EndometriosisRENDONCT07776574
Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function
An observational study of Endometriosis and Endometriosis (Diagnosis), run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Endometriosis (Diagnosis), Urinary Tract Diseases
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2026to 1 Jul 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University in Prague
Prague, 120 00
Kristyna Hlinecka, 605413210, Kristyna.Hlinecka2@vfn.cz
Michael Fanta, MD,PhD, Ass.Prof., 00420224967001, Michael.Fanta@vfn.cz
About this study
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.
Read more
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.
- Keywords
- deep infiltrated endometriosis, ureteral endometriosis, nephrectomy
- Medical subject headings
- Endometriosis, Disease, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study assessment, at least 2 years after surgery.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From surgery to long-term study assessment, at least 2 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Apr 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776574
- Sponsor's protocol ID
- 11025Grant
- Other IDs
- RVO-VFN64165
- Acronym
- RENDO
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function
- ClinicalTrials.gov ID
- NCT07776574
- Acronym / sponsor ID
- RENDO / 11025Grant
- Keywords
- deep infiltrated endometriosis, ureteral endometriosis, nephrectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: 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.
Hydronephrosis Grade Assessed by Renal Ultrasound
Time frame: 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.
Intrarenal Arterial Peak Systolic Velocity Measured by Pulsed-Wave Doppler Ultrasound
Time frame: 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.
Intrarenal Arterial End-Diastolic Velocity Measured by Pulsed-Wave Doppler Ultrasound
Time frame: 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.
Intrarenal Arterial Resistive Index Measured by Pulsed-Wave Doppler Ultrasound
Time frame: 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.
4 secondary outcomes
Persistent Ureteral Dilatation Assessed by Ultrasound
Time frame: At study assessment, at least 2 years after surgery.
Prevalence of Arterial Hypertension
Time frame: At study assessment, at least 2 years after surgery.
Recurrence of Upper Urinary Tract Involvement After Surgery
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
Time frame: From surgery to long-term study assessment, at least 2 years after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Endometriosis (Diagnosis), run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristýna HLinecká, MD PhD (+420605413210, Kristyna.Hlinecka2@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.