Burch Colposuspension and Mid-urethral Sling Operations

Incontinence Clinical Trial

Official title:

Comparison of Burch Colposuspension and Mid-urethral Sling Operations for Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071288
• Other study ID #: 2018.02.02
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Stress urinary incontinence is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons.

Depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension.

The researchers aimed to compare these two types of operations performed on patients. In this way, the superiority and disadvantage of each other in two procedures will be demonstrated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• A total laparoscopic hysterectomy was planned for benign causes,

• Patients scheduled for simultaneous operation for incontinence

Exclusion Criteria:

• Patients previously operated for urinary incontinence

• Patients whose diagnosis of stress urinary incontinence is uncertain

• Patients with urinary tract infection

Related Conditions & MeSH terms

• Incontinence

Intervention

Procedure:
• total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes
total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman 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	recurrence	in patients who underwent total laparoscopic hysterectomy and simultaneous incontinence surgery for benign reasons; In the early postoperative period, relapse will be evaluated at 1 month, 6 months and 12 months.	2 years