A study of the efficacy and safety of the treatment of Erectile dysfunction treatment with oral daily Tadalafil and Low intensity shockwave at penis.

A study of the efficacy and safety of the treatment of Erectile dysfunction treatment with oral daily Tadalafil and Low intensity shock wave at penis.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250611003

Enrollment

Registered

2025-06-11

Start date

2024-04-19

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile dysfunction Androgen declining Aging male Vasculogenic Erectile dysfunction ED tadalafil Erectile dysfunction Low intensity shockwave treatment ESWT SWT penile doppler ultrasound flaccid penile doppler ultrasound Androgen declining

Interventions

The patients will receive Low intensity shockwave treatment at the penis once a week for 6 weeks consecutively and receive tadalafil 5 mg tablet take daily for 90 days.,The patients will receive sham

Experimental Procedure/Surgery,Sham Comparator Drug,Active Comparator Procedure/Surgery

Low intensity shockwave treatment and tadalafil 5 mg oral tablet.,Sham Low intensity shockwave treatment and tadalafil 5 mg oral tablet.,Low intensity shockwave treatment at the penis and placebo tabl

Eligibility

Sex/Gender

Male

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male patients age over 40 years old. 2. Erectile dysfunction at least mild degree from IIEF.

Exclusion criteria

Exclusion criteria: 1. Hba1c above than 9.0 2. LDL cholesterol above than 190 3. PSA (Prostatic Specific Antigen) above than 4.0 4. Severe liver impairment Child-Puge score class C or renal impairment with chronic kidney stage 4 or 5. 5. Psychiatric problems or being treated with psychiatrist. 6. Bed ridden condition. 7. Not fully recovered from stoke. 8. Spinal injury above than T6 level or paraplegia. 9. Can not have daily activities by himself. 10. Blood pressure above 160/100 mmHg or lower than 90/60 mmHg. 11. Recent Myocardial Infarction within 3 months. 12. Retina diseases. 13. Patients taking anti-Coagulants. 14. Patients taking Nitrite or Nitroglycerine medicines. 15. Allergic to PDE5-inhibitors.

Design outcomes

Primary

Measure	Time frame
IIEF(International Index of Erectile Function) and AMS(Aging Male Symptoms Score). at day 0,45,90 after interventions. Questionnaires	—

Secondary

Measure	Time frame
Penile doppler ultrasound. at day 0, 90 after interventions. Peak systolic Velocity and Resistive index of cavernosal artery at the penis.	—

Countries

Thailand

Contacts

Public ContactYossak Sakulchaiyakorn

Burapha university

yossak@go.buu.ac.th038386554

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026