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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03640364

Enrollment

250

Registered

2018-08-21

Start date

2018-04-01

Completion date

2021-06-30

Last updated

2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Urge Incontinence

Keywords

pelvic organ prolapse, incontinence, minimally invasive, vaginal surgery, macroporous, lightweight, mesh, polypropylene, POP, urge

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination	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.
Change in score of standardized ICIQ documentation	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

Secondary

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

Countries

Germany

Contacts

Primary ContactDirk G Kieback, MD, Ph.D

dirk.kieback@helios-gesundheit.de+49 4621 812

Backup ContactMarek Volkmer, MD

marek.volkmer@helios-gesundheit.de+49 4621 812

Outcome results