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Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress

NCT01230450 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2013-01-24

No results posted yet for this study

Summary

Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).

Conditions

  • Female Stress Incontinence

Interventions

PROCEDURE

sub-urethral tape (TVT-O)

Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape

OTHER

stand standard mid-urethral sling (TVT-O)

Sponsors & Collaborators

  • Aberdeen Royal Infirmary

    collaborator OTHER

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Mohamed Abdel-Fattah, MRCOG · University of Aberdeen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-10-31
Completion
2011-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230450 on ClinicalTrials.gov