The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy

The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT.

Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician.

Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Post Prostatectomy)
• Intervention / Treatment: Behavioral: somatosensory interactive pelvic floor muscle training; Procedure: pelvic floor magnetic stimulation therapy; Behavioral: standard pelvic floor muscle training

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Assistant, BSc; Phone Number: 852-22554852; Email: stac@hku.hk

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Contact: Nurse Consultant, BNurs; Phone Number: 86-021-34186000; Email: xy20848@rjh.com.cn
      • Contact: Nurse Consultant, BNurs
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Research Assistant; Phone Number: 852-22554852; Email: stac@hku.hk
    • Contact: Yung NA, BM, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)

Exclusion Criteria:

• patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard pelvic floor muscle training group	Behavioral: standard pelvic floor muscle training; traditional verbal instructions and paper-based educational materials of PFMT are given to participants. All patients would receive PFMT under the guidance of digital rectal examination by nurses, and their pelvic floor muscle function was graded according to the Oxford Grading System (grades 0-5), ensuring the correctness of subsequent PFMT.
Active Comparator: somatosensory interactive pelvic floor muscle training group	Behavioral: somatosensory interactive pelvic floor muscle training; synchronized PFMT guidance through a combination of audio and video
Experimental: standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group	Behavioral: somatosensory interactive pelvic floor muscle training; synchronized PFMT guidance through a combination of audio and video; Procedure: pelvic floor magnetic stimulation therapy; stimulation frequency was set at 10 Hz, with stimulation administered in cycles of 5 seconds on followed by 5 seconds off. Each treatment session lasted 20 minutes, conducted twice a week, for a total of 10-12 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	A higher score indicates a more severe urinary incontinence and thus a worse outcome. Reduction in score is expected for subjects with clinical improvement. Range of score: 0 - 21 Severity of urinary incontinence: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)	1, 3, and 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure	Time Frame
urine leakage volume from the 1-hour pad test	1, 3, and 6 months postoperatively

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pelvic floor muscle training; post operative urinary incontinence
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: PFMT-RARP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Arrangement not approved by national law of institute.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No