An observational study in Endometriosis, Endometriosis (Diagnosis) and Urinary Tract Diseases, sponsored by Charles University, Czech Republic. Recruiting at 1 site in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Charles University, Czech Republic · Observational
Endometriosis is a chronic estrogen-dependent disease characterized by the presence and growth of endometrium-like tissue outside the uterine cavity.
This ectopic endometrial tissue induces a chronic local and systemic inflammatory response, resulting in the most common manifestations of the disease: chronic pelvic pain, infertility, and pelvic adhesions. In deep endometriosis (DE), adhesions and infiltrative growth may damage adjacent organs.
Overall, endometriosis affects approximately 10% of women of reproductive age. Its prevalence is higher among women with infertility (20-50%) and among patients with chronic pelvic pain (up to 90%).
The disease is usually categorized as superficial peritoneal, ovarian, or deep endometriosis (DE). Deep endometriosis is a progressive form of the disease that may affect organs beyond the pelvic cavity, including the urinary tract, alter their anatomy, and cause functional impairment.
Urogenital involvement occurs in approximately 1-5.5% of all women with endometriosis; the prevalence is substantially higher among patients with DE, reaching 16-53% according to the available literature.
Within the urinary tract, the bladder is most commonly affected (70-85%), followed by the ureters (9-23%), kidneys (approximately 4%), and urethra (approximately 2%).
Ureteral endometriosis is therefore a relatively rare but clinically significant entity. It may be unilateral or bilateral, with a predominance of left-sided involvement.
Two basic forms are distinguished:
Ureteral stenosis causes secondary hydronephrosis and, unless treated in a timely manner, may lead to a progressive loss of renal function.
The disease frequently remains asymptomatic for a prolonged period. Up to half of cases are diagnosed incidentally or only at an advanced stage, when renal damage is already irreversible.
Early detection and timely planning of surgical management are therefore essential for preserving renal function.
The main surgical procedures are:
Despite the clinical significance of the condition, prospective studies objectively evaluating the evolution of renal function after the individual types of surgical management of ureteral endometriosis are still lacking.
A modern diagnostic strategy combining specialized ultrasound, dynamic renal scintigraphy (MAG3), and analysis of urinary biomarkers of tubular injury (KIM-1, CCL-2, L-FABP) enables earlier detection of renal dysfunction and more accurate monitoring of postoperative recovery. Identification of sensitive biomarkers of early renal injury and validation of an algorithm for their use could substantially improve decisions regarding the timing of surgery and subsequent postoperative follow-up.
Based on our experience, some patients surgically treated for hydronephrosis caused by DE-related ureteral stenosis show persistent morphological changes on renal ultrasound and the manifestation of systemic conditions such as arterial hypertension during long-term follow-up. To date, no study has focused on the long-term follow-up of patients with ureteral DE and its potential consequences. The expected benefit of this study is to establish clear criteria for the indication of surgical treatment of ureteral endometriosis and to develop an evidence-based protocol for long-term follow-up.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's planned enrollment of 20 is below the median of 135 across 349 observational studies indexed under Endometriosis.
Browse Endometriosis studies →Charles University, Czech Republic is the lead sponsor of 228 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:• age ≥ 18 years;
Exclusion Criteria:• pregnancy;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A cohort of approximately 20 patients with DE-related ureteral stenosis indicated for surgical treatment. Renal function and imaging findings will be evaluated before surgery and subsequently at regular intervals during postoperative follow-up.
long-term follow-up of previously operated patients A cohort of women who previously underwent surgical treatment of ureteral endometriosis (ureterolysis, ureteroureterostomy, UCNA) and are at least 24 months after surgery. Functional and imaging examinations of the kidneys will be performed, and the long-term treatment outcomes and the incidence of arterial hypertension will be evaluated in comparison with a control group.
The project will comprise two complementary components: Group F (long-term follow-up of patients at least 2 years after surgery) and Group S (the pilot component of the project - patients assessed before surgery).
Group F: To assess the long-term consequences of renal involvement in patients who underwent surgery for hydronephrosis caused by ureteral stenosis associated with deep endometriosis, including the impact on the renal parenchyma and the incidence of arterial hypertension compared with a control group of women of reproductive age without DE involvement. The effect of the type of surgical procedure (ureterolysis, ureteroneocystostomy - UCNA, ureteroureterostomy) on long-term outcomes will also be evaluated, including the risk of recurrent involvement and the need for potential reintervention. Control group: Women of reproductive age with no history of hydronephrosis, other renal disease, or endometriosis will be recruited from among patients evaluated for other benign conditions. As part of the study, they will undergo renal ultrasonography with assessment of renal morphology (parenchyma and Doppler perfusion characteristics), and the presence of arterial hypertension will be evaluated.
Time frame: 3 years
Hydronephrosis Grade Assessed by Renal Ultrasound
Hydronephrosis will be assessed by renal ultrasonography and classified as Grade 0, I, II, III, or IV. The distribution of hydronephrosis grades will be compared between the study group and the control group.
Time frame: At study assessment, at least 2 years after surgery.
Intrarenal Arterial Peak Systolic Velocity Measured by Pulsed-Wave Doppler Ultrasound
Peak systolic velocity will be measured in intrarenal arteries using pulsed-wave Doppler ultrasonography and reported in centimetres per second.
Time frame: At study assessment, at least 2 years after surgery.
Intrarenal Arterial End-Diastolic Velocity Measured by Pulsed-Wave Doppler Ultrasound
End-diastolic velocity will be measured in intrarenal arteries using pulsed-wave Doppler ultrasonography and reported in centimetres per second.
Time frame: At study assessment, at least 2 years after surgery.
Intrarenal Arterial Resistive Index Measured by Pulsed-Wave Doppler Ultrasound
The intrarenal arterial resistive index will be calculated from pulsed-wave Doppler measurements using peak systolic velocity and end-diastolic velocity. Resistive index values will be compared between the study group and the control group.
Time frame: At study assessment, at least 2 years after surgery.
Persistent Ureteral Dilatation Assessed by Ultrasound
Ureteral dilatation will be assessed by ultrasonography and classified as transient or persistent. The number and proportion of participants with persistent ureteral dilatation will be reported.
Time frame: At study assessment, at least 2 years after surgery.
Prevalence of Arterial Hypertension
The number and proportion of participants with arterial hypertension will be assessed and compared between patients after surgery for hydronephrosis associated with ureteral deep endometriosis and women in the control group.
Time frame: At study assessment, at least 2 years after surgery.
Recurrence of Upper Urinary Tract Involvement After Surgery
The number and proportion of participants with recurrent ureteral dilatation or hydronephrosis after surgery for ureteral involvement associated with deep endometriosis will be recorded.
Time frame: From surgery to long-term study assessment, at least 2 years after surgery. Secondary Outcome Measure 4
Need for Reintervention for Recurrent Ureteral Involvement
The number and proportion of participants requiring additional surgical or urological intervention because of recurrent ureteral obstruction or hydronephrosis will be recorded.
Time frame: From surgery to long-term study assessment, at least 2 years after surgery.
Plan to share: Undecided
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