Comparative Study Between Rezum and Tamsulosin | NCT07169773 | Trialant

Comparative Study Between Rezum and Tamsulosin | NCT07169773 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rezum group	Active Comparator	47 patient underwent Rezum therapy	Device: Rezum
tamsulosin group	Active Comparator	47 patients were given Tamsulosin medical treatment	Drug: Tamsulosin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The International Prostate Symptom score (IPSS)	Measurement of The International Prostate Symptom score (IPSS) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 / Maximum : 35 Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic	Time Frame: for each case in both groups the investigator assess IPSS at 3, 6, 12 after procedures through study completion, an average of 1 year
The Maximum Urinary flow rate (Qmax)	Measurement of The Maximum Urinary flow rate (Qmax) in both groups After 3, 6, 12 months of operation, the procedure is performed. Qmax is measured by (ml/sec) Normal values are described as a Qmax above 15 ml/sec and below 10 ml/sec is considered abnormal	Time Frame: for each case in both groups the investigator assess Qmax at 3, 6, 12 months after procedures through study completion, an average of 1year
The Quality of Life (QoL)	Measurement of The Quality of Life (QoL) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy	[Time Frame: for each case in both groups the investigator assess QoL at 3, 6, 12 months after procedures through study completion, an average of 1 year
The Prostate size	the prostate size was measured by grams by Trans-rectal ultra sound	Time Frame: for each case in both groups the investigator assess prostate size at 3, 6, 12 months after procedures through study completion, an average of 1 year.

Secondary Outcomes

Measure	Description	Time Frame
Incidence of complications	For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system. It uses a 5-grade scale (I-V), to classify complications from minor issues not requiring intervention (Grade I) to death (Grade V).	through 1 year

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40676194	Result	Samir M, Mahmoud MA, Abdelmonem HA, Elrefaie M, Gad KA. A comparative analysis of the outcomes of Rezum therapy based on prostate size: a four-year retrospective analysis. World J Urol. 2025 Jul 17;43(1):443. doi: 10.1007/s00345-025-05793-0.

Condition Browse Module

Intervention Browse Module