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Clinical Trials/NCT05452811
NCT05452811
Completed
Not Applicable

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

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country150 target enrollmentMay 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
150
Locations
1
Primary Endpoint
Surgical success
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2022
End Date
October 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ozan Karadeniz

Principal investigator

Kanuni Sultan Suleyman Training and Research Hospital

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

Outcomes

Primary Outcomes

Surgical success

Time Frame: 12 months after intervention

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

Secondary Outcomes

  • estimated blood loss(intraoperative)
  • complications(up to 6 weeks)

Study Sites (1)

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