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

Urinary Urge Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640364
• Other study ID #: HCR051631
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: June 2021

Study information

• Verified date: August 2018
• Source: Helios Medical Center Schleswig
• Contact: Dirk G Kieback, MD, Ph.D
• Phone: +49 4621 812
• Email: dirk.kieback[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Locations

Country	Name	City	State
Germany	Helios Medical Center	Schleswig

Sponsors (1)

Lead Sponsor	Collaborator
Helios Medical Center Schleswig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination	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
Primary	Change in score of standardized ICIQ documentation	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	Anatomical correction of female pelvic organ prolapse	Clinical examination of pelvic floor anatomy	Checked after 6 weeks, six months and twelve months