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| Name | Class |
|---|---|
| Kappa Santé | INDUSTRY |
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This is a prospective, multicentre, non-interventional study, conducted in France and Spain, in primary care practices and designed to assess the QoL of patients under phytotherapy or alpha-blockers for LUTS/BPH. The study will not provide or recommend any treatment or procedure.
Any patient with moderate to severe LUTS/BPH initiating treatment with PT or AB during the inclusion period will be invited to participate in the study. Per usual practice, the physician will prescribe a treatment independently of the study. Patients will be consecutively enrolled in each of the 2 groups (PT or AB), regardless of the number of patients already enrolled in the other group. An average of 6 patients per General Practitioner (GP) is expected, i.e. 3 patients in each group. A GP who has reached 3 patients in a group will continue to recruit in the second group until reaching 2 groups of 3 patients. Once the two groups of 3 patients have been completed, the inclusions may be re-opened following the same procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phytotherapy | Patients initiating a first-line phytotherapy treatment for LUTS/BPH in monotherapy |
| |
| Alpha-blockers | Patients initiating a first-line alpha-blockers treatment for LUTS/BPH in monotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phytotherapy | Drug | Phytotherapy or alphablockers |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) M6 | Mean difference in BPHQOL9 scores between baseline and M6, by group of treatment (PT and AB). For BPHQOL9, the total score can range from 0 to 90 (sum of all 9 items). A higher score means a better quality of life. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9), M6 | Mean difference in BPHQOL9 scores between baseline and M3 or M6, by group of treatment For BPHQOL9, the total score can range from 0 to 90 (sum of all 9 items). A higher score means a better quality of life. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation | BPHQOL9 total score and IPSS QoL score will be estimated per patient at each time measurement (baseline, M3 and M6) in order to assess corelations between both scores | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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Participating sites will be encouraged to propose the study to all patients meeting the eligibility criteria, in a consecutive manner, when they come for consultation, in order to minimize bias in patient selection.Each investigator site will include the samenumber of patients initiating PT and initiating AB.Treatment choice should be made by the investigator as routine practice. No medical therapy is required for this study.Investigators should ensure that IPSS total score meets the eligibility criteria before enrolling patients in the study.
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| Name | Affiliation | Role |
|---|---|---|
| EID | Pierre Fabre Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Office of Delsart MD | Bersée | France | ||||
| Medical Office of Breton MD |
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| Quality of life Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) |
Quality of life changes using BPHQOL9 questionnaire over the 6-month period. For BPHQOL9, the total score can range from 0 to 90 (sum of all 9 items). A higher score means a better quality of life. |
| 6 months |
| Urinary symptoms profiles | Urinary symptoms profiles using International Prostate Score Symptom (IPSS) questionnaire over the 6-month period by group of treatment. Score has a total range from 0 to 35 (sum of the first 7 questions) with 3 defined severity states (0-7 = mild; 8-19 = moderate; 20-35 = severe). A higher score means a worse urinary difficulties. | 6 months |
| Sexual Fonction | Sexual function and satisfaction using Male Sexual Health Questionnaire (MSHQ) over the 6-month period by group of treatment. The MSHQ total score ranges from 0 to 125 (sum of all items). Higher scores indicate better sexual function. | 6 months |
| Safety (Adverse events) | Safety assessment over the 6-month period by group of treatment | 6 months |
| Béziers |
| France |
| Medical Office of Guiu MD | Ferrals-les-Corbières | France |
| Medical Office of Patron MD | Gap | France |
| Medical Office of Coulon MD | Giromagny | France |
| Medical Office of Dassa MD | Istres | France |
| Medical Office of Rigaud MD | Lamagistère | France |
| Medical Office of Specht MD | Lambersart | France |
| Medical Office of Mesguich MD | Le Blanc-Mesnil | France |
| Medical Office of Dassonval MD | Marles-les-Mines | France |
| Medical Office of Cayron MD | Montpellier | France |
| Medical Office of Chassagne MD | Montpellier | France |
| Medical Office of Baranes MD | Paris | France |
| Medical Office of Labregere MD | Paris | France |
| Medical Office of Merlin MD | Raimbeaucourt | France |
| Medical Office of Lemercier MD | Royan | France |
| Medical Office of Margueritte MD | Six-Fours-les-Plages | France |
| Maison de Santé MEDIVIE | Templeuve-en-Pévèle | France |
| Medical Office of Demoulin MD | Val-de-Vesle | France |
| Medical Office of David MD | Verzy | France |
| Cs Vargas, Santander | Santander | Cantabria | Spain |
| C.S. San Jose | A Coruña | Spain |
| C.S. Zona Ii | Albacete | Spain |
| C.S. Aldea Moret | Cáceres | Spain |
| C.S. Fuencarral | Madrid | Spain |
| C.S. Mendiguchia | Madrid | Spain |
| Centro Urología, Andrología Y Salud Sexual | Palma de Mallorca | Spain |
| C.S. Rotxapea | Pamplona | Spain |
| C.S. Soria Rural | Soria | Spain |
| C.S. Laguna de Duero | Valladolid | Spain |
| Cs Villamayor de Gallego | Zaragoza | Spain |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D008517 | Phytotherapy |
| D000317 | Adrenergic alpha-Antagonists |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
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