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

17 sierpnia 2026 zaktualizowane przez: Charles University, Czech Republic

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.

Przegląd badań

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

20

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

      • Prague, Czechy, 120 00
        • Rekrutacyjny
        • General University in Prague
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

  • 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).

Opis

Inclusion Criteria:• age ≥ 18 years;

  • 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.

Exclusion Criteria:• pregnancy;

  • 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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).
Ramy czasowe: 3 years

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
Ramy czasowe: At study assessment, at least 2 years after surgery.
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
Ramy czasowe: At study assessment, at least 2 years after surgery.
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
Ramy czasowe: At study assessment, at least 2 years after surgery.
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
Ramy czasowe: At study assessment, at least 2 years after surgery.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Persistent Ureteral Dilatation Assessed by Ultrasound
Ramy czasowe: At study assessment, at least 2 years after surgery.
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.
At study assessment, at least 2 years after surgery.
Prevalence of Arterial Hypertension
Ramy czasowe: At study assessment, at least 2 years after surgery.
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.
At study assessment, at least 2 years after surgery.
Recurrence of Upper Urinary Tract Involvement After Surgery
Ramy czasowe: From surgery to long-term study assessment, at least 2 years after surgery. Secondary Outcome Measure 4
The number and proportion of participants with recurrent ureteral dilatation or hydronephrosis after surgery for ureteral involvement associated with deep endometriosis will be recorded.
From surgery to long-term study assessment, at least 2 years after surgery. Secondary Outcome Measure 4
Need for Reintervention for Recurrent Ureteral Involvement
Ramy czasowe: From surgery to long-term study assessment, at least 2 years after surgery.
The number and proportion of participants requiring additional surgical or urological intervention because of recurrent ureteral obstruction or hydronephrosis will be recorded.
From surgery to long-term study assessment, at least 2 years after surgery.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2029

Ukończenie studiów (Szacowany)

1 lipca 2029

Daty rejestracji na studia

Pierwszy przesłany

4 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

20 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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