Chemotherapy EffectLUTSINCT05844059
Lower Urinary Tract Symptoms After Intravesical Therapy
An observational study of Chemotherapy Effect and Chemotherapeutic Toxicity, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chemotherapy Effect, Chemotherapeutic Toxicity, Lower Urinary Tract Symptoms
- What is being tested?
- Validated questionnaires
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 21 Apr 2023to 24 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with urinary bladder carcinoma requiring instillation therapy
Who may be able to join
- Urinary bladder carcinoma requiring instillation therapy
- Complete resection of the tumor
- No intravesical chemotherapy in the last 3 months
Who cannot join
- Patients who are unable to complete the questionnaires
- Patients who are not willing to participate
- Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Nikolaos Pyrgidis
Munich, Bavaria, 81377
Nikolaos Pyrgidis, 004989440073531, nikolaos.pyrgidis@med.uni-muenchen.de
About this study
Official title: Lower Urinary Tract Symptoms After Intravesical Therapy With Mitomycin C or BCG in Patients With Carcinoma of the Bladder
With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. The study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin C or BCG.
- Conditions
- Chemotherapy Effect, Chemotherapeutic Toxicity, Lower Urinary Tract Symptoms, Overactive Bladder
- Being tested
- Validated questionnaires
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validated questionnairesOther
BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing instillation therapy with BCG | All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer Receives: Other: Validated questionnaires | |
| Patients undergoing instillation therapy with Mitomycin C | All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer Receives: Other: Validated questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of instillation therapy on quality of life
Quality of life will be measured with validated questionnaires such as the ICIQ-OABqol
Measured: During the study period approximately 12 months
Effect of instillation therapy on sexuality
Sexuality will be measured with validated questionnaires such as the IIEF-EF (men) and the FSFI (women)
Measured: During the study period approximately 12 months
Effect of instillation therapy on lower urinary tract symptoms
Lower urinary tract symptoms will be measured with validated questionnaires such as the BPIC-SS, the ICIQ-MLUTS (men) and the ICIQ-FLUTS (women)
Measured: During the study period approximately 12 months
Secondary outcomes (2)
Complications during instillation therapy
The frequency of all complications will be measured and will be subsequently classified based on the Clavien-Dindo classification
Measured: During the study period approximately 12 months
Discontinuation rate of instillation therapy
Measured: During the study period approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Apr 2023
- Primary completion24 Apr 2025 (estimated)
- Study completion24 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedikt Ebner, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844059
- Sponsor's protocol ID
- 23-0226
- Acronym
- LUTSI
- Status last verified
- May 2023
- First submitted
- 22 Apr 2023
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Urinary Tract Symptoms After Intravesical Therapy With Mitomycin C or BCG in Patients With Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT05844059
- Acronym / sponsor ID
- LUTSI / 23-0226
- Conditions
- Chemotherapy Effect, Chemotherapeutic Toxicity, Lower Urinary Tract Symptoms, Overactive Bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 24 Apr 2025 (estimated)
- Study completion
- 24 Apr 2026 (estimated)
- First posted
- 6 May 2023 (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.
With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. The study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin C or BCG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing instillation therapy with BCG | – | Other: Validated questionnairesAll patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer |
| Patients undergoing instillation therapy with Mitomycin C | – | Other: Validated questionnairesAll patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with urinary bladder carcinoma requiring instillation therapy
Key inclusion criteria (3 listed)
- Urinary bladder carcinoma requiring instillation therapy
- Complete resection of the tumor
- No intravesical chemotherapy in the last 3 months
Key exclusion criteria (3 listed)
- Patients who are unable to complete the questionnaires
- Patients who are not willing to participate
- Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)
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 |
|---|---|---|
| Validated questionnairesBPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS | Other | Patients undergoing instillation therapy with BCG, Patients undergoing instillation therapy with Mitomycin C |
Primary outcome
Effect of instillation therapy on quality of life
Time frame: During the study period approximately 12 months
Quality of life will be measured with validated questionnaires such as the ICIQ-OABqol
Effect of instillation therapy on sexuality
Time frame: During the study period approximately 12 months
Sexuality will be measured with validated questionnaires such as the IIEF-EF (men) and the FSFI (women)
Effect of instillation therapy on lower urinary tract symptoms
Time frame: During the study period approximately 12 months
Lower urinary tract symptoms will be measured with validated questionnaires such as the BPIC-SS, the ICIQ-MLUTS (men) and the ICIQ-FLUTS (women)
2 secondary outcomes
Complications during instillation therapy
Time frame: During the study period approximately 12 months
Discontinuation rate of instillation therapy
Time frame: During the study period approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- 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. This study is not recruiting at the moment.
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 Chemotherapy Effect and Chemotherapeutic Toxicity, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos Pyrgidis, Urologist (004989440073531, nikolaos.pyrgidis@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of instillation therapy on quality of life (time frame: During the study period approximately 12 months). The study lists 3 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 6 May 2023.