The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique.
This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University. The study will focus on a group of patients who will undergo a Burch colposuspension procedure, which is a surgical treatment for stress urinary incontinence. The patients will be randomly divided into two groups. The first group will undergo a traditional Burch colposuspension, which involves lifting the vagina towards the Cooper ligament. The second group will receive a modified Burch colposuspension, which involves applying lateral tension for the anterior vaginal wall before the routine suspension on the Cooper ligament. The patients will then be followed for at least 3 months. Data will be collected from the patients included in the study before the surgical operation, and then the patients will be followed up for at least three months after the surgery. The data will be compared between the two groups in terms of voiding dysfunction after surgery, which will be assessed according to International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms ICIQ\_FLUTS and by assessing uroflowmetry, urinary retention, and post-void residual (PVR) urine. Additionally, the recovery from stress incontinence will be compared by using The Patient's Global Impression of Improvement (PGI-I) and the stress test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Peforming two stitches between the anterior vaginal wall and Cooper's ligament.
Performing lateral tension for the anterior vaginal wall towards the intersection point of the arcus tendineus and the lower edge of the pubic bone then performing two stitches between the anterior vaginal wall and Cooper's ligament.
Damascus university
Damascus, Syria
Subjective voiding dysfunction after surgery, first evaluation
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Time frame: One week after surgery
Urinary peak flow rate after surgery, first evaluation
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Time frame: One week after surgery
Residual urine after surgery, first evaluation
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Time frame: One week after surgery
Urinary retention after surgery, first evaluation
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Time frame: One week after surgery
Subjective voiding dysfunction after surgery, second evaluation
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Time frame: One month after surgery
Urinary peak flow rate after surgery, second evaluation
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Time frame: One month after surgery
Residual urine after surgery, second evaluation
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Time frame: One month after surgery
Urinary retention after surgery, second evaluation
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Time frame: One month after surgery
Subjective voiding dysfunction after surgery, third evaluation
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Time frame: Three months after surgery
Urinary peak flow rate after surgery, third evaluation
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Time frame: Three months after surgery
Residual urine after surgery, third evaluation
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Time frame: Three months after surgery
Urinary retention after surgery, third evaluation
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Time frame: Three months after surgery
Subjective recovery from urinary incontinence, first evaluation
Subjective recovery from urinary incontinence will be assessed by the Patient's Global Impression of Improvement (PGI-I). It is an instrument designed to measure a patient's interpretation of symptom changes following intervention. The patient enters his answer on a 7-point scale scored as (1) "very much better," to (7) "very much worse."
Time frame: one week after surgery
Objective recovery from urinary incontinence, first evaluation
Objective recovery will be assessed by a urinary stress test by filling the bladder and telling the patient to make an effort and cough and repeat it three times. The negative test is considered an objective recovery
Time frame: one week after surgery
Subjective recovery from urinary incontinence, second evaluation
Subjective recovery from urinary incontinence will be assessed by the Patient's Global Impression of Improvement (PGI-I). It is an instrument designed to measure a patient's interpretation of symptom changes following intervention. The patient enters his answer on a 7-point scale scored as (1) "very much better," to (7) "very much worse."
Time frame: One month after surgery
Objective recovery from urinary incontinence, second evaluation
Objective recovery will be assessed by a urinary stress test by filling the bladder and telling the patient to make an effort and cough and repeat it three times. The negative test is considered an objective recovery
Time frame: One month after surgery
Subjective recovery from urinary incontinence, third evaluation
Subjective recovery from urinary incontinence will be assessed by the Patient's Global Impression of Improvement (PGI-I). It is an instrument designed to measure a patient's interpretation of symptom changes following intervention. The patient enters his answer on a 7-point scale scored as (1) "very much better," to (7) "very much worse."
Time frame: three months after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Objective recovery from urinary incontinence, third evaluation
Objective recovery will be assessed by a urinary stress test by filling the bladder and telling the patient to make an effort and cough and repeat it three times. The negative test is considered an objective recovery
Time frame: three months after surgery