Pelvic Organ ProlapseNCT02998216
Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation
An observational study of Pelvic Organ Prolapse, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Bilateral sacrospinous fixation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to May 2017
- 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: All female patients who are planned to receive a bilateral sacrospinous fixation as a treatment for pelvic organ prolapse Stage IV will be eligible for inclusion in the study.
Who may be able to join
- age 18 and above
- pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
- signed informed consent
Who cannot join
- gynecologic surgery in the three past months before planned surgery
- history of prolapse surgery
- participation in another study
- need to simultaneously perform other surgical procedures (i.e. rectopexy)
- ongoing chemotherapy of treatment with immunosuppressant drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72072
About this study
Official title: Pelvic Floor Symptoms and Patients´ Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Bilateral sacrospinous fixation
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral sacrospinous fixationProcedure or surgery
Also called Bilateral sacrospinous vaginal suspension
Bilateral sacrospinous vaginal suspension
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pelvic floor symptoms
Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
Measured: Twelve months
Secondary outcomes (3)
Anatomical outcome / Prolapse stage after surgery
Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996)
Measured: Twelve months
Changes in quality of life
Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
Measured: Twelve months
Changes in sexual activity
Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christl Reisenauer, Professor, Principal investigator, Universitys Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998216
- Sponsor's protocol ID
- 442/2016BO2
- Status last verified
- Nov 2016
- First submitted
- 11 Nov 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kavvadias T, Schoenfisch B, Brucker SY, Reisenauer C. Anatomical and functional outcomes after hysterectomy and bilateral sacrospinous ligament fixation for stage IV uterovaginal prolapse: a prospective case series. BMC Urol. 2020 Aug 19;20(1):126. doi: 10.1186/s12894-020-00694-3.
PubMed 32814553
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Symptoms and Patients´ Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02998216
- Acronym / sponsor ID
- 442/2016BO2
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- 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.
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.
Study design
- Observational model
- Cohort
- 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
- All female patients who are planned to receive a bilateral sacrospinous fixation as a treatment for pelvic organ prolapse Stage IV will be eligible for inclusion in the study.
Key inclusion criteria (3 listed)
- age 18 and above
- pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
- signed informed consent
Key exclusion criteria (5 listed)
- gynecologic surgery in the three past months before planned surgery
- history of prolapse surgery
- participation in another study
- need to simultaneously perform other surgical procedures (i.e. rectopexy)
- ongoing chemotherapy of treatment with immunosuppressant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral sacrospinous fixationAlso: Bilateral sacrospinous vaginal suspensionBilateral sacrospinous vaginal suspension | Procedure or surgery | – |
Primary outcome
Assessment of pelvic floor symptoms
Time frame: Twelve months
Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
3 secondary outcomes
Anatomical outcome / Prolapse stage after surgery
Time frame: Twelve months
Changes in quality of life
Time frame: Twelve months
Changes in sexual activity
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Derived from this study: PubMed 32814553Kavvadias T, Schoenfisch B, Brucker SY, Reisenauer C. Anatomical and functional outcomes after hysterectomy and bilateral sacrospinous ligament fixation for stage IV uterovaginal prolapse: a prospective case series. BMC Urol. 2020 Aug 19;20(1):126. doi: 10.1186/s12894-020-00694-3.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
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Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
Christl Reisenauer, Professor principal investigator
Universitys Hospital Tuebingen
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 Pelvic Organ Prolapse, run by University Hospital Tuebingen 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 3 inclusion and 5 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 20 Dec 2016. 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 Tilemachos Kavvadias, MD (+49 7071 2982211, tilemachos.kavvadias@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pelvic floor symptoms (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998216, which also lists 1 linked publication.
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 20 Dec 2016.