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Completed

NCT Number: NCT05452811

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34307, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Burch Colposuspension

Procedure

Anti-incontinence surgery for stress urinary incontinence

Primary outcomes

  1. 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

  1. estimated blood loss

    Time frame: intraoperative

    Blood loss during surgery ( taking blood count-WBC)

  2. complications

    Time frame: up to 6 weeks

    Complications occurring in between during surgery and 6.th week of surgery

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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