Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIzzet Celegen
About this trial
This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 years or older
Positive stress test (urine leakage on coughing with a comfortably full bladder)
Q-tip test showing urethral hypermobility (>30 degrees)
Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy)
Disqualifiers
History of prior midurethral sling surgery
Mixed urinary incontinence or urge-dominant symptoms
Pelvic organ prolapse stage > II according to the POP-Q system
Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury)
Trial design
Design model
Parallel
Treatments tested in this trial
1.2 cm Mesh TOT
DevicePatients in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. The modified mesh width is being evaluated for its effect on surgical success, symptom improvement, and postoperative complications.
1.0 cm Mesh TOT
DevicePatients in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which is the standard procedure. This group serves as a comparator to assess the impact of the modified mesh width.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: 1.2 cm Mesh (Intervention Group)Experimental treatment 1 intervention
Group B: 1.0 cm Mesh (Control Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Objective Cure Rate Based on Negative Stress Test
Objective cure will be defined as the absence of urinary leakage during a standardized cough stress test with a comfortably full bladder. The test will be performed by a blinded assessor at 6 months postoperatively.
Time frame
6 months postoperativelySecondary outcomes
1
Change in ICIQ-SF Score
Change in total score on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), measured before surgery and at 6 months postoperatively. The ICIQ-SF ranges from 0 to 21, with higher scores indicating worse symptom severity and greater impact on quality of life.
Time frame
6 months postoperatively2
Incidence of Mesh-Related Complications
Incidence of mesh-related complications including mesh erosion, bladder outlet obstruction, infection, and pain. Complications will be assessed by physical examination and patient-reported symptoms during follow-up visits.
Time frame
6 months postoperatively3
Recurrence of Stress Urinary Incontinence
Proportion of patients who present with recurrence of stress urinary incontinence, defined as a positive cough stress test or self-reported symptoms of urine leakage during physical activity. Time Frame: 6 months postoperatively
Time frame
6 months postoperatively4
Patient Satisfaction Score
Patient satisfaction will be measured using a structured questionnaire that includes a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction. Assessment will be conducted at the 6-month follow-up visit.
Time frame
6 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Izzet Celegen
Lead sponsor
Yuzuncu Yil University
Sponsor institution
Source ClinicalTrials.gov