Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard pelvic floor muscle training group | Active Comparator |
| |
| somatosensory interactive pelvic floor muscle training group | Active Comparator |
| |
| standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatosensory interactive pelvic floor muscle training | Behavioral | synchronized PFMT guidance through a combination of audio and video |
|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| urine leakage volume from the 1-hour pad test | 1, 3, and 6 months postoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Assistant, BSc | Contact | 852-22554852 | stac@hku.hk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
Arrangement not approved by national law of institute.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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. |
|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong | Hong Kong |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided