NCT07442396

Brief Summary

The aim is to investigate the effectiveness of exercise in the treatment of erectile dysfunction and premature ejaculation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

February 25, 2026

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • International Index of Erectile Dysfunction

    Mean change in International Index of Erectile Dysfunction scores. There are five specific areas addressed including Erectile Function (questions:1-5 \& 15;score range: 0-5, maximum score:30); Orgasmic Function (questions:9-10; score range:0-5; maximum score:10); Sexual desire (questions:11-12; score range:1-5; maximum score:10); Intercourse satisfaction (questions:6-8; score range:0-5; maximum score:15); Overall satisfaction (questions:13-14; score range:1-5; maximum score:10). The lower the score represents greater dysfunction within each domain.

    10 weeks

  • Premature Ejaculation Diagnostic Tool

    it was developed by Symonds et al. (2007) to better define premature ejaculation for use in clinical studies, this is a 5-point Likert-type scale consisting of 5 items. The scale was adapted to Turkish by Serefoglu et al. (2009). The highest score that can be obtained from the scale is 20.0 and the lowest score is 0.0. Scores higher than 11 are defined as "Premature Ejaculation", scores of 9-10 are defined as "possible Premature Ejaculation", and scores of eight or less are defined as "no Premature Ejaculation".

    10 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

only patients who receive medical treatment and informational training

Other: control

exercise group

EXPERIMENTAL

Patients who receive pelvic floor exercises in addition to medical treatment and education.

Other: exercise

Interventions

controlOTHER

Patients in the control group will be followed with normal conventional medical treatment.

Also known as: medical treatment
control group

Participants in the exercise group will undergo an 8-week, 3-day-a-week exercise program.

Also known as: Pelvic Floor Exercise Group
exercise group

Eligibility Criteria

Age25 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsdiseases seen in men
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male individuals aged 25-45 years
  • Individuals diagnosed with erectile dysfunction and premature ejaculation
  • Individuals who voluntarily agree to participate in the study and sign the informed consent form
  • Individuals who have the physical and cognitive capacity to participate in pelvic floor physiotherapy applications

You may not qualify if:

  • Individuals with a history of surgery in the pelvic region
  • Individuals with a diagnosis of neurological disease or neurological disorder that may affect pelvic floor muscle function
  • Presence of active infection, inflammation, or painful pathology in the pelvic region
  • Individuals who regularly use medications that significantly affect sexual function
  • Individuals with serious psychiatric illness or cognitive impairment that may hinder study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar university

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Yaacov D, Nelinger G, Kalichman L. The Effect of Pelvic Floor Rehabilitation on Males with Sexual Dysfunction: A Narrative Review. Sex Med Rev. 2022 Jan;10(1):162-167. doi: 10.1016/j.sxmr.2021.02.001. Epub 2021 Apr 27.

    PMID: 33931383BACKGROUND
  • Sahin E, Brand A, Cetindag EN, Messelink B, Yosmaoglu HB. Pelvic physical therapy for male sexual disorders: a narrative review. Int J Impot Res. 2025 Dec;37(12):941-949. doi: 10.1038/s41443-025-01034-5. Epub 2025 Feb 27.

    PMID: 40016382BACKGROUND
  • Niu C, Ventus D, Wen G, Santtila P. Associations between self-reports of physical activity, interoceptive awareness, autonomic regulation, premature ejaculation, and erectile dysfunction in Chinese men. Int J Impot Res. 2025 Dec;37(12):992-1001. doi: 10.1038/s41443-025-01072-z. Epub 2025 Apr 19.

    PMID: 40251377BACKGROUND

MeSH Terms

Conditions

Erectile DysfunctionPremature Ejaculation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersEjaculatory Dysfunction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Parsa Keihani

    Uskudar University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr.

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 2, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations