- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387893
A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia
October 1, 2015 updated by: Kaiser Permanente
Study of a Self-Administered Maneuver to Initiate and Maintain Urine Flow Impeded by Benign Prostatic Hyperplasia
The objective of this study was to evaluate the effectiveness of the Digital Repetitive Infrapubic Pressure maneuver, a self-administered procedure used to provide symptomatic relief in initiating and maintaining urine flow impeded by benign prostatic hyperplasia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eligible patients were alternately assigned to either immediate instruction on the use of the Digital Repetitive Infrapubic Pressure maneuver (immediate intervention group) or to a return appointment to receive instructions in the maneuver four weeks after the initial assessment date (delayed intervention group).
Patients were to utilize the procedure on every occasion they had difficulty initiating, maintaining, or completing urine flow between the time of their instruction and their subsequent visit.
At the initial assessment visits and the final visit, the patients completed an International Prostate Score Sheet (IPSS).
A telephone survey was conducted with all patients an average of nine months following their instruction in the maneuver, to determine the extent to which they were still using it.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Clara, California, United States, 95014
- Kaiser Permanente
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- mild to moderate symptoms of difficulty initiating and maintaining the flow of urine
- not currently receiving treatment for the condition
- not taking an alpha-blocker at least one month before randomization
- not taking 5-alpha reductase inhibitor six months or more before randomization.
Exclusion Criteria:
- non-ambulatory
- taking medications known to affect urination,
- any of the following: a debilitating concomitant illness, a history of prostate or bladder cancer or prostate surgery or radiation treatment to the pelvis, urethral stricture, neurogenic bladder, current urinary tract infection or otherwise potentially compromised urinary tract systems, a creatinine level of over 3.0 mg per deciliter, or a residual urinary volume after voiding of over 350 cubic centimeters.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Immediate & Delayed Instruction
Male patients with mild to moderate lower urinary tract symptoms will alternately be assigned to either immediate intervention or delayed intervention groups.
Statistical assessments will be performed to establish comparability of baseline characteristics in the two groups.
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The Digital Repetitive Infrapubic Pressure maneuver is performed by exerting moderate inwards pressure with the index and middle fingers, spread slightly apart, palm-side up, pushing into the fold of skin at the base of the penis, where it comes forward beneath the pubic bones, one fingertip on each side of the penis' suspensory ligament.
By repeatedly pushing inwards and slightly upwards, at a rate of about once per second, to a distance of about two centimeters, at times of significant urinary hesitancy it is often possible either to initiate spontaneous flow, or to pass a small quantity of urine with each push, such that after a minute or two one can empty the bladder to a satisfactory degree.
While a few men find it useful when voiding in a standing position, for the majority, the maneuver requires a forward-leaning seated posture for optimal results.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the International Prostate Symptom Score (IPSS)
Time Frame: The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months
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The primary efficacy analyses compared the change over time in the IPSS scores between the immediate and the delayed intervention groups, and the changes over time between pre- and post-intervention scores for all patients completing the study.
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The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continued use of technique following intervention
Time Frame: Nine months after intial 4 week intervention
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Secondary efficacy analysis: The number of patients (percentage of patients completing the study) who were still employing the technique on follow-up nine months later.
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Nine months after intial 4 week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Perrin L French, MD, Kaiser Permanente Santa Clara
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 29, 2011
First Submitted That Met QC Criteria
July 1, 2011
First Posted (Estimate)
July 6, 2011
Study Record Updates
Last Update Posted (Estimate)
October 2, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN-07PFren-01-H
- 02-0115-9922 (Other Grant/Funding Number: KPNC Community Benefit Research Fund Grant #02-0115-9922)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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