Phytotherapy
DrugPhytotherapy or alphablockers
Other names: Alpha-blockers
NCT Number: NCT07144709
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.
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Notify Me40 year and older
Male
Observational
Medical Office of Delsart MD, Bersée, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Phytotherapy or alphablockers
Other names: Alpha-blockers
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
Safety assessment over the 6-month period by group of treatment
Time frame: 6 months
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
Pierre Fabre Medicament
Industry
A 6-months Prospective, Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockersfor Benign Prostatic Hyperplasia
Acronym: PERQoL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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