Urinary Bladder NeoplasmsNCT05264337
Lymphedema After Urologic Surgery
An observational study of Urinary Bladder Neoplasms and Prostatic Neoplasms, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial summary
Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms, Prostatic Neoplasms, Testicular Neoplasms
- What is being tested?
- Self-reported lymphedema, Dielectric constant ratio and Limb volume
- How many people
- 400 participants
- Where
- 2 sitesSweden
- Study dates
- 14 Mar 2022to Jan 2030
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing urologic surgery that includes lymph node dissection
Who may be able to join
- Patients undergoing urologic surgery with lymph node dissection
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Henrik Kjölhede, MD PhD, +46-31-3421000, henrik.kjolhede@vgregion.se
- Recruiting
Örebro University Hospital
Örebro
Peter Kirrander, MD PhD, peter.kirrander@regionorebrolan.se
About this study
Official title: Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection
Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.
- Being tested
- Self-reported lymphedema, Dielectric constant ratio, Limb volume
- Keywords
- Lymphedema, Lymph Node Excision
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Neoplasms, Testicular Neoplasms, Penile Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-reported lymphedemaOther
Lymphedema as reported by LymQOL questionnaire.
Dielectric constant ratioOther
Measurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D.
Limb volumeOther
Measurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference.
| Study group | Role | What they receive |
|---|---|---|
| Radical Cystectomy | Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer Receives: Other: Self-reported lymphedema; Other: Dielectric constant ratio; Other: Limb volume | |
| Radical Prostatectomy | Patients undergoing radical prostatectomy with pelvic lymph node dissection for prostate cancer Receives: Other: Self-reported lymphedema | |
| Retroperitoneal | Patients undergoing retroperitoneal lymph node dissection for testicular cancer Receives: Other: Self-reported lymphedema | |
| Other | Patients undergoing other urologic surgery with lymph node dissection of inguinal, iliacal or retroperitoneal lymph nodes Receives: Other: Self-reported lymphedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with self-reported lymphedema at 12 months
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Measured: 12 months after surgery
Number of patients with self-reported lymphedema at 24 months
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Measured: 24 months after surgery
Change in tissue water content measured by MoistureMeterD Compact at 12 months
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Measured: 12 months after surgery
Change in tissue water content measured by MoistureMeterD Compact at 24 months
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Measured: 24 months after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months
Measured: 12 months after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months
Measured: 24 months after surgery
Secondary outcomes (9)
Number of patients with self-reported lymphedema at 1 month
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Measured: 1 month after surgery
Number of patients with self-reported lymphedema at 3 months
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Measured: 3 months after surgery
Number of patients with self-reported lymphedema at 6 months
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Measured: 6 months after surgery
Change in tissue water content measured by MoistureMeterD Compact at 1 month
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Measured: 1 month after surgery
Change in tissue water content measured by MoistureMeterD Compact at 3 months
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Measured: 3 months after surgery
Change in tissue water content measured by MoistureMeterD Compact at 6 months
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Measured: 6 months after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month
Measurements of circumference every 6 cm along the lower limbs.
Measured: 1 month after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month
Measurements of circumference every 6 cm along the lower limbs.
Measured: 3 month after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month
Measurements of circumference every 6 cm along the lower limbs.
Measured: 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start14 Mar 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Henrik Kjölhede, MD, PhD, Principal investigator, Sahlgrenska University Hospital, Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264337
- Sponsor's protocol ID
- 2021-04840
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT05264337
- Acronym / sponsor ID
- 2021-04840
- Keywords
- Lymphedema, Lymph Node Excision
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 3 Mar 2022 (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.
Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Radical Cystectomy | – | Other: Self-reported lymphedema, Other: Dielectric constant ratio, Other: Limb volumePatients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer |
| Radical Prostatectomy | – | Other: Self-reported lymphedemaPatients undergoing radical prostatectomy with pelvic lymph node dissection for prostate cancer |
| Retroperitoneal | – | Other: Self-reported lymphedemaPatients undergoing retroperitoneal lymph node dissection for testicular cancer |
| Other | – | Other: Self-reported lymphedemaPatients undergoing other urologic surgery with lymph node dissection of inguinal, iliacal or retroperitoneal lymph nodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing urologic surgery that includes lymph node dissection
Key inclusion criteria (1 listed)
- Patients undergoing urologic surgery with lymph node dissection
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-reported lymphedemaLymphedema as reported by LymQOL questionnaire. | Other | Other, Radical Cystectomy, Radical Prostatectomy, Retroperitoneal |
| Dielectric constant ratioMeasurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D. | Other | Radical Cystectomy |
| Limb volumeMeasurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference. | Other | Radical Cystectomy |
Primary outcome
Number of patients with self-reported lymphedema at 12 months
Time frame: 12 months after surgery
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Number of patients with self-reported lymphedema at 24 months
Time frame: 24 months after surgery
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Change in tissue water content measured by MoistureMeterD Compact at 12 months
Time frame: 12 months after surgery
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Change in tissue water content measured by MoistureMeterD Compact at 24 months
Time frame: 24 months after surgery
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months
Time frame: 12 months after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months
Time frame: 24 months after surgery
9 secondary outcomes
Number of patients with self-reported lymphedema at 1 month
Time frame: 1 month after surgery
Number of patients with self-reported lymphedema at 3 months
Time frame: 3 months after surgery
Number of patients with self-reported lymphedema at 6 months
Time frame: 6 months after surgery
Change in tissue water content measured by MoistureMeterD Compact at 1 month
Time frame: 1 month after surgery
Change in tissue water content measured by MoistureMeterD Compact at 3 months
Time frame: 3 months after surgery
Change in tissue water content measured by MoistureMeterD Compact at 6 months
Time frame: 6 months after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month
Time frame: 1 month after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month
Time frame: 3 month after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month
Time frame: 6 month 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 16 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Henrik Kjölhede, MD, PhD principal investigator
Sahlgrenska University Hospital, Gothenburg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms and Prostatic Neoplasms, run by Vastra Gotaland Region at 2 sites in Sweden.
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 1 inclusion and 1 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 Henrik Kjölhede, MD, PhD (+46-31-3421000, henrik.kjolhede@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with self-reported lymphedema at 12 months (time frame: 12 months after surgery). The study lists 6 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 16 Jan 2026.