Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
Van, 65090, Turkey (Türkiye)
Location status: Recruiting
Location contact
Yusuf Başkıran, MD
CONTACT
Yusuf Başkıran, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06924450
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Van, 65090, Turkey (Türkiye)
Location status: Recruiting
Yusuf Başkıran, MD
CONTACT
Yusuf Başkıran, MD
PRINCIPAL_INVESTIGATOR
This is a prospective, single-blind, randomized controlled trial evaluating the effect of mesh width on surgical outcomes in transobturator tape (TOT) procedures for women with stress urinary incontinence (SUI). A total of 106 participants will be randomized using a computer-generated allocation into two groups receiving either a 1.2 cm mesh (intervention group) or a 1.0 cm mesh (standard procedure).
The procedures will be conducted by a single experienced surgeon using a monofilament polypropylene mesh to ensure standardization. Surgical technique, anesthesia protocols, and perioperative management will be identical in both groups.
Primary outcome is objective cure, defined as negative stress test at 6 months. Secondary outcomes include symptom improvement (ICIQ-SF), mesh-related complications (erosion, infection, retention), and patient satisfaction assessed via structured Likert survey.
Follow-up visits are scheduled at 1 week, 1 month, and 1 year. Postoperative assessments will be conducted by a blinded evaluator. The study aims to evaluate whether wider mesh width provides superior anatomical support and reduces complication rates in comparison to standard mesh.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients 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.
Patients 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.
Time frame: 6 months postoperatively
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 postoperatively
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 postoperatively
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 postoperatively
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 postoperatively
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.
Contact information is provided by the study sponsor or research team.
Izzet Celegen
Other
Acronym: MOTOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06161506
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Bethesda, Maryland, United States
View Trial DetailsNCT04133675
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Royal Oak, Michigan, United States
View Trial DetailsNCT06480227
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
La Jolla, California, United States
View Trial DetailsNCT07387640
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Istanbul, Turkey (Türkiye)
View Trial Details