ClinicalTrials.gg
CompletedNCT06369545Updated Oct 16, 2024

Chronic Pelvic Pain Syndrome in Males

An interventional study of EXERCISE and TENS in Pelvic Pain Syndrome, sponsored by Biruni University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-10-16.

Sponsored by Biruni University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome.

Read the detailed description

Volunteers who are between the ages of 20-40, diagnosed with chronic pelvic pain syndrome, and who meet the inclusion criteria will be included in the study and will be randomized into 2 groups: Group I (TENS) and Group II (ESWT).

02

Conditions studied

  • Pelvic Pain Syndrome

Keywords

  • Chronic Pelvic Pain Syndrome
  • Male
  • ESWT
  • TENS
03

In context

Lead sponsor

Biruni University is the lead sponsor of 179 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged between 20-40 years old males
  2. Diagnosis of Chronic Pelvic Pain Syndrome

Exclusion criteria

Exclusion Criteria:

  1. Cancer
  2. Surgery related to pelvic floor

2. Receiving drug treatment

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    GROUP I: TENS

    PHYSIOTHERAPY PROGRAM PLUS TENS

    Other: EXERCISE · Other: TENS

  • Active comparator
    GROUP II: ESWT

    PHYSIOTHERAPY PROGRAM PLUS ESWT

    Other: EXERCISE · Other: ESWT

Interventions

  • OtherEXERCISE

    All participants included in this group will receive Exercises

  • OtherTENS

    All participants included in this group will receive TENS

  • OtherESWT

    All participants included in this group will receive ESWT

06

What researchers measure

Primary outcomes

  1. VISUAL ANALOUGE SCALE

    It evaluates pain intensity grading between 0-10. Higher score shows severe pain.

    Time frame: baseline and immediately after the intervention

  2. National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)

    This assesses the quality of life. The index has sub dimensions(pain, urinary symptoms, quality of life impact). The score evaluation of the pain scale is between 1 and 21 points, the score evaluation of the urination scale is between 0 and 10 points, and the score evaluation of the quality of life scale is between 0 and 12 points.

    Time frame: baseline and immediately after the intervention

  3. ALGOMETER

    This evaluates pain tolerance threshold of the patients.The less score shows pain intolerance.

    Time frame: baseline and immediately after the intervention

Secondary outcomes

  1. Hospital Anxiety and Depression Scale- HAD

    This evaluates depresive symtoms of the patients.This scale is a self-rating scale. The scale is a 4-point Likert type scale consisting of 14 items in total, including anxiety and depression subscales (Aydemir, Güvenir, Küey, \& Kültür, 1997). 7 items in the scale are for anxiety and 7 items are for depression. Participants will be asked to mark each item considering the situation they have experienced in the last week. Each item contains four options. Options will be scored between 0-3 points. The lowest score for the anxiety and depression subscales is 0 and the highest score is 21 points.

    Time frame: baseline and immediately after the intervention

  2. Nottingham Health Profile-NHP

    This evaluates quality of life of the patients. The survey consists of 6 sections. These sections are pain, emotional reactions, social isolation, physical activity, energy and sleep. It consists of 38 items in total. Each section is scored between 0-100 points. 0 will be considered the best score and 100 will be considered the worst score.

    Time frame: baseline and immediately after the intervention

  3. Digital Muscle Testing

    To evaluate muscles's strenght using by Power Track. Higher cosre shows good strneght.

    Time frame: baseline and immediately after the intervention

  4. Flexibility Measurements

    To measure flexibility of the muscles, manually. The amount of elasticity is measured and the result is recorded in cm.

    Time frame: baseline and immediately after the intervention

  5. ROM Assessments

    To measure range of motion of the joints by using goniometer.

    Time frame: baseline and immediately after the intervention

  6. Lasegue Test

    To measure flexibility of the sciatic nerve, manually.

    Time frame: baseline and immediately after the intervention

07

Study locations

1 site
  • Faculty of Health Sciences in Biruni University
    Istanbul, Zeytinburnu 34010, Turkey (Türkiye)
08

References and documents

Publications

  • Schneider MP, Tellenbach M, Mordasini L, Thalmann GN, Kessler TM. Refractory chronic pelvic pain syndrome in men: can transcutaneous electrical nerve stimulation help? BJU Int. 2013 Jul;112(2):E159-63. doi: 10.1111/bju.12005. Epub 2013 Feb 22. PubMed 23433012 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Apr 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2024
First posted
Apr 17, 2024
StartActual
Jan 1, 2024
Primary completionActual
Apr 4, 2024
CompletionActual
Aug 15, 2024
Last update
Oct 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06369545
Lead sponsor
Biruni University
Responsible party
Ugur Cavlak (Clinical Professor, Biruni University) — Principal investigator
First posted
Apr 17, 2024
Start date
Jan 1, 2024
Primary completion
Apr 4, 2024
Completion
Aug 15, 2024
Last update
Oct 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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