Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology

August 17, 2018 updated by: Dirk G. Kieback, M.D., Ph.D, Helios Medical Center Schleswig

Multicenter Prospective Non-randomised Trial of Bilateral Sacrospinous Colposuspension (BSC) in the Treatment of Female Genital Prolapse Accompanied by Urinary Urge Symptomatology

Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse

Study Overview

Status

Unknown

Conditions

Detailed Description

A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence.

Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

female patients with pelvic organ prolapse suffering from symptoms of urinary urge incontinence

Description

Inclusion Criteria:

  • urge urinary incontinence or symptoms thereof
  • 18 years old or older
  • Compliance regarding data collection, therapy and follow-up
  • written informed consent
  • simultaneous performance of surgical colporrhaphy permitted

Exclusion Criteria:

  • pelvic organ prolapse without symptoms of urinary urge
  • age less than 18 years
  • no informed consent
  • lack of compliance
  • adverse reaction to polypropylene
  • life expectancy less than anticipated duration of protocol
  • ASA 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination
Time Frame: Checked after 6 weeks, six months and twelve months
The change in symptoms after the surgical intervention is evaluated by clinical examination . The clinical examination is descriptive, not quantitative and no units are applicable or reportable.
Checked after 6 weeks, six months and twelve months
Change in score of standardized ICIQ documentation
Time Frame: Checked after 6 weeks, six months and twelve months
The International Consultation on Incontinence Questionnaire is used to evaluate Change in Quality of life and urge symptomatology
Checked after 6 weeks, six months and twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomical correction of female pelvic organ prolapse
Time Frame: Checked after 6 weeks, six months and twelve months
Clinical examination of pelvic floor anatomy
Checked after 6 weeks, six months and twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helios Medical Center Schleswig

Investigators

  • Principal Investigator: Dirk G Kieback, MD,Ph.D, Helios Medical Center Schleswig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCR051631

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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