Back to resultsA Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
the Digital Repetitive Infrapubic Pressure maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms, LUTS, Self-Administered Maneuver, Symptomatic Relief, Digital Repetitive Infrapubic Pressure maneuver
Eligibility Criteria
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.
Sites / Locations
- Kaiser Permanente
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Immediate & Delayed Instruction
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in the International Prostate Symptom Score (IPSS)
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.
Secondary Outcome Measures
Continued use of technique following intervention
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01387893
Brief Title
A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia
Official Title
Study of a Self-Administered Maneuver to Initiate and Maintain Urine Flow Impeded by Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms, LUTS, Self-Administered Maneuver, Symptomatic Relief, Digital Repetitive Infrapubic Pressure maneuver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate & Delayed Instruction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
the Digital Repetitive Infrapubic Pressure maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the International Prostate Symptom Score (IPSS)
Description
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.
Time Frame
The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months
Secondary Outcome Measure Information:
Title
Continued use of technique following intervention
Description
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.
Time Frame
Nine months after intial 4 week intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrin L French, MD
Organizational Affiliation
Kaiser Permanente Santa Clara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Santa Clara
State/Province
California
ZIP/Postal Code
95014
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia
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