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Clinical Trials/NCT02238678
NCT02238678
Unknown
Not Applicable

Impact of Deep Endometriosis Surgery on Bladder Function

Medical University of Vienna0 sites50 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Infiltrating Endometriosis
Sponsor
Medical University of Vienna
Enrollment
50
Primary Endpoint
Urodynamic assessment after deep infiltrating endometriosis surgery
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
June 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laterza Rosa Maria

Dr. med

Medical University of Vienna

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Bladder symptoms after surgery for deep infiltrating endometriosis(2 years)
  • correlation between localisation of the endometriosis lesion and postoperative bladder function.(2 years)

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