deltatrials
Completed OBSERVATIONAL NCT00658944

Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence

Preoperative MUCP and VLPP Failed to Predict Long Term (4-Years) Outcome in Patients Who Underwent Transobturator Mid-Urethral Slings. a Prospective Observational Descriptive Study

Sponsor: University Of Perugia

Updated 6 times since 2017 Last updated: Apr 15, 2008 Started: May 31, 2002 Primary completion: Dec 31, 2007 Completion: Feb 29, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Urinary Incontinence and is currently completed. University Of Perugia leads this study, which shows 6 recorded versions since 2002 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

A prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching University Uro-gynecological Department. 65 patients affected by stress or mixed urinary incontinence (stress component clinically predominant), defined according to International Continence Society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or \> 40 cmH20 and ≤ or \> 60 cmH2O respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).

A prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching University Uro-gynecological Department. 65 patients affected by stress or mixed urinary incontinence (stress component clinically predominant), defined according to International Continence Society guidelines, associated or not with urethral hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or \> 40 cmH20 and ≤ or \> 60 cmH2O respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Jan 2021 — Jul 2024 [monthly]

    Completed

  4. Jun 2018 — Jan 2021 [monthly]

    Completed

  5. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

Show 1 earlier version
  1. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

May 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University Of Perugia
Data source: University Of Perugia

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations