Cystocele and Stress Urinary Incontinence(SUI):Simultaneous repair (Sim-Pair) by a modified surgical technique using transobturator mesh -Prospective study

Not Applicable

Recruiting

• Conditions: Stress urinary incontinence; Vaginal wall prolapse; Surgery - Surgical techniques

• Registration Number: ACTRN12608000596303
• Lead Sponsor: Pelvic health Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Women presenting with stage 2 or more bladder prolapse (cystocele) and Stress Urinary Incontinence[revealed and occult] who desire reconstructive surgery,

Exclusion Criteria

Women with less than stage 2 prolapseWomen who do not demonstrate SUIWomen with Intrinsic sphincter deficiency ( defined as maximum urethral closure pressure of more than orequal to 20 cm of water)Women less than 18 yrsWomen who decline participationWomen unable to give informed consentWomen with previous mesh based repair for bladder prolapse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of Urodynamic stress incontinence(USI) and less than Stage 2 prolapse using Pelvic Organ Prolapse Quantification (POP-Q).[Outcome is measured at baseline.Follow up at 3,6,12,24 months after surgery]

Secondary Outcome Measures

Name	Time	Method
Operation time[On the day of operation];Length of hospital stay[From day of surgery until discharge];Intra and postoperative complications; eg haemorrhage, infection, bladder and urethral injury, voiding dysfunction, mesh exposure or erosion.[Intraoperative and over the period 24 months of postoperative period];Quality of life questionnaires:Bristol Female lower urinary tract symptom (BFLUTS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)[3,6,12,24 months after surgery];Patient subjective assessment of improvement; BFLUTS & PISQ.Main indicators being improvement of symptoms and quality of life.[3,6,12,24 months after surgery]