Skip to content

Randomized clinical trial to assess the effectiveness and the safety of single versus double stitch laparoscopic procedure (Burch Colposuspension) for women with Stress Urinary Incontinence

Evaluation of One-Stitch Versus Two-Stitch Laparoscopic Burch Colposuspension for Stress Urinary Incontinence (SUI): A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2025/030
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary incontinence

Interventions

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: Gynaecolog

Sponsors

Dr. Prabath Randombage
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: • 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).

Design outcomes

Primary

MeasureTime frame
Objective continence success: Absence of urinary leakage during a standardized pad test [6 and 12 months post-surgery.]

Secondary

MeasureTime frame
Subjective continence success using a questionnaire [at 6 weeks,6 and 12 moths post-surgery ] Operative time (minutes). [ during the surgey ] Early post-operative complications of laparoscopic Burch colposuspension. Retropubic bleeding/hematoma ? tachycardia, falling Hb, suprapubic mass · Urinary retention/incomplete emptying (from over-elevation/edema) · Port-site issues: bleeding, infection; rarely early hernia · Ileus; unrecognized bowel/urinary tract injury presenting late with peritonitis or hematuria [During surgery –2 weeks ] Intermediate Post-operative complications of laparoscopic Burch colposuspension De novo urgency/urge incontinence (detrusor overactivity) · Voiding dysfunction/obstructive symptoms, high post-void residuals · Suture-related problems: intravesical/urethral suture ? irritative LUTS, hematuria, calculus · Retropubic abscess or infected hematoma · Pelvic/suprapubic pain; neuropathic groin pain (ilioinguinal/genitofemoral entrapment) · Dyspareunia Late · Recurrent stress urinary incontinence (failure of suspension) [2 weeks –12 weeks] Chronic post operative complications of Burch Coloposuspension Urinary retention/obstruction · Bladder/urethral erosion or, very rarely, fistula [ After 2 weeks] Patient satisfaction and quality-of-life improvement (measured using validated scales such as the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form [ICIQ- UI SF]). [ At 6 and 12 months post surgery]

Countries

Sri Lanka

Contacts

Public ContactDr.Prabath Randombage

Senior Lecturer (Grade II) Department of Obstetrics & Gynaecology

prabathrandombage@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026