UnknownNot Applicable

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

Germany250 participantsStarted 2018-04-01

Plain-language summary

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

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination

Timeframe: Checked after 6 weeks, six months and twelve months

Change in score of standardized ICIQ documentation

Timeframe: Checked after 6 weeks, six months and twelve months

Trial details

NCT IDNCT03640364

SponsorHelios Medical Center Schleswig

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-06

Contact for this trial

Dirk G Kieback, MD, Ph.D

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

View on ClinicalTrials.gov More Urinary Urge Incontinence trials