Postprostatectomy Incontinence
Conditions
Brief summary
More than 50% patients underwent prostatectomy suffered from postoperative incontinence, and the effect of pelvic floor muscle training is very limited. Electrical acupuncture stimulation therapy has been demonstrated to work on other kinds of Urinary Incontinence. Before this trial, the researchers have conducted pre-experiments where electrical acupuncture stimulation therapy was conducted for few postprostatectomy Incontinence patients. On the basis of the preliminary work, this prospective, random control research aims to verify the safety and effectiveness of electroacupuncture in the treatment of postprostatectomy Incontinence.
Interventions
Participants received acupuncture at bilateral Baliao. After skin disinfection, sterile adhesive pads were placed on bilateral Baliao, and acupuncture needles were inserted through the adhesive pads. Following needle insertion, small, equal manipulations of twirling, lifting, and thrusting were performed on all needles to reach de qi. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.
DEVICEsham Acupuncture
Participants received sham acupuncture at locations one inch besides bilateral Baliao without needle insertion. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* localized prostate cancer (stage: cT1-cT2, N0, M0) * 4-6weeks after prostatectomy * postprostatectomy prostate specific antigen (PSA) test below cured level * incontinence one month after surgery * ECOG score:0-1
Exclusion criteria
* history of neoadjuvant hormonal therapy * history of transurethral resection of the prostate (TUPR) * history of operation on pelvis * history of incontinence before prostatectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continence rate after 6 weeks of treatment | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of urine pad quantity for 24 hours after 4 courses compared with baseline | 3 years | — |
| change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline | 3 years | — |
| changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline | 3 years | — |
| Long-term urinary continence recovery | 3 year | time from randomization to urinary continence |
Countries
China
Contacts
Primary ContactXuefeng Qiu
Backup ContactHongqian Guo
Outcome results
None listed