Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Nocturia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Acupuncture group will receive 10 treatments of acupuncture over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

The waitlist control group will not receive any acupuncture treatments during the 14-week waiting period. Patients in waitlist control group will have the option to receive up to 10 acupuncture treatments after a 14-week waiting period.

10 treatments of acupuncture over the course of 10 weeks

Acupuncture

Waitlist Control

Patients will complete Patient Reported Outcomes (PRO)

Questionnaires

Kevin Liou, MD

Jun Mao, MD, MSCE

Kevin Loiu, MD

Jun Mao, MSCE

The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.

An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

If a participant completes at least 8 out of 10 acupuncture sessions. Feasibility will be evaluated based on the respective definitions of success for the acupuncture.

Memorial Sloan Kettering Cancer Center

Prostatic Hyperplasia

Hyperplasia

Dysuria

This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment.

Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).

Urolift

Bilal Chughtai, MD

Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).

Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.

This is a single-arm study, involving one time administration of Urolift in outpatient setting prior to stereotactic body radiation therapy

Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)

Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.

Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.

Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year.

Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.

Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.

Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms.

The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.

Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes.

Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.

Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment

NeoTract, Inc.

Teleflex

Weill Medical College of Cornell University

Blood and Lymph Conditions

Lymphedema

Polyuria

Lymphatic Diseases

Lower Urinary Tract Symptoms

Urological Manifestations

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

patients planned for transperitoneal pelvic lymph node dissection for treatment of urogenital cancer (including prostate or bladder cancer)

The information about lymphoedema and its prevention is given during the hospital stay by the physical therapist of the department of urology. Skincare consists of daily skin moisturizer of feet and legs and prevention and care of wounds. Active exercises are performed to gain endurance and muscle strength after surgery and to stimulate the blood and lymph circulation. The exercises are supervised by the home physical therapist. Frequency of the supervised exercises is gradually decreased. If a patient develops lymphoedema, he/she receives compression stockings.

usual care

Nele Devoogdt, Prof. Dr.

Charlotte Van Calster, MSc.

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence/ prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated.

Additionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).

Lymphoedema is caused by malfunction of the lymphatic system whether or not in combination with extra load on this system. Some patients develop lymphoedema after treatment for cancer: secondary lymphoedema or acquired lymphoedema. In 2018, 11 645 patients in Belgium were diagnosed with urogenital cancer cancer, including prostate and bladder cancer. A possible treatment consists of prostatectomy or cystectomy in combination with transperitoneal pelvic lymph node dissection. Patients who undergo treatment for cancer may develop lower limb lymphoedema or lymphoedema at midline. To the researchers knowledge, investigation of incidence of lower limb lymphoedema (LLL) is limited. Also, the prognostic variables for the development of LLL are unknown. Furthermore, no scientific evidence consists regarding which (combination of) clinical measurement methods are most sensitive to detect early LLL after transperitoneal pelvic lymph node dissection. Thresholds to identify subclinical lymphoedema in one or both legs are lacking. Besides lymphoedema in the lower limbs, treatment for cancer also often results in urinary problems. Especially urinary stress incontinence has been described in literature. However, in clinical practice, it is clear that prostatectomy is often associated with other urinary complications, as nocturia and nocturnal polyuria. To the researchers knowledge, there are no trials investigating the prognostic variables for the development of nocturia/ nocturnal polyuria after transperitoneal pelvic lymph node dissection for urogenital cancer.

Therefore, the researchers will execute a trial investigating the epidemiology (i. e incidence, prevalence and prognostic variables), detection methods and the feasibility of a trial about the early treatment of LLL after transperitoneal pelvic lymph node dissection for urogenital cancer. The epidemiology of LLL, nocturia and nocturnal polyuria will be investigated.

Participants: 150 patients undergoing a transperitoneal pelvic lymph node dissection for urogenital cancer will be included. These participants will be followed-up from baseline (pre-surgery) until 1 year post-surgery. All participants are evaluated at the University Hospitals Leuven, campus Gasthuisberg.

Procedure: The potential participant will be screened first to see if the patients meets the inclusion criteria. After signing the informed consent form, the participant will be followed in the prospective observational trial. The duration of the prospective observational trial is 2 years. Participants can be included until 1 year after the start of the trial.

Evaluation: There will be clinical evaluation of lymphoedema as well as treatment for lymphoedema. Participants in the prospective observational trial will be evaluated 4 times: baseline (pre-surgery), 6 weeks, 6 and 12 months post-surgery.

Treatment: All participants in the prospective observational trial receive standard of care. This consists out of information, skincare and exercises. The information about lymphoedema and its prevention is given by the physical therapist of the department of urology during the hospital stay. Skincare consists of daily moisturizer of legs and feet and prevention and care of wounds. The exercises are supervised by the home physical therapist. The frequency of the session at the physical therapist are gradually decreased.

Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer

Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study

Calculation of the proportion of patients who developed leg lymphoedema during a certain time interval (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients who developed midline lymphoedema during a certain time interval (defined as 20% or more increase of the baseline water content at the prepubic region)

Dependent variable = presence of leg lymphoedema/ presence of midline lymphoedema Independent variable= Age (years) will be self-reported through interview.

Baseline fat mass will be measured using Bio-impedance Spectroscopy

Baseline physical activity level will be assessed with the International Physical Activity Questionnaire (IPAQ).

The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.

Educational level will be self-reported through interview.

Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.

Information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.

Number of positive lymph nodes is collected through the patient's medical file.

Information regarding the complications related to the surgery as well as adjuvant therapies is collected. Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications.

Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.

Type of lymph node dissection: Limited- Standard- Extended- Super extended

Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.

Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.

Calculation of the proportion of patients with leg lymphoedema at a certain time point (defined as 5.0% or more increase of the leg volume) and calculation of the proportion of patients with midline lymphoedema at a certain time point (defined as 20% or more increase of the baseline water content at the prepubic region): 6 weeks, 6 and 12 months post-surgery

To investigate reliability, all participants with lower limb lymphoedema at 12 months post-surgery will be evaluated three times with each evaluation method: intra and interrater reliability will be determined

To determine feasibility of each method, time efficiency will be examined for each method: setup time (time needed to prepare the measurement), execution time ( time needed for a bilaterally execution of the measurement) and total time (required for the setup and the execution of the measurement) (min, sec)

limitations regarding clinical feasibility will be listed and scored (yes/no) for each method.

As "gold standard" to compare the different measurement methods with, every patient will be evaluated individually once by the project's international expert panel, during a monthly (virtual) meeting (2 up to 3h). They will decide whether patients should be labelled as showing 'presence of early signs of lower limb lymphoedema (1)' or 'no signs (0)'. Decision making will occur with an initial assessment of the experts, i.e. in advance of the monthly meeting. Then the project manager will lead the meeting on the basis of the assessments and subsequently conduct a new 'vote'. In case \>2/3 of the experts (= clear majority) decides a patient should receive a diagnosis of lymphoedema, then this patient receives the diagnosis.

outcomes resulting from the measurement method will be compared against the yes/no score regarding clinical presence of LLL from our international expert group

Calculation of the proportion of patients with nocturia/ nocturnal polyuria at a certain time point: baseline, at 6 weeks, 6 and 12 months post-surgery

Age (years) will be self-reported through interview

late-night fluid intake will be assessed through the micturition chart that (during 24 hours, in the week prior to the assessment visit) has to be filled in by the patient before surgery and at 6 weeks, 6 months and 12 months after surgery. The patient has to write down the time, frequency and quantity of urinating during the day and night. The time of drinking a consumption, the amount of a consumption and which consumption also has to be recorded.

late-night caffeine/alcohol use (3 hours before going to bed) will be assessed through the micturition chart that (during 24 hours, in the week prior to the assessment visit) has to be filled in by the patient before surgery and at 6 weeks, 6 months and 12 months after surgery. The patient has to write down the time, frequency and quantity of urinating during the day and night. The time of drinking a consumption, the amount of a consumption and which consumption also has to be recorded.

Baseline physical activity level will be assessed with the International Physical Activity Questionnaire (IPAQ).

The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old.

information regarding the type of urogenital cancer (prostate versus bladder) and the stage of the urogenital cancer is collected (i.e. histological subtype, PSA (if PCa), pTN stage, ISUP grade group (if PA); by exploring the patient's medical file.

information regarding the lymph node stage is collected by exploring the patient's medical file.

Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications. Complications will be determined as 30-day, 90-day or late (\>90 days) complications.

Information about the type of lymph node dissection is collected by exploring the patient's medical file.

Type of lymph node dissection: Limited- Standard- Extended- Super extended

number of lymph nodes removed: by exploring the patient's medical file.

Cancer treatment characteristics , including radiotherapy are collected; by exploring the patient's medical file.

Cancer treatment characteristics are collected, including the presence of postoperative drain, are collected by exploring the patient's medical file.

The presence of leg lymphoedema (defined as 5.0% or more increase of the leg volume) and midline lymphoedema (defined as 20% or more increase of the baseline water content at the prepubic region)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues	NCT05540392	Survivorship Prostate Cancer	Acupuncture Waitlist Contro... Questionnaires	18 Years -	Memorial Sloan Kettering Cancer Center
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.	NCT05148156	Benign Prostati...	Urolift	40 Years - 99 Years	Weill Medical College of Cornell University
Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer	NCT05300308	Urogenital Canc... Lower Limb Lymp... Nocturia Nocturnal Polyu...	usual care	18 Years -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for nocturia

Every month we try and update this database with for nocturia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nocturia

Every month we try and update this database with for nocturia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nocturia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.