The number of surgeries as a treatment for female SUI has increased, and an alternative approach using a transobturator passage of the tape has been developed; the midurethral slings (MUS) procedures has become increasingly popular. In literature Few studies compared these two widespread techniques used for the management of SUI, and none, at the best of our knowledge, evaluated before the sexual function after these procedures.
Single-incision slings (SIS) have been developed to reduce procedure-related discomfort without negatively affecting the benefit. Similar to the transobturator slings, the SIS perforates the obturator internus muscle and the foramen obturatum but does not perforate the adductor muscles, resulting in less postoperative pain.
Thus, the aim of the study was to prospectively evaluate the effect of TVT-O vs. SIS procedures on the sexual function and QoL in female patients with SUI by using the Female Sexual Function Index (FSFI) and International Consultation on Incontinence Modular Questionnaire-Short Form (ICIQ-SF).
In total, 48 patients were included in the study and were divided into groups for treatment of SUI: 24 patients underwent insertion of tension-free transobturator suburethral tape (TVT-O group) and 24 underwent insertion of transobturator single-incision mini-sling (SIS group). Patients were divided by a simple randomization (after a stratified randomization to control all the baseline covariates between the two study arms) in the two treatment groups. Using a computer table generation of random numbers: group 1 (n = 24 women) was treated with TVT-O to correct SUI, and group 2 (n = 24 women) was treated with the SIS. Both groups were evaluated with the same questionnaires after 6 and 12 months of treatment to assess the impact of continence on quality of life and the sexual function. The preoperative urodynamic assessment of the patients was performed in accordance with the International Continence Society guidelines.
Only sexual-active patients were enrolled in the study; the participants who have had at least one sexual activity within three months prior to surgery were considered as being sexual active. Before the surgery and at six months of follow-up (when the participants attended the Urogynecology outpatient clinic), the participants were asked to complete the Italian versions of the FSFI questionnaires for the assessment of sexual function and the ICIQ-SF questionnaires.
Mean operative time was 23.5 mins (range: 13-26) in TVT-O group, and 22.5 mins (range: 12.8-25) in SIS group. No intra and postoperative complications occurred. One patient of TVT-O group experienced a vaginal wall erosion (21 days after surgery) and one of the SIS group reported a denovo outlet obstruction. No patients reported a denovo urgency incontinence and/or overactive bladder.
All women who had an active sexual life preoperatively reported sexual activity after procedures. The mean time of postoperative sexual activity resumption was 36 days (range : 32-44 days).
The 6 months postoperative results indicated that the total FSFI scores increased from 23.96 ± 5.56 to 28.09 ± 3.34 for the TVT-O group and from 23.51 ± 3.78 to 27.42 ± 3.62 for the SIS group. Additionally, significant improvements were also found in all the domains considered (sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain). No statistically significant differences were observed between the two treatment groups. Furthermore, the mean postoperative ICIQ-SF scores were significantly lower than the mean preoperative ICIQ-SF scores (an indicator of improvement of QoL).
At the initial follow-up of 6 months 18/21 (85.7%) and 17/21 (80.9%) patients after SIS and TVT-O groups respectively experienced a complete recovery of urinary continence. At 12 months follow-up after surgery, 19 (90.4%) patients who successfully underwent the SIS procedure reported a complete resolution of urinary incontinence while 2 (9.5%) reported an improvement in urinary incontinence. In the TVT-O group, total recovery of urinary incontinence was observed in 18/21 (85.7%) of patients, and an improvement in the incontinence was observed in 1/21 (4.1%) of patients who had showed negative results during the physical examination. In addition, one vaginal wall erosion complication was observed in the TVT-O group, and one patient reported acute retention of urine in the SIS group.
To the best of our knowledge this is the first study to compare sexual function in patients affected by SUI submitted to SIS versus TVT-O. Minimally invasive mid-urethral slings have become the standard surgical procedure for treatment of stress urinary incontinence in women. The TVT-O procedure is an inside-out transobturator sling technique that is a modified version of the TVT procedure. It has gained worldwide use because of its safety, simplicity, and effectiveness in treating SUI. However, limited investigation exists on the effect of transobturator sling procedures, including TVT-O, on sexual function.
For avoiding the complications due to the blind needle passage through the retropubic space (TVT sling) or transobturator foramen (TOT sling), the new SIS systems were introduced. These slings aim to obtain the same suburethral support with less invasivity by anchoring the two arms in the obturator fascia while avoiding the passage through the adductor muscles.
In this study no evidence of a significant difference in terms of continence rates between SIS (90.4%) and TVT-O (89.8%) groups was observed. However, this lack of significant differences has to be carefully interpreted because of the study main limitations: short term follow-up, and the small number of enrolled patients.
Sentilhes et al. have found no significant differences after surgery regarding the frequency and appreciation of sexual intercourse, extent of sexuality, and frequency of leakage during intercourse.
A review by Abdel-Fattah et al. reflected the primary suboptimal results of SIS with inferior patient-reported and objective cure rates on the short-term follow-up and higher reoperation rates for SUI when compared with standard midurethral tapes.
In a multicentre prospective randomised trial in six UK centers, Mostafa and colleagues compared the postoperative pain profile, peri-operative details, and short-term patient reported and objective success rates of single-incision mini-slings (SIS) versus standard mid-urethral slings (TVT-O) in 137 women suffering from pure SUI. The adjustable single-incision sling was associated with a significantly improved postoperative pain profile and earlier return to work when compared to standard mid-urethral slings, with encouraging results in patient-reported and objective success rates at short-term follow-up.
In our study, both the sling systems provided high continence rates without major complications: 90.4% in SIS group and 89.8% in TVT-O group with total continence or improvement support equality of data. A median follow-up period of 12 months is short for the comparison of objective outcome measures to reveal the benefits of different sling systems.
Thus, the limitations of the study include the differences between pre- and postoperative results that were minimal, probably because of the small number of sample size. Furthermore, sexual function is affected by multiple factors such as anatomy, traditional culture, education, and psychological factors, and the FSFI questionnaire hardly reflects all the possible problems related to sexual function. It would have been useful to have had a longer follow-up period to see whether sexual function changed over time.
The current evidence of pelvic floor surgery on sexual function is contradictory. Many studies dealing with the changes of sexual function after incontinence surgery show varying results.
SIS and the TVT-O procedures seem to be effective and safe in the operative treatment of female SUI. Twelve-months of follow-up data showed comparable continence rates for SIS and TVT-O without any severe side-effects or complications. The results also showed improved QoL after the surgery. In addition, significant improvements in sexual function were also observed for both the TVT-O and SIS procedures. In our study, both the sling systems are equally effective in improving continence and sexual function of female patients with SUI.
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