Erectile DysfunctionNCT04885101
Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction
A study testing LISWT Group and NARFT Group in people with Erectile Dysfunction, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
Trial summary
This is a randomized clinical trial study with the formation of three groups. After signing the informed consent form, in two copies of equal content, the patient will be evaluated by an experienced physiotherapist and will answer a questionnaire of socio-demographic data and basic anamnesis. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- LISWT Group and NARFT Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-80 years.
- Men with a report of complaints of erectile dysfunction.
Who cannot join
- History of neurological disease.
- History of diabetes mellitus.
- History of Peyronie's disease.
- History of psychiatric illness.
- History of prostatectomy.
- Patients with anatomical malformations in the genital region.
- Penile prosthesis users.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, 40.290-000
Patricia V Lordelo, Phd, +5571988592400, pvslordelo@hotmail.com
About this study
Official title: Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction: Randomized Controlled Clinical Trial
This is a randomized clinical trial study with the formation of three groups. After signing the informed consent form, in two copies of equal content, the patient will be evaluated by an experienced physiotherapist and will answer a questionnaire of socio-demographic data and basic anamnesis.
Then, in a private and individualized room, participants will be guided by researchers trained to complete the self-administered questionnaires: International Erectile Function Index (IIFE), Erection Quality Questionnaire (EQQ), SF-36 and Hospital Anxiety Scale and Depression (EHAD). After applying the questionnaires, a physical evaluation by an experienced physiotherapist will be performed.
Read more
To induce erection of the penis an injection of a vasoactive agent (prostaglandin E1, alprostadil) will be administered in the corpora cavernosa. Then the length of the penis (swollen, elongated and flaccid) and penile circumference will be measured. Soon after, Dynamic Doppler Ultrasonography with Penis Doppler (UDDP) will be performed. The parameters that will be used in the UDDP to provide a general vascular diagnosis include Peak Systolic Speed (VSP), Final Diastolic Speed (VDF) and Resistive Index (IR).
In the case of a controlled and randomized clinical trial, the patient may be randomly allocated to one of three groups: the Non-Ablative Radiofrequency group (NARFT); the Low Intensity Shockwave Therapy Group (LISWT) and; the Sham Group that will perform the Vacuum Therapy (SHAM). In the NARFT group, the radio frequency will be applied, the device used will be the HERTIX Radiofrequency. The shock wave therapy application protocol in the LISWT group will use the THORK Shock Wave. While in the SHAM group, the vacuum therapy will be used, the research subjects will use the automatic version with simple on / off and release valve commands.
As in the other groups, participants in the Sham group will have a session every seven days for eight weeks. The entire evaluation protocol will be applied before (pre-test) and after treatment (post-test).
- Conditions
- Erectile Dysfunction
- Being tested
- LISWT Group, NARFT Group, Sham Group
- Keywords
- Extracorporeal Shockwave Therapy, Radiofrequency Therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LISWT GroupProcedure or surgery
The treatment consists of a weekly session and 4,000 pulses will be emitted each of the eight sessions totaling 32,000 pulses with a frequency of 18Hz and 100mJ of energy.
NARFT GroupProcedure or surgery
The device used will be with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. Eight radio frequency sessions will be held with an interval of seven days between them.
Sham GroupProcedure or surgery
In the RNA group, radiofrequency will be applied, the device used will be the Nèartek Esthetic Ibramed - Tecarterapia e Radiofrequency Apparatus, with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. The radiofrequency will be applied with the patient in the supine position on both sides of the penis with an opposite dispersion plate against the radiofrequency emitter. To perform the procedure, the therapist will use a glove. Eight radio frequency sessions will be held with an interval of seven days between them.
| Study group | Role | What they receive |
|---|---|---|
| LISWT Group | Experimental | Participants who will submitted to active procedure with Low Intensuty Shockwave Therapy. Receives: Procedure: LISWT Group |
| NARFT Group | Experimental | Participants who will submitted to active procedure with Non-Ablative Radiofrequency Therapy Receives: Procedure: NARFT Group |
| Sham Group | Sham comparator | Participants who submitted to sham procedure with vaccum therapy. Receives: Procedure: Sham Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak systolic velocity
Performed by means of ultrasonography with doppler of the penis through the induction of the erection, being considered arterial insufficiency the value below 25 cm / s
Measured: Change from baseline peak systolic velocity immediately after intervention.
Change in end diastolic velocity
Performed by means of ultrasonography with doppler of the penis through the induction of the erection, being considered venous occlusive disease the value above 5 cm / s
Measured: Change from baseline end diastolic velocity immediately after intervention.
Change in cavernous artery diameter
Performed by means of ultrasonography with doppler of the penis through the induction of the erection.
Measured: Change from baseline cavernous artery diameter immediately after intervention.
Secondary outcomes (3)
Change in International Index of Erectile Function
It is a questionnaire with 5 questions about penile erection that can vary from 5 to 25 points. Higher scores indicate better clinical condition.
Measured: Change from baseline International Index of Erectile Function immediately after intervention.
Change in Questionnaire of Erectile Quality
It is a questionnaire with 6 questions about the quality of erection based on the Likert scale. That is, it does not offer number values.
Measured: Change from baseline Questionannaire of Erectile Quality immediately after intervention.
Change in measurement of penis length and diameter.
These measurements are made with a paper ruler with the penis flaccid and after ten minutes of induction for erection.
Measured: Change from baseline measurement of penis lenght and diameter immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Oct 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted men diagnosed with Erectile Dysfunction alocated in three groups: Non-Ablative Radiofrequency Therapy (NARFT), Low Intensity Shockwave Therapy (LISWT) or Sham.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Collaborators
- Indústria Brasileira Equipamentos Médicos - IBRAMED
- Responsible party
- Sponsor
- Investigators
- Patrícia V Lordêlo, PhD, Study chair, Centro de Atenção Pélvica - CAAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885101
- Sponsor's protocol ID
- CAAP DE
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. No abstract available.
PubMed 8510302McMahon CG, Abdo C, Incrocci L, Perelman M, Rowland D, Waldinger M, Xin ZC. Disorders of orgasm and ejaculation in men. J Sex Med. 2004 Jul;1(1):58-65. doi: 10.1111/j.1743-6109.2004.10109.x.
PubMed 16422984Mobley DF, Khera M, Baum N. Recent advances in the treatment of erectile dysfunction. Postgrad Med J. 2017 Nov;93(1105):679-685. doi: 10.1136/postgradmedj-2016-134073. Epub 2017 Jul 27.
PubMed 28751439Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
PubMed 8254833Stein RA. Endothelial dysfunction, erectile dysfunction, and coronary heart disease: the pathophysiologic and clinical linkage. Rev Urol. 2003;5 Suppl 7(Suppl 7):S21-7.
PubMed 16985979Feldman HA, Johannes CB, Derby CA, Kleinman KP, Mohr BA, Araujo AB, McKinlay JB. Erectile dysfunction and coronary risk factors: prospective results from the Massachusetts male aging study. Prev Med. 2000 Apr;30(4):328-38. doi: 10.1006/pmed.2000.0643.
PubMed 10731462Mobley D, Baum N. Smoking: Its Impact on Urologic Health. Rev Urol. 2015;17(4):220-5.
PubMed 26839519Wespes E, Amar E, Hatzichristou D, Hatzimouratidis K, Montorsi F, Pryor J, Vardi Y; EAU. EAU Guidelines on erectile dysfunction: an update. Eur Urol. 2006 May;49(5):806-15. doi: 10.1016/j.eururo.2006.01.028. Epub 2006 Feb 9.
PubMed 16530932Porst H, Burnett A, Brock G, Ghanem H, Giuliano F, Glina S, Hellstrom W, Martin-Morales A, Salonia A, Sharlip I; ISSM Standards Committee for Sexual Medicine. SOP conservative (medical and mechanical) treatment of erectile dysfunction. J Sex Med. 2013 Jan;10(1):130-71. doi: 10.1111/jsm.12023.
PubMed 23343170Chaussy C, Brendel W, Schmiedt E. Extracorporeally induced destruction of kidney stones by shock waves. Lancet. 1980 Dec 13;2(8207):1265-8. doi: 10.1016/s0140-6736(80)92335-1.
PubMed 6108446Chung E, Wang J. A state-of-art review of low intensity extracorporeal shock wave therapy and lithotripter machines for the treatment of erectile dysfunction. Expert Rev Med Devices. 2017 Dec;14(12):929-934. doi: 10.1080/17434440.2017.1403897. Epub 2017 Nov 29.
PubMed 29119841
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04885101
- Acronym / sponsor ID
- CAAP DE
- Conditions
- Erectile Dysfunction
- Keywords
- Extracorporeal Shockwave Therapy, Radiofrequency Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Collaborators
- Indústria Brasileira Equipamentos Médicos - IBRAMED
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial study with the formation of three groups. After signing the informed consent form, in two copies of equal content, the patient will be evaluated by an experienced physiotherapist and will answer a questionnaire of socio-demographic data and basic anamnesis.
Then, in a private and individualized room, participants will be guided by researchers trained to complete the self-administered questionnaires: International Erectile Function Index (IIFE), Erection Quality Questionnaire (EQQ), SF-36 and Hospital Anxiety Scale and Depression (EHAD). After applying the questionnaires, a physical evaluation by an experienced physiotherapist will be performed.
To induce erection of the penis an injection of a vasoactive agent (prostaglandin E1, alprostadil) will be administered in the corpora cavernosa. Then the length of the penis (swollen, elongated and flaccid) and penile circumference will be measured. Soon after, Dynamic Doppler Ultrasonography with Penis Doppler (UDDP) will be performed. The parameters that will be used in the UDDP to provide a general vascular diagnosis include Peak Systolic Speed (VSP), Final Diastolic Speed (VDF) and Resistive Index (IR).
In the case of a controlled and randomized clinical trial, the patient may be randomly allocated to one of three groups: the Non-Ablative Radiofrequency group (NARFT); the Low Intensity Shockwave Therapy Group (LISWT) and; the Sham Group that will perform the Vacuum Therapy (SHAM). In the NARFT group, the radio frequency will be applied, the device used will be the HERTIX Radiofrequency. The shock wave therapy application protocol in the LISWT group will use the THORK Shock Wave. While in the SHAM group, the vacuum therapy will be used, the research subjects will use the automatic version with simple on / off and release valve commands.
As in the other groups, participants in the Sham group will have a session every seven days for eight weeks. The entire evaluation protocol will be applied before (pre-test) and after treatment (post-test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The study will be conducted men diagnosed with Erectile Dysfunction alocated in three groups: Non-Ablative Radiofrequency Therapy (NARFT), Low Intensity Shockwave Therapy (LISWT) or Sham.
| Arm | Type | Receives |
|---|---|---|
| LISWT Group | Experimental | Procedure: LISWT GroupParticipants who will submitted to active procedure with Low Intensuty Shockwave Therapy. |
| NARFT Group | Experimental | Procedure: NARFT GroupParticipants who will submitted to active procedure with Non-Ablative Radiofrequency Therapy |
| Sham Group | Sham comparator | Procedure: Sham GroupParticipants who submitted to sham procedure with vaccum therapy. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 30-80 years.
- Men with a report of complaints of erectile dysfunction.
Key exclusion criteria (7 listed)
- History of neurological disease.
- History of diabetes mellitus.
- History of Peyronie's disease.
- History of psychiatric illness.
- History of prostatectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LISWT GroupThe treatment consists of a weekly session and 4,000 pulses will be emitted each of the eight sessions totaling 32,000 pulses with a frequency of 18Hz and 100mJ of energy. | Procedure or surgery | LISWT Group |
| NARFT GroupThe device used will be with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. Eight radio frequency sessions will be held with an interval of seven days between them. | Procedure or surgery | NARFT Group |
| Sham GroupIn the RNA group, radiofrequency will be applied, the device used will be the Nèartek Esthetic Ibramed - Tecarterapia e Radiofrequency Apparatus, with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. The radiofrequency will be applied with the patient in the supine position on both sides of the penis with an opposite dispersion plate against the radiofrequency emitter. To perform the procedure, the therapist will use a glove. Eight radio frequency sessions will be held with an interval of seven days between them. | Procedure or surgery | Sham Group |
Primary outcome
Change in peak systolic velocity
Time frame: Change from baseline peak systolic velocity immediately after intervention.
Performed by means of ultrasonography with doppler of the penis through the induction of the erection, being considered arterial insufficiency the value below 25 cm / s
Change in end diastolic velocity
Time frame: Change from baseline end diastolic velocity immediately after intervention.
Performed by means of ultrasonography with doppler of the penis through the induction of the erection, being considered venous occlusive disease the value above 5 cm / s
Change in cavernous artery diameter
Time frame: Change from baseline cavernous artery diameter immediately after intervention.
Performed by means of ultrasonography with doppler of the penis through the induction of the erection.
3 secondary outcomes
Change in International Index of Erectile Function
Time frame: Change from baseline International Index of Erectile Function immediately after intervention.
Change in Questionnaire of Erectile Quality
Time frame: Change from baseline Questionannaire of Erectile Quality immediately after intervention.
Change in measurement of penis length and diameter.
Time frame: Change from baseline measurement of penis lenght and diameter immediately after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 8510302NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. No abstract available.
- Background: PubMed 16422984McMahon CG, Abdo C, Incrocci L, Perelman M, Rowland D, Waldinger M, Xin ZC. Disorders of orgasm and ejaculation in men. J Sex Med. 2004 Jul;1(1):58-65. doi: 10.1111/j.1743-6109.2004.10109.x.
- Background: PubMed 28751439Mobley DF, Khera M, Baum N. Recent advances in the treatment of erectile dysfunction. Postgrad Med J. 2017 Nov;93(1105):679-685. doi: 10.1136/postgradmedj-2016-134073. Epub 2017 Jul 27.
- Background: PubMed 8254833Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
- Background: PubMed 16985979Stein RA. Endothelial dysfunction, erectile dysfunction, and coronary heart disease: the pathophysiologic and clinical linkage. Rev Urol. 2003;5 Suppl 7(Suppl 7):S21-7.
- Background: PubMed 10731462Feldman HA, Johannes CB, Derby CA, Kleinman KP, Mohr BA, Araujo AB, McKinlay JB. Erectile dysfunction and coronary risk factors: prospective results from the Massachusetts male aging study. Prev Med. 2000 Apr;30(4):328-38. doi: 10.1006/pmed.2000.0643.
- Background: PubMed 26839519Mobley D, Baum N. Smoking: Its Impact on Urologic Health. Rev Urol. 2015;17(4):220-5.
- Background: PubMed 16530932Wespes E, Amar E, Hatzichristou D, Hatzimouratidis K, Montorsi F, Pryor J, Vardi Y; EAU. EAU Guidelines on erectile dysfunction: an update. Eur Urol. 2006 May;49(5):806-15. doi: 10.1016/j.eururo.2006.01.028. Epub 2006 Feb 9.
- Background: PubMed 23343170Porst H, Burnett A, Brock G, Ghanem H, Giuliano F, Glina S, Hellstrom W, Martin-Morales A, Salonia A, Sharlip I; ISSM Standards Committee for Sexual Medicine. SOP conservative (medical and mechanical) treatment of erectile dysfunction. J Sex Med. 2013 Jan;10(1):130-71. doi: 10.1111/jsm.12023.
- Background: PubMed 6108446Chaussy C, Brendel W, Schmiedt E. Extracorporeally induced destruction of kidney stones by shock waves. Lancet. 1980 Dec 13;2(8207):1265-8. doi: 10.1016/s0140-6736(80)92335-1.
- Background: PubMed 29119841Chung E, Wang J. A state-of-art review of low intensity extracorporeal shock wave therapy and lithotripter machines for the treatment of erectile dysfunction. Expert Rev Med Devices. 2017 Dec;14(12):929-934. doi: 10.1080/17434440.2017.1403897. Epub 2017 Nov 29.
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrícia V Lordêlo, PhD study chair
Centro de Atenção Pélvica - CAAP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LISWT Group and NARFT Group in people with Erectile Dysfunction, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrícia V Lordêlo, PhD (+5571988592400, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak systolic velocity (time frame: Change from baseline peak systolic velocity immediately after intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885101, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.