Perineal trauma at vaginal childbirth has been reported to occur in 47–78% of primiparous women.1,2 Perineal tears are widely classified into four categories, of which a first-degree injury involves the perineal skin or vaginal mucosa only; a second-degree tear involves the perineal body (bulbocavernosus and superficial transverse perineal muscles) but not the sphincters; a third-degree tear involves the anal sphincter complex; and a fourth-degree extends all the way into the anorectal mucosa.3 DeLancy et al described three levels of vaginal support, level III being the most distal portion supported by the levator ani and the perineal body muscles.4 If anatomy after an obstetric laceration is not restored, a second-degree tear may lead to loss of level III support, and symptoms such as a sensation of an open or wide vagina, vaginal flatulence and sexual dysfunction.4–6 The lower one third of the posterior vagina is fused with the perineal body and separation of fibers in the perineal body leaves the rectum unsupported and may result in a distal posterior prolapse.7 The anal canal consequently bulges and protrudes out of the vaginal opening during defecation, and a damaged perineum is therefore often associated with a distal rectocele.7,8
After sequelae from an obstetric injury involving the perineum and the posterior vaginal wall, surgical correction of the anatomy may be indicated. The procedure involves midline approximation and suturing of the perineal native tissues (perineorrhaphy), as well as the distal posterior vaginal wall (distal posterior colporrhaphy). The technique used for reconstruction of the perineal body is, however, not standardized and poorly evaluated.9 A few descriptive studies assessing results of a secondary perineal repair exists, with patient satisfaction rates ranging between 88% and 96%.10–12 However, these trials have not assessed possible improvement in pelvic floor dysfunction symptoms using condition specific validated questionnaires. Furthermore, outcomes of surgery in comparison with conservative treatment, in women with perineal defects, are largely unknown. Physical therapy is generally regarded as first-line management for many pelvic floor disorders,13 and has in postpartum women shown to reduce the risk of prolapse, incontinences and sexual dysfunction symptoms as compared with watchful waiting.14
We performed a single center, randomized, controlled trial aiming to evaluate subjective and objective outcomes after pelvic floor muscle therapy, as compared with perineorrhaphy and distal posterior colporrhaphy, in the treatment of women with pelvic floor dysfunction symptoms resulting from a poorly healed second-degree perineal tear who were at minimum 6 months postpartum.
We designed a single center, open-label, randomized, controlled trial with two parallel arms. The study took place at the Department of Obstetrics and Gynecology at the South General Hospital in Stockholm, Sweden, from October 15, 2015, to June 7, 2018. Patients eligible for the study were Swedish speaking primiparous or multiparous adult women (18 years or older) who were referred to our urogynecologic outpatient clinic owing to bothersome pelvic floor symptoms related to a poorly healed second-degree perineal injury. A poorly healed second-degree perineal tear includes a detachment of the bulbocavernosus and the superficial transverse perineal muscles, which leads to a thin perineal body and an open vaginal introitus. The definition of a poorly healed second-degree perineal laceration is, however, not standardized. The height of the perineal body in adult nulliparous women, according to the definition of the pelvic organ prolapse quantification (POP-Q) system, ranges between 3.1 and 4.1 cm.15–18 and a “thin perineal body” in the current study was arbitrarily defined as a perineal body thickness less than 2 cm on bidigital palpation of the perineum, at the level of the caudal part of the external sphincter muscle. Two-dimensional ultrasound examination, with a vaginal probe placed perpendicular to the vaginal canal at the same level, was used to verify that the bulbocavernosus and the superficial transverse perineal muscles were partially or completely detached from the perineal body.19,20Figure 1 illustrates anatomical findings of a poorly healed second-degree perineal tear, apparent at solely visual inspection of the vulva and perineum of a patient in lithotomy position Exclusion criteria were perineal thickness of more than 2 cm on bidigital palpation, indication for any concomitant pelvic floor surgery, being less than 6 months postpartum, lactational amenorrhea, history of a previous fourth-degree laceration, connective tissue disorder, current use of systemic corticosteroids, diabetes mellitus, occult sphincter tear on ultrasound examination, or indication for anal sphincter muscle reconstruction. Women who had undergone previous pelvic floor surgery or who had a concomitant pelvic-organ prolapse in the anterior or apical compartment of stage 2 or higher (as defined by the POP-Q system21) were excluded.
Patients who met the eligibility criteria were randomized in a 1:1 ratio to either surgical treatment (perineorrhaphy with distal posterior colporrhaphy) or conservative treatment (tutored pelvic floor muscle therapy). Oral and written informed consent was obtained from all participants. Randomization was performed without stratification in balanced blocks of four, using a web-based tool. An independent statistician designed the randomization table. All eligibility criteria were checked with an electronic checklist during randomization. The treatment assignments were not concealed. Inclusion and follow-up assessments were performed by a physician who did not perform the surgical procedures to reduce information and ascertainment bias. No blinding was used.
Patients who were randomized to surgical treatment were scheduled for perineorrhaphy with distal posterior colporrhaphy. The surgical procedure was standardized before initiation of the study and recorded for review (Video 1). All surgeries were performed under local anesthesia at the outpatient surgical ward, by one of by five urogynecologists. Patients who were randomized to conservative treatment were referred to a physical therapist and received an initial evaluation of their pelvic floor muscle strength. They were subsequently educated about the function of the pelvic-floor muscles, as well as, how to perform a correct pelvic-floor muscle contraction. Furthermore, women were taught how to precontract the pelvic floor muscles against increases in intra-abdominal pressure. Biofeedback-assisted or functional electrostimulation therapy would be used when needed. The patients then received a pelvic floor exercise program and were scheduled for 1–3 follow-up visits. A program to help women build up 10 maximal contractions, each 5 seconds long, three times per day and one maximal contraction of 30–60 seconds was provided.
Outcome measures were registered at randomization and at the 6 months follow-up visit. Subjective outcomes were collected from questionnaires, which the patients filled in without involvement of a caregiver. The Patient Global Impression of Improvement scale was used for our primary outcome. The Patient Global Impression of Improvement is validated for assessing outcomes after incontinence and prolapse interventions.22,23 It uses a seven grade Likert scale where the patient is asked to assess subjective level of improvement ranging from “very much worse” up to “very much better.” Cure or treatment success is defined by patient choosing answer options “much better” or “very much better.”
Secondary outcomes included assessment of bother caused by pelvic floor dysfunction symptoms preoperatively and postoperatively using the Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire. Three nonvalidated questions for vaginal symptoms were added: “Do you experience a sensation of a wide or open vagina?” “Do you experience air going in and out of the vagina?” and “Do you experience excessive discharge?” The Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire address symptoms, distress and effect on quality of life in women with pelvic floor disorders.24 Both questionnaires consist of three domains; one reflecting urinary symptoms (Urinary Distress Inventory/Urinary Impact Questionnaire), one reflecting bowel symptoms (Colorectal-Anal Distress Inventory/Colorectal-Anal Impact Questionnaire), and one reflecting prolapse or vaginal symptoms (Pelvic Organ Prolapse Distress Inventory/Pelvic Organ Prolapse Impact Questionnaire). Each subscale ranges from 0 to 100, with a maximum summary score of 300. High scores indicate greater bother. The short version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire was used to asses sexual functions.25 It is a 12-item questionnaire with scores ranging from 0 to 48, where higher scores indicate better sexual function. The Hospital Anxiety and Depression Scale was used for evaluation of depression and anxiety symptoms. It is a 14-item questionnaire with scores ranging from 0 to 21 on an anxiety and depression domain.
Objective outcome measures included the POP-Q system and evaluation of the perineal body thickness using both ultrasound examination and bidigital palpation (index finger in the rectum and thumb on the posterior vestibulum at the level of the external sphincter). The perineal thickness on bidigital palpation was divided into three categories: less than 1 cm, 1–2 cm, or more than 2 cm. The height of the perineal body (with exclusion of internal anal sphincter) was measured with a transperineal ultrasound examination using a simple two-dimensional B-mode ultrasound system with a 3- to 6-Mhz curved array transducer.26 The triangular hyperechoic area between the vagina and anorectum was identified as the perineal body, with its apex anterior to the anorectal junction.27 Surgical characteristics and adverse events during follow-up were registered in a separate protocol.
The current literature does not support a robust formal sample size calculation for the primary outcome of interest. Our power analysis assumed subjective success according to the Patient Global Impression of Improvement definition would be reported by 60% in the surgery group and 20% in the physical therapy group. According to these assumptions we needed 28 patients in each arm to have an 80% power to detect a significant difference between the groups regarding the primary outcome (assuming a 5% two-sided significance level). Anticipating a 20% loss to follow-up a total of 70 patients (35 in each arm) had to be recruited.
Primary analysis was undertaken on an intention-to-treat (ITT) basis and was compared with results of a per-protocol analysis. The principal ITT analysis was performed with worst case imputation of missing outcomes (assuming treatment failure). A sensitivity analysis was performed with original data and by imputation of missing data with multiple imputation (10 iterations). An as-treated approach was used when assessing perioperative data and safety. Effect sizes (odds ratios with 95% CIs) of the primary outcome were calculated using univariate logistic regression. Baseline characteristics of the comparative groups were summarized using standard descriptive statistics. Categorical variables are compared with Fisher exact test and continuous outcomes are analyzed using the Mann–Whitney U test. Within group comparisons were analyzed with Wilcoxon signed rank test for continuous outcomes and McNemar's test for categorical outcomes. P<0.05 was considered significant for all comparisons. All statistical analyses were performed with the use of SPSS Statistics for Windows 26.0.
The study was approved by the Research Ethics Committee at Karolinska Institutet, Stockholm, Sweden and conforms to the CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomized trials. The study protocol was registered at ClinicalTrials.gov (NCT02545218) before recruitment, and the trial was conducted in accordance with the protocol.
A total of 109 women fulfilled the eligibility criteria during the enrollment period (October 15, 2015–June 7, 2018), of whom a total of 70 women were randomized. Figure 2 illustrates the disposition of patients according to the CONSORT guidelines.28 A comparison of baseline characteristics (age, body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], parity, smoking status, and degree of maximal laceration) between the included and nonincluded eligible patients showed that those in the nonincluded group had higher BMIs (median BMI 22 [interquartile range 5] vs 24 [interquartile range 4], P=.03) and median parity (2 [minimum–maximum 1–6] vs 2 [minimum–maximum 1–7], P=.008). There was one crossover in each group. Three patients (1.4%) in the surgery group declined participation post randomization. There was no loss to follow-up, although one patient did not return for her follow-up visit at 6 months but returned all the questionnaires. One patient in the physical therapy group did not meet inclusion criteria (had a history of a fourth-degree perineal tear), which was noticed after randomization. One patient in the surgery group underwent a concomitant mid-urethral sling procedure in breach of the protocol. Patient characteristics and questionnaire scores were similar (P>.05) between the groups at baseline (Table 1). The median age of the study group was 35 years. The median parity was two deliveries, and median duration postpartum was 10 months at enrollment in the study.
The primary outcome (Patient Global Impression of Improvement) for both original and imputed data as well as the per-protocol analysis are presented in Table 2. Treatment success, defined as answer options “much better” and “very much better” in the ITT analysis with worst case imputation of missing outcomes, was significantly more frequent in the surgery group (25/35 [71%] vs 4/35 [11%]), corresponding to a treatment effect in percentage points of 60% (95% CI 42–78%; odds ratio 19 [95% CI 5–69]). There were minor changes when analyzing original data and when using multiple imputation of the missing outcomes. The result of the per-protocol analysis was similar to that of the ITT analysis.
Table 3 presents secondary outcomes within both groups at baseline and at the 6 months follow-up visit. All questionnaire scores (including subscales) among the patients receiving surgical treatment improved significantly, whereas the physical therapy group improved only in the prolapse domain of the Pelvic Floor Distress Inventory and in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores. Table 4 shows a comparison of the delta value (follow-up value minus baseline value) between the two treatment groups. The surgery group was superior to the physical therapy group with regard to all aspects of symptomatic improvement.
Distribution of pelvic floor dysfunction symptoms in women with a perineal body defect before and after treatment are shown in Table 5. The women in the physical therapy group did not improve significantly regarding any of the symptoms. Symptoms of obstructed defecation became much less frequent in women receiving surgical treatment; 46% reported digital assistance during defecation preoperatively in comparison with 9.4% at follow-up. A total of 51% reported symptoms of stress urinary incontinence preoperatively, and the number decreased to 31% postoperatively (P=.005). Gas incontinence was also common (49%) but did not improve significantly after either surgery or physical therapy. Vaginal symptoms such as a sensation of a wide or open vagina was reported by nearly all patients at baseline. Women who reported “daily” presence of this symptom diminished from 88% to 9% after surgery. A total of 81% (57/70) of the study participants were sexually active at recruitment compared with 88% (59/67) at follow-up. Women in the surgery group improved significantly regarding pain during sexual intercourse (dyspareunia), P=.01. No patient in the surgery group stopped having sexual intercourse postoperatively or reported de novo dyspareunia.
The mean operation time was 35 minutes (range 20–66), and the mean amount of blood loss was 22 mL (SD ±15 mL). A total of five women (15.6%) were affected by local wound infections and were treated with oral antibiotics (amoxicillin or clavulanic acid plus metronidazole). Two women had to undergo reoperation owing to postoperative hematoma or bleeding. There were no bowel injuries.
In this randomized controlled trial, we compared surgery with structured pelvic floor muscle therapy in women with symptoms of a poorly healed second-degree perineal tear subsequent to childbirth, who presented by earliest 6 months postpartum. Surgical treatment resulted in a higher success rate on the basis of the Patient Global Impression of Improvement and also in significantly greater improvement in all secondary endpoints at 6 months of follow-up.
Patients seeking counseling owing to symptoms related to a poorly healed perineal laceration are often advised to perform pelvic floor muscle exercises, because physical therapy is generally regarded as first-line management for many pelvic floor disorders.13 Pelvic muscle exercises may well lead to agonist muscle hypertrophy, but whether or not symptoms will improve depend on whether the agonist muscle can compensate for the lost muscle functions. The present trial showed that structured pelvic floor muscle training is not very effective in reducing symptoms associated with persisting grade 2 perineal trauma and tissue defects.
The physical therapy group improved significantly only in the prolapse domain (Pelvic Organ Prolapse Distress Inventory) of the Pelvic Floor Distress Inventory, which corroborates findings in previous trials assessing the effect of tutored pelvic floor muscle training in women with prolapse.29 Somewhat surprisingly, urinary symptoms did, however, not improve after physical therapy. It could be that women with poorly healed second-degree perineal tears cannot contract the muscles surrounding the urethra as effectively as women with an intact perineum. The perineal membrane is intimately associated with the compressor urethrae and the urethrovaginal sphincter.30 If the bulbocavernosus and puboperinealis muscles have lost their anchoring point in the perineum, they cannot support the urethra during Valsalva. This theory is supported by the observation that surgically merging the detached muscle ends back to the perineal body leads to a significant improvement in symptoms of urinary incontinence.
Ulubay et al10 described anatomical changes, patient satisfaction and sexual function in a case series of 38 women undergoing perineorrhaphy, as a treatment for the sensation of a wide vagina. The patient satisfaction rate was 87.9% in comparison with 80% in the present study (according to the per-protocol analysis of all patients underwent surgery). Four patients (10%) in their trial reported de novo dyspareunia, whereas none in our study did so. In another case series, Inan et al12 described 40 women undergoing perineoplasty, which in agreement with the present study experienced a significantly improved sexual function postoperatively. None of the previous studies used validated questionnaires to assess pelvic floor dysfunction symptoms, nor did they include a control group which limit any comparisons.
It is well known that pelvic organ dysfunction may be associated with overall social, functional and hygienic impairment. The study population in the present study had a mean Hospital Anxiety and Depression Scale score of 11–12 points at baseline, which indicates a clinically significant anxiety or depression disorder. This corroborates previous findings of an association between pelvic floor dysfunction and symptoms of depression.31 We found that women who reported treatment success (thus mainly women in the surgery group) had a mean Hospital Anxiety and Depression Scale score of 8 at follow-up (P=.005), which correlates to a low probability of psychiatric illness. This suggests that pelvic floor dysfunction symptoms have a considerable effect on women's mental health and that treatment leading to symptom relief is essential for their psychological well-being.
Dyspareunia is a known complication of vaginal surgery, and previous studies show conflicting results regarding de novo dyspareunia after posterior compartment procedures.32 However, it seems as if a poorly healed perineal body by itself is a risk factor for dyspareunia—42% of the included women in this study answered “often” or “always” on the question “Do you feel pain during sexual intercourse?” in comparison with a prevalence of 7.5% in the general population.33 The overall Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score in the study population at baseline was 32 (SD ±6), which is similar to a study by Ostrzenski et al, where women with perineal defects had a mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score of 30 (SD ±6).34 Our data suggest that surgical correction of the perineal anatomy is beneficial, because none of the patients in the surgical group reported de novo dyspareunia. Instead, close to two thirds of sexually active women reported preoperative dyspareunia as compared with less than one third postoperatively. Contributing to this positive outcome may be a minimal dissection, avoiding excessive excision of skin or mucosa distal to the hymen and not using levator ani sutures.
Strengths of the study includes the randomized design, the standardized interventions and the use of validated questionnaires. A multi-center design would have increased the generalizability of our findings and could be a valuable next step in our understanding of how to manage patients with perineal injury after delivery. The standardized surgical procedure was performed by one of five different urogynecologists, which minimizes some of the performance bias. For obvious reasons the treatment allocation could not be blinded, which to some extent may introduce placebo effects. Patient satisfaction and expectations of symptom relief are likely to be affected by whether the woman was assigned to the treatment she was hoping for or believed in. Further, the nonblinded outcome assessment may have caused measurement bias. The questionnaires used to evaluate subjective outcomes have shown a strong correlation to treatment success in the management of pelvic floor disorders.22,23,35 Nonetheless, they do not entirely capture the whole spectrum of symptoms, such as the sensation of an open vagina or vaginal flatulence. The ICIQ Vaginal Symptoms questionnaire could be an important complement to the Pelvic Floor Distress Inventory in women with perineal injuries, but it must first undergo appropriate language translation and validation if used in a Swedish setting.36 The follow-up at 6 months was chosen on the basis of muscle physiology. Previous studies have shown that 15 weeks of specific muscle training is needed to gain muscle hypertrophy and that statistically significant strength increase has been found after pelvic floor muscle training lasting from 3 to 6 months.37 However, this time span only allows us to only assess short term outcomes after surgery.
In summary, the results of this trial suggest that surgical treatment is superior to pelvic floor muscle training in treating women with a poorly healed second-degree perineal tear. Surgery seems to do more good than harm regarding improvement of pelvic floor and sexual function, as well as quality of life. A combination of surgery and physical therapy is likely to result in the most optimal result at long term, but further research is needed to substantiate this notion.
Authors' Data Sharing Statement
- Will individual participant data be available (including data dictionaries)? No.
- What data in particular will be shared? Not available.
- What other documents will be available? Study protocol, statistical analysis plan, informed consent form.
- When will data be available (start and end dates)? Not available.
- By what access criteria will data be shared (including with whom, for what types of analyses, and by what mechanism)? Not available.
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