Impact of Deep Endometriosis Surgery on Bladder Function

Deep Infiltrating Endometriosis Clinical Trial

Official title:

Impact of Deep Endometriosis Surgery on Bladder Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02238678
• Other study ID #: ENDOBLAD 1057/2014
• Status: Active, not recruiting
• Phase: N/A
• First received: August 28, 2014
• Last updated: September 10, 2014
• Start date: June 2014

Study information

• Verified date: August 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Infiltrating Endometriosis
• Endometriosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Department of Obstetrics and Gynaecology, Insubria Unievrsity, Varese (Italy)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years	No
Secondary	Bladder symptoms after surgery for deep infiltrating endometriosis	using standardized validated questionnaires -OABQ short form, ICIQ short form questionnaire, micturition diary.	2 years	No
Secondary	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	2 years	No