Investigation of the Effectiveness of Connective Tissue Massage in Individuals With Erectile Dysfunction Symptoms

March 7, 2024 updated by: Mesut Arslan, Bitlis Eren University
In this study, it is planned to investigate the effect of connective tissue massage on symptom severity, autonomic functions, psychological state and quality of life in individuals with erectile dysfunction symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The most common sexual dysfunctions in men include erectile dysfunction and premature ejaculation. Erectile dysfunction (ED) is defined as the inability to achieve and maintain the penile erection necessary for sexual intercourse for at least 6 months.The prevalence of ED generally varies between 37.2%-48.6%.

There are various treatment methods used in individuals with ED symptoms. While urologists use oral phosphodiesterase-5 inhibitor drugs (such as sildenafil and vardenafil) as the first step, intracavernosal papaverine or alprostadil injections and vacuum devices may be preferred afterwards. When these treatments are inadequate, penile prostheses can be used. In addition, various physiotherapy techniques such as pelvic floor muscle training, electrical stimulation, massage and aerobic exercises are also recommended for these individuals.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bitlis, Turkey, 13000
        • Recruiting
        • Bitlis Eren University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male subjects aged 20-65 years with ED complaints for at least 6 months will be included in the study. In addition, sexually active individuals will be included in the study

Exclusion Criteria:

  • Patients with diabetes and renal diseases, uncontrolled hypertension, priapism, pacemaker users, history of psychiatric or psychological illness, skin lesions/ulcer in the penis or lumbosacral region, and patients who are unable to cooperate will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control roup
The control group will receive standard treatment (lifestyle recommendations + medical (PDE-5 inhibitors)).
Experimental: CTM group
In addition to the standard treatment, connective tissue massage will be applied to the CTM group.
Other: Connective tissue massage(CTM)
CTM will be applied by a trained physiotherapist for 3 days/week for 4 weeks. Application time will be approximately 15-20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The International Index of Erectile Function (IIEF-5)
Time Frame: Change from baseline at 4 weeks
İt is a 5-question questionnaire used to assess erectile dysfunction. Patients' answers to each question are scored between 1 and 5. A total score above 21 indicates normal erectile function, while a score of 21 and below indicates ED. According to the total score obtained from the scale, ED is divided into 4 categories. Severe (1-7), moderate (8-11), moderate to mild (12-16), mild (17-21) and no ED (22-25).
Change from baseline at 4 weeks
Premature Ejaculation Diagnostic Tool (PEDT)
Time Frame: Change from baseline at 4 weeks
İt is a 5-question questionnaire that evaluates control, frequency, minimum stimulation, distress and interpersonal difficulty parameters related to premature ejaculation (PE). A total score of 8 indicates no PE, 9-10 indicates possible PE, and a score equal to or higher than 11 indicates PE.
Change from baseline at 4 weeks
Composite Autonomic Symptom Score (COMPASS 31)
Time Frame: Change from baseline at 4 weeks
İt is a 31-question questionnaire that assesses autonomic symptoms in 6 different areas: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder function and pupillomotor. Survey score varies between 0-100 points. A high score on the questionnaire indicates the presence and severity of autonomic dysfunction.
Change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety Stress Scale (DASS-21)
Time Frame: Change from baseline at 4 weeks
It evaluates the condition of the individual in the last week. It is a 21-question questionnaire consisting of 3 subscales: depression, anxiety and stress. Survey score varies between 0-63 points. A high score on the questionnaire indicates the presence and severity of depression, anxiety and stress.
Change from baseline at 4 weeks
Quality of Life Questionnaire (SF-36)
Time Frame: Change from baseline at 4 weeks
It is a 36-question questionnaire consisting of 8 subscales including physical function, physical role, emotional role, pain, vitality, general health and mental health. Survey score varies between 0-100 points. A high score obtained from the questionnaire indicates that the individual has a good quality of life.
Change from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Estimated)

December 21, 2024

Study Completion (Estimated)

December 21, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED-CTM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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