Evaluation of surgical methods for treatment of female stress urinary incontinence

Aims: Paper I & II: To compare the subjective and objective results of open Burch colposuspension and laparoscopic colposuspension using sutures or mesh and staples in randomised trials. Paper III: To assess the short and long term results of the Tension-free Vaginal Tape (TVT)-procedure in a large observational study and to identify factors predictive of successful outcome. Paper IV: To compare direct health care costs for incontinence surgery in Sweden using four different surgical procedures and to relate health care costs to subjective cure thus creating a simple cost effectiveness ratio. Patients and methods: Papers I & II: Women with stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a predominant stress component were included. Paper I: Multicenter Randomised Controlled Trial comparing open Burch colposuspension (n = 120) to laparoscopic colposuspension with mesh and staples (n = 120). Paper II: Three-armed Randomised Trial comparing open Burch colposuspension (n = 79), laparoscopic colposuspension using sutures (n = 53) and laparoscopic colposuspension using mesh and staples (n = 79). Papers I & II Evaluation one year after surgery included subjective cure, quality of life assessed by a visual analogue scale, leakage in a 48-hour pad-test and in Paper II a standardised stress test. Paper III: Prospective observational trial of 707 consecutive women with SUI (n = 396) or MUI (n = 311) treated with the TVT-procedure. Subjective cure after 1, 2 and 5 years was evaluated by a postal questionnaire. A sub-sample of 59 women was objectively evaluated 5 years after surgery. Factors influencing the cure rate were analysed using a stepwise multiple regression analysis. Paper IV: A model was constructed representing a hospital with standardised surgical equipment, staff and average unit costs in 2003 value. Clinical data collected from the studies in Paper I, II and III and hospital cost data were put into the model to create the different cost elements. Results: Paper I & II: Objective cure 1 year after surgery was higher after open colposuspension and laparoscopic suspension using sutures compared to laparoscopic colposuspension using mesh and staples. Subjective findings were in concordance with the objective results. Performing an open colposuspension was less time consuming than performing a laparoscopic colposuspension but resulted in more blood loss than both the laparoscopic methods. Patients in the laparoscopic colposuspension group using mesh and staples had a shorter duration of catheter use and hospital stay. Paper III: Subjective cure rate was 83% after 1 year and 73% after 5 years. Objective cure rate was 83% in the subgroup after 5 years. In patients with MUI the cure rate was lower than in patients with SUI (after 5 years 55% vs 81%). Type of incontinence was the only independent variable found to influence surgical outcome. Paper IV: The total cost per individual, showed a lower cost for TVT compared to the other three methods. The direct costs for a TVT were only 56% of the costs for an open colposuspension and 59% of the costs for a laparoscopic colposuspension using sutures. The TVT procedure was more cost-effective, in costs per subjectively cured patient, compared to all other three methods. Conclusions: Open colposuspension had a higher objective and subjective cure rate 1 year after surgery, but with a greater blood loss, greater risk of urinary retention and a longer hospital stay than laparoscopic colposuspension using mesh and staples. The use of sutures, irrespective of whether the surgical approach was laparoscopic or open surgery, was superior to the laparoscopic mesh and staples technique. The TVT-procedure, performed in over 700 women at a single unit, was found to be safe and efficient. Type of incontinence was the only independent variable found to predict for outcome of surgery. When using an economic model and comparing health care costs for surgical treatment of female stress urinary incontinence in Sweden, the TVT-procedure generated a lower direct cost and cost per subjectively cured patient

Factors influencing the outcome of surgery for pelvic organ prolapse

Pelvic organ prolapse (POP) surgery is a common gynecological procedure. Our aim was to assess the influence of obesity and other risk factors on the outcome of anterior and posterior colporrhaphy with and without mesh. Data were retrieved from the Swedish National Register for Gynecological Surgery on 18,554 women undergoing primary and repeat POP surgery without concomitant urinary incontinence (UI) surgery between 2006 and 2015. Multivariate logistic regression analyses were used to identify independent risk factors for a sensation of a vaginal bulge, de novo UI, and residual UI 1 year after surgery. The overall subjective cure rate 1 year after surgery was 80% (with mesh 86.4% vs 77.3% without mesh, p < 0.001). The complication rate was low, but was more frequent in repeat surgery that were mainly mesh related. The use of mesh was also associated with more frequent de novo UI, but patient satisfaction and cure rates were higher compared with surgery without mesh. Preoperative sensation of a vaginal bulge, severe postoperative complications, anterior colporrhaphy, prior hysterectomy, postoperative infections, local anesthesia, and body mass index (BMI) 30 were risk factors for sensation of a vaginal bulge 1 year postsurgery. Obesity had no effect on complication rates but was associated increased urinary incontinence (UI) after primary surgery. Obesity had no influence on cure or voiding status in women undergoing repeat surgery. Obesity had an impact on the sensation of a vaginal bulge and the presence of UI after primary surgery but not on complications

A Swedish population-based evaluation of benign hysterectomy, comparing minimally invasive and abdominal surgery

Objective: The aim was to evaluate surgical routes for benign hysterectomy in a Swedish population, including abdominal and minimally invasive surgery. Study design: Prospectively collected data from the Swedish National GynOp Registry 2009–2015: 13 806 hysterectomy cases were included: abdominal (AH, n = 7485), vaginal (VH, n = 3767), conventional laparoscopic (LH, n = 1539) and robotically-assisted (RAH, n = 1015). Results: The VH group had the shortest operation time at 75 min, AH 97 min and RAH 104 min. LH was longest at 127 min (p < 0.005). The mean estimated blood loss was higher in the AH group (250 ml) compared to all minimally invasive surgery (MIS, 65–172 ml); p < 0.005). Conversion rates were 10% for LH, 4.8% for VH and 1.6% for RAH (p < 0.005). Hospitalization and patient-reported time to normal activities of daily living (ADL) were longer for AH compared to MIS (p < 0.005). Time to return to work was eight days longer in the AH group (35 days) compared with the MIS groups (p < 0.005). Complications were fewest in the VH group at 5.4% compared with AH 7.6% and RAH 8.7% (both p < 0.001), but did not significantly differ from the LH group at 6.6%. Overall patient satisfaction was reported to be 86–94% one year after surgery. Conclusion: Women operated on for benign hysterectomy with minimally invasive methods in Sweden 2009–2015 had reduced length of hospitalization, as well as time to resuming normal ADL and return to work, compared to AH. Postoperative outcome measures were improved by minimally invasive methods and MIS should preferably be used