Urinary Urge IncontinenceNCT03640364
Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology
An observational study of Urinary Urge Incontinence, run by Helios Medical Center Schleswig at 1 site in Germany.
Trial summary
Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Urge Incontinence
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female patients with pelvic organ prolapse suffering from symptoms of urinary urge incontinence
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Helios Medical Center
Schleswig, 24837
Marek Volkmer, MD, +49 4621 812 ext. 1271, marek.volkmer@helios-gesundheit.de
Mona Litz, +49 4621 812 ext. 1271, mona.litz@elios-gesundheit.de
About this study
Official title: 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
Read the 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.
- Conditions
- Urinary Urge Incontinence
- Keywords
- pelvic organ prolapse, incontinence, minimally invasive, vaginal surgery, macroporous, lightweight, mesh, polypropylene, POP, urge
- Medical subject headings
- Urinary Incontinence, Urge, Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Checked after 6 weeks, six months and twelve months
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
Measured: Checked after 6 weeks, six months and twelve months
Secondary outcomes (1)
Anatomical correction of female pelvic organ prolapse
Clinical examination of pelvic floor anatomy
Measured: Checked after 6 weeks, six months and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Apr 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Medical Center Schleswig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk G. Kieback, M.D., Ph.D, Helios Medical Center Schleswig
- Investigators
- Dirk G Kieback, MD,Ph.D, Principal investigator, Helios Medical Center Schleswig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640364
- Sponsor's protocol ID
- HCR051631
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Non-randomised Trial of Bilateral Sacrospinous Colposuspension (BSC) in the Treatment of Female Genital Prolapse Accompanied by Urinary Urge Symptomatology
- ClinicalTrials.gov ID
- NCT03640364
- Acronym / sponsor ID
- HCR051631
- Conditions
- Urinary Urge Incontinence
- Keywords
- pelvic organ prolapse, incontinence, minimally invasive, vaginal surgery, macroporous, lightweight, mesh, polypropylene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Helios Medical Center SchleswigUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients with pelvic organ prolapse suffering from symptoms of urinary urge incontinence
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- pelvic organ prolapse without symptoms of urinary urge
- age less than 18 years
- no informed consent
- lack of compliance
- adverse reaction to polypropylene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
1 secondary outcome
Anatomical correction of female pelvic organ prolapse
Time frame: Checked after 6 weeks, six months and twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk G Kieback, MD,Ph.D principal investigator
Helios Medical Center Schleswig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Urge Incontinence, run by Helios Medical Center Schleswig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dirk G Kieback, MD, Ph.D (+49 4621 812 ext. 1271, dirk.kieback@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.