Clinical trial NCT05452811: Open Retropubic Versus Laparoscopic Colposuspension (Burch Operation) Techniques for Female Stress or Mixed Urinary Incontinence; A Ten-year Experience in a Tertiary Center
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: Burch colposuspension
laparoscopy
outcome
retropubic
stress urinary incontinence
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Surgical success
timeFrame: 12 months after intervention
Secondary outcomes:
measure: estimated blood loss
timeFrame: intraoperative
measure: complications
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References: