Stress Urinary Incontinence (SUI)
Conditions
Keywords
sling, transvaginal tape, urethral ligament plication
Brief summary
In the treatment of urinary incontinence caused by coughing, sneezing, or heavy lifting, the investigators will perform urinary tract tightening surgery, both with and without a sling, to address the relaxed urinary tract. The investigators would like to evaluate the one-year success and results of the sling or non-sling urinary tract tightening surgery the investigators will perform on the participants.
Detailed description
The participants will undergo surgery to tighten the urinary tract due to urinary incontinence. There are two types of surgery: with and without a sling. Both have a high success rate. However, in rare cases, complications related to the sling method can occur in some patients. The urinary incontinence will be prevented with either the sling or non-sling method. The investigators will call the participants for follow-up appointments after the surgery to share the results with them.
Interventions
PROCEDURETransvaginal tape
Method: The procedure uses a, usually polypropylene, mesh tape placed under the mid-urethra to reinforce the pelvic muscles. Approach: It involves a small vaginal incision and two small abdominal incisions to pull the tape through, which is then adjusted for proper tension.
PROCEDUREUrethral ligament plication
By vaginal route, plication of the four attachments of pubourethral ligament (PUL) as retropubic part of PUL, midurethral part of PUL, external urethral ligament and pubococygeous muscle with 2-0 polyester suture.
Sponsors
Sanliurfa Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Being 18 years of age or older 2. Presence of stress urinary incontinence symptoms 3. Agreeing to undergo surgery
Exclusion criteria
1. Pregnancy 2. Being under 18 years of age 3. Suspicion of malignancy 4. History of previous mid-urethral sling or urinary incontinence surgery 5. Urinary incontinence due to neurological bladder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the outcome measures of transvaginal tape (TVT) and urethral ligament plication (ULP) surgeries: number of participants that have negatif cough test and subjective continence status. | at first postoperative year | the continence status at one-year of TVT and ULP surgeries by cough stress test and subjective complaint about stress urinary incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complications and adverse events | during postoperative first year | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". During first postoperative year, the complications; like mesh erosion, suture reaction, bleeding, need for suture removal, need for mesh removal, urinary retention, bladder injury, bowel injury |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORPeter Emmanuel Petros, DSc DS PhD MB BS MD FRCOG
Unaffiliated, retired
Outcome results
None listed