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Colposuspension or tension free vaginal tape with anterior repair for urinary incontinence and prolapse: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34759911
Enrollment
31
Registered
2006-05-17
Start date
2006-05-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Urodynamic stress incontinence/ vaginal prolapse (anterior) Urological and Genital Diseases Incontinence

Interventions

1. Colposuspension 2. Suburethal tension free vaginal tape with anterior vaginal repair

Sponsors

University Hospitals of Leicester NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Eligible patient numbers, by centre 2. Proportion of patients consenting to randomisation 3. Reasons for non-randomisation 4. Improvement in disease specific quality of life score at 6 weeks and 12 months

Secondary

MeasureTime frame
1. Change in POP-Q score at 6 weeks and 12 months 2. Change in 24 hour pad test at 6 weeks and 12 months 3. Change in diary completed leakage episodes at 6 weeks and 12 months 4. Change in incidence of USI on urodynamics at follow up 5. Incidence of DOA on urodynamics at follow up at 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026