Postprostatectomy IncontinenceNCT04972669
The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
A study testing Electrical Acupuncture Stimulation in people with Postprostatectomy Incontinence, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Postprostatectomy Incontinence
- What is being tested?
- Electrical Acupuncture Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of neoadjuvant hormonal therapy
- history of transurethral resection of the prostate (TUPR)
- history of operation on pelvis
- history of incontinence before prostatectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Hongqian Guo, MD, 8613605171690, dr.ghq@nju.edu.cn
Qun Lu, MD, 8615195856020, luqun_1989@126.com
About this study
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.
- Conditions
- Postprostatectomy Incontinence
- Being tested
- Electrical Acupuncture Stimulation, sham Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Acupuncture StimulationDevice
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.
sham AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | sham electroaupuncture Receives: Device: sham Acupuncture |
| experimental group | Experimental | Electroaupuncture Receives: Device: Electrical Acupuncture Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continence rate after 6 weeks of treatment
Measured: 3 years
Secondary outcomes (4)
change of urine pad quantity for 24 hours after 4 courses compared with baseline
Measured: 3 years
change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline
Measured: 3 years
changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline
Measured: 3 years
Long-term urinary continence recovery
time from randomization to urinary continence
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Mar 2021
- Primary completion20 Dec 2024
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprostatectomy IncontinenceStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972669
- Sponsor's protocol ID
- IUNU-PC-105
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2021
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Niu J, Wang Y, Wang Y, Shi J, Liang J, Zhao X, Xu T, Guo H, Qiu X. Electroacupuncture in Patients With Early Urinary Incontinence After Radical Prostatectomy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2534491. doi: 10.1001/jamanetworkopen.2025.34491.
PubMed 41026492
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
- ClinicalTrials.gov ID
- NCT04972669
- Acronym / sponsor ID
- IUNU-PC-105
- Conditions
- Postprostatectomy Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Device: sham Acupuncturesham electroaupuncture |
| experimental group | Experimental | Device: Electrical Acupuncture StimulationElectroaupuncture |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- history of neoadjuvant hormonal therapy
- history of transurethral resection of the prostate (TUPR)
- history of operation on pelvis
- history of incontinence before prostatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Acupuncture StimulationParticipants 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. | Device | experimental group |
| sham AcupunctureParticipants 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. | Device | control group |
Primary outcome
Continence rate after 6 weeks of treatment
Time frame: 3 years
4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 41026492Niu J, Wang Y, Wang Y, Shi J, Liang J, Zhao X, Xu T, Guo H, Qiu X. Electroacupuncture in Patients With Early Urinary Incontinence After Radical Prostatectomy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2534491. doi: 10.1001/jamanetworkopen.2025.34491.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Acupuncture Stimulation in people with Postprostatectomy Incontinence, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuefeng Qiu (13776509416, hydewoods@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continence rate after 6 weeks of treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.