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NCT Number: NCT06292702

Reducing Early Urinary Disorders After Stress Incontinence Surgery: The Role of Vaginal Wall Tension.

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Damascus university

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The female patients with urinary incontinence are visiting the urology clinic due to a history of stress urinary incontinence, with failure of conservative treatment or non-compliance with treatment.

Exclusion criteria

  • Patients refusing study participation.
  • Contraindication to general anesthesia.
  • Contraindication to laparoscopic surgery.
  • Coexisting other type of urinary incontinence with urodynamic disturbance.
  • Preoperative post-void residual urine.
  • Previous pelvic irradiation.
  • Concurrent anatomical deformity associated with genital prolapse, cystocele, or intrinsic sphincteric deficiency ( ISD ).

Treatment and study plan

Traditional Burch colposuspension

Procedure

Peforming two stitches between the anterior vaginal wall and Cooper's ligament.

Modified Burch colposuspension

Procedure

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.

Primary outcomes

  1. Subjective voiding dysfunction after surgery, first evaluation

    Time frame: One week after surgery

    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

  2. Urinary peak flow rate after surgery, first evaluation

    Time frame: One week after surgery

    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.

  3. Residual urine after surgery, first evaluation

    Time frame: One week after surgery

    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.

  4. Urinary retention after surgery, first evaluation

    Time frame: One week after surgery

    Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.

  5. Subjective voiding dysfunction after surgery, second evaluation

    Time frame: One month after surgery

    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

  6. Urinary peak flow rate after surgery, second evaluation

    Time frame: One month after surgery

    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.

  7. Residual urine after surgery, second evaluation

    Time frame: One month after surgery

    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.

  8. Urinary retention after surgery, second evaluation

    Time frame: One month after surgery

    Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.

  9. Subjective voiding dysfunction after surgery, third evaluation

    Time frame: Three months after surgery

    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

  10. Urinary peak flow rate after surgery, third evaluation

    Time frame: Three months after surgery

    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.

  11. Residual urine after surgery, third evaluation

    Time frame: Three months after surgery

    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.

  12. Urinary retention after surgery, third evaluation

    Time frame: Three months after surgery

    Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.

Secondary outcomes

  1. Subjective recovery from urinary incontinence, first evaluation

    Time frame: one week after surgery

    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."

  2. Objective recovery from urinary incontinence, first evaluation

    Time frame: one week after surgery

    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

  3. Subjective recovery from urinary incontinence, second evaluation

    Time frame: One month after surgery

    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."

  4. Objective recovery from urinary incontinence, second evaluation

    Time frame: One month after surgery

    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

  5. Subjective recovery from urinary incontinence, third evaluation

    Time frame: three months after surgery

    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."

  6. Objective recovery from urinary incontinence, third evaluation

    Time frame: three months after surgery

    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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Reduce Voiding Dysfunction After Laparoscopic Burch Colposuspension by Using Lateral Tension for the Anterior Vaginal Wall Before Cooper's Ligament Suspension in Stress Incontinence Women. (A Randomized Controlled Clinical Trial).

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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