Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

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.

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Key information

Conditions

Stress Urinary Incontinence (SUI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Observational

Primary location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

previous surgical treatment for stress urinary incontinence (SUI)

Treatment and study plan

Primary outcomes

Cough Stress Test

Time frame: 12 months post procedure

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

Secondary outcomes

mesh related complications

Time frame: 12 months post procedure

possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period
Urinary Distress Inventory 6 (UDI-6)

Time frame: baseline and 12 months postoperatively

This validated questionnaires will be given to subject to collect subjective data
Urinary Impact Questionnaire (UIQ-7)

Time frame: baseline and 12 months postoperatively

this validated questionnaire will be completed by subject to collect subjective data
Sandvick Severity Index Questionnaire

Time frame: baseline and 12 months postoperatively

This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 13, 2013
Registry last updated: Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed