Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Urinary Incontinence

Prostatic Neoplasms

Enuresis

Urinary Incontinence, Stress

Nocturnal Enuresis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Combined group with 8 weeks of pelvic floor muscle training, knack maneuver and lifestyle recommendations.

Only 8-week PFMT (including knack maneuver)

It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).

Patients in this group were given 8-week PFMT (including knack maneuver) and lifestyle recommendations for the treatment of urinary incontinence symptoms.

First research arm

Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.

Second research arm

Third research arm

Serap Kaya, Assoc Prof

The main purpose of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program to be given in addition to the pelvic floor muscle training (PFMT) program, which has been proven to be effective in individuals with urinary incontinence symptoms after prostatectomy. This study is a prospective, controlled, randomized clinical trial. The study includes an 8-week pelvic floor muscle training, Knack maneuver and lifestyle recommendations.

In summary, it is stated in the literature that PFMT and lifestyle recommendations are beneficial in the treatment of urinary incontinence (UI). However, although there is evidence of the effectiveness of the Knack maneuver in stress UI in women, there is no evidence of the Knack maneuver in urinary incontinence after prostatectomy. On the other hand, the literature on the effect of lifestyle recommendations after prostatectomy is very limited.

Therefore, the aim of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program, which will be given in addition to the PFMT program, which has been demonstrated in individuals with UI complaints after radical prostatectomy, in a randomized controlled design.

The main purpose of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program to be given in addition to the pelvic floor muscle training (PFMT) program, which has been proven to be effective in individuals with urinary incontinence symptoms after prostatectomy. This study is a prospective, controlled, randomized clinical trial. The study includes an 8-week pelvic floor muscle training, Knack maneuver and lifestyle recommendations.

It was planned to enroll 72 individuals with urinary incontinence problems after radical prostatectomy in this randomized controlled clinical study. A physical therapist is responsible for all assessments.

Participants were included in one of three treatment groups (G1: Pelvic floor muscle training + Knack maneuver + lifestyle recommendations; G2: Pelvic floor muscle training + Knack maneuver G3: Pelvic floor muscle training).

In summary, it is stated in the literature that PFMT and lifestyle recommendations are beneficial in the treatment of urinary incontinence (UI). However, although there is evidence of the effectiveness of the Knack maneuver in stress UI in women, there is no evidence of the Knack maneuver in urinary incontinence after prostatectomy. On the other hand, the literature on the effect of lifestyle recommendations after prostatectomy is very limited.

Therefore, the aim of this study is to reveal the effectiveness of the Knack maneuver and lifestyle recommendations program, which will be given in addition to the PFMT program, which has been demonstrated in individuals with UI complaints after radical prostatectomy, in a randomized controlled design.

With this study, the effectiveness of different programs to be applied to individuals suffering from urinary incontinence after prostatectomy will be determined and compared. It will increase the level of evidence for the treatment of urinary incontinence, a common complaint after prostate cancer surgery. In this direction, it will also contribute to the development of public health.

The study will be conducted in patients suffering from urinary incontinence after prostatectomy.

Comparison of the Effectiveness of Different Conservative Treatment Protocols in Postprostatectomy Urinary Incontinence

Comparison of the Effectiveness of Different Conservative Treatment Protocols in Individuals With Symptom of Postprostatectomy Urinary Incontinence : a Randomized Controlled Trial

Compliance with lifestyle change recommendations

Compliance with smoking, alcohol, tea, caffeine, carbonated beverage, water consumption, bowel order management, exercise and physical activity recommendations will be evaluated separately.

Adherence to the home exercise program will be assessed.

Symptom severity and impact of incontinence on life

Individual's perception of symptom severity

Incontinence severity Pad Test assesses urine loss and leakage volume of the participant

Impact of incontinence on quality of life

Hacettepe University

Principal investigator

Quality of Life

Pelvic Floor Muscle Training

Lisa A Osborne, D.Phil.

Lisa A Osborne, Ph.D.

Phil Reed, D.Phil.

The research aims to assess the relationship between treatments for a range of urogynaecological problems (pelvic floor dysfunction, cancers) and patient reported values, psychological states, and quality of life. The impact of treatments on patients' health outcomes will be measured, using specific urogynaecological outcome measures (for either pelvic floor dysfunction or cancer), and patient reported measures of general health and quality of life. Patients' psychological states and values will be measured by validated self-report instruments for these areas. Researchers will obtain consent for participation from patients. Following consent, baseline measures will be taken at the patients' routine appointment about 4 weeks prior to undergoing treatment (e.g., surgery or physiotherapy for pelvic floor dysfunction, or surgery for a urogynaecology cancer). These measures will be the routinely collected physical data obtained by medical staff, and patient reported measures of their general health, psychological state, and quality of life. These questionnaires should take about 30 minutes to complete, in total. The patients will undergo treatment (physiotherapy programme or surgery), which will not be affected by this research. About four weeks post treatment, patients will receive their usual appointment, and routinely collected physical data will be obtained by medical staff, and patients will complete the measures as described above. With the patient's consent, the above evaluation will be repeated at every follow-up appointment that the patient has (i.e. after 3months, and then at yearly intervals, for 5 years). The impact of treatments on objective routine health measures taken by medical staff, and on patient reported measures of health, quality of life, personal values, and psychological functioning, will be documented at each measurement point. Additionally, relationships between psychological states/values and both objective and subjective ratings of how treatments have impacted the patients will be established.

Aims The research aims to assess the relationship between treatments for various uro-gynaecological problems (pelvic floor dysfunction, and cancer) and both: (i) objective physical outcomes, and (ii) self reported outcomes in terms of general health, and quality of life, at a number of time points post treatment (4 week, 3months, 1year, and yearly, thereafter).

In addition, the research aims to assess the relationship between psychological factors (depression, anxiety, and values) prior to treatment, and treatment outcomes (specific outcome, self reported general health, and quality of life), at time points post treatment (4 week, 3months, 1year, and yearly, thereafter), for patients with various gynaecological problems (pelvic floor dysfunction, and cancers).

Participants and Recruitment Consecutive patients referred for treatments (physiotherapy, surgery) for uro-gynaecological problems (pelvic floor dysfunction, cancer) will be asked if they would like to participate in this evaluative study. The initial approach will be made through a letter sent out with their appointment details, which will give information about the study. This will make clear that their treatment will not depend on their participation in the study. The patients also will be given the chance to discuss their participation with the specialist nurse at the time of their pre-treatment assessment, and will give their consent (by completing and signing a Consent Form) on the day of their taking part in the research study, after they have had time to think about their participation and ask any questions that they may have.

Design and Methodology Following their consent, at the initial consultation prior to treatment (about 4 weeks prior to treatment), baseline measures will be taken from the patients. These measures will be the routinely collected physical data, obtained by the medical staff, plus a series of patient-reported measures, concerned with the patients' general health (GHQ28), depression and anxiety (HADS), values (PVQII), and quality of life (EQ5D, WHOQoL-BREF, and QLQC30). These questionnaires should take about 30 minutes to complete, in total. The patients will then undergo their treatment (the type of treatment decided upon forms no part of this study). About four weeks post-treatment, the patients will receive their usual physical screening by medical staff, and will, again, complete the same forms as described above. The patients will then be asked if they would complete the same questionnaires at a series of subsequent time points (approximately after 3 months post treatment, and then yearly for five years). The changes across the objectively- and subjectively-reported health status, and in the patient-reported quality of life, and psychological functioning will be measured. Additionally, the relationship between the baseline patient-reported psychological states (depression and anxiety) and values, and the objective (physical measures), and subjectively-reported (general health and quality of life) outcomes, will be assessed.

Treatments for Urogynaecological Problems and Patient Selfreports

Relationship Between Treatments for Urogynecological Problems and Patient Reported Values, Psychological States, and Quality of Life

Hospital Anxiety and Depresion Scales, ranging from 0-21 for both scales, with 9 or more being considered as showing signs of depression or anxiety.

Euro-qual 5D measures health related quality of life on 5 dimensons (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each rated as: "no problems," "slight problems," "moderate problems," "severe problems," and "unable to"/"extreme problems"

Personal Values Questionnaire measures patient selected areas of their life which they value (e.g., health, family), giving a score between 0 and 25, with higher scores indicating a more strongly heald value.

Abertawe Bro Morgannwg University Health Board

Swansea University

Professor Phil Reed

Amino Acids

All Drugs and Chemicals

Alanine

Participants will ingest an active supplement containing beta-alanine for a period of maximum 6 months. During the whole period, participants will take part in a structured program of PMFT. After first month, the participants will undergo radical prostatectomy.

Participants will ingest a placebo supplement containing no beta-alanine for a period of maximum 6 months. During the whole period, participants will take part in a structured program of PMFT. After first month, the participants will undergo radical prostatectomy.

Participants will receive 1150mg of beta-alanine three times a day

Beta-Alanine

Participants will receive matching placebo three times a day

Placebo

Participants in both groups will undergo PFMT training program

Pelvic floor muscle training (PFMT)

Vladimir Student, MD, PhD

The purpose of this study is to evaluate the effectiveness of beta-alanine in combination with pelvic floor muscle training (PFMT) compared to PFMT plus placebo in men undergoing radical prostatectomy.

This study will assess efficacy of beta-alanine in combination with PFMT for the treatment of participants with urinary incontinence after radical prostatectomy. B-alanine is a component of L-carnosine (with L-histidine), which is needed for its synthesis. Βeta-alanine, thanks to its bioavailability) is a commonly used supplement that can improve exercise performance by increasing the amount of carnosine in striated muscle tissues. Supplementation of beta-alanine in elderly patients has resulted in an increase in physical activity, less fatigue and overall increase in L-carnosine concentration in muscles. PFMT utilization is considered a strong predictor of early return of urinary continence after radical prostatectomy (RP). We hypothesize, that combination of PFMT with beta-alanine could result in improved urinary continence after RP. The intervention will start 30 days before the surgery and will continue until primary outcome is met. Beta-alanine/placebo will be given daily. Efficacy, pharmacokinetics, biomarkers, tissue histology, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 6 months.

Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)

Continence is defined by number of pads used and measured by one hour pad test. Number of pads use will be determined according to EPIC-SF questionnaire

To assess physical activity of the participants using Physical activity level (PAL), the number of participants having recommended PAL (PAL 1.75: a weekly average PAL of ≥1.75) \< 1.4 = extremely inactive, \> 2.4 = extremely active

Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined

Incidence of adverse events in the combined beta-alanine and PFMT compared to PFMT and placebo treatment. Surgical complications will be evaluated according to Clavien-Dindo classification

During the study period, participants will be asked to fill in clinical validated EuroQuol-5dimensions-5levels (EQ-5D-5L) questionnaire 0 = the worst to 100 = the best QoL outcome

Integrity and architecture of muscle tissue will be assessed in 4 µm thick sections of formalin-fixed, paraffin-embedded, hematoxylin-eosin stained tissue samples.

Palacky University

University Hospital Olomouc

Director of the study

Analgesics

Psychotropic Drugs

Vasoconstrictor Agents

Cardiotonic Agents

Duloxetine Hydrochloride

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Neurotransmitter Agents

Antidepressive Agents

Dopamine

Dopamine Agents

Duloxetine 60mg for 3 months PMFT weekly for 3 months

Duloxetine

Rafael Sanchez-Salas, MD

Objectives:

Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.

Secondary:

* Comparison of time to achieve continence between the four arms.
* Comparison of urinary symptoms and quality of life improvement between the four arms.
* Assessment of adverse events in Duloxetine arms.

Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".

Secondary outcome:

* time to achieve continence
* Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH).
* Urinary symptoms measured with International Prostate Symptom Score (IPSS).

No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.

Statistical methods

* Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.
* Comparison of quality of life outcomes between the four arms
* Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).

Prospective RCT on Post Prostatectomy Urine Leak

A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy

Proportion of patient achieving continence at 6 months

Quality of life tested in relation to incontinence using questionnaire at 6 months

Institut Mutualiste Montsouris

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

PFMT educational intervention including a 120 min workshop and 8 weeks of self training

an educational intervention to learn about the pelvic floor and how to train it

PFMT educational intervention

Mireia Pelaez, PhD

Mireia Pelaez

A PFMT educational intervention was designed for women with metastasic breast cancer. It consisted in a 120 min workshop and 8 weeks of non-supervised (but with follow-up) self-training. ICIQ, IQOL and ad hoc questions were performed before the workshop and after the 8 weeks training to see the prevalence of UI, the impact in their quality of life and the empowerment of self-training.

Urinary incontinence (UI) affects women of all ages and has a great impact on the quality of life. Cancer treatments such as chemotherapy or hormone therapy may play an important rol in the development and worsening of pelvic floor disorders. Little evidence on the prevalence and impact of UI in metastassis breast cancer women is known.

A protocol was designed to analyze the effect of a PFMT educational intervention on the UI and the impact on the QoL, as well as in the empowerment feeling of the participants. Feasibility of the protocol will be analized to design an optimal RCT for testing our hypothesis

During the usual visits, oncologist wil recruit women with advanced breast cancer who meet the inclusion criteria for the participation.

PFMT Educational Intervention for Patients With Advancer Breast Cancer

Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer

Number of patients enrolled divided by number of patients eligible

Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log

Information about number of participants who dropped out, and reason for drop-out

Adherence will be difined as the percentage of completed weeks of training out of 8 weeks. A week will be considerered valid when the train was performed at least in 2 different days.

A satisfaction 9 item questionnaire was design (Scale 1-5) to obtain information about the satisfaction with the (1) duration, (2) the content, (3) explanations, (4) atmosphere (5)number of participants during the workshop and (6) the importance for other patients to access this information, (7) increase in knowledge, (8) knowledge to train alone and (9) overall satisfaction.

By the ICIQ-UI Short Form, which is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. It has 4 items, and the scoring scale is 0-21.

The I-QOL measures the effect of urinary incontinence on quality of life.It is divided into 3 subscales: Avoidance and limiting behavior, Psychosocial impact, and Social embarrassment (SE). Subjects use a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all)

A 11 item questionnaire was designed to analyse the population's initial knowledge of pelvic floor health and compare it with the knowledge maintained after the intervention. 5-point scale (0-4).

Onkologikoa

Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1 month before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.

Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 3 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.

Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 2-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website

Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.

Perioperative Care and Wetness Management

Kathryn L Burgio, PhD MA BA

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.

Many men develop urine leakage after radical prostatectomy. Usually it is temporary, but pelvic floor muscle training including bladder control strategies has been shown to reduce the severity of incontinence and reduce the time to regaining continence. This study will test 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.

This study is a randomized, controlled trial of the telehealth-delivered, evidence-based, intervention developed in the pilot/developmental study. Participants will be randomized 1:1 to treatment or to a control group. 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.

Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

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; higher scores indicate worse condition.

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form total score. Scores range from 0-21; higher scores indicate worse condition.

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.

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.

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.

Patient's rating of satisfaction (Completely satisfied, Somewhat satisfied, Not at all satisfied)

Participant self-report of perceived percent improvement from 0% to 100%

Participant's global perception of their improvement (Much better, Better, About the same, Worse, Much worse)

Single quality of life question: "How disturbing is the urine leakage problem to you?" (not at all, somewhat, or extremely disturbing)

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).

Single quality of life question: "Have you been able to return to work since your surgery?" (yes, no, retired or disabled)

Single quality of life question: "Have you been able to resume your usual activities since your surgery?" (yes, no)

Emory University

University of Pennsylvania

University of Alabama at Birmingham

VA Office of Research and Development

Participants in this group will participate in an evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content will also include general perioperative care; wetness, odor and skin care management; and outcome measures.

Pelvic Floor Muscle Training: Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website

Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.

Telehealth With Pelvic Floor Muscle Training

Participants in this group will receive a telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.

Perioperative Care and Wetness Management: Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.

Telehealth Without Pelvic Floor Muscle Training

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Body mass index is a weight-to-height ratio used as an indicator of obesity and underweight. It is calculated by dividing an individual's weight in kilograms by the square of their height in meters.

Body mass index

< High school

HS or GED

College or beyond

Education

Employment

Living situation

Smoking status

Degenerative disc disease

Asthma, COPD

Heart failure

Diabetes

Neurological disease

Stroke or TIA

Depression

Anxiety

Prostate specific antigen (PSA), ng/mL

The Gleason score is used to describe prostate cancer cells based on pathologist examination of a biopsy sample. The cells are graded on a scale of 1 to 5, with Grade 1 cells resembling normal prostate tissue. Gleason scores usually range from 6 to 10. A Gleason score of 6 is low grade, 7 is intermediate grade, and 8 to 10 is high grade cancer.

Gleason score

Surgical approach

Surgical technique

The neurovascular bundles lie postero-laterally to the prostate and are typically spared during prostatectomy to preserve sexual function. A "nerve-sparing" procedure involves dissecting the nerve bundle off the side of the prostate.

Neurovascular bundle sparing

245 participants were enrolled in the trial, but only 197 received the assigned intervention. 9 did not have the planned prostatectomy; 39 never started the assigned intervention.

Kathryn L. Burgio, PhD

Data were not collected beyond the 12-month follow up, at which point fewer than 50% of participants in both groups had achieved continence. Thus, their time to continence could not be determined and the medians could not be calculated.

Participants in this group participated in an evidence-based pelvic floor muscle training program that was adapted to telehealth format. Training was begun 1-4 weeks before surgery and continued 2 months after surgery. Content was accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively. In addition to the pelvic floor muscle training, content also included general perioperative care; wetness, odor and skin care management; and outcome measures.

Participants in this group received a telehealth program that included general perioperative care; wetness, odor and skin care management; and outcome measures. The program was begun 1-4 weeks before surgery and continued 2 months after surgery. Content was accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.

Time to Continence

Mean values for the telehealth and no telehealth groups on the ICIQ-SF are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean ICIQ-SF score in the no telehealth group at 6 months was 7.0 (standard deviation 4.4) and in the telehealth group was 7.1 (SD 4.3). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline ICIQ-SF score, and p values were combined using the Rubin-Licht method.

Two individuals were missing all outcome measures; data for these two participants were not imputed and were not included in the analysis, resulting in 94 individuals analyzed in the Telehealth without Pelvic Floor Muscle Training group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of the Effectiveness of Different Conservative Treatment Protocols in Postprostatectomy Urinary Incontinence	NCT04804839	Urinary Inconti... Prostate Cancer Urinary Inconti... Urinary Inconti...	First research ... Second research... Third research ...	18 Years -	Hacettepe University
Treatments for Urogynaecological Problems and Patient Selfreports	NCT02549157	Urogynaecologic...	Pelvic Floor Mu...	18 Years -	Swansea University
Treatments for Urogynaecological Problems and Patient Selfreports	NCT02549157	Urogynaecologic...	Pelvic Floor Mu...	18 Years -	Swansea University
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)	NCT04862533	Prostate Cancer Urinary Inconti... Beta-Alanine Pelvic Floor Mu... Radical Prostat...	Beta-Alanine Placebo Pelvic floor mu...	40 Years - 80 Years	University Hospital Olomouc
Prospective RCT on Post Prostatectomy Urine Leak	NCT02367404	Prostate Cancer Urinary Inconti...	Duloxetine Pelvic Floor Mu...	-	Institut Mutualiste Montsouris
PFMT Educational Intervention for Patients With Advancer Breast Cancer	NCT04953377	Advanced Breast...	PFMT educationa...	18 Years -	Onkologikoa
Prospective RCT on Post Prostatectomy Urine Leak	NCT02367404	Prostate Cancer Urinary Inconti...	Duloxetine Pelvic Floor Mu...	-	Institut Mutualiste Montsouris
Perioperative Post-Prostatectomy Incontinence Home Telehealth Program	NCT01960998	Urinary Inconti... Prostate Cancer	Pelvic Floor Mu... Perioperative C...	-	VA Office of Research and Development
Prospective RCT on Post Prostatectomy Urine Leak	NCT02367404	Prostate Cancer Urinary Inconti...	Duloxetine Pelvic Floor Mu...	-	Institut Mutualiste Montsouris
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)	NCT04862533	Prostate Cancer Urinary Inconti... Beta-Alanine Pelvic Floor Mu... Radical Prostat...	Beta-Alanine Placebo Pelvic floor mu...	40 Years - 80 Years	University Hospital Olomouc

Spots Global Cancer Trial Database for pelvic floor muscle training