NCT04972669

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

March 17, 2025

Status Verified

November 1, 2024

Enrollment Period

3.8 years

First QC Date

July 9, 2021

Last Update Submit

March 13, 2025

Conditions

Postprostatectomy Incontinence

Outcome Measures

Primary Outcomes (1)

  • Continence rate after 6 weeks of treatment

    3 years

Secondary Outcomes (4)

  • 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

Study Arms (2)

control group

SHAM COMPARATOR

sham electroaupuncture

Device: sham Acupuncture

experimental group

EXPERIMENTAL

Electroaupuncture

Device: Electrical Acupuncture Stimulation

Interventions

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.

experimental group
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.

control group

Eligibility Criteria

AgeUp to 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • localized prostate cancer (stage: cT1-cT2, N0, M0)
  • weeks after prostatectomy
  • postprostatectomy prostate specific antigen (PSA) test below cured level
  • incontinence one month after surgery
  • ECOG score:0-1

You may not qualify if:

  • history of neoadjuvant hormonal therapy
  • history of transurethral resection of the prostate (TUPR)
  • history of operation on pelvis
  • history of incontinence before prostatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41026492DERIVED

Central Study Contacts

Xuefeng Qiu

CONTACT

13776509416hydewoods@163.com

Hongqian Guo

CONTACT

13605171690dr.ghq@nju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 22, 2021

Study Start

March 1, 2021

Primary Completion

December 20, 2024

Study Completion

March 20, 2025

Last Updated

March 17, 2025

Record last verified: 2024-11

Locations

CN(1)