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

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).

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Traditional Burch colposuspension; Procedure: Modified Burch colposuspension

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • Damascus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 ).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional laparoscopic Burch procedure; Patients who were randomized to receive classic laparoscopic Burch colposuspension.	Procedure: Traditional Burch colposuspension; Peforming two stitches between the anterior vaginal wall and Cooper's ligament.
Experimental: Modified laparoscopic Burch procedure: Patients who were randomized to receive modified laparoscopic Burch colposuspension by applying lateral tension for the anterior vaginal wall before performing traditional anterior vaginal wall suspension toward Cooper's ligament.	Procedure: Modified Burch colposuspension; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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	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.	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.	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.	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	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.	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.	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.	Three months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	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	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."	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	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."	three months after surgery
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	three months after surgery

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Samir M Enzawi, M.D, Ph.D, dr.enzsamir58@gmail.com

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stress urinary incontinence.; Burch colposuspension.; Voiding dysfunction.; Tension-free vaginal tape.; TVT, TOT, TVT-O.
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: Modified Burch Colposuspension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No