Eligibility, male only, with Urinary Incontinence or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to ContinencePrimary· 6 months
Time to continence was based on the time point at which participants reported no urinary incontinence on the International Consultation on Incontinence (ICI) Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). ICIQ-UI SF is one of a series of ICI questionnaires that have been meticulously developed and tested. The ICIQ-UI SF is a brief (4 items), reliable (Cronbach's alpha = 0.95), questionnaire that quantifies both symptom burden and impact of incontinence and has been validated in men and women. It was administered weekly during the 6 months after surgery. Scores range from 0-21; hig
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
NA
NA – NA
Telehealth Without Pelvic Floor Muscle Training
NA
NA – NA
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Total ScoreSecondary· 6 months, 9 months, 12 months
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition.
6 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
7.1
± 4.3
Telehealth Without Pelvic Floor Muscle Training
7.0
± 4.4
9 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
6.2
± 3.9
Telehealth Without Pelvic Floor Muscle Training
6.7
± 5.1
12 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
5.9
± 4.1
Telehealth Without Pelvic Floor Muscle Training
6.0
± 4.7
Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI)Secondary· 6 months, 9 months, 12 months
This measure, validated as a stand-alone assessment, consists of 4 questions from the full Expanded Prostate Cancer Index (EPIC), a health-related quality of life assessment tool. The EPIC was developed based on advice from an expert panel and prostate cancer survivors, expanding the 20-item University of California - Los Angeles Prostate Cancer Index. Scores range from 0-100; higher scores indicate worse condition.
6 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
63.9
± 22.1
Telehealth Without Pelvic Floor Muscle Training
63.5
± 24.1
9 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
67.7
± 21.2
Telehealth Without Pelvic Floor Muscle Training
65.1
± 26.2
12 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
70.4
± 20.4
Telehealth Without Pelvic Floor Muscle Training
68.0
± 25.3
Incontinence Impact Questionnaire - Short Form (IIQ-SF)Secondary· 6 months, 9 months, 12 months
This measure, validated in men with post-prostatectomy incontinence, measures the impact of incontinence on regular activities. It is a condition-specific quality of life measure that has been widely used in incontinence clinical trials. There are seven items. Response options are: "not at all," "slightly," "moderately," "greatly." Scores range from 0-100; higher scores indicate greater impact.
6 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
19.4
± 22.4
Telehealth Without Pelvic Floor Muscle Training
22.3
± 24.1
9 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
15.2
± 21.4
Telehealth Without Pelvic Floor Muscle Training
19.3
± 24.9
12 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
13.5
± 20.7
Telehealth Without Pelvic Floor Muscle Training
16.5
± 23.7
International Prostate Symptom Scale - Quality of Life QuestionSecondary· 6 months, 9 months, 12 months
Validated single question: "If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that?" Response options: delighted, pleased, mostly satisfied, mixed (about equally satisfied and dissatisfied), mostly dissatisfied, unhappy, terrible.
Single quality of life question: "How much does leakage of urine restrict your activities?" (not at all, some of the time, most of the time, all of the time).
6 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
57
Telehealth Without Pelvic Floor Muscle Training
48
Telehealth With Pelvic Floor Muscle Training
34
Telehealth Without Pelvic Floor Muscle Training
34
Telehealth With Pelvic Floor Muscle Training
4
Telehealth Without Pelvic Floor Muscle Training
7
Telehealth With Pelvic Floor Muscle Training
6
Telehealth Without Pelvic Floor Muscle Training
5
9 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
70
Telehealth Without Pelvic Floor Muscle Training
63
Telehealth With Pelvic Floor Muscle Training
25
Telehealth Without Pelvic Floor Muscle Training
23
Telehealth With Pelvic Floor Muscle Training
1
Telehealth Without Pelvic Floor Muscle Training
4
Telehealth With Pelvic Floor Muscle Training
5
Telehealth Without Pelvic Floor Muscle Training
4
12 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
74
Telehealth Without Pelvic Floor Muscle Training
65
Telehealth With Pelvic Floor Muscle Training
19
Telehealth Without Pelvic Floor Muscle Training
17
Telehealth With Pelvic Floor Muscle Training
4
Telehealth Without Pelvic Floor Muscle Training
7
Telehealth With Pelvic Floor Muscle Training
4
Telehealth Without Pelvic Floor Muscle Training
5
Return to WorkSecondary· 6 months, 9 months, 12 months
Single quality of life question: "Have you been able to return to work since your surgery?" (yes, no, retired or disabled)
6 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
63
Telehealth Without Pelvic Floor Muscle Training
49
Telehealth With Pelvic Floor Muscle Training
3
Telehealth Without Pelvic Floor Muscle Training
5
Telehealth With Pelvic Floor Muscle Training
1
Telehealth Without Pelvic Floor Muscle Training
2
Telehealth With Pelvic Floor Muscle Training
34
Telehealth Without Pelvic Floor Muscle Training
38
9 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
62
Telehealth Without Pelvic Floor Muscle Training
55
Telehealth With Pelvic Floor Muscle Training
3
Telehealth Without Pelvic Floor Muscle Training
2
Telehealth With Pelvic Floor Muscle Training
1
Telehealth Without Pelvic Floor Muscle Training
3
Telehealth With Pelvic Floor Muscle Training
35
Telehealth Without Pelvic Floor Muscle Training
34
12 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
66
Telehealth Without Pelvic Floor Muscle Training
52
Telehealth With Pelvic Floor Muscle Training
3
Telehealth Without Pelvic Floor Muscle Training
4
Telehealth With Pelvic Floor Muscle Training
1
Telehealth Without Pelvic Floor Muscle Training
2
Telehealth With Pelvic Floor Muscle Training
31
Telehealth Without Pelvic Floor Muscle Training
36
Resumption of Normal ActivitySecondary· 6 months, 9 months, 12 months
Single quality of life question: "Have you been able to resume your usual activities since your surgery?" (yes, no)
6 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
5
Telehealth Without Pelvic Floor Muscle Training
7
Telehealth With Pelvic Floor Muscle Training
23
Telehealth Without Pelvic Floor Muscle Training
28
Telehealth With Pelvic Floor Muscle Training
73
Telehealth Without Pelvic Floor Muscle Training
59
9 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
4
Telehealth Without Pelvic Floor Muscle Training
5
Telehealth With Pelvic Floor Muscle Training
19
Telehealth Without Pelvic Floor Muscle Training
19
Telehealth With Pelvic Floor Muscle Training
78
Telehealth Without Pelvic Floor Muscle Training
70
12 months
Group
Value
95% CI
Telehealth With Pelvic Floor Muscle Training
4
Telehealth Without Pelvic Floor Muscle Training
3
Telehealth With Pelvic Floor Muscle Training
16
Telehealth Without Pelvic Floor Muscle Training
17
Telehealth With Pelvic Floor Muscle Training
81
Telehealth Without Pelvic Floor Muscle Training
74
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine control. This study tests an evidence-based, pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07172854 — Pelvic Floor Muscle Training With Aerobic Exercise and Relaxation After Radical Prostatectomy
· NA
· not yet recruiting
NCT07075900 — Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
· NA
· recruiting
NCT07048145 — Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
· NA
· active not recruiting
NCT06627452 — Effectiveness of DNS on Incontinence Severity, Pelvic Floor Strength and QoL in Urinary Incontinence
· NA
· completed
NCT06419517 — Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor
· NA
· completed
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 9 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01960998.