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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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