Deep Infiltrating EndometriosisNCT02238678
Impact of Deep Endometriosis Surgery on Bladder Function
An observational study of Deep Infiltrating Endometriosis, run by Medical University of Vienna.
Trial summary
It has been demonstrated that ligaments, both cardinal and uterosacral contain a considerable amount of autonomic nerve tissues. The resection of deep infiltrating endometriotic nodules at the level of the uterosacral ligaments or the rectovaginal space is supposed to damage the supplying autonomic nerve fibers of the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Deep Infiltrating Endometriosis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2014
- 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: - Patients with confirmed diagnosis of deep infiltrating endometriosis requiring surgical treatment
Who may be able to join
- Patients with confirmed diagnosis of deep infiltrating endometriosis requiring surgical treatment
- Patient planned to be submitted to laparoscopic surgery finalize to eradicate the endometriosis pathology
- Naïve patients for OAB treatment.
- Patients must be capable of independent toileting
- Patients must be able to fully understand all study procedures and to provide written informed consent to study participation
Who cannot join
- Patient previously submitted to pelvic surgery for any urogynaecological disease;
- Patients previously submitted to DE surgery
- Patient with documented clinical, instrumental, or laparoscopic preoperative diagnosis of bladder endometriosis;
- Patient with documented urinary tract infection
- Patient with history of diabetes mellitus, psychiatric, or neurological disease;
- Pregnant patients
- Patients < 18 years
About this study
It has been demonstrated that ligaments, both cardinal and uterosacral contain a considerable amount of autonomic nerve tissues. The resection of deep infiltrating endometriotic nodules at the level of the uterosacral ligaments or the rectovaginal space is supposed to damage the supplying autonomic nerve fibers of the lower urinary tract. The bladder receives motor and sensitive innervations from both the sympathetic fibers, most of which arise from the hypogastric plexuses and nerves, and the parasympathetic fibers, which arise from the pelvic splanchnic nerves and the inferior hypogastric plexus; therefore, even bladder function may be impaired in women affected by deep endometriosis.
Very few data have been published regarding the urodynamic functional evaluation of bladder in patient with deep endometriosis.So far, it is unknown if the surgery itself causes the postoperative bladder dysfunction or if the surgery unmasks a subclinically pre-existing detrusor pathology.
Read more
Since the urinary postoperative complications have a strong impact on quality of life of the deep endometriosis patients and often requires management (due to a poor spontaneous remission), it is crucial a better understanding of the problem. That will help for a more appropriate pre-operative counselling.
Aims of this study are to evaluate the bladder function before and after deep endometriosis surgery, using standardized validated instruments and to correlate the localisation of the endometriosis lesion, the type/area of surgical dissection with the postoperative bladder function.
This is a prospective multicenter cohort study involving the Department of General Gynaecology and Gynecological Oncology of Medical University of Vienna (Austria) and the Department of Obstetrics and Gynaecology of Insubria University, Varese (Italy).
A total of 50 patients are planned to be included. The study protocol consider a Preoperative Assessment (clinical examination, transvaginal pelvic ultrasound, preoperative specific questionnaire including obstetric, medical, and surgical history and standardized questions on pelvic floor dysfunctions, standardized instrumental assessment of the pelvic floor) a Intraoperative Assessment (during laparoscopy, the localizations of endometriotic lesions recorded and identified by anatomical sites, numbers, and depth of infiltration). Before and 3 months after surgery a Urodynamic assessment is planned.
- Conditions
- Deep Infiltrating Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Deep endometriosis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic assessment after deep infiltrating endometriosis surgery
to evaluate the bladder function before and after deep endometriosis surgery (Unit of Measure: First Desire (ml) from Urodynamic Assessment)
Measured: 2 years
Secondary outcomes (2)
Bladder symptoms after surgery for deep infiltrating endometriosis
using standardized validated questionnaires -OABQ short form, ICIQ short form questionnaire, micturition diary.
Measured: 2 years
correlation between localisation of the endometriosis lesion and postoperative bladder function.
to correlate the localisation of the endometriosis lesion, the type/area of surgical dissection with a specific urodynamic pattern and/or a specific low urinary tract symptom
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
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 Deep Infiltrating EndometriosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Laterza Rosa Maria, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238678
- Sponsor's protocol ID
- ENDOBLAD 1057/2014
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Laterza RM, Uccella S, Serati M, Umek W, Wenzl R, Graf A, Ghezzi F. Is the Deep Endometriosis or the Surgery the Cause of Postoperative Bladder Dysfunction? J Minim Invasive Gynecol. 2022 Apr;29(4):567-575. doi: 10.1016/j.jmig.2021.12.017. Epub 2022 Jan 2.
PubMed 34986409
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Deep Endometriosis Surgery on Bladder Function
- ClinicalTrials.gov ID
- NCT02238678
- Acronym / sponsor ID
- ENDOBLAD 1057/2014
- Conditions
- Deep Infiltrating Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- First posted
- 12 Sep 2014 (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.
It has been demonstrated that ligaments, both cardinal and uterosacral contain a considerable amount of autonomic nerve tissues. The resection of deep infiltrating endometriotic nodules at the level of the uterosacral ligaments or the rectovaginal space is supposed to damage the supplying autonomic nerve fibers of the lower urinary tract. The bladder receives motor and sensitive innervations from both the sympathetic fibers, most of which arise from the hypogastric plexuses and nerves, and the parasympathetic fibers, which arise from the pelvic splanchnic nerves and the inferior hypogastric plexus; therefore, even bladder function may be impaired in women affected by deep endometriosis.
Very few data have been published regarding the urodynamic functional evaluation of bladder in patient with deep endometriosis.So far, it is unknown if the surgery itself causes the postoperative bladder dysfunction or if the surgery unmasks a subclinically pre-existing detrusor pathology.
Since the urinary postoperative complications have a strong impact on quality of life of the deep endometriosis patients and often requires management (due to a poor spontaneous remission), it is crucial a better understanding of the problem. That will help for a more appropriate pre-operative counselling.
Aims of this study are to evaluate the bladder function before and after deep endometriosis surgery, using standardized validated instruments and to correlate the localisation of the endometriosis lesion, the type/area of surgical dissection with the postoperative bladder function.
This is a prospective multicenter cohort study involving the Department of General Gynaecology and Gynecological Oncology of Medical University of Vienna (Austria) and the Department of Obstetrics and Gynaecology of Insubria University, Varese (Italy).
A total of 50 patients are planned to be included. The study protocol consider a Preoperative Assessment (clinical examination, transvaginal pelvic ultrasound, preoperative specific questionnaire including obstetric, medical, and surgical history and standardized questions on pelvic floor dysfunctions, standardized instrumental assessment of the pelvic floor) a Intraoperative Assessment (during laparoscopy, the localizations of endometriotic lesions recorded and identified by anatomical sites, numbers, and depth of infiltration). Before and 3 months after surgery a Urodynamic assessment is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep endometriosis patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients with confirmed diagnosis of deep infiltrating endometriosis requiring surgical treatment
Key inclusion criteria (5 listed)
- Patients with confirmed diagnosis of deep infiltrating endometriosis requiring surgical treatment
- Patient planned to be submitted to laparoscopic surgery finalize to eradicate the endometriosis pathology
- Naïve patients for OAB treatment.
- Patients must be capable of independent toileting
- Patients must be able to fully understand all study procedures and to provide written informed consent to study participation
Key exclusion criteria (7 listed)
- Patient previously submitted to pelvic surgery for any urogynaecological disease;
- Patients previously submitted to DE surgery
- Patient with documented clinical, instrumental, or laparoscopic preoperative diagnosis of bladder endometriosis;
- Patient with documented urinary tract infection
- Patient with history of diabetes mellitus, psychiatric, or neurological disease;
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
Urodynamic assessment after deep infiltrating endometriosis surgery
Time frame: 2 years
to evaluate the bladder function before and after deep endometriosis surgery (Unit of Measure: First Desire (ml) from Urodynamic Assessment)
2 secondary outcomes
Bladder symptoms after surgery for deep infiltrating endometriosis
Time frame: 2 years
correlation between localisation of the endometriosis lesion and postoperative bladder function.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Derived from this study: PubMed 34986409Laterza RM, Uccella S, Serati M, Umek W, Wenzl R, Graf A, Ghezzi F. Is the Deep Endometriosis or the Surgery the Cause of Postoperative Bladder Dysfunction? J Minim Invasive Gynecol. 2022 Apr;29(4):567-575. doi: 10.1016/j.jmig.2021.12.017. Epub 2022 Jan 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Infiltrating Endometriosis, run by Medical University of Vienna.
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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urodynamic assessment after deep infiltrating endometriosis surgery (time frame: 2 years). 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 NCT02238678, 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 12 Sep 2014.