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

NCT06740071 | Recruiting

• 1 other identifier: PFMT-RARP
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer (Post Prostatectomy)

Keywords

pelvic floor muscle training; post operative urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• urine leakage volume from the 1-hour pad test

  1, 3, and 6 months postoperatively

Study Arms (3)

standard pelvic floor muscle training group

ACTIVE COMPARATOR

Behavioral: standard pelvic floor muscle training

somatosensory interactive pelvic floor muscle training group

ACTIVE COMPARATOR

Behavioral: somatosensory interactive pelvic floor muscle training

standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group

EXPERIMENTAL

Behavioral: somatosensory interactive pelvic floor muscle training; Procedure: pelvic floor magnetic stimulation therapy

Interventions

somatosensory interactive pelvic floor muscle training BEHAVIORAL

synchronized PFMT guidance through a combination of audio and video

somatosensory interactive pelvic floor muscle training group; standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group

pelvic floor magnetic stimulation therapy PROCEDURE

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

standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group

standard pelvic floor muscle training BEHAVIORAL

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.

standard pelvic floor muscle training group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Ruijin Hospital: collaborator

Study Sites (2)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Research Assistant, BSc

CONTACT

852-22554852; stac@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)