The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
Location status: Recruiting
Location contact
Hongqian Guo, MD
CONTACT
Qun Lu, MD
CONTACT
Recruiting
NCT Number: NCT04972669
The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
Up to 75 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Electrical Acupuncture Stimulation
DeviceParticipants 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.
Sham acupuncture
DeviceParticipants 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.
Primary outcomes
-
Continence rate after 6 weeks of treatment
Time frame: 3 years
Secondary outcomes
-
change of urine pad quantity for 24 hours after 4 courses compared with baseline
Time frame: 3 years
-
change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline
Time frame: 3 years
-
changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline
Time frame: 3 years
-
Long-term urinary continence recovery
Time frame: 3 year
time from randomization to urinary continence
Study contacts
Contact information is provided by the study sponsor or research team.
Hongqian Guo
CONTACT
Xuefeng Qiu
CONTACT
Sponsors and collaborators
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Registry information
Important dates
- Study start
- 2021
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Jul 22, 2021
- Registry last updated
- Mar 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.