Colposuspension or tension free vaginal tape with anterior repair for urinary incontinence and prolapse: a pilot study
Completed
- Conditions
- rodynamic stress incontinence/ vaginal prolapse (anterior)Urological and Genital DiseasesIncontinence
- Registration Number
- ISRCTN34759911
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 31
Inclusion Criteria
Women with urodynamic stress incontinence (USI) and anterior vaginal prolapse of stage II or more assessed by Pelvic Organ Prolapse Quantification score (POP-Q)
Exclusion Criteria
1. Detrusor overactivity (DOA) on urodynamics
2. Previous incontinence or prolapse surgery
3. Apical or posterior vaginal prolapse of stage II or more on POP-Q
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Eligible patient numbers, by centre<br>2. Proportion of patients consenting to randomisation<br>3. Reasons for non-randomisation<br>4. Improvement in disease specific quality of life score at 6 weeks and 12 months
- Secondary Outcome Measures
Name Time Method 1. Change in POP-Q score at 6 weeks and 12 months<br>2. Change in 24 hour pad test at 6 weeks and 12 months<br>3. Change in diary completed leakage episodes at 6 weeks and 12 months<br>4. Change in incidence of USI on urodynamics at follow up<br>5. Incidence of DOA on urodynamics at follow up at 12 months