An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Study Overview
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Brief Summary
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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.

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

Conditions
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Survivorship, Prostate Cancer

Intervention / Treatment
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* Procedure: Acupuncture
* Other: Waitlist Control
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Prior PC diagnosis No evidence of Prostate Cancer Clinically meaningful nocturia, defined as ≥2 nocturia episodes every night for the past month Exclusion Criteria: <1 month since completion of PC treatment (surgery, chemotherapy, radiation, ADT) Score of ≥5 on the STOP-Bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea Other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome) Untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia) Initiation of new medications for urinary symptoms in the past 4 weeks Altered dosing of medications for urinary symptoms in the past 4 weeks Plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study Implanted electronically charged medical device Unable to provide consent for himself Unwilling to adhere to all study-related procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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. | Procedure: Acupuncture<br>* 10 treatments of acupuncture over the course of 10 weeks<br>Other: Questionnaires<br>* Patients will complete Patient Reported Outcomes (PRO)<br>|
| Experimental: Waitlist Control<br>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. | Other: Waitlist Control<br>* 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.<br>Other: Questionnaires<br>* Patients will complete Patient Reported Outcomes (PRO)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Urinary issue, Nocturia, 22-270