1. Rationale and purpose of introduction
Stress urinary incontinence (SUI) is an uncontrollable leakage of urine that occurs when abdominal pressure is increased by exertion, sneezing, or coughing. The overall incidence of SUI is as high as 30% to 60% in Western countries and is also very common in China. The efficacy of mid-urethral suspension for SUI in women has been widely recognized, and in 1996, the tension-free vaginal sling (TVT) was introduced, and in 2003, de Leval proposed the “inside-out” tension-free vaginal sling with closed holes based on the traditional TVT – TVT-O. -TVT-O, which minimizes the damage to the urethra and bladder, almost eliminates the possibility of arterial damage in the closed hole, requires no special equipment, and has similar efficacy to TVT, can completely replace the traditional open suspension. Therefore, it is necessary to introduce and promote this technology.
2. the development of this technique at home and abroad and the comparison of similar techniques
The posterior pubic bladder neck suspension (Burch procedure) and the suspension belt procedure are the traditional surgical methods. The open Burch procedure was considered the gold standard procedure for the treatment of stress urinary incontinence 10 years ago. In recent years, with the development of laparoscopic techniques and advances in minimally invasive surgical techniques, minimally invasive treatment of stress urinary incontinence has also made great strides. The advantages of laparoscopic treatment of stress urinary incontinence with Burch surgery are: finer separation due to the magnification of the laparoscope, avoidance of large open incisions, less intraoperative bleeding, shorter hospital stay, faster recovery, less postoperative pain medication needed, faster recovery of bowel function, and earlier return to normal sexual life. The disadvantages are: longer time needed to learn to master, longer operation time, older patients or patients with complications cannot tolerate the operation, and high complications of bladder injury. In addition to synthetic suspensions, autologous fascia and cadaveric fascia are still reported to be used for suspension band surgery. The efficacy of mid-urethral suspension for female stress urinary incontinence has been generally recognized. The most applied suspension belt procedure is the TVT procedure.
The principle of the TVT procedure for female SUI is that when the patient’s abdominal pressure increases, the sling passively blocks the downward moving urethra, causing the pressure in the urethra to increase and exceed the bladder pressure, preventing urinary overflow. This procedure has been rapidly promoted because it is simpler and less invasive than previous treatments and has a shorter hospital stay. However, as the procedure continues to spread, there are increasing reports of complications, such as bladder perforation, nerve, vascular, and bowel injuries. Because the procedure requires crossing the retropubic space, it should be used with caution in patients with a history of pelvic surgery to avoid damage to the intestines or pelvic organs.
In 2001, Delorme first reported a modified transconjunctival urethral sling, the TOT, which is a urethral suspension procedure that is performed through the skin at the base of the thighs bilaterally and through an incision in the anterior vaginal wall around the closed hole. The risk of neurological or vascular injury due to the TOT technique was found to be minimal by autopsy, and cystoscopy was not required, but there was still a risk of vaginal, bladder, and urethral injury.
In 2003, de Leval proposed the “inside-out” tension-free vaginal sling through the closed orifice – TVT-O, in which a curved puncture needle is passed through the anterior vaginal wall incision around the pubic branch on each side, through the medial aspect of the closed orifice, and out through the bilateral thighs. The root of the thighs is pierced. Studies have shown that TVT-O can minimize urethral and bladder injury, with almost no possibility of arterial injury to the foramen ovale, and the efficacy is similar to that of TVT.
Since 2004, the TVT-O procedure has been gradually introduced into China, and Prof. Guo Hongqian of Gulou Hospital was the first to perform this procedure in Jiangsu Province, and is one of the earlier units in China to perform this procedure. Our results show that TVT-O has the advantages of simple surgery, less trauma and less complications. As long as the procedure is performed in strict accordance with its operating protocol, complications are minimal. The fact that TVT-O does not require cystoscopy makes it more favorable for obstetricians and gynecologists and medical units without cystoscopy to perform the procedure. the feature that TVT-O does not pass through the retropubic space extends the indications for the procedure, and a history of pelvic surgery is no longer a contraindication.
3. Progress of tissue application after the introduction of the technique
After the introduction of the tension-free vaginal sling (TVT and TVT-O) program, the new technology was successfully launched through the promotion of the website, posters and lectures to make the patients aware of the characteristics and superiority of the technology. The introduction of this technology has enabled our hospital to reach a provincial or even domestic leading level in the treatment of female stress urinary incontinence. The technology is simple, fast, minimally invasive, and requires low equipment, making the patient’s hospitalization period much shorter and producing a good social effect.
4. The main technical indicators achieved and technical improvements made after the introduction of this technology
(1) TVT technology has a simple method, little damage, short hospitalization time, fast recovery and exact results.
(2) TVT-O is more free from the need for intraoperative cystoscopic equipment; it reduces the risk of potential bladder-urethral injury in TVT surgery; TVT-O expands the indications for surgery, and those with a history of pelvic surgery are no longer contraindicated.
(3) Technical improvements: routine preoperative urodynamic examination to clarify the diagnosis; increased preoperative vaginal irrigation and prophylactic use of antimicrobial agents to reduce the chance of infection; TVT can be performed without the use of a handle to simplify the surgical procedure; TVT-O should be performed by turning the handle to puncture with the puncture needle close to the pubic bone branch from above the closed foramen to avoid damage to the closed foramen nerves and blood vessels; the guided needle poking through the skin method instead of the sharp knife Pre-incision of the skin to reduce positioning errors and bleeding; precise intraoperative collection and calculation of bleeding volume for analysis and conclusion.
5. Applications.
Methods: 129 patients diagnosed with SUI by clinical and urodynamic examination were retrospectively analyzed. The age ranged from 36 to 82 years,mean (58.3±12.2) years. The duration of disease ranged from 2 to 30 years, with a mean of (8.6±5.5) years.
Results: (1) 110 cases of TVT: the average operation time was 32±7 min, the cure rate was 88.2%, improvement was 8.2%, and failure was 3.6%. Complications: postoperative dyspareunia 10.9%, bladder injury 5.5%, and retropubic hematoma 1.8%. The average number of hospital days was 2.8 days. (2) 19 cases of TVT-O: the average operation time was 15±3 min, the cure rate was 94.7%, improvement was 5.3%, and there were no failed cases. Complications: 5.2% had difficulty in urination after surgery, 10.5% had transient mobility disorders of both lower limbs that resolved on their own. The average number of hospital days was 2.5 days.
Conclusion: Tension-free vaginal sling (TVT and TVT-O) is simple, minimally invasive, with few comorbidities and positive efficacy, and is a safe and effective method for the treatment of SUI in women. Our experience is in general agreement with domestic and international reports. In contrast, TVT-O is more favorable for obstetricians and gynecologists and medical units without cystoscopy because it does not require cystoscopy, and the fact that TVT-O does not pass through the retropubic space extends the indications for the procedure so that a history of pelvic surgery is no longer a contraindication.