Clinical trial NCT06292702: Reducing Early Urinary Disorders After Stress Incontinence Surgery: The Role of Vaginal Wall Tension.
Official 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence.
Burch colposuspension.
Voiding dysfunction.
Tension-free vaginal tape.
TVT, TOT, TVT-O.
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 ).

Primary outcomes:
measure: Subjective voiding dysfunction after surgery, first evaluation
timeFrame: One week after surgery
measure: Urinary peak flow rate after surgery, first evaluation
timeFrame: One week after surgery
measure: Residual urine after surgery, first evaluation
timeFrame: One week after surgery
measure: Urinary retention after surgery, first evaluation
timeFrame: One week after surgery
measure: Subjective voiding dysfunction after surgery, second evaluation
timeFrame: One month after surgery
measure: Urinary peak flow rate after surgery, second evaluation
timeFrame: One month after surgery
measure: Residual urine after surgery, second evaluation
timeFrame: One month after surgery
measure: Urinary retention after surgery, second evaluation
timeFrame: One month after surgery
measure: Subjective voiding dysfunction after surgery, third evaluation
timeFrame: Three months after surgery
measure: Urinary peak flow rate after surgery, third evaluation
timeFrame: Three months after surgery
measure: Residual urine after surgery, third evaluation
timeFrame: Three months after surgery
measure: Urinary retention after surgery, third evaluation
timeFrame: Three months after surgery
Secondary outcomes:
measure: Subjective recovery from urinary incontinence, first evaluation
timeFrame: one week after surgery
measure: Objective recovery from urinary incontinence, first evaluation
timeFrame: one week after surgery
measure: Subjective recovery from urinary incontinence, second evaluation
timeFrame: One month after surgery
measure: Objective recovery from urinary incontinence, second evaluation
timeFrame: One month after surgery
measure: Subjective recovery from urinary incontinence, third evaluation
timeFrame: three months after surgery
measure: Objective recovery from urinary incontinence, third evaluation
timeFrame: three months after surgery
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus university
Study officials:
affiliation: dr.enzsamir58@gmail.com
name: Samir M Enzawi, M.D, Ph.D
role: STUDY_DIRECTOR
References:
citation: Natale F, La Penna C, Saltari M, Piccione E, Cervigni M. Voiding dysfunction after anti-incontinence surgery. Minerva Ginecol. 2009 Apr;61(2):167-72.
citation: Steele SS, Bailly GG. Choosing the right sling for your patient. Can Urol Assoc J. 2017 Jun;11(6Suppl2):S132-S134. doi: 10.5489/cuaj.4635.
citation: Sassani JC, Artsen AM, Moalli PA, Bradley MS. Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration. Obstet Gynecol. 2020 May;135(5):1084-1090. doi: 10.1097/AOG.0000000000003805.
citation: Karlovsky ME. How to Avoid and Deal with Pelvic Mesh Litigation. Curr Urol Rep. 2016 Aug;17(8):55. doi: 10.1007/s11934-016-0613-3.
citation: Barr SA, Thomas A, Potter S, Melick CF, Gavard JA, McLennan MT. Incidence of successful voiding and predictors of early voiding dysfunction after retropubic sling. Int Urogynecol J. 2016 Aug;27(8):1209-14. doi: 10.1007/s00192-016-2972-1. Epub 2016 Feb 19.
citation: Valdevenito JP, Mercado-Campero A, Naser M, Castro D, Ledesma M, Arribillaga L. Voiding dynamics in women with urinary incontinence but without voiding symptoms. Neurourol Urodyn. 2020 Nov;39(8):2223-2229. doi: 10.1002/nau.24475. Epub 2020 Aug 7.