The Role for Psychological Intervention in Men with

Premature Ejaculation

John P. Mulhall MD MSc FECSM FACSDirector, Sexual & Reproductive Medicine Program

Urology Service

Memorial Sloan Kettering Cancer Center

Defining Success in PE Research

•Correct definition

•Type of PE defined

•IELT: how measured?

•Validated instrument used?

•Is intervention defined? nature, duration, compliance?

•What control group was used?

•Durability of response?

•Use of systematic reviews (metanalysis)

Definition of PE

Mulhall JP. Premature Ejaculation. Campbell’s Urology 2011

Classification of PE

Pathophysiology of PE

Primary PE is a neurochemical disorder involving alterations in serotonin levels or serotoninreceptor alterations with secondary psychological sequelae which act as promoters and perpetuators.

Pathophysiology of PE

•Current approaches reflect our poor understanding of the mechanism of PE development

•Significant differences in men with lifelong vs acquired PE

•Management strategies based on biological and psychological perspectives

•While psychological issues are invariably present in men with PE, it is likely that these are secondary

Aims of Psychotherapeutic Interventions

•Learn techniques to control and delay ejaculation

•Increase confidence in sexual performance

•Lessen performance anxiety

•Modify maladaptive sexual scripts

•Circumnavigate barriers to intimacy

•Resolve inter-personal issues

•Improve partner communication

Althof SA. TAU 2016; 5:475

History of Psychotherapeutic Interventions

•James Semans (1956) - Introduced stop/start technique- Based on idea ejaculation is a conditioned reflex- 100% success in patients controlling ejaculation

•Masters & Johnson (1970s)- Introduced squeeze technique- 2-week program- 98% had remission of PE- 3% failure at 5 year follow-up

•No researcher has ever been able to replicate either of these study’s results!

Althof SA. TAU 2016; 5:475

Cochrane Review (2011)

•Randomized and quasi-randomized studies evaluating psychological interventions for PE

•All patients with PE

•Varied definitions

•Any psychological intervention

•Control group defined

•Outcomes: IELT, symptom improvement, questionnaire improvement

Melnick T, Cochrane Rev, 2011

Cochrane Review (2011)

•504 references – 487 excluded

•13 of remaining 17 excluded after reading full paper

•4 studies included with 253 patients (Carufel 2006; Li 2006; Yuan 2008; Abdel-Hamid 2001)

Melnick T, Cochrane Rev, 2011

Defining Success in PE ResearchDe Carufel Li Yuan Abdel-Hamid

N 36 90 64 31

Design BT v None BT+Med v Med BT+Med v BT v Med

5 way crossover

Definition 2 mins NR - ND

PE Type ND ND ND- ND

IELT Measurement

Stopwatch Self-report ND Stopwatch

Validated Inventory

None CIPE None None

Intervention Defined

PFT ND ND Squeeze

Control Group Waitlist Med Med Crossover

Durability of Response

12w 6w - 4w

Cochrane Review: Risk of Bias

Melnick T, Cochrane Rev, 2011

Cochrane Review: Risk of Bias

Melnick T, Cochrane Rev, 2011

Abdel-Hamid Study (2001)

•31 patients received 1 of 4 drugs (clomipramine, sildenafil sertraline, paroxetine) on as needed basis (BIW) 3-5h prior to sexual relations or were instructed to use squeeze technique

•Five four week periods with 2 week washout periods

•IELT (stopwatch)

•Not included in the Cochrane Review as he data in the article were not sufficient and database was no longer available (according to authors when contacted)

Abdel-Hamid IA et al. IJIR, 2011;31:41

Systematic Review: BT vs WL (IELT)

Cooper K et al. JSM 2015;3:174

Systematic Review: BT + Drug vs Drug (IELT)

Cooper K et al. JSM 2015;3:174

Systematic Review: BT vs Drug (IELT)

Cooper K et al. JSM 2015;3:174

ICSM 2009 Recommendation

“Pharmacological agents should be encouraged as a first line intervention for PE”

Althof SA. JSM 2010

Dr. Althof Conclusion I

“The majority of psychotherapy outcome studies do not meet standard for EBM. They tend to be

uncontrolled, have small numbers and inadequate follow-up and due to definitional controversies are

surveying heterogenous populations”

Althof SA. TAU 2016; 5:475

Take Home Messages

•Psychological intervention is not a cure for PE

•Data supporting use of psychological interventions for PE as monotherapy are weak and inconsistent

•Some weak evidence suggests combination therapy (BT + medication) may be better than BT alone

•There is no clear data on the sustainability of any psychological intervention in PE treatment (as mono or combination therapy)

•Further research is necessary to answer the role of such therapy in men with PE

Psychological InterventionsApproved Therapy?

•Would the FDA approve behavioral therapy (BT) for PE?- The trials to date could not support a NDA and BT would never be approved

•Comparing BT to a surgical treatment?- BT holds that status of venous ligation surgery- No robust data demonstrating clear efficacy as monotherapy or any durability data in favor of it as a treatment and thus should hold experimental status

The Gauntlet

It is incumbent upon our mental health professionals to design and conduct

appropriate trials to define the efficacy and durability of BT in the treatment of PE (of different types). The current trial data and anecdotal reports are alone not adequate.

Dr. Althof Conclusion II

“Overall, there is weak and inconsistent evidence regarding the effectiveness of psychological

intervention for the treatment of PE.”

Melnick T, Althof SA, et al. Cochrane Reviews 2011