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

NCT ID: NCT06740071

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer (Post Prostatectomy)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard pelvic floor muscle training group

Group Type ACTIVE_COMPARATOR

standard pelvic floor muscle training

Intervention Type 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.

somatosensory interactive pelvic floor muscle training group

Group Type ACTIVE_COMPARATOR

somatosensory interactive pelvic floor muscle training

Intervention Type BEHAVIORAL

synchronized PFMT guidance through a combination of audio and video

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

Group Type EXPERIMENTAL

somatosensory interactive pelvic floor muscle training

Intervention Type BEHAVIORAL

synchronized PFMT guidance through a combination of audio and video

pelvic floor magnetic stimulation therapy

Intervention Type 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

Interventions

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somatosensory interactive pelvic floor muscle training

synchronized PFMT guidance through a combination of audio and video

Intervention Type BEHAVIORAL

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

Intervention Type PROCEDURE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Yung NA

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Site Status RECRUITING

Countries

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China Hong Kong

Central Contacts

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Research Assistant, BSc

Role: CONTACT

852-22554852

Facility Contacts

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Nurse Consultant, BNurs

Role: primary

86-021-34186000

Research Assistant

Role: primary

852-22554852

Other Identifiers

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PFMT-RARP

Identifier Type: -

Identifier Source: org_study_id

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