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

NCT ID: NCT05452811

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2022-10-30

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.

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.

Conditions

Stress Urinary Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Burch colposuspension

Intervention Type: PROCEDURE

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.

Burch colposuspension

Intervention Type: PROCEDURE

Anti-incontinence surgery for stress urinary incontinence

Interventions

Burch colposuspension

Anti-incontinence surgery for stress urinary incontinence

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ozan Karadeniz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KanuniSSSEAH

Identifier Type: -

Identifier Source: org_study_id