What is the efficacy and safety of one-stitch versus two-stitch laparoscopic Burch colposuspension in the surgical management of stress urinary incontinence (SUI)?

1. Study Setting(s) The study will be conducted at the following locations: • Primary site: Professorial Gynaecology Unit, Colombo North Teaching Hospital (CNTH), Ragama. • Secondary sites: Gynaecological theatres and clinics at Hemas Hospital (Pvt) Ltd, Wattala, and Leesons Hospital (Pvt) Ltd, Ragama. Patient recruitment will occur through gynaecology outpatient clinics, patient assessment rooms, theatre admissions, and inpatient wards of the aforementioned hospitals.

2. Randomization a. Method of Randomization into Study Arms • Block randomization will be used to ensure balance between the two arms throughout the study period. • Block size: A block size of 4 will be used to maintain equal distribution in each group. b. Unit of Randomization • The individual patient is the unit of randomization. c. Method of Sequence Generation • A computer-generated random sequence will be used to assign participants to either the one-stitch or two-stitch surgical group in a 1:1 ratio. d. Method of Allocation Concealment • Allocation will be concealed using sequentially numbered, sealed, opaque envelopes (SNOSE technique), prepared by an independent researcher not involved in the clinical care or outcome assessment.

3. Intervention Details Intervention: • Surgical Procedure: Laparoscopic Burch colposuspension. Technique: • In the one-stitch group, a single non-absorbable No. 1.0 black silk suture will be placed bilaterally at the mid-urethral level and anchored to Cooper’s ligament. • In the two-stitch group, two non-absorbable No. 1.0 black silk sutures will be placed bilaterally—one at the mid-urethral level and one at the bladder neck level—and both anchored to Cooper’s ligament. Standardization: • All procedures will follow a standardized laparoscopic technique. • Patients will undergo general anaesthesia. • Operative and perioperative care (including pain management and catheterization) will be uniformly provided for both groups. Who Performs the Intervention: • All surgeries will be performed by experienced laparoscopic gynaecological surgeons affiliated with the study institutions, ensuring surgical consistency and technical expertise.

4. Blinding Blinding procedures implemented in this RCT include: • Participants will not be informed of the specific surgical technique used. • Healthcare providers (surgeons) cannot be blinded due to the nature of the surgical intervention. • Data collectors and outcome adjudicators will remain blinded during follow-up assessments and data recording to minimize observer bias. • Data analysts will analyze de-identified data without knowledge of group assignments.

• Adult women clinically diagnosed with stress urinary incontinence (SUI). • Consented for laparoscopic Burch colposuspension. • No prior surgical treatment for SUI. • Aged 30-70 years

• Presence of urge incontinence or mixed incontinence with urge symptoms as the dominant component. • History of recurrent SUI, or grade >2 pelvic organ prolapse. • Contraindications to general anesthesia or laparoscopic surgery (e.g., severe obesity, significant comorbidities).