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

NCT06292702 | Completed

• 1 other identifier: Modified Burch Colposuspension
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinence.; Burch colposuspension.; Voiding dysfunction.; Tension-free vaginal tape.; TVT, TOT, TVT-O.

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• Subjective recovery from urinary incontinence, first evaluation

  one week after surgery

• Objective recovery from urinary incontinence, first evaluation

  one week after surgery

• Subjective recovery from urinary incontinence, second evaluation

  One month after surgery

• Objective recovery from urinary incontinence, second evaluation

  One month after surgery

• Subjective recovery from urinary incontinence, third evaluation

  three months after surgery

Study Arms (2)

Traditional laparoscopic Burch procedure

EXPERIMENTAL

Patients who were randomized to receive classic laparoscopic Burch colposuspension.

Procedure: Traditional Burch colposuspension

Modified laparoscopic Burch procedure:

EXPERIMENTAL

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

Interventions

Traditional Burch colposuspension PROCEDURE

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

Traditional laparoscopic Burch procedure

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.

Modified laparoscopic Burch procedure:

Eligibility Criteria

• Age: 25 Years - 75 Years
• Gender Eligibility Details: Monosexual research (females with stress urinary incontinence)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ).

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus university

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 19255563 RESULT

• 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.

  PMID: 28616112 RESULT

• 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.

  PMID: 32282600 RESULT

• 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.

  PMID: 27287606 RESULT

• 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.

  PMID: 26894607 RESULT

• 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.

  PMID: 32767826 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Samir M Enzawi, M.D, Ph.D

  dr.enzsamir58@gmail.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: January 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)