Open Retropubic Versus Laparoscopic Colposuspension (Burch Operation) Techniques for Female Stress or Mixed Urinary Incontinence; A Ten-year Experience in a Tertiary Center

NCT05452811 | Completed

• 1 other identifier: KanuniSSSEAH
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate postoperative course, efficacy, and complication rates of Open Burch Colposuspension and Laparoscopic Burch Colposuspension techniques in stress or mixed urinary incontinence at a single training and research hospital over the last 10 years in Istanbul, Turkey.

Conditions

Stress Urinary Incontinence

Keywords

Burch colposuspension; laparoscopy; outcome; retropubic; stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Surgical success

  Provided by the patient's feeling of the "Absence of a bulge in the vagina"

  12 months after intervention

Secondary Outcomes (2)

• estimated blood loss

  intraoperative

• complications

  up to 6 weeks

Study Arms (2)

Open Burch Colposuspension

The retropubic space was entered through a laparotomy Pfannenstiel incision, and two permanent sutures were placed on each side lateral to the urethra, one set at the level of the mid urethra and the other set at the level of the bladder neck.

Procedure: Burch colposuspension

Laparoscopic Burch Colposuspension

After a pneumo peritoneum was established entrance to the retropubic space began with a transverse incision of the anterior peritoneum using sharp dissection and electrocautery. The space was developed using blunt and sharp dissection to identify clearly the retropubic anatomy, including the pubic symphysis, bladder neck, and Cooper's ligaments. The bladder neck was identified and the paraurethral tissue was exposed. A no. 0 permanent suture then was introduced through the 10-mm port and was grasped with a laparoscopic needle driver. With the surgeon's hand in the vagina to elevate the paraurethral tissue, two figure-of-eight sutures incorporating full-thickness vagina excluding epithelium were placed on each side, one set lateral to the mid urethra and the other set lateral to the bladder neck. Each of these sutures then was passed through the ipsilateral Cooper's ligament and was secured with a series of extracorporeal knots using an endoscopic knot pusher.

Procedure: Burch colposuspension

Interventions

Burch colposuspension PROCEDURE

Anti-incontinence surgery for stress urinary incontinence

Laparoscopic Burch Colposuspension; Open Burch Colposuspension

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A retrospective cohort study was performed on 150 patients with a diagnosis of SUI or mixed urinary incontinence who underwent anti-incontinence surgery between January 2011 to May 2022 in the department of Obstetrics and Gynecology of Kanuni Sultan Suleyman Training and Research Center in Istanbul.

You may qualify if:

• patients having SUI or mixed urinary incontinence whom conservative therapy (Kegel's pelvic floor exercises, bladder training, electrical stimulation, or medication) failed
• SUI had been proven by urodynamic assessments.
• patients who had urethral hypermobility supported by a Q-type test with a cotton swab angle greater than 300
• patients having a residual urinary volume of less than 100 mL were included.

You may not qualify if:

• history of anti-incontinence surgery
• pelvic inflammatory diseases
• urinary retention
• SUI with intrinsic sphincter deficiency
• neurogenic bladder
• suspected malignancy
• urge incontinence
• chronic cystitis
• urinary tract infection
• prescription of anticoagulant or antipsychotic treatment
• coagulation disorders
• physically and medically unsuitable for colposuspension surgery
• pregnancy and loss to follow-up.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34307, Turkey (Türkiye)

Location

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 11, 2022
• Study Start: May 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: October 30, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)