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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05452811
• Other study ID #: KanuniSSSEAH
• Status: Completed
• Start date: May 15, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 30, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Burch colposuspension
Anti-incontinence surgery for stress urinary incontinence

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical success	Provided by the patient's feeling of the "Absence of a bulge in the vagina"	12 months after intervention
Secondary	estimated blood loss	Blood loss during surgery ( taking blood count-WBC)	intraoperative
Secondary	complications	Complications occurring in between during surgery and 6.th week of surgery	up to 6 weeks