Patients
In the period between December 2001 and April 2005, 72 women underwent a sacrospinous hysteropexy at the University Medical Center Utrecht, The Netherlands.
A woman was eligible for participation if she had a symptomatic pelvic organ prolapse and wanted surgical correction with preservation of the uterus. Exclusion criteria were abnormal uterus or ovaries on ultrasound examination, abnormal bleeding pattern and abnormal cervical cytology. All women answered a standardized questionnaire covering urogenital symptoms, defecatory symptoms and quality of life before and after surgery. Urodynamic assessment was performed in all women preoperatively. We did not try to diagnose occult stress incontinence. The study was approved by the local ethics committee.
Surgery
Surgery was performed by two experienced surgeons who at least had performed 20 sacrospinous hysteropexies before start of the study. The sacrospinous hysteropexy was performed unilaterally to the right ligament. A midline incision in the posterior vaginal wall is extended to the posterior part of the cervix. Through sharp and blunt dissection, the right sacrospinous ligament is made visible with the use of three Breisky retractors. Two non-absorbable Prolene® sutures (Ethicon, Sommerville, NJ, USA) are placed through the right sacrospinous ligament, approximately 2 cm median to the ischial spine, and subsequently placed through the posterior side of the cervix in the midline. An additional anterior and/or posterior colporrhaphy (fascia plication), with absorbable Vicryl® 2-0 interrupted sutures (Ethicon, Sommerville, NJ, USA), was performed when indicated by the judgment of the individual gynecologist. In case of stress urinary incontinence, confirmed by urodynamic tests, a surgical procedure of the Tension-free Vaginal Tape (TVT, Ethicon, Sommerville, NJ, USA) was performed as described by Ulmsten [12]. All women received peri-operative thrombosis prophylaxis (anti-Xa) and a single dose of intravenous prophylactic antibiotic (amoxicillin/clavunalic acid). Post-operatively, a 14-French Foley indwelling bladder catheter with a 5-ml balloon was placed in all women and removed after 1 day (in case of an additional anterior colporrhaphy after 3 days).
Measurements
Data collection took place in October/September 2005, at least 3 months after surgery of the last participating woman. The following data were collected: age at the time of surgery; medical history; hospital stay and perioperative and postoperative complications. The anatomical outcome of all women was assessed with the Pelvic Organ Prolapse Quantification score (POP-Q) [13], which is described by the International Continence Society as a reliable and specific method to measure the pelvic organ support. Before surgery, POP-Q was performed by one of the two surgeons. After surgery, POP-Q was performed by one of three independent investigators. In the analysis, we dichotomized the POP-Q stage of prolapse into stage 1 or less and stage 2 or higher. Although we know that women with pelvic organ prolapse experience symptoms that do not necessarily correlate with the severity of prolapse, we have chosen this approach to try to separate potential clinical irrelevant from clinical relevant recurrences [14].
Urogenital symptoms were measured before and after surgery with a standardized questionnaire, the Urogenital Distress Inventory (UDI), which has been validated for the Dutch population [15]. In this validation study on a large population-based sample, it was shown that the domain construction of the Dutch version was different from the original one. The following five domains were identified: urinary incontinence, overactive bladder, pain, obstructive micturition and prolapse. The scores of these domains vary between 0 and 100. A high score on a particular domain indicates more bothersome symptoms. The incidence of urinary incontinence before surgery was measured as follows: a woman was considered to have stress urinary incontinence if she replied positively to the question “Do you experience urinary leakage related to physical activity, coughing or sneezing?”. Urge urinary incontinence was scored if the question, “do you experience urinary leakage related to the feeling of urgency?” was answered positively.
All patients completed a questionnaire, the Defecatory Distress Inventory (DDI) to assess the presence of defecation symptoms before and after surgery. This questionnaire was developed by our research group to assess the presence of defecation symptoms [16]. The DDI consists of 15 items about symptoms related to obstructive defecation, constipation, fecal incontinence and pain related to defecation. The questions were developed after studying the literature and international definitions, interviewing patients who presented with constipation or fecal incontinence, and by interviewing three experts in the field from the Department of Surgery and Department of Obstetrics and Gynecology from the University Medical Center Utrecht, The Netherlands. Eventually, a structured interview of the 15 selected items was held with 20 female patients. The DDI was used as, at present, there are no other Dutch validated questionnaires to measure quality of life related to defecation symptoms. The design on the questions is identical to those of the UDI with domain scores between 0 and 100. Again, a high score on a particular domain indicates more bothersome symptoms. The DDI was used in previous studies at our department [4, 9, 17].
Before and after surgery, disease-specific quality of life was measured with the Incontinence Impact Questionnaire (IIQ), validated for the Dutch population [15]. These questions cover the following five domains: physical functioning, mobility, emotional functioning, social functioning and embarrassment. The score ranged between 0 (best quality of life) and 100 (worst quality of life).
Effect sizes were measured as a useful way to estimate whether an improvement on a particular domain was considered to have a small, moderate or large clinical relevance.
Statistical analysis
Descriptive statistics were used for the whole population. To compare scores on urogenital and defecatory symptoms before and after surgery a paired samples t test was used. The significance level was set at α of 0.05. The effect size was calculated by Cohen’s d test which is defined as the difference between two means divided by the pooled standard deviation for those means [18]. An effect size of 0.2 was considered to be small, 0.5 to be median and 0.8 or higher to be large [18]. Statistical analysis was performed in SPSS 12.0 for Windows.