The present study was a clinical trial study which was conducted on 138 women with stress urinary incontinence referred to Imam Reza Hospital of Kermanshah city during 2012–2019. Samples were selected by purposive method. The women with mass index less than 30 kg / m2 were included in the study. Then, all patients before surgery underwent cystoscopy, Marshall test and cough stress test, urinary tract mobility test and, if necessary, urodynamic test, pelvic examination and post-void residual (PVR) urine test and completed the incontinence impact questionnaire-7 (IIQ-7). Exclusion criteria also included dissatisfaction with participation in the study, patients with a history of pelvic floor static adjustment surgeries and urinary incontinence correction surgeries, people with pelvic organ prolapse, and simultaneous presence of other types of urinary incontinence.
After selecting the patients, the researcher explained the goals and methods of the study to the patients and asked them to complete the informed consent form if they wished to participate in the study. Then, patients using a random number table randomly divided into two groups of transversal (n = 69) and longitudinal incision (n = 69). All surgeries were performed by one urologist. Data collected before and after surgery included urine analysis test, hemoglobin 24 hours before and after surgery, amount of pads used per day, information on incontinence impact questionnaire-7 (IIQ-7) and patients' PVR urine test. All patients received prophylactic antibiotics (1 gram of intravenous Cefazolin) 30 minutes before surgery. General or regional anesthesia was performed according to the anesthesiologist. Patients were placed in a lithotomy position with the knee bent at 70 degrees. Foley catheter size 16 was fixed for the patient. Then, a 2-2.5 cm vaginal incision is made perpendicular to the longitudinal axis of the duct and after incision, partial release of periurethral tissue in the space between vaginal mucosa and pubocervical fascia is performed with scissors. Two 1 cm incisions were made in the skin of the suprapubic region. Then, the TVT trocar entered the paravertebral tunnel through the vaginal incision, then entered the retropubic space with a special needle controlled pressure and exited the suprapubic incision, and the same steps were performed on the opposite side and came out of the suprapubic incision (Fig. 1).
Cystoscopy was performed to ensure that the bladder and urethra were healthy. The position of the mesh was also determined by trans-libral ultrasonography by a radiologist and evaluated 60 months after surgery.
The surgical method of the two groups was similar in both groups except for the type of incision. In the longitudinal incision, a vaginal incision is made in the midline of the anterior wall of the vagina with a maximum length of 1.5 centimeters, which is the beginning of the incision at a distance of 1.5 centimeters from the mesentery.
In the transverse vaginal incision, an incision was made 2-2.5 cm long, perpendicular to the longitudinal axis of the urethra and in the middle third of the urethra. The length of the urethra was considered from the external entrance of the urethra to the neck of the bladder, which was detected by touching the Foley catheter embedded inside the urethra.
The rest of the steps are similar in the two groups:
Surgical procedure TVT: The patient is placed in a lithotomy position (bending the thighs at a 70-degree angle). The type of anesthesia is spinal or general, and the outcome of surgery and its complications do not differ significantly from different types of anesthesia. In this surgery, we need 3 incisions. 2 1 cm incisions on the skin of the suprapubic area (on the upper edge of the pubis bone) so that each incision is 2 to 2.5 cm away from the midline and a vaginal incision made in one longitudinal group and transversely in the other group. Skin incisions are made to facilitate the passage of TVT special needles.
After vaginal incision, partial release of paravertral tissues in the space between vaginal mucosa and pubocervical fascia is performed with surgical scissors. Before the trocar passes, a special guide is inserted into the duct catheter and by it, the duct and bladder are pushed to the opposite side to get away from the trocar crossing. The trocar (TVT special needle) is then inserted through the vaginal incision into the paravertrial tunnel (which we have already created), so that the needle is placed between the surgeon's index finger in the vagina and the lower edge of the ramus pubis. Then, with a controlled pressure, a special needle pierces the endoplavicular fascia and enters the retzius space, and after passing through the rectus muscle fascia, it exits the suprapubic incision. The same steps are done on the opposite side. The two ends of the mesh strip are fixed to the ends of the double-sided needles and pass through the vaginal space and then retropubically and exit the suprapubic incision. After each needle is passed, a cystoscopy is performed to make sure the bladder and urethra are healthy. If the bladder is damaged, the trocar is removed and re-routed.
To adjust the position and control the tension of the mesh strip, a space is placed between the urethra and the part of the sling that is under the duct, the size of the tip of the surgical clamp or Hegar dilator No. 8, to minimize obstructive complications after surgery. To adjust the position and control the tension of the mesh strip, a space is placed between the urethra and the part of the sling that is under the duct, the size of the tip of the surgical clamp or Hegar dilator No. 8, to minimize obstructive complications after surgery. After adjusting the mesh, the vaginal wound and skin incisions are closed with 3 − 0 or 4 − 0 absorbable sutures and vaginal gauze is placed.
Finally, patient information was entered into a researcher-made questionnaire that was designed based on the main objectives of the study and its validity was confirmed by 5 urology professors. Statistical analysis was conducted by SPSS 24 (Chi-square test, Fisher's exact test) and P-Value < 0.05 was considered statistically significant.
This study has been approved by the ethics committee of Kermanshah University of Medical Sciences with code 1398.941IR.KUMS.REC. In addition, it was registered in the Iranian Registry of Clinical Trials (IRCT) with code 4N20180519039715IRCT.