Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function

NCT07776574 | Recruiting

• 2 other identifiers: 11025GrantRVO-VFN64165
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• "Extrinsic" - ureteral stenosis caused by periureteral fibrosis and the presence of DE lesions without infiltration of the ureteral wall.
• "Intrinsic" - ureteral stenosis caused by direct infiltration of the ureteral wall by endometriotic tissue. 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:
• ureterolysis - release of the ureter from fibrotic adhesions, preferred for the extrinsic form;
• ureteroneocystostomy (UCNA) - indicated for the intrinsic form when the affected segment must be resected and the ureter reimplanted into the bladder;
• ureteroureterostomy (ureteral anastomosis) - appropriate for the intrinsic form when, following resection, the distal ureteral segment is sufficiently long to allow anastomosis of healthy margins. 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.

Conditions

Endometriosis; Endometriosis (Diagnosis); Urinary Tract Diseases

Keywords

deep infiltrated endometriosis; ureteral endometriosis; nephrectomy

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  At study assessment, at least 2 years after surgery.

Secondary Outcomes (4)

• Persistent Ureteral Dilatation Assessed by Ultrasound

  At study assessment, at least 2 years after surgery.

• Prevalence of Arterial Hypertension

  At study assessment, at least 2 years after surgery.

• Recurrence of Upper Urinary Tract Involvement After Surgery

  From surgery to long-term study assessment, at least 2 years after surgery. Secondary Outcome Measure 4

• Need for Reintervention for Recurrent Ureteral Involvement

  From surgery to long-term study assessment, at least 2 years after surgery.

Study Arms (2)

surgery group A

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.

Follow up group

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women who suffer with deep infiltrated endometriosis affecting ureteral tract
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Group F (postoperative follow-up) Expected number of participants: approximately 50 patients Control group: 15 women of reproductive age with no history of hydronephrosis, other renal disease, or endometriosis; they 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. * Group S (prospective pilot cohort) Expected number of participants: 15 women with ureteral endometriosis indicated for surgical treatment (ureterolysis, UCNA, ureteroureterostomy).

You may qualify if:

• hydronephrosis caused by DE-related ureteral stenosis;
• for Group F: a history of surgical treatment of ureteral endometriosis (ureterolysis, ureteroureterostomy, UCNA) at our center at least 24 months previously;
• for Group S: indication for surgical treatment because of hydronephrosis or clinically significant ureteral stenosis;
• signed informed consent.

You may not qualify if:

• malignancy;
• congenital uropathy;
• other renal diseases;
• inability to undergo dynamic renal scintigraphy (e.g., allergy to the radiopharmaceutical or severe comorbidities precluding the examination);
• previous urinary tract surgery unrelated to ureteral endometriosis that could substantially confound the assessment of renal function.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

General University in Prague

Prague, 120 00, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

• Urine sampling for the assessment of biomarkers of tubular injury

MeSH Terms

Conditions

Endometriosis; Disease; Urologic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Male Urogenital Diseases

Central Study Contacts

Kristýna HLinecká, MD PhD

CONTACT

+420605413210; Kristyna.Hlinecka2@vfn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: August 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Locations

CZ (1)