Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

Ataturk University

Status: Completed

Conditions: Genuine Stress Incontinence

Treatments: Procedure: laparoscopic burch colposuspension operation; Procedure: minisling suburethral sling

Study type: Interventional

Funder types: Other

Identifiers

NCT05225168

B.30.2.ATA.0.01.00/284

Details and patient eligibility

About

When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI.

Full description

When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. To be between the ages of 18-80
2. Isolated genuine stress incontinence or accompanying pelvic organ prolapse
3. Having accepted surgery for stress urinary incontinence -

Exclusion criteria

• 1. Previously undergo pelvic organ prolapse surgery 2. Having a chronic lung disease such as asthma or Chronic obstructive pulmonary disease (COPD) 3. Having juvenile diabetes mellitus 4. History of gynecological cancer 5. Mesh allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

laparoscopic burch colposuspension group

Active Comparator group

Description:

this group will only have laparoscopic burch colposuspension

Treatment:

Procedure: laparoscopic burch colposuspension operation

Minisling Suburethral Sling group

Active Comparator group

Description:

this group will only have Minisling Suburethral Sling

Treatment:

Procedure: minisling suburethral sling