Overactive BladderPhase 3VesiCaPNCT02805452
Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
A Phase 3 study testing Succinate of Solifenacin in people with Overactive Bladder, run by Center Eugene Marquis at 5 sites in France.
Trial summary
The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Succinate of Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 5 sitesFrance
- Study dates
- Jul 2016to 15 Jul 2017
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate adenocarcinoma (histological confirmation),
- Indication for prostate cancer radiotherapy (standard schema with a total dose from 70 to 80 Gray (GY)),
- Patient affiliation to the French Social Security System,
- Patient information and written informed consent,
- Patient complaining of urinary symptoms during radiotherapy,
- Occurrence of OverActive Bladder (OAB) subscore with the Urinary Symptom Profile (USP) scale greater or equal to 5.
Who cannot join
- Prostate irradiation contraindication
- History of bladder or prostate surgery,
- History of of pelvic radiotherapy,
- Individual deprived of liberty or placed Under the authority of a tutor,
- Age < 18 years,
- Flowmetry Qmax < 10ml/s and/or post-void residual urine > 100 ml (during urology preinclusion visit)
Show all 19Show fewer
- Previous known OAB
- Patients treated with non-authorized drugs,
- Patients treated with anticholinergic or cholinesterase inhibitors within 12 months before irradiation,
- Patients treated with anticholinergic during and weeks following irradiation and before Succinate of Solifenacin treatment start,
- Patients treated with botulinum toxin within 9 months before screening,
- Patients treated with alpha-blockers, 5-alpha reductase inhibitor within 12 months preceding irradiation, during and weeks following irradiation and before Succinate of Solifenacin treatment start,
- Contraindication of Succinate of Solifenacin
- Hypersensitivity or allergy to Solifenacin succinate or to any other antimuscarinic agent,
- Specific precautions of use for patients having decompensated urinary tract obstruction at risk of urinary retention, vegetative neuropathy, long QT syndrome and an hypokaliemia, history of long QT or patients at risk of QT prolongation, obstructive gastrointestinal disorders.
- Patients treated with oral biphosphonates, drugs that cause QT prolongation or by substrates having affinity for CYP3A4 isoenzyme as verapamil and Diltiazem, or treated with CYP3A4 inductors as rifampicin, phenytoin, carbamazepine
- Galactose hereditary intolerance, lactase deficiency or a malabsorption syndrome of glucose and galactose.
- Patient enable to follow study medical care for family, social, geographical or psychological reasons.
- Participation to another clinical study on urinary toxicity and/or molecule that could modify this toxicity and its evolution.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique Pasteur Lanroze
Brest
CH Bretagne Sud
Lorient
CH Lyon Sud
Lyon
Hôpital Saint Louis
Paris
Centre Eugene Marquis
Rennes, 35042
About this study
Official title: Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.
Read the detailed description
A multicenter Phase III, randomized, double-blinded, parallel group placebo-controlled study.
2 groups:
- Control arm = pts. with placebo
- Experimental arm = pts. with Solifenacin succinate 5 mg - Vesicare® All patients with an OAB sub-score using the USP scale greater to 5 during prostate cancer radiotherapy will be included, receiving either a placebo or Solifenacin succinate (5mg) for duration of 3 months.
The randomization will be stratified on the radiotherapy dose (1 to 40 Gy or 40 to 70/80 Gy).
Screening:
For all patients, OAB items of the USP scale will be completed before each standard weekly assessment during prostate radiotherapy. Patients who reach an OAB sub-score greater to 5 will be addressed to an urologist in order to confirm absence of Qmax < 10ml/sec at initial assessment, or post-void residual urine > 100 milliliter (ml).
Inclusion \& treatment:
A week at most after pre-screening, patients will be randomized to receive either Vesicare®-5mg or a placebo. In both study arms, the treatment should be continued for 3 months.
Follow-up:
The radiation oncologist will perform patients' follow-up for the study at the treatment initiation, 6 weeks and 3 months after start of the treatment (Vesicare or placebo).
The questionnaires for the evaluation of OAB syndrome, acute urinary toxicity and quality of life should be completed for each follow-up visit. The voiding diary will be completed during 3 days before (or if not, 3 days after) all the evaluation times.
An urologist will perform an uroflowmetry and a post-voiding echography (or a bladder scan) before initiation of the treatment, and after 6 weeks of treatment.
Statistics and sample size PATIENTS ENROLMENT 70 patients will be included (considering 66 patients completing the full study) within 3 recruitment centers
- Conditions
- Overactive Bladder
- Being tested
- Succinate of Solifenacin, Placebo of Succinate of Solifenacin
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Succinate of SolifenacinDrug
Placebo of Succinate of SolifenacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Succinate of Solifenacin | Experimental | 1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months. Receives: Drug: Succinate of Solifenacin |
| Placebo of Succinate of Solifenacin | Placebo comparator | 1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months. Receives: Drug: Placebo of Succinate of Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Urinary Symptom Profile (USP) questionnaire
Score will be measured after study drug treatment initiation.
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion30 May 2017
- Study completion15 Jul 2017
Why it stopped: Target of recruitment not reachable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud de Crevoisier, MD, Principal investigator, Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805452
- Sponsor's protocol ID
- 2014-RdC-PRO-Th
- Other IDs
- 2014-004296-22, 2014
- Acronym
- VesiCaP
- Status last verified
- Jan 2018
- First submitted
- 10 Jun 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
- ClinicalTrials.gov ID
- NCT02805452
- Acronym / sponsor ID
- VesiCaP / 2014-RdC-PRO-Th
- Conditions
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target of recruitment not reachable
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.
Detailed description
A multicenter Phase III, randomized, double-blinded, parallel group placebo-controlled study.
2 groups:
- Control arm = pts. with placebo
- Experimental arm = pts. with Solifenacin succinate 5 mg - Vesicare® All patients with an OAB sub-score using the USP scale greater to 5 during prostate cancer radiotherapy will be included, receiving either a placebo or Solifenacin succinate (5mg) for duration of 3 months.
The randomization will be stratified on the radiotherapy dose (1 to 40 Gy or 40 to 70/80 Gy).
Screening:
For all patients, OAB items of the USP scale will be completed before each standard weekly assessment during prostate radiotherapy. Patients who reach an OAB sub-score greater to 5 will be addressed to an urologist in order to confirm absence of Qmax < 10ml/sec at initial assessment, or post-void residual urine > 100 milliliter (ml).
Inclusion \& treatment:
A week at most after pre-screening, patients will be randomized to receive either Vesicare®-5mg or a placebo. In both study arms, the treatment should be continued for 3 months.
Follow-up:
The radiation oncologist will perform patients' follow-up for the study at the treatment initiation, 6 weeks and 3 months after start of the treatment (Vesicare or placebo).
The questionnaires for the evaluation of OAB syndrome, acute urinary toxicity and quality of life should be completed for each follow-up visit. The voiding diary will be completed during 3 days before (or if not, 3 days after) all the evaluation times.
An urologist will perform an uroflowmetry and a post-voiding echography (or a bladder scan) before initiation of the treatment, and after 6 weeks of treatment.
Statistics and sample size PATIENTS ENROLMENT 70 patients will be included (considering 66 patients completing the full study) within 3 recruitment centers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Succinate of Solifenacin | Experimental | Drug: Succinate of Solifenacin1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months. |
| Placebo of Succinate of Solifenacin | Placebo comparator | Drug: Placebo of Succinate of Solifenacin1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate adenocarcinoma (histological confirmation),
- Indication for prostate cancer radiotherapy (standard schema with a total dose from 70 to 80 Gray (GY)),
- Patient affiliation to the French Social Security System,
- Patient information and written informed consent,
- Patient complaining of urinary symptoms during radiotherapy,
Key exclusion criteria (19 listed)
- Prostate irradiation contraindication
- History of bladder or prostate surgery,
- History of of pelvic radiotherapy,
- Individual deprived of liberty or placed Under the authority of a tutor,
- Age < 18 years,
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 |
|---|---|---|
| Succinate of Solifenacin | Drug | Succinate of Solifenacin |
| Placebo of Succinate of Solifenacin | Drug | Placebo of Succinate of Solifenacin |
Primary outcome
Score of Urinary Symptom Profile (USP) questionnaire
Time frame: At 6 weeks
Score will be measured after study drug treatment initiation.
Results and safety
The study was stopped early (reason given: Target of recruitment not reachable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
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.
Renaud de Crevoisier, MD principal investigator
Centre Eugène Marquis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Succinate of Solifenacin in people with Overactive Bladder, run by Center Eugene Marquis at 5 sites in France.
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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Target of recruitment not reachable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Urinary Symptom Profile (USP) questionnaire (time frame: At 6 weeks). 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 19 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.