premature ejaculation
Conditions
Interventions
Group 1:Pudendal nerve stimulation with SNM system.
Group 2:sacral nerve stimulation with SNM system.
Group 3:Standard Medical therapy with Dapoxetine.
Sponsors
TONGJI Hospital, TONGJI medical college of HuaZhong University of Science & Technology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Stable monogamous relationship for =2 years; 2) Met the DSM-IV-TR criteria for PE, indicated a PEDT score = 11, and reported an IELT of = 2 min in 75% of evaluable events during screening/baseline period; 3) Couple relationship was seriously influenced; 4) Non- surgical treatments are less efficacy; 5) Able to complete study documentation and return for follow-up evaluation; 6) The subjects participating the clinical trial are voluntary and are able to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) History of medical or psychiatric illness, such as spinal cord injury; Patients or partner has other forms of sexual dysfunction; 2) Known hypersensitivity to Dapoxetine; 3) Received other PE treatments 3 months before screening; 4) Bleeding complications or coagulation disorders; 5) History of malignant tumor; 6) Patients with mental or cognitive impairment, and unable to cooperate with surgery; 7) Implant site requiring diathermy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravaginal Ejaculatory Latency Time, IELT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Premature ejaculation diagnosis tool, PEDT;Patient Global Impression of Change,PGIC;voiding diary; | — |
Countries
China
Contacts
Public ContactJihong Liu
TONGJI Hospital, TONGJI medical college of HuaZhong University of Science & technology
Outcome results
None listed