Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Stress Urinary Incontinence

NCT ID: NCT01799122

Last Updated: 2016-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Randomized comparison of two surgeries for the treatment of female stress urinary incontinence.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence Urethral Sling Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Precise sling vs TVT-O sling

Group Type ACTIVE_COMPARATOR

Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women with stress urinary incontinence with a positive cough test
* patient request surgery for treatment

Exclusion Criteria

* prodominantely overactive bladder
* previous failed procedure
* MUCP \<20 cm H2O
* presence of vaginal prolapse \> stage 1
* voiding dysfunction (PVR\>100 mL)
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ken Maslow

Assistent Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ken Maslow

Winnipeg, Manitoba, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ken D Maslow, MD

Role: primary

204-235-3039

References

Explore related publications, articles, or registry entries linked to this study.

Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

Reference Type DERIVED
PMID: 37888839 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2012:047

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy/Safety of Midurethral Sling
NCT05255289 RECRUITING NA