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RECRUITING
NCT06740071
NA

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-05-01

Completion Date

2027-04

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

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

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.

Locations (2)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong