NCT01982188

Brief Summary

This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

October 31, 2013

Last Update Submit

August 10, 2016

Conditions

Stress Urinary Incontinence (SUI)

Keywords

single incision slingcough stress testMiniArcUDI-6UIQ-7Sandvick Severity Index (SSI)

Outcome Measures

Primary Outcomes (1)

  • Cough Stress Test

    Subjects will undergo a cough stress test to evaluate for stress urinary incontinence.

    12 months post procedure

Secondary Outcomes (4)

  • mesh related complications

    12 months post procedure

  • Urinary Distress Inventory 6 (UDI-6)

    baseline and 12 months postoperatively

  • Urinary Impact Questionnaire (UIQ-7)

    baseline and 12 months postoperatively

  • Sandvick Severity Index Questionnaire

    baseline and 12 months postoperatively

Study Arms (1)

Single incision sling

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our study population included all women undergoing single incision sling placement at the time of robotic sacrocolpopexy

You may qualify if:

  • all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period

You may not qualify if:

  • previous surgical treatment for stress urinary incontinence (SUI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Charbel Salamon, MD

    Atlantic Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 13, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

US(1)