A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01387893
First received: June 29, 2011
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Benign Prostatic Hyperplasia
Behavioral: the Digital Repetitive Infrapubic Pressure maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of a Self-Administered Maneuver to Initiate and Maintain Urine Flow Impeded by Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Nine months after intial 4 week intervention ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: May 2008
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: the Digital Repetitive Infrapubic Pressure maneuver
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men over 45 years of age
  • 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:

  • under 45 years old
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387893

Locations
United States, California
Kaiser Permanente
Santa Clara, California, United States, 95014
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Perrin L French, MD Kaiser Permanente Santa Clara
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01387893     History of Changes
Other Study ID Numbers: CN-07PFren-01-H, 02-0115-9922
Study First Received: June 29, 2011
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Benign Prostatic Hyperplasia
BPH
Lower Urinary Tract Symptoms
LUTS
Self-Administered Maneuver
Symptomatic Relief
Digital Repetitive Infrapubic Pressure maneuver

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014