PTNS for the treatment of Premature Ejaculation- A Feasibility Study
Research type
Research Study
Full title
Percutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation- A Feasibility Study
IRAS ID
215617
Contact name
Frank Chinegwundoh
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
011587, internal reference number ( ReDA Ref)
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
In this study we will be investigating if Percutaneous Tibial Nerve Stimulation (PTNS) is an effective treatment for Premature Ejaculation. Although PTNS has not been used to treat premature ejaculation in men before, it is a safe and widely used technique in the NHS and globally to treat other problems that can be influenced by nerves of the sacral the plexus such as faecal and urinary incontinence. Ejaculation is also influenced by the sacral plexus.
A study by vanBalken et al. (2006), reported incidental improvement in sexual function following PTNS (for management of overactive bladder; OAB), particularly in female participants - this gave rise to the idea for undertaking the current feasibility-study.
Our treatment protocol is based on the recommendations by NICE guidelines, the manufacturers and as used by other centres throughout the NHS for the management of faecal incontinence (FI) and urinary incontinence (including overactive bladder; OAB) (Boyle et al., 2010; Allison, 2011).
Patients presenting to the premature ejaculation clinic (from GPs referrals and general urology clinics) will be identified and then referred by the clinical team. The research team will seek written informed consent for participation in the study.
We will use the Urgent® PC neuromodulation system (Uroplasty Ltd., Manchester, UK) to provide tibial nerve stimulation. The patient will be asked to sit with their foot elevated as the stimulation is delivered to their tibial nerve. Each session will last around 30 minutes. Patients will undergo one session per week for 12 weeks. Patients will be asked to fill out validated questionnaires before treatment and then weekly for 12 weeks.
If PTNS proves to be successful in the treatment of premature ejaculation then we plan to carry out further Randomised Control Trials to compare it with Dapoxitine and/or behavioural therapy. Separate ethics approval will be sought for any future randomised controlled trials.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/0277
Date of REC Opinion
3 Mar 2017
REC opinion
Favourable Opinion