Evidence map›Paper›PMID 41766021›Full record

Trial reportWorld journal of urology2026

A fixed dose combination of tamsulosin and tadalafil in men with benign prostatic hyperplasia and erectile dysfunction: a prospective, multicenter, phase IV study.

Chirag Gupta, Avinash T S, Dushyant Shamlabhai Pawar, Abhay Khandekar, G Ravindra Deshmukh, Vinay Kumar, Ajwani Vikky Ramesh, Shah Ishan Hemantkumar, Patankar Suresh Balkrishna, Mandodari Rajurkar and 4 more

Abstract readMulticenter StudyClinical Trial, Phase IV
In one paragraph

Trial report in World journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Chirag GuptaDepartment of Urology, Jaipur National University Institute for Medical Science and Research Center, Jaipur, Rajasthan, India.
Avinash T SDepartment of Urology, Sparsh Super Specialty Hospital, Bangalore, Karnataka, India.
Dushyant Shamlabhai PawarDepartment of Urology, Indus Hospital, Ahmedabad, Gujarat, India.
Abhay KhandekarDepartment of Urology, Siddhivinayak Hospital, Ahmedabad, Gujarat, India.
G Ravindra DeshmukhDepartment of Urology, Jasleen Hospital, Nagpur, Maharashtra, India.
Vinay KumarDepartment of Surgery, GSVM Medical College, Kanpur, Uttar Pradesh, India.
Ajwani Vikky RameshDepartment of Urology, Anand Multispecialty Hospital, Vadodara, Gujarat, India.
Shah Ishan HemantkumarDepartment of Urology, Dr. M K Shah Medical College and Research Center, Smt S.M.S. Multispecialty Hospital, Ahmedabad, Gujarat, India.
Patankar Suresh BalkrishnaDepartment of Urology, Ace Hospital and Research Center, Pune, Maharashtra, India.
Mandodari RajurkarMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Plot 201 B/1, Sun House, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India.
Dipesh SonawaneMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Plot 201 B/1, Sun House, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India. dipesh.sonawane@sunpharma.com.ORCID http://orcid.org/0009-0006-9837-006X
Dipak PatilMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Plot 201 B/1, Sun House, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India.
Pravin GhadgeMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Plot 201 B/1, Sun House, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India.
Suyog MehtaMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Plot 201 B/1, Sun House, Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of a fixed-dose combination (FDC) of tamsulosin prolonged release (PR) and tadalafil in moderate-severe benign prostatic hyperplasia (BPH) and erectile dysfunction (ED).

methodsThis was a single-arm, phase IV, prospective clinical trial in sexually active men aged 45–75 years with BPH [International Prostate Symptom Score (IPSS) score ≥ 8] and ED [International Index of Erectile Function-Erectile Function (IIEF-EF) score ≤ 25] who were taking tamsulosin 0.4 mg PR and tadalafil 5 mg. Eligible patients received FDC of tamsulosin+tadalafil (0.4 + 5 mg) capsules for 12 weeks. The endpoints included treatment-emergent adverse events (TEAEs), total IPSS, IPSS storage and voiding sub-scores, maximum urinary flow rate (Qmax), post-void residual (PVR) volume, IIEF-EF (questions 1–5 and 15) score, and IPSS quality of life (QoL) index.

resultsA total of 172 were enrolled. Overall, 12 TEAEs were reported in 10 (5.81%) patients. None of the TEAEs were severe, serious, life-threatening, or required treatment interruption. A statistically significant improvement (p < 0.0001) in total IPSS after 4, 8, and 12 weeks was observed. Similar improvements from baseline were also observed in IPSS storage and voiding sub-scores, IPSS QoL, Qmax, PVR volume, and IIEF-EF (questions 1–5 and 15) score (p < 0.05 for each parameter). The proportion of men with normal erectile function significantly increased at week 12 (p = 0.0003).

conclusionThe FDC of tamsulosin and tadalafil was associated with significant improvements in lower urinary tract symptoms and EF over 12 weeks and was well tolerated in Indian men with moderate-severe BPH and ED.

trial registrationProspectively registered at Clinical Trials Registry—India on 10th June 2022 [CTRI/2022/06/043152].

Indexed as

Erectile DysfunctionPhosphodiesterase 5 InhibitorsProstatic HyperplasiaTadalafilTamsulosinAgedDrug CombinationsHumansMaleMiddle AgedProspective StudiesTreatment OutcomeDrug CombinationsPhosphodiesterase 5 InhibitorsTadalafilTamsulosinBenign prostatic hyperplasiaErectile dysfunctionInternational prostate symptom scoreLower urinary tract symptomsTadalafilTamsulosin

Identifiers

PMID41766021
PMCPMC12950645

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.