Comparison of the Efficacy and Safety of Dapoxetine, Kegel Exercises, and Acupuncture in the Treatment of Premature Ejaculation: A Randomized, Double-Blind, Placebo-Controlled Trial

NCT07067970 | Not Yet Recruiting DMC

• 1 other identifier: 2222486777
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of dapoxetine, Kegel exercises, acupuncture, and their placebo controls in the treatment of premature ejaculation (PE). PE is a common male sexual dysfunction characterized by ejaculation occurring within one minute of vaginal penetration, causing distress or interpersonal difficulties (Althof et al., 2014). A total of 250 male participants will be randomized into five groups (dapoxetine, placebo, Kegel exercises, acupuncture, sham acupuncture) for a 12-week treatment period followed by a 4-week follow-up. The primary outcome is the increase in intravaginal ejaculation latency time (IELT), with secondary outcomes including the Premature Ejaculation Diagnostic Tool (PEDT) score, Sexual Quality of Life-Male (SQoL-M) score, and adverse effects.

Conditions

Premature Ejaculation

Keywords

premature ejaculation; acupuncture; dapoksetin; kegel; sham-acupuncture

Outcome Measures

Primary Outcomes (1)

• Intravaginal Ejaculation Latency Time (IELT):

  Measured by stopwatch during sexual intercourse, reported as the weekly average. Participants will record IELT for each sexual encounter.

  Time points: Baseline, Week 4, Week 8, Week 12, and Follow-up (Week 16

Secondary Outcomes (1)

• Premature Ejaculation Diagnostic Tool (PEDT):

  Time points: Baseline, Week 4, Week 8, Week 12, and Follow-up (Week 16).

Study Arms (5)

Dapoxetine Group:

EXPERIMENTAL

Dosage: 30 mg dapoxetine taken 1-3 hours before sexual activity (maximum 3 doses per week). Duration: 12 weeks.

Drug: serotonin reuptake inhibitor (SSRI)

Placebo Group

PLACEBO COMPARATOR

Dosage: Placebo tablet identical in appearance and taste to dapoxetine, following the same dosing protocol. Duration: 12 weeks.

Drug: Placebo

Kegel Exercises Group

EXPERIMENTAL

Protocol: Three sets of 10-15 pelvic floor muscle contractions daily, supervised by a physiotherapist. Duration: 12 weeks.

Behavioral: Exercise

Acupuncture Group

ACTIVE COMPARATOR

Protocol: Two 30-minute sessions per week using standardized acupuncture points (e.g., CV4, SP6, ST36) by licensed acupuncturists. Duration: 12 weeks

Other: Acupuncture

Sham Acupuncture Group

SHAM COMPARATOR

Protocol: Superficial needle application avoiding active acupuncture points, following the same frequency and duration. Duration: 12 weeks.

Other: Sham

Interventions

serotonin reuptake inhibitor (SSRI) DRUG

Dapoxetine Group Dosage: 30 mg dapoxetine, taken orally 1-3 hours before anticipated sexual activity, with a maximum of 3 doses per week. Administration: Provided in blister packs to ensure compliance. Reference: McMahon et al., 2011.

Dapoxetine Group:

Placebo DRUG

Dosage: Placebo tablets identical in appearance and taste to dapoxetine, administered on the same schedule (1-3 hours before sexual activity, maximum 3 doses per week). Administration: Provided in identical blister packs.

Placebo Group

Acupuncture OTHER

Protocol: Two 30-minute acupuncture sessions per week, targeting standardized points (e.g., CV4, SP6, ST36) known to influence sexual function and autonomic nervous system regulation. Administration: Performed by licensed acupuncturists following a standardized protocol. Reference: Sunay et al., 2011.

Acupuncture Group

Sham OTHER

Sham Acupuncture Group:Protocol: Two 30-minute sessions per week using superficial needle insertion at non-active points to minimize therapeutic effects while maintaining the placebo effect. Administration: Performed by licensed acupuncturists to ensure consistency with the active acupuncture group

Sham Acupuncture Group

Exercise BEHAVIORAL

Kegel Exercises Group:Protocol: Participants will perform pelvic floor muscle exercises consisting of three sets of 10-15 contractions daily, each held for 5-10 seconds followed by relaxation. Training: Participants will receive initial training from a licensed physiotherapist, with weekly follow-up sessions to ensure proper technique and adherence. Reference: Pastore et al., 2014.

Kegel Exercises Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: premature ejaculation is male condition
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male, aged 18-50 years. Diagnosed with lifelong or acquired PE per ISSM criteria (IELT \< 2 minutes, lack of ejaculatory control, and associated distress or interpersonal difficulties).
• In a stable sexual relationship with a partner for at least 6 months. Willing to provide written informed consent and comply with study procedures.

You may not qualify if:

• Presence of erectile dysfunction (diagnosed via International Index of Erectile Function score \< 21).
• Severe psychiatric disorders (e.g., major depression, bipolar disorder) or neurological conditions (e.g., multiple sclerosis, Parkinson's disease).
• Current use of selective serotonin reuptake inhibitors (SSRIs) or other psychotropic medications.
• History of alcohol or substance dependence. Known contraindications to dapoxetine (e.g., hepatic impairment) or acupuncture (e.g., bleeding disorders).
• Previous pelvic floor surgery or trauma affecting pelvic floor muscles.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Sunay D, Sunay M, Aydogmus Y, Bagbanci S, Arslan H, Karabulut A, Emir L. Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial. Eur Urol. 2011 May;59(5):765-71. doi: 10.1016/j.eururo.2011.01.019. Epub 2011 Jan 18.

  PMID: 21256670 BACKGROUND

• Pastore AL, Palleschi G, Fuschi A, Maggioni C, Rago R, Zucchi A, Costantini E, Carbone A. Pelvic floor muscle rehabilitation for patients with lifelong premature ejaculation: a novel therapeutic approach. Ther Adv Urol. 2014 Jun;6(3):83-8. doi: 10.1177/1756287214523329.

  PMID: 24883105 BACKGROUND

• McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.

  PMID: 21059176 BACKGROUND

• Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An Update of the International Society of Sexual Medicine's Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014 Jun;2(2):60-90. doi: 10.1002/sm2.28.

  PMID: 25356302 BACKGROUND

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Selective Serotonin Reuptake Inhibitors; Acupuncture Therapy; salicylhydroxamic acid; Exercise

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Complementary Therapies; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

ALi İhsan Memmi

CONTACT

+90 5379220997; alimemmi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinding will be maintained by ensuring that participants and outcome assessors are unaware of group assignments. Dapoxetine and placebo tablets will be identical in appearance and packaging. Acupuncture and sham acupuncture procedures will use standardized needles to maintain blinding, with sham acupuncture involving superficial needle insertion at non-active points.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: A Randomized, Double-Blind, Placebo-Controlled Trial Participants will be assigned to one of the following five groups for a 12-week intervention period:Dapoxetine Group:Dosage: 30 mg dapoxetine, taken orally 1-3 hours before anticipated sexual activity, with a maximum of 3 doses per week. Administration: Provided in blister packs to ensure compliance. Reference: McMahon et al., 2011. Placebo Group:Dosage: Placebo tablets identical in appearance and taste to dapoxetine, administered on the same schedule (1-3 hours before sexual activity, maximum 3 doses per week). Administration: Provided in identical blister packs. Kegel Exercises Group:Protocol: Participants will perform pelvic floor muscle exercises consisting of three sets of 10-15 contractions daily, each held for 5-10 seconds followed by relaxation. Training: Participants will receive initial training from a licensed physiotherapist, with weekly follow-up sessions to ensure proper technique and adherence.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

TU (1)