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

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05452811

Collaborator

(none)

150

Enrollment

Location

5.5

Anticipated Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	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 Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 15, 2022

Actual Primary Completion Date :

Jul 15, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Surgical success [12 months after intervention]
Provided by the patient's feeling of the "Absence of a bulge in the vagina"

Secondary Outcome Measures

estimated blood loss [intraoperative]
Blood loss during surgery ( taking blood count-WBC)
complications [up to 6 weeks]
Complications occurring in between during surgery and 6.th week of surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.