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

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

    • California
      • Santa Clara, California, United States, 95014
        • Kaiser Permanente

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
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.
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.

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
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.
The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continued use of technique following intervention
Time Frame: Nine months after intial 4 week 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.
Nine months after intial 4 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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