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

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.

Study Overview

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

Detailed Description

A retrospective cohort study was conducted in all Burch Colposuspension cases performed between January 2001 and May 2022 at Kanuni Sultan Süleyman Training and Research Center. All patients' data were reviewed from the electronic medical records and analyzed who underwent Burch colposuspension surgery either with an open or laparoscopic approach. The primary outcome was surgical success, whereas secondary outcomes were perioperative and postoperative data including surgical type (open or laparoscopic), operating time, duration of hospital stay, estimated blood loss, complications during surgery, and additional interventional procedure types.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34307
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Anti-incontinence surgery for stress urinary incontinence
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; Anti-incontinence surgery for stress urinary incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success	Provided by the patient's feeling of the "Absence of a bulge in the vagina"	12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimated blood loss	Blood loss during surgery ( taking blood count-WBC)	intraoperative
complications	Complications occurring in between during surgery and 6.th week of surgery	up to 6 weeks

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 3, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: outcome; laparoscopy; Burch colposuspension; retropubic; stress urinary incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: KanuniSSSEAH

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
• product manufactured in and exported from the U.S.: No