing part of the fibroid divided by fibroid volume. Clinical symptoms and fibroid size on T2W-MRI were quantified at 3 and 6 months' follow-up. The primary endpoint was a clinically relevant improvement in the transformed Symptom Severity Score (tSSS) of the Uterine Fibroid Symptom and Quality of Life questionnaire, defined as a 10-point reduction. RESULTS: Volumetric ablation resulted in a mean NPV ratio of 0.40 ± 0.22, with a mean NPV of 141 ± 135 cm(3). Mean fibroid volume was 353 ± 269 cm(3) at baseline, which decreased to 271 ± 225 cm(3) at 6 months (P < 0.001), corresponding to a mean volume reduction of 29 % ± 20 %. Clinical follow-up showed that 54 % (25/46) of the patients reported a more than 10-point reduction in the tSSS. Mean tSSS improved from 50.9 ± 18.4 at baseline to 34.7 ± 20.2 after 6 months (P < 0.001). CONCLUSION: Volumetric MR-HIFU is effective for patients with symptomatic uterine fibroids. At 6 months, significant symptom improvement was observed in 54 % of patients. KEY POINTS: • Volumetric MR-guided high-intensity focused ultrasound is a novel ablation technique for leiomyomatosis. • We prospectively evaluated the outcome of volumetric MR-HIFU ablation for symptomatic fibroids. • This study showed that volumetric MR-HIFU results in an effective treatment. • A randomised controlled trial would set this technique in an appropriate context.

Protocol for translabial 3D-ultrasonography for diagnosing levator defects (TRUDIL): a multicentre cohort study for estimating the diagnostic accuracy of translabial 3D-ultrasonography of the pelvic floor as compared to MR imaging.

BACKGROUND: Pelvic organ prolapse (POP) is a condition affecting more than half of the women above age 40. The estimated lifetime risk of needing surgical management for POP is 11%. In patients undergoing POP surgery of the anterior vaginal wall, the re-operation rate is 30%. The recurrence risk is especially high in women with a levator ani defect. Such defect is present if there is a partially or completely detachment of the levator ani from the inferior ramus of the symphysis. Detecting levator ani defects is relevant for counseling, and probably also for treatment. Levator ani defects can be imaged with MRI and also with Translabial 3D ultrasonography of the pelvic floor. The primary aim of this study is to assess the diagnostic accuracy of translabial 3D ultrasonography for diagnosing levator defects in women with POP with Magnetic Resonance Imaging as the reference standard. Secondary goals of this study include quantification of the inter-observer agreement about levator ani defects and determining the association between levator defects and recurrent POP after anterior repair. In addition, the cost-effectiveness of adding translabial ultrasonography to the diagnostic work-up in patients with POP will be estimated in a decision analytic model. METHODS/DESIGN: A multicentre cohort study will be performed in nine Dutch hospitals. 140 consecutive women with a POPQ stage 2 or more anterior vaginal wall prolapse, who are indicated for anterior colporapphy will be included. Patients undergoing additional prolapse procedures will also be included. Prior to surgery, patients will undergo MR imaging and translabial 3D ultrasound examination of the pelvic floor. Patients will be asked to complete validated disease specific quality of life questionnaires before surgery and at six and twelve months after surgery. Pelvic examination will be performed at the same time points. Assuming a sensitivity and specificity of 90% of 3D ultrasound for diagnosing levator defects in a population of 120 women with POP, with a prior probability of levator ani defects of 40%, we will be able to estimate predictive values with good accuracy (i.e. confidence limits of at most 10% below or above the point estimates of positive and negative predictive values).Anticipating 3% unclassifiable diagnostic images because of technical reasons, and a further safety margin of 10% we plan to recruit 140 patients. TRIAL REGISTRATION: Nederlands trial register NTR2220.

Midline fascial plication under continuous digital transrectal control: which factors determine anatomic outcome?

INTRODUCTION AND HYPOTHESIS: The aim of the study was to report anatomic and functional outcome of midline fascial plication under continuous digital transrectal control and to identify predictors of anatomic failure. METHODS: Prospective observational cohort. Anatomic success defined as POP-Q stage or= II underwent midline fascial plication under continuous digital transrectal control. Median follow-up was 14 months (12-35 months), and anatomic success was 80.3% (95% CI 75-86). Independent predictors of failure were posterior compartment POP stage >or= III [OR 8.7 (95% CI 2.7-28.1)] and prior colposuspension [OR 5.6 (95% CI 1.1-27.8)]. Sixty-three percent of patients bothered by obstructed defaecation experienced relief after surgery. CONCLUSIONS: Anatomic and functional outcomes were good. Risk factors for anatomic failure were initial size of posterior POP (stage >or= III) and prior colposuspension.

Association of First-Trimester Echogenicity of the Puborectalis Muscle With Mode of Delivery.

OBJECTIVE: To evaluate the association between mean echogenicity of the puborectalis muscle, measured using transperineal ultrasonography, in women during their first pregnancy and the subsequent mode of delivery. METHODS: This is a secondary analysis of a prospective observational study on the association between stress urinary incontinence and levator muscle avulsion after delivery of a first pregnancy. In this study, 280 nulliparous women with singleton pregnancies were examined with transperineal ultrasound examination at 12 and 36 weeks of gestation. Patients were recruited from an obstetrics practice associated with the university medical center in Utrecht, the Netherlands. Mean echogenicity of the puborectalis muscle values were measured at rest, in pelvic floor muscle contraction, and during the Valsalva maneuver. The subsequent mode of delivery was classified into five categories: spontaneous vaginal delivery, instrumental vaginal delivery, elective cesarean delivery, cesarean delivery resulting from nonreassuring fetal status, and cesarean delivery resulting from failure to progress. Mean echogenicity of the puborectalis muscle values according to mode of delivery were compared by analysis of variance and Tukey's post hoc test. RESULTS: Of the 254 women included, 157 had spontaneous vaginal delivery, 47 underwent cesarean delivery (11 elective, 36 emergency), and 45 had vacuum operative vaginal delivery; in five patient files, the mode of delivery was not recorded. Of the analyzed women, those who delivered by cesarean because of failure to progress had a significantly lower mean echogenicity of the puborectalis muscle in pelvic floor contraction at 12 weeks of gestation (mean echogenicity of 116±14) than women who had spontaneous vaginal delivery (132±21; Tukey's post hoc test, P=.03), instrumental vaginal delivery (138±21; P=.004), and cesarean delivery resulting from nonreassuring fetal status (139±20; P=.02). CONCLUSION: Lower mean echogenicity of the puborectalis muscle values in pelvic floor contraction during the first pregnancy at 12 weeks of gestation is associated with subsequent cesarean delivery as a result of failure to progress.

Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial.

OBJECTIVE: To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence (SUI). METHODS: This single-blinded randomized controlled trial involved 156 women with clinically proven SUI. Women were allocated to receive either an adjustable single-incision or a transobturator sling. The primary outcome was postoperative pain score on a visual analog scale. Secondary outcomes were objective and subjective cure rates at 12 months, symptom bother scores, quality of life, and complications. RESULTS: The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group. Maximum difference in pain score was reported on the evening of the day of surgery; median pain score was 1.0 (interquartile range 2.0) in the adjustable sling group and 3.0 (interquartile range 4.5) in the transobturator sling group (Mann Whitney U test P<.001). There was no statistical difference in analgesic use. The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8% and 88.6% (P=.760), and the subjective cure rates were 77.2% and 72.9% (P=.577), respectively. No difference in the complication rate was found. CONCLUSION: An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up. CLINICAL TRIAL REGISTRATION: Netherlands Trial Register, http://www.trialregister.nl, NTR: 2558. LEVEL OF EVIDENCE: I.

Translabial three-dimensional ultrasonography compared with magnetic resonance imaging in detecting levator ani defects.

OBJECTIVE: To assess the diagnostic performance of translabial three-dimensional ultrasonography in detecting major levator ani defects in women with pelvic organ prolapse compared with magnetic resonance imaging (MRI) and to assess the interobserver agreement in detecting levator ani defects with translabial three-dimensional ultrasonography. METHODS: In a multicenter cohort study, 140 women indicated for primary surgery of pelvic organ prolapse quantification stage II or more cystocele were included. Patients undergoing mesh surgery or concomitant stress incontinence surgery were excluded. All consenting patients underwent translabial three-dimensional ultrasonography and MRI of the pelvic floor before surgery. Two observers (out of a pool of four observers) assessed translabial three-dimensional ultrasound images; two other observers (out a pool of five observers) assessed MRIs for levator ani muscle damage. In case of disagreement, the images were discussed in a consensus meeting. RESULTS: Of the 135 scans, 45 major levator ani defects were detected on ultrasonogram (33.3%) and 32 were confirmed at MRI (23.7%). Of the 41 major levator ani defects detected on MRI, nine were missed at translabial three-dimensional ultrasonogram. Sensitivity was 0.78 (32 of 41) (95% confidence interval [CI] 0.65-0.91) and specificity was 0.86 (81 of 94) (95% CI 0.79-0.93) in detecting major levator ani defects with translabial three-dimensional ultrasonography compared with MRI. There was good agreement scoring levator ani defects on translabial three-dimensional ultrasonography, with a κ of 0.67 (95% CI 0.58-0.76); agreement in recognizing major levator ani defects was moderate, with a κ of 0.53 (95% CI 0.37-0.69). CONCLUSION: Translabial three-dimensional ultrasonography shows reasonable agreement with MRI in detecting major levator defects. Because of the moderate interobserver agreement, it will be difficult to implement ultrasonography in daily practice. CLINICAL TRIAL REGISTRATION: Netherlands Trial Register, www.trialregister.nl, NTR2220.

Surgery for pelvic organ prolapse in women of 80 years of age and older.

BACKGROUND: To investigate the long-term results of women over 80 years of age following surgery for pelvic organ prolapse. Design. Retrospective, descriptive study. METHODS: We reviewed all records of women of 80 years and older operated for pelvic organ prolapse; all patients alive were contacted through a postal questionnaire. RESULTS: A total of 2058 operations for pelvic organ prolapse were performed in the study period. One hundred and twenty-eight patients were 80 years and older with the mean age of 83 years (range 80-92 years). In three cases, serious complications occurred, and one of them died shortly after the operation. Follow-up was done with a postal questionnaire. Eighty-eight percent of patients who were alive at the time of data analysis returned the questionnaire. The mean duration of follow-up was 28 months (range 1-80 months). There were no patients who reported a relapse of prolapse. Urinary incontinence, urge, stress, or mixed incontinence, was present in almost half of the cases. The time to full recovery after the operation was experienced to be less than 3 months for 48%. General satisfaction with the procedure was high with 88% being (very) satisfied. CONCLUSION: The operative correction of a pelvic organ prolapse in a group of women 80 years and older is a successful operation, with an acceptable morbidity and a high satisfaction of the patients.