Management of Third and Fourth-Degree Perineal Tears After Vaginal Birth. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry No. 015/079, December 2020).

Purpose This guideline provides recommendations for the diagnosis, treatment and follow-up care of 3rd and 4th degree perineal tears which occur during vaginal birth. The aim is to improve the management of 3rd and 4th degree perineal tears and reduce the immediate and long-term damage. The guideline is intended for midwives, obstetricians and physicians involved in caring for high-grade perineal tears. Methods A selective search of the literature was carried out. Consensus about the recommendations and statements was achieved as part of a structured process during a consensus conference with neutral moderation. Recommendations After every vaginal birth, a careful inspection and/or palpation by the obstetrician and/or the midwife must be carried out to exclude a 3rd or 4th degree perineal tear. Vaginal and anorectal palpation is essential to assess the extent of birth trauma. The surgical team must also include a specialist physician with the appropriate expertise (preferably an obstetrician or a gynecologist or a specialist for coloproctology) who must be on call. In exceptional cases, treatment may also be delayed for up to 12 hours postpartum to ensure that a specialist is available to treat the individual layers affected by trauma. As neither the end-to-end technique nor the overlapping technique have been found to offer better results for the management of tears of the external anal sphincter, the surgeon must use the method with which he/she is most familiar. Creation of a bowel stoma during primary management of a perineal tear is not indicated. Daily cleaning of the area under running water is recommended, particularly after bowel movements. Cleaning may be carried out either by rinsing or alternate cold and warm water douches. Therapy should also include the postoperative use of laxatives over a period of at least 2 weeks. The patient must be informed about the impact of the injury on subsequent births as well as the possibility of anal incontinence.

Skeletal Muscle-Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study.

BACKGROUND AND AIMS: Fecal incontinence (FI) improvement following injection of autologous skeletal muscle-derived cells has been previously suggested. This study aimed to test the efficacy and safety of said cells through a multicenter, placebo-controlled study, to determine an appropriate cell dose, and to delineate the target patient population that can most benefit from cell therapy. METHODS: Patients experiencing FI for at least 6 months were randomized to receive a cell-free medium or low or high dose of cells. All patients received pelvic floor electrical stimulation before and after treatment. Incontinence episode frequency (IEF), FI quality of life, FI burden assessed on a visual analog scale, Wexner score, and parameters reflecting anorectal physiological function were all assessed for up to 12 months. RESULTS: Cell therapy improved IEF, FI quality of life, and FI burden, reaching a preset level of statistical significance in IEF change compared with the control treatment. Post hoc exploratory analyses indicated that patients with limited FI duration and high IEF at baseline are most responsive to cells. Effects prevailed or increased in the high cell count group from 6 to 12 months but plateaued or diminished in the low cell count and control groups. Most physiological parameters remained unaltered. No unexpected adverse events were observed. CONCLUSIONS: Injection of a high dose of autologous skeletal muscle-derived cells followed by electrical stimulation significantly improved FI, particularly in patients with limited FI duration and high IEF at baseline, and could become a valuable tool for treatment of FI, subject to confirmatory phase 3 trial(s). (ClinicalTrialRegister.eu; EudraCT Number: 2010-021463-32).

Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence.

BACKGROUND: In an earlier pilot study with 10 women, we investigated a new approach for therapy of faecal incontinence (FI) due to obstetric trauma, involving ultrasound-guided injection of autologous skeletal muscle-derived cells (SMDC) into the external anal sphincter (EAS), and observed significant improvement. In the current study, we tested this therapeutic approach in an extended patient group: male and female patients suffering from FI due to EAS damage and/or atrophy. Furthermore, feasibility of lower cell counts and cryo-preserved SMDC was assessed. METHODS: In this single-centre, explorative, baseline-controlled clinical trial, each patient (n = 39; mean age 60.6 ± 13.81 years) received 79.4 ± 22.5 × 106 cryo-preserved autologous SMDC. Changes in FI parameters, Fecal Incontinence Quality of Life (FIQL), anorectal manometry and safety from baseline to 1, 6 and 12 months post implantation were evaluated. RESULTS: SMDC used in this trial contained a high percentage of myogenic-expressing (CD56+) and muscle stem cell marker-expressing (Pax7+, Myf5+) cells. Intervention was well tolerated without any serious adverse events. After 12 months, the number of weekly incontinence episodes (WIE, primary variable), FIQL and patient condition had improved significantly. In 80.6% of males and 78.4% of females, the WIE frequency decreased by at least 50%; Wexner scores and severity of FI complaints decreased significantly, independent of gender and cause of FI. CONCLUSIONS: Injection of SMDCs into the EAS effectively improved sphincter-related FI due to EAS damage and/or atrophy in males and females. When confirmed in a larger, placebo-controlled trial, this minimal invasive procedure has the potential to become first-line therapy for FI. TRIAL REGISTRATION: EU Clinical Trials Register, EudraCT 2010-023826-19 (Date of registration: 08.11.2010).

Ten-year follow-up after the tension-free vaginal tape procedure.

OBJECTIVE: The current study aimed to evaluate objective and subjective results 10 years after the tension-free vaginal tape procedure. STUDY DESIGN: Two hundred ten patients who underwent a tension-free vaginal tape procedure at the 2 participating units between 1999 and 2001 were invited for follow-up. Evaluation at 10 years included history, clinical examination, cystoscopy, urodynamics, a cough stress test, and the Incontinence Outcome Questionnaire. RESULTS: Interview data were available for 67%; full clinical investigation was performed in 56% of patients. At 10 years, the clinical stress test was negative in 84%, slightly positive in 8.5%, and strongly positive in 4.3%. Subjectively, 57% of patients considered themselves "cured," 23% "improved," 6.4% "unchanged," and 11% "worse." Eleven of 141 (7.8%) had been reoperated in the interim. The rate of de novo urgency was 20%. Obesity seemed to be a risk factor for failure. CONCLUSION: These data indicate satisfactory objective and subjective cure rates 10 years after tension-free vaginal tape procedure placement.

The natural history of clinically unrecognized anal sphincter tears over 10 years after first vaginal delivery.

OBJECTIVE: To estimate the influence of clinically unrecognized anal sphincter injuries detected by endoanal ultrasonography 3 months after first vaginal delivery on symptoms of anal incontinence over the subsequent 10-year period. METHODS: One-hundred fifty-six consecutive primigravid women were recruited, anal endosonography performed, and bowel habit predelivery characterized by means of a validated 24-point questionnaire. After excluding four women with a clinically recognized sphincter tear after delivery and 18 who delivered by cesarean, these procedures were repeated 3 months postpartum. The questionnaire was repeated at 5 and 10 years to estimate continence change over the decade after delivery. Logistic regression was used to examine the effect of clinically unrecognized sphincter tears on continence. RESULTS: After delivery, continence deteriorated from baseline in 37 (28%) women, eight of whom had anal sphincter tears. Continence did not deteriorate in 97 women, six of whom had anal sphincter tears. At 10 years, 59 (55%) of 107 contactable women had continence scores greater than zero, 23 of whom had deteriorated from baseline. There was a significant relationship between a sphincter tear that was symptomatic after delivery and continence deterioration sustained at 5 and 10 years (odds ratio 2.8 for change in continence score). However, no relationship was found over 10 years for those women who sustained a sphincter tear but whose continence did not deteriorate postpartum. CONCLUSION: Ultrasonographic anal sphincter defects without postpartum incontinence are not associated with deterioration in continence over the following decade. LEVEL OF EVIDENCE: II.

The Incontinence Outcome Questionnaire: an instrument for assessing patient-reported outcomes after surgery for stress urinary incontinence.

The aim of this study is to develop and psychometrically test a questionnaire (Incontinence Outcome Questionnaire, IOQ) for assessing quality of life (QOL) after surgery for stress urinary incontinence that can be used as a single measurement after the intervention. A total of 171 patients who underwent the tension-free vaginal tape (TVT/TVT-O) operation for stress urinary incontinence completed the King s Health Questionnaire (KHQ), the Short Form-12 (SF-12) and the IOQ. The internal consistency, internal and external validity and responsiveness of the IOQ were tested. The IOQ-QOL subscale showed good internal consistency (Cronbach's alpha=0.83) and significant correlations with the KHQ and the SF-12 scales (r=0.30-0.56). Partial correlations with objective parameters showed a significant relation for the IOQ-QOL subscale with objective continence/incontinence. The results of our study suggest that the IOQ is a valid and reliable instrument for assessing QOL after incontinence surgery and can be used if baseline or pre-operative data are unavailable.

Quality of life and continence 1 year after the tension-free vaginal tape operation.

OBJECTIVE: The purpose of this study was to evaluate changes in condition-specific and generic quality of life (QOL) and continence rates 1 year after the tension-free vaginal tape (TVT) operation for stress urinary incontinence. STUDY DESIGN: A total of 99 patients undergoing the TVT operation underwent clinical and urodynamic assessment and completed the German language King's Health Questionnaire (KHQ) and the Short Form 36 (SF-36) before and 3 and 12 months after surgery. Overall, 72 TVTs were performed as isolated procedure and 27 in combination with other operations. Data were analyzed with the Chi-square test, analyses of variance, and the Tukey test. RESULTS: Overall, the objective continence rate was 80% at 1 year and did not differ significantly between patients with or without concomitant surgery. Significant and clinically relevant (>10 points) improvements were seen in all domains of the KHQ except General Health perception. The SF-36 showed statistically significant but not clinically significant improvement. CONCLUSION: The TVT operation is associated with improved condition-specific QOL in women with stress urinary incontinence. The condition-specific KHQ is more appropriate than the generic SF-36 for evaluating treatment results in women treated for incontinence.

Assessment of the predictive value of a bowel symptom questionnaire in identifying perianal and anal sphincter trauma after vaginal delivery.

PURPOSE: The purpose of this study was to determine whether a postpartum bowel-habit questionnaire could reliably identify females who had sustained perineal and anal sphincter trauma after vaginal delivery. METHODS: A prospective cohort design was used to recruit 156 consecutive primigravid females, of whom 134 delivered vaginally without clinical evidence of a third-degree tear. These 134 females completed a specific anal continence questionnaire and underwent anal endosonography before and after delivery to identify those with postpartum deterioration in anal continence and to relate this to sonographic evidence of anoperineal trauma. RESULTS: Anal continence deteriorated in 37 females (27.6 percent) after delivery, 16 of whom (43.2 percent) had sonographic evidence of trauma. There was no postpartum deterioration of continence in the remaining 97 females, 17 (17.5 percent) of whom had sonographic evidence of trauma. Sensitivity, specificity, positive predictive value, and negative predictive value of the questionnaire for sonographic trauma were 48.5, 79.2, 43.2, and 82.5 percent, respectively, with corresponding values of 57.1, 75.8, 21.6, and 93.8 percent for external anal sphincter disruption. CONCLUSION: A bowel-habit questionnaire will detect approximately 60 percent of females who sustain external sphincter tears after vaginal delivery.

Influence of the subpubic arch angle on anal sphincter trauma and anal incontinence following childbirth.

OBJECTIVE: To assess the relationship between the subpubic arch angle, anal sphincter and perineal trauma, and anal incontinence after childbirth in nulliparous women. DESIGN: Prospective cohort study. SETTING: University teaching hospital. SAMPLE: One hundred thirty-four low risk nulliparous women. METHODS: Measurements of the bony pelvic outlet were made to calculate the subpubic arch angle. Endosonographic assessment of the perineum and anal sphincter was made before and after delivery. A specific bowel function questionnaire was completed before and after delivery. MAIN OUTCOME MEASURES: Perineal and anal sphincter trauma, and deteriorating anal continence after delivery. RESULTS: Thirty-two women with a subpubic arch angle of less than 90 degrees had significantly prolonged first and second stages of labour when compared with 102 women whose subpubic arch was wider. Following delivery, anal continence deteriorated in more women with a narrow subpubic angle (69% vs 21%, P < 0.001) but this was unrelated to the incidence of anal sphincter and perineal trauma. CONCLUSIONS: A narrow subpubic arch is strongly associated with prolonged labour and postpartum anal incontinence in nulliparous women. However, perineal and anal sphincter trauma, assessed by ultrasound, does not account for the higher rate of postpartum analincontinence in women with a narrow subpubic arch angle.

Female anal sphincter: age-related differences in asymptomatic volunteers with high-frequency endoanal US.

PURPOSE: To evaluate endoanal ultrasonographic (US) anatomy in a large group of nulliparous women by using a high-frequency 10-MHz transducer to define normal age-related differences in sphincter morphology. MATERIALS AND METHODS: One hundred fifty asymptomatic nulliparous women (mean age, 31 years; range, 19-80 years) underwent endoanal US with a high-frequency 10-MHz transducer. Anal canal structures were measured at high, middle, and low levels and were correlated with age by using the Pearson simple linear correlation coefficient. RESULTS: Internal sphincter thickness showed a highly significant positive correlation with age at both sites at which it was measured (high anal canal, r = 0.34, P <.001; middle anal canal, r = 0.33, P <.001). External sphincter thickness showed a highly significant negative correlation with age at all sites measured (high anal canal, r = -0.65, P <.001; middle anal canal, r = -0.49, P <.001; low anal canal, r = -0.21, P =.012). There was no significant correlation between age and thickness of subepithelial tissue, longitudinal muscle, or puborectalis muscle. Subjects whose internal sphincter showed mixed echogenicity were significantly older than those whose internal sphincter was uniformly hypoechoic (mean, 47.4 vs 34.6 years; P <.001). Subjects with mixed internal sphincter echogenicity also had a significantly thinner external sphincter at high (mean thickness, 3.8 vs 4.6 mm; P <.001) and middle (mean thickness, 3.7 vs 4.1 mm; P =.03) anal canal levels. CONCLUSION: At older ages there are increased internal anal sphincter thickness and decreased external anal sphincter thickness. Diagnosis of external sphincter atrophy on the basis of sphincter thinning requires that one distinguish between abnormal thinning and age-related differences.