terine suspension and vaginal repair with mesh in the management of uterovaginal prolapse: Outcome of 100 women at 12 months follow-up
Not Applicable
Completed
- Conditions
- Pelvic Organ ProlapseSurgery - Surgical techniques
- Registration Number
- ACTRN12609000110280
- Lead Sponsor
- A/Prof. Christopher Maher
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Stage two or more anterior compartment prolapse with stage one or more uterine and posterior compartment prolapse and willingness to consider uterine preservation surgery
Exclusion Criteria
Uterine or cervical pathology, abnormal menstrual bleeding, prior mesh implantation and inability to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective (anatomical) success rate, defined as less than stage 2 prolapse at all compartments according to the Pelvic Organ Prolapse Quantification system (POP-Q)[six weeks post-operatively and six-monthly thereafter for 2 years]
- Secondary Outcome Measures
Name Time Method Subjective success rate, defined as no prolapse sensation (Queensland Pelvic Floor Questionnaire, a validated symptom and quality of life questionnaire)[six weeks post-operatively and six-monthly thereafter for 2 years];patients' satisfaction on a 1 to 10 Visual Analogue Scale (VAS)[six weeks post-operatively and six-monthly thereafter for 2 years];functional (bladder, bowel and sexual) outcomes (Queensland Pelvic Floor Questionnaire, a validated symptom and quality of life questionnaire)[six weeks post-operatively and six-monthly thereafter for 2 years];Complication rates. Data on perioperative complications (Bladder / bowel injury, blood loss > 400ml, blood transfusions) will be taken from the patients' charts, mesh related complications (erosion, contraction) will be assessed through pelvic examination and complications affecting functional outcomes (dyspareunia) will br assessed through interview and validated questionnaires.[six weeks post-operatively and six-monthly thereafter for 2 years]