- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07776574
Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function (RENDO)
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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Kristýna HLinecká, MD PhD
- Telefoonnummer: +420605413210
- E-mail: Kristyna.Hlinecka2@vfn.cz
Studie Locaties
-
-
-
Prague, Tsjechië, 120 00
- Werving
- General University in Prague
-
Contact:
- Kristyna Hlinecka
- Telefoonnummer: 605413210
- E-mail: Kristyna.Hlinecka2@vfn.cz
-
Contact:
- Michael Fanta, MD,PhD, Ass.Prof.
- Telefoonnummer: 00420224967001
- E-mail: Michael.Fanta@vfn.cz
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
- 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).
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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).
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Persistent Ureteral Dilatation Assessed by Ultrasound
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11025Grant
- RVO-VFN64165 (Ander subsidie-/financieringsnummer: grant of The General University Hospital in Prague RVO-VFN64165)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .